examining new methods yields new discoveries

examining new methods yields new discoveries
examining
new methods
yields
new discoveries
Table of Contents
Why Do Our Customers Value ILC Dover?
5
Validated Containment THAT WORKS
6
Why DoverPac Containment System? 7
®
ArmorFlex Family of Compliant Static Dissipative Films 8
ArmorFlex® 104 Film
9
®
ArmorFlex 113 Film
11
ArmorFlex 114 Film 13
DoverPac®
15
DoverPac - Contained Powder Discharge 17
DoverPac® - Contained Powder Charging 19
Coaxial DoverPac - Nanogram Powder Transfer 25
®
®
®
®
G2Pac -
<100µg/m3
Containment Powder Transfer
27
DoverPac® Continuous Liner 23” Diameter - Contained Powder Discharge to Drums
28
DoverPac® Continuous Liner 14” Diameter - Contained Powder Discharge to Drums
32
Continuous Liner Bag In Bag Out - Contained Transfer
36
Antistatic Drum Liners
38
Contained Processes - Flexible Enclosures / Glovebags
39
DoverPac® Document Transfer Enclosure 43
Drum Transfer System - Contained Drum Dispensing
45
Mill Containment System 49
Drum Sampling Enclosure System 51
Drum Sampling Enclosure FAQ’s
53
DoverPac SF
®
55
DoverPac® SF (BioPharmaceutical) - From Lab Scale Through Production Processes 57
Tray Dryer Enclosure Technology
59
Mill Containment System - Bohle BTS 100 61
Table of Contents continued >
3
Table of Contents
Tablet Coater Containment System - O’Hara LCM Tablet Coater
63
Contained Offloading of Aurora Filters - Processing from Nutsche Filters 65
Mill Containment System - Jet Mills 69
Granulator Containment Technology 71
Process Area Barrier Curtains 75
Contained Blending - Transfer Sleeve, DoverPac®, Continuous Liner Technology 77
Contained Blending - Flexible Enclosure Technology 81
DoverPac SF Powder Transfer Systems
87
Sentinel Clear™
88
®
Sentinel Clear™ Hood FAQ’s
90
Weigh & Dispense
92
CrimpLoc™
94
ArmorFlex Family 96
Pharma Tek CMO Case Study for Retrofit Containment Technology 98
®
EZ BioPac™
100
FlexiVac™ 101
Ventilated Enclosure System
103
Why Do Our Customers Value ILC Dover?
We keep the cost of making drugs
down
We make the medicine people
take safer by protecting the drug
product from contamination
Lower cost of ownership with
disposibles vs. capital
No cross contamination eliminates
need for dedicated facilities
We keep the people who make
medicine safe
Life critical softgoods that are the
key to the system
ILC’s products do what they claim
and we are there to support our
process after the installation
5
ArmorFlex
Validated ®Containment
110 Film
THAT WORKS
Containment
Systems
DoverPac®
Our flagship product that offers
the capability to offload and
charge potent compounds
Continuous Liners
Multiple size continuous liner
packs designed to support
contained drum loading
DoverPac®SF
Charging system designed to
interface with split butterfly
valves or sanitary flanges
Flexible Enclosures
Standard and custom enclosures designed to provide
containment for a range of
process equipment
One of our major customers says it best,
”You guys provide the only
containment that works!”
As the pioneer of flexible containment systems, ILC
Dover has collaborated with our customers in the pharmaceutical industry to develop a range of validated API
containment solutions that interface with a wide variety
of process equipment. All of our products are designed
to be safe, effective and user friendly. The same knowledge of flexible film and fabric systems and attention
to detail that allows us to be NASA’s sole supplier of
spacesuits, uniquely qualifies us to design and produce
unparalleled containment systems.
Some of the key benefits offered by using
flexible containment:
Ability to rapidly upgrade existing equipment
to handle potent compounds
Reduced capital costs
Increased throughput when compared
to other systems
Improved ergonomics
Drum Transfer System
For offloading drummed
materials in a safe and efficient
manner at fixed and varying
heights
Faster project start-up
cGMP through nanogram processing
Mill Containment System
Critical safety and cross contamination avoidance during particle
size reduction operations
Providing Flexible Containment Solutions
to the Pharmaceutical Industry since 1997
6
Why DoverPac® Containment System?
Containment
Systems
Multiple O-Ring Technology
Our patented system of progressively advancing to a new clean zone
on a canister allows multiple powder transfers without breaking
containment.
Contained Separation
Crimps: The use of DoverPacs® and Continuous Liners is enhanced
by this ILC innovation. Our crimps permit reliable, repeatable oneperson contained separation of sample sleeves and charging
and discharging necks.
Flexible Enclosures
We know that existing pharmaceutical plants are sometimes cramped
and many times not originally designed to support the processing
of potent compounds. Our custom flexible enclosures permit safe,
contained operation with a wide range of processing equipment.
Engineering, Systems, Service Capability
Custom engineered hardware interfaces with your specific processing
equipment. On-site surveys to engineer your application offered.
Product performance testing and customer training at ILC’s containment processing suite or on site provided. Personal and proactive
customer service representatives available. Seasoned professional
engineering team supports standard and custom containment
solutions. We are the first to validate flexible containment.
Manufacturing
Each DoverPac® is manufactured in a clean working environment
using custom sealing equipment designed and manufactured by ILC.
This approach allows us to control the manufaturing quality of the
product and to add design features that improve the overall reliabilty of
the product. One such example is the fact that all DoverPacs® employ
strong overlap seams even in 3-dimensional intersection areas (e.g.,
where the fill neck enters the main body of the liner). It’s this attention
to design and manufacturing detail that makes DoverPac® the first and
only choice for containment.
7
ArmorFlex® Family of Compliant Static Dissipative Films
Containment
Systems
One of the key elements of our DoverPac® line of products is the ArmorFlex®
material. These films are custom formulated by ILC to deliver superior
elongation performance (nearly 500%) for ruggedness and high strength.
This feature coupled with a unique blend of safe and effective anti-static
additives allows all of the DoverPac® products to deliver reliable
high-level containment.
From the original ArmorFlex®104 to the most recent film,
ArmorFlex®114, we pioneer the advancement of flexible materials.
This is evidenced by the introduction of ArmorFlex®114, the
first permanent, non-blooming static dissipative film to meet
the 2002/72/EC (and amendments) Directive and EP 3.1.3.
8
ArmorFlex® 104 Film
Containment
Systems
ArmorFlex® 104
Film
Passes incendivity testing
Designed and manufactured using
only FDA compliant materials
Verfied quality and reliability
No animal-derived components
Complies with USP Class VI
No halogenated compounds
and safe for incineration
ArmorFlex® 104 was developed in 1997 and has
been in use by pharmaceutical manufacturers
globally ever since. Proven in myriad applications, ArmorFlex® 104 supports processes
from wetcake to dry powder storage and
transfer.
9
ArmorFlex®®104
ArmorFlex
104Film
Film
Solvent Contact Resistance
Containment
Systems
Chemical
Resistance
Acetone
Very Good
Acetonitrile
Excellent
Anisole
Very Good
Physical Property Data
Butyl Acetate
Excellent
Property
Test Method
Results
Cyclohexane
Very Good
Cyclohexane –
Ethyl Acetate (50/50)
Puncture Resistance
Fed Std 191-5120
11 lbf
Very Good
Tear Strength
ASTM D 624-91 Die C
470 ppi (min)
Dichloromethane
Fair
Diethylether
Very Good
Tensile Strength
ASTM D 412-97
5500 psi (min)
Elongation
ASTM D 412-97
490% (min)
Results
Dimethylacetamide
Very Good
Ethanol
Excellent
Ethyl Acetate
Excellent
European Norm Data
HCL (37.4%)
Very Good
EN Number
Test
Heptane
Excellent
HMDS
Fair
EN 388: 1994
Protection against
mechanical risks
EN 420: 1994,
Paragraph 4.4.42
Determination of
pH value
KOH (50%)
Excellent
Methanol
Very Good
2-Methoxyethanol
Excellent
n-Methylpiperazine
Excellent
n-Methypyrrolidone
Excellent
Mineral Oil
Very Good
NaOH (50%)
Excellent
Reagent (3A) Alcohol
Very Good
Tetrahydrofuran
Very Good
Toluene
Fair
Criteria
% Change in
Physical Properties Resistance
10
0 - 10
Excellent
10 - 20
Very Good
20 - 30
Good
> 30
Fair
CFR Conformance
21 CFR 177.1520
21 CFR 178.3130
21 CFR 182.90
Pass
USP Conformance
Conforms to USP 24 <661> for
buffering capacity, heavy metals,
non-volatile residues, residue on
ignition, thermal analysis, and IR
(ID identity). Passes USP Class VI
(7 day implant) testing.
ArmorFlex® 113 Film
Containment
Systems
ArmorFlex® 113
Film
Superior visual clarity, ideal
for Flexible Enclosures and
Flexible Isolators
Polyethylene base film provides
excellent solvent resistance
Permanent antistat provides
better than 1 x 1011 Ohms per
square surface resistivity
5 year shelf life
No animal derived components
At ILC Dover we “create what’s next” by listening
to our customers. In response to operators’
No incineration off-gassing
concerns
input we’ve developed a new addition to the
ArmorFlex® family of films – AF 113. The
clarity of the product makes this the clear
film of choice for flexible enclosures and
flexible isolators.
www.doverpac.com [email protected]
Ph 302.335.3911 x506 or 800.631.9567
ONE MOONWALKER RD, FREDERICA, DELAWARE USA 19946-2080
11
ArmorFlex®®113
ArmorFlex
113Film
Film
ArmorFlex® 113 Solvent Resistance
Solvent Contact Recommendations
Chemical
Resistance
Acetone
Excellent
Acetonitrile
Excellent
Anisole
Good
Butyl Acetate
Very Good
Cyclohexane
Fair
Cyclohexane –
Ethyl Acetate (50/50)
Good
Dichloromethane
Very Good
Diethylether
Excellent
Dimethylacetamide
Excellent
Dimethylformamide
Excellent
Ethanol
Excellent
Ethyl Acetate
Very Good
HCL (37.4%)
Excellent
n-Heptane
Good
HMDS
Excellent
Isopropanol
Excellent
KOH (50%)
Excellent
Methanol
Excellent
2-Methoxyethanol
Excellent
n-Methylpiperazine
Very Good
n-Methypyrrolidone
Excellent
Mineral Oil
Very Good
NaOH (50%)
Excellent
Reagent (3A) Alcohol
Excellent
Tetrahydrofuran
Excellent
Toluene
Very Good
Water, Distilled
Containment
Systems
Mill impeller and screen change out
The superior visibility provided by AF113
lets you see inside the enclosure as if
looking through glass.
Excellent
Criteria
% Change in
Physical Properties Resistance
0 - 10
Excellent
10 - 20
Very Good
20 - 30
Good
> 30
Fair
Processing drums
Providing Flexible Containment Solutions to the
Pharmaceutical Industry since 1997
12
ArmorFlex® 114 Film
Containment
Systems
ArmorFlex® 114
Film
Complies with FDA 21 CFR
Fully compliant to 2002/72/EC
and amendments
Meets test parameters of EP 3.1.3
Passes USP <661>
Physicochemical Tests for Plastics
Passes USP <88> Class VI
(7 day implant)
At ILC Dover we are always “creating what’s next”
by listening carefully to our customers.
In response to customer input and emerging
regulations, we’ve developed a robust new
film to support our DoverPac® Containment
Systems. This revolutionary film,
Passes <87> biological reactivity,
in vitro
No animal derived components
5-year shelf life
Permanent antistat replaces
migrating additives
ArmorFlex® 114, delivers permanent
Passes Chilworth incendivity tests
static dissipative properties while
Tested for solvent resistance
meeting FDA and 2002/72/EC
requirements for food contact
DMF filed with FDA
and EP 3.1.3 test conditions.
13
ArmorFlex
114Film
Film
ArmorFlex®®114
ArmorFlex® 114 Solvent Resistance
Solvent Contact Recommendations
Chemical
Resistance
Acetone
Excellent
Acetonitrile
Excellent
Anisole
Good
Butyl Acetate
Good
Cyclohexane
Excellent
Cyclohexane –
Ethyl Acetate (50/50)
Excellent
Dichloromethane
Excellent
Diethylether
Excellent
Dimethylacetamide
Excellent
Dimethylformamide
Excellent
Ethanol
Excellent
Ethyl Acetate
Excellent
HCL (37.4%)
Very Good
n-Heptane
Very Good
HMDS
Excellent
Isopropanol
Excellent
KOH (50%)
Very Good
Methanol
Excellent
2-Methoxyethanol
Excellent
Methylethyketone
Excellent
n-Methylpiperazine
Excellent
n-Methypyrrolidone
Excellent
Methyl-tert-butylether
Excellent
Mineral Oil
Very Good
Reagent (3A) Alcohol
Excellent
NaOH (50%)
Excellent
Tetrahydrofuran
Very Good
Toluene
Fair
Water, Distilled
Excellent
Charging mills with
DoverPac® and
offloading to IBC with
transfer sleeves.
Bag in-bag out sleeves
Continuous liners
Criteria
% Change in
Physical Properties Resistance
0 - 10
Excellent
10 - 20
Very Good
20 - 30
Good
> 30
Fair
Providing Flexible Containment Solutions to the
Pharmaceutical Industry since 1997
14
Containment
Systems
DoverPac®
Containment
Systems
Benefits
Verified containment as a system
Proven to be lowest cost of ownership
ArmorFlex® 114 film is Static
Dissipative with a permanent antistat,
confirmed to 2002/72/EC and amendments, FDA CFR 21, and test
requirements of EP 3.1.3
Standard and custom installations
CE Marked configurations
UN DOT approved configurations
Lowest carbon footprint in a complete
containment process
14” offloading and
charging necks
using ArmorFlex®
for the crimping
process
Bag Out Sleeves
to maintain
high containment during
DoverPac®
change
Sample sleeve can
be designed into
any DoverPac® for
contained, tamper proof
sampling
DoverPac® PATENTED
system for high containment connection
to the o-ring canister.
Containment proven
using third party testing
to SMEPAC protocol for
<1.0 μg/m3 with results
<250 nanograms/m3
O-rings are captured
to prevent accidental
loss to the process
vessel during bag out
operations (inlet &
outlet necks)
15
DoverPac®
Proven DoverPac® Attachment
16
DoverPac® - Contained Powder Discharge
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
Offloading Using
the Individual
DoverPac® System
Contained processing to
protect the operators
cGMP processing in a
completely closed operation
to protect the product
Available in sizes ranging
from 20L to 2000L
100% inflation tested
CE Marked
System Description
This easy-to-use system has been proven effective in containing active
pharmaceutical ingredients and other hazardous compounds. Its
use assures a safe and effective transfer of powders, an operational
requirement that cannot be achieved with a standard FIBC or big bag.
The DoverPac® contained powder transfer system includes a flexible
ArmorFlex® liner with restraint for containing powders and a set of
hardware that fits the flange of a vessel.
While specific powders react differently due to their particle size, OEB 5
(<1.0 µg/m3) levels have been demonstrated on a task basis with results in the
nanogram range. This is based on proven applications, third party testing to
the “SMEPAC” protocols on similar designs, and the 100% inflation tests
performed on the delivered systems.
Significant capital cost
savings over rigid isolation
systems
Significant reduction in
cleaning time, waste, and
validation expenses
Integral sampling sleeve
Static dissipative film with
groundable restraint (type c)
Uses ILC Dover’s Patented Technology
Uses ILC Dover’s Patented Technology
17
DoverPac® - Contained Powder Discharge
Containment
Systems
F L E X IFBLLEEX C
I NNM
EN
ON
GO
I ELSO G I E S
I BOLN
E TA
CO
TA
I NTMTEENCTH N
T EOCLH
Basic Basic
Offloading
Offloading
Process
Steps Steps
Process
Materials
Materials
® is ILC
® Dover's
ArmorFlex
proprietary
familyfamily
of films
ArmorFlex
is ILC Dover's
proprietary
ofused
filmsexclusively
used exclusively
® family
® family
of highofpotency
flexibleflexible
containment
products.
in the in
DoverPac
high potency
containment
products.
the DoverPac
DetailsDetails
are available
in a databook
upon request.
are available
in a databook
upon request.
Offloading
Canister
and Transition
Adapter
Offloading
Canister
and Transition
Adapter
The canister
pictured
at the at
right
the setthe
up set
on up on
The canister
pictured
theshows
right shows
a straight
transition
adapter
at ILC’sattest
facility.
While While
a straight
transition
adapter
ILC’s
test facility.
®
®
canisters
typically
are 316L
steel, Hastelloy
canisters
typically
arestainless
316L stainless
steel, Hastelloy
canisters
also are
available.
This unit
has
anhas
initial
canisters
also
are available.
This
unit
an initial
groovegroove
for thefor
canister
end cap,
grooves
for
the canister
endadditional
cap, additional
grooves
for
liner attachment
(typically
5 or 105grooves
depending
liner attachment
(typically
or 10 grooves
depending
and Transition
Canister
and Transition
on process
requirements
and available
height),
and 1 andCanister
on process
requirements
and available
height),
1
Adapter Adapter
AttachedAttached
to ILC to ILC
groovegroove
for thefor
cleaning
sleevesleeve
or clean-in-place
(CIP) (CIP)
the cleaning
or clean-in-place
Dover Test
Rig.Test Rig.
Dover
sleevesleeve
attachment.
attachment.
Attach Attach
Bag out Bag
stub out stub
is
This hardware
is
The canister
is supplied
with a with
12” sanitary
flange flange
on
The canister
is supplied
a 12” sanitary
onThis hardware
suppliedsupplied
with a 240
withgrit
a 240 grit
each end.
for a common
designdesign
for attacheachThis
end.allows
This allows
for a common
for attach(15RA)
internal
finish
(15RA)
internal
finish
ment to
vessel
specificspecific
transition
adapters
and our
CIPour CIP
ment
to vessel
transition
adapters
and
and a 180
(32 RA)
andgrit
a 180
grit (32 RA)
tundish.
tundish.
external external
finish. Other
finish. Other
materialsmaterials
and finishes
The custom
transition
adapter
is fittediswith
flange
on
and finishes
The custom
transition
adapter
fitteda with
a flange
on
can be quoted
can besepaquoted sepaone end
that
interfaces
with the
vessel
flange flange
(or valve
one
end
that interfaces
with
the vessel
(or valve
rately.
that is that
in-line
on theon
vessel
flange).
The opposite
end is endrately.
is in-line
the vessel
flange).
The opposite
is
a 12” sanitary
flange flange
that interfaces
with the
canister.
a 12” sanitary
that interfaces
with
the canister.
For flanges
smallersmaller
than 12",
a conical
transition
adapter
For flanges
than
12", a conical
transition
adapter
is usedistoused
allow
flow directly
into the
vessel
to powder
allow powder
flow directly
into
the vessel
without
accumulation
on theon
hardware.
The adapter
without
accumulation
the hardware.
The adapter
1/2” a 1/2”
also isalso
fittediswith
vacuum
flange flange
port with
fitteda with
a vacuum
porta with
sanitary
flange flange
for attachment
to the to
vacuum
and and
sanitary
for attachment
the vacuum
nitrogen
sources
to allow
nitrogen
sources
to inert
allowprocessing.
inert processing.
Purge/Vacuum
Arrangement
Purge/Vacuum
Arrangement
To sample,
extend sleeve
fill and fill
To sample,
extendand
sleeve
Note: Common
vacuum/purge
supply connection
to HEPA to HEPA
Note: Common
vacuum/purge
supply connection
filter provides
backwash
function function
to extendtofilter
life.filter life.
filter provides
backwash
extend
Place crimp
on crimp
Placecap
crimp
cap onbody
crimp body
18
DoverPac® - Contained Powder Discharge
Containment
Systems
Containment
Systems
FlexLoc Clamp
The FlexLoc clamp is used to secure the neck of
the liner to the canister. Construction of the molded
clamp is of FDA compliant elastomer with integrated
stainless steel band clamp. The clamp has a molded
ridge along one surface to help install it in the correct
orientation.
The FlexLoc functions to prevent powder from going
between the inside of the liner and the outside of the
canister to minimize cleaning operations. The clamp
is designed to operate in the offloading and the
charging operations.
ILC crimps have been
designed and tested to
compress standard diameter
liners and sleeves made
with ArmorFlex® film
Load crimp into installation tool
Crimp Separation Kit
Contained separation between vessels and DoverPacs®
is achieved through a Crimp Separation Kit, using ILC's
FlexLoc Clamp
uniquely designed crimp system.
Crimps are color coded to assure that the right crimp is selected for
the right product. Red crimps are used for the 14” necks, blue crimps
are for the 23" diameter continuous liners, and yellow crimps are for
the 4" diameter sample sleeve on the DoverPacs® .
Position crimp
A Crimp Separation Kit includes:
• 200 Crimps
• 1 Crimp Hand tool
Squeeze tool until crimps are
engaged -- then release tool
• 1 Cutter
• 100 Cable Ties (7” Nylon)
• 1 User's Manual
Additional spare items can be ordered separately by their individual
model/part numbers.
The crimps have been designed and tested to compress the standard
diameters liners made with ArmorFlex® film. Use on any other system
will preclude the crimps from closing correctly, which could result in
operator and product exposures.
Cut and separate
The hand tool applies two crimps at once. The cutter is used to cut
between the two crimps, and then the cap is slid onto the closed
crimp body.
Install crimp cap on crimp body
19
DoverPac® - Contained Powder Discharge
Containment
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Systems
Containment
Systems
Typical DoverPac® Discharging Arrangement
Other System Components and Accessories
Other system components and accessories developed by ILC Dover
to support contained pharmaceutical ingredient processing include:
• Wash In Place Enclosure
• Clean In Place System
• In Line Filter Kit
20
DoverPac® - Contained Powder Transfer
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
Charging Using
the Individual
DoverPac® System
Contained processing to
protect the operators
cGMP processing in a
completely closed operation
to protect the product
Available in sizes ranging
from 20L to 2000L
100% inflation tested
CE Marked
System Description
This easy-to-use system has been proven effective in containing active
pharmaceutical ingredients and other hazardous compounds to
assure a safe and effective transfer of powders, an operational
requirement that cannot be achieved with a standard FIBC or big bag.
The DoverPac® contained powder transfer system includes a flexible
ArmorFlex® liner with restraint for containing powders and a set of
hardware that fits the flange of a vessel.
While specific powders react differently due to their particle size,
OEB 5 (<1.0 µg/m3) levels have been demonstrated on a task basis with
results in the nanogram range. This is based on proven applications,
third party testing to the “SMEPAC” protocols on similar designs, and
the 100% inflation tests performed on the delivered systems.
Significant capital cost
savings over multiple rigid
isolation systems
Significant reduction in
cleaning time, waste, and
validation expenses
Static dissipative film with
groundable restraint (type c)
Uses ILC Dover’s Patented Technology
Uses ILC Dover’s Patented Technology
21
DoverPac® - Contained Powder Transfer
Containment
FLEX
FL
I BELXEI BCLOE NCTA
ON
I NTA
M IENNMT ETNETC T
H ENCOHLN
OO
GLI E
OSG I E S
Basic
Basic
Process
Process
FlowFlow
of of
a Contained,
a Contained,
Flexible
Flexible
Charging
Charging
System
System
Systems
Materials
Materials
® is ILC
® isDover's
ArmorFlex
ArmorFlex
ILC Dover's
proprietary
proprietary
family
family
of films
of films
usedused
exclusively
exclusively
in in
® family
® family
of high
of high
potency
potency
flexible
flexible
containment
containment
products.
products.
the DoverPac
the DoverPac
Details
Details
are available
are available
in a databook
in a databook
uponupon
request.
request.
Charging
Charging
Canister
Canister
and and
Transition
Transition
Adapter
Adapter
Lift over
Liftvessel
over vessel
The canister
The canister
pictured
pictured
at theatright
the right
shows
shows
the set
the set
up on
upa on
straight
a straight
transition
transition
adapter
adapter
at ILC’s
at ILC’s
test test
facility.
facility.
While
While
canisters
canisters
typically
typically
are 316L
are 316L
stain-stain®
®
canisters
canisters
also also
are available.
are available.
less steel,
less steel,
Hastelloy
Hastelloy
This This
unit has
unit an
hasinitial
an initial
groove
groove
for the
forcanister
the canister
end cap,
end cap,
additional
additional
grooves
grooves
for liner
for liner
attachment
attachment
Canister
Canister
Attached
Attached
to ILC to
Dover
ILC Dover
(typically
(typically
5 or 10
5 orgrooves
10 grooves
depending
depending
on process
on process
Test Rig
Test Rig
requirements
requirements
and available
and available
height),
height),
and and
1 groove
1 groove
for the
forcleaning
the cleaning
sleeve
sleeve
or clean-inor clean-inplaceplace
(CIP)(CIP)
sleeve
sleeve
attachment.
attachment.
The canister
The canister
is supplied
is supplied
with with
a 12”a sanitary
12” sanitary
flange
flange
on each
on each
end. end.
This This
allows
allows
for afor
common
a common
design
design
for attachment
for attachment
to vessel
to vessel
specific
specific
transition
transition
adapters
adapters
and our
and CIP
ourtundish.
CIP tundish.
AttachAttach
liner then
linerbag
thenout
bag
stub
out stub
The custom
The custom
transition
transition
adapter
adapter
is fitted
is fitted
with with
a flange
a flange
on one
on end
one that
end that
interfaces
interfaces
with with
the vessel
the vessel
flange
flange
(or valve
(or valve
that is
that
in-line
is in-line
on the
onvessel
the vessel
flange).
flange).
The opposite
The opposite
end is
end
a 12”
is a sanitary
12” sanitary
flange
flange
that interfaces
that interfaces
with with
the the
canister.
canister.
For flanges
For flanges
smaller
smaller
thanthan
12", a
12",
conical
a conical
transition
transition
adapter
adapter
is used
is used
to allow
to allow
powder
powder
flow flow
directly
directly
into the
intovessel
the vessel
without
without
accumulation
accumulation
on on
the hardware.
the hardware.
The adapter
The adapter
also also
is fitted
is fitted
with with
a vacuum
a vacuum
flange
flange
port port
with with
1/2” sanitary
flange
flange
for attachment
for attachment
to the
tovacuum
the vacuum
and nitrogen
and nitrogen
sources
sources
a 1/2”a sanitary
to allow
to allow
inertinert
processing.
processing.
Purge/Vacuum
Purge/Vacuum
Arrangement
Arrangement
EmptyEmpty
Note: Common
Note: Common
vacuum/purge
vacuum/purge
supplysupply
connection
connection
to HEPA
to HEPA
filter provides
filter provides
backwash
backwash
function
function
to extend
to extend
filter life.
filter life.
Crimp Crimp
22
DoverPac® - Contained Powder Transfer
Containment
Systems
Containment
Systems
This hardware is supplied with a 240 grit (15 RA) internal finish and a
180 grit (32 RA) external finish. (Other materials and finishes also can
be provided.)
Please note that for vessels that normally operate under pressure, a
valve is required to isolate the liner from the vessel while the vessel is
under pressure. This pressure-rated valve is normally supplied by the
customer and installed between the vessel and the transition adapter.
FlexLoc Clamp
The FlexLoc clamp is used to secure the neck of the liner to the
canister. Construction of the molded clamp is of FDA compliant
elastomer with integrated stainless steel band clamp. The clamp
has a molded ridge along one surface to help install it in the correct
orientation.
FlexLoc Clamp
ILC crimps have been designed and tested to compress
standard diameter liners
made with ArmorFlex® film
The FlexLoc functions to prevent powder from going between the
inside of the liner and the outside of the canister to minimize cleaning
operations. The clamp is designed to operate in the offloading and the
charging operations.
Crimp Separation Kit
Load crimp into installation tool
Contained separation between vessels and DoverPacs® is achieved
through a Crimp Separation Kit, using ILC's uniquely designed crimp
system.
Crimps are color coded to assure that the right crimp is selected for
the right product. Red crimps are used for the 14” necks on the
DoverPacs®.
Position crimp
A Crimp Separation Kit includes:
• 200 Crimps
• 1 Crimp Hand tool
• 1 Cutter
• 100 Cable Ties (7” Nylon)
• 1 User's Manual
Squeeze tool until crimps are engaged
-- then release tool
Additional spare items can be ordered separately by their individual
model/part numbers.
After filling, the liner is twisted and crimped closed. The hand tool
applies two crimps at once. The cutter is used to cut between the
two crimps, and then the cap is slid onto the closed crimp body.
Cut and separate
Install crimp cap on crimp body
23
DoverPac® - Contained Powder Transfer
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
Containment
Systems
Use of Lifting Bar
Lifting Bars
A lifting bar and hoist are used in order to position the DoverPac® restraints
over the vessel interface for charging. The lifting bar comes in two sizes to
accommodate DoverPac® sizes. Hoists typically are supplied by the
customer.
Typical DoverPac® Charging Arrangement
Attaching the restraint to lifting bar
Securing the liner neck
Other System Components and Accessories
Other system components and accessories developed by ILC Dover
to support contained pharmaceutical ingredient processing include:
• Wash In Place Enclosure
• Clean In Place System
• In Line Filter Kit
24
Coaxial DoverPac® - Nanogram Powder Transfer
Containment
Systems
O verview
The Coaxial neck DoverPac® was originally designed to allow secondary containment to be used
with a DoverPac® in the late 1990’s for charging and offloading vessels through isolators. Given
the increase in highly potent API manufacturing, the use of this system with either rigid isolators
or flexible enclosures is a complimentary processing option.
The Coaxial Neck DoverPac® serves the dual function of contained transfer and storage system.
These are available in standard 45, 185, 400, and 700Liter volumes. Custom sizes can also be
accommodated.
HOW DOES IT WORK?
This system is designed to provide containment
to the OEB 5 (less than 1 μg/m3 with a goal of
below 200 nanograms/m3 on a task basis). To
achieve this, the secondary containment (i.e.
flexible enclosure and the outer neck) at the
primary connection points are applied. Figure
1 shows the offloading set up during exposure
monitoring trials.
1
3
2
1. Vessel Outlet
2. Flexible Enclosure
3. Inner Neck
Attachment
4. Support Frame
5. Outer Neck
Attachment
The installation sequence follows:
•
The top of the enclosure is attached to the
first canister on the vessel outlet.
•
The bottom of the enclosure is attached to
the canister on the support frame.
•
The external neck on the DoverPac® is then
attached to the outlet point of the canister
on the frame.
•
The internal neck of the DoverPac® is pulled up
through the lower canister and is attached to
the groove on the vessel canister by using the
integral glove sleeves on the flexible enclosure.
4
5
Figure 1
Once the vessel is offloaded, the internal neck is crimped off and pushed back down through the
canister on the frame by using the enclosure to access the neck area. The operator then extracts
his/her arms from the enclosure and crimps off the external neck.
The crimping process, Figure 2, is employed for the contained separation operations. This process
consists of installing two injection molded crimps into the hand tool, twisting the liner neck,
ratcheting the crimps closed, cutting between the two crimps, and installing the protective cap.
Figure 2
25
Coaxial DoverPac® - Nanogram Powder Transfer
In addition to offloading vessels, the system can
be applied to charging processes as shown in
Figure 3. The flexible enclosure design is either
supported by a frame or bungee cords.
1. Vessel Inlet
2. Flexible Enclosure
3. Inner Neck Attachment
4. Outer Neck Attachment
5. DoverPac®
5
F E AT U R E S
4
2
•
Standard DoverPac® hardware interfaces
•
Standard and custom sizes
•
Two barriers for containment
•
Product contact with regulatory
compliant materials
BENEFITS
3
Uses a broad range of solutions depending
on containment level needed
•
1
Tailored to specific batch sizes
•
Figure 3
Provides nanogram levels of protection
without high capital costs
•
Eliminates risk to product
•
W H AT C O N TA I N M E N T L E V E L P R O V I D E D ?
OEB 5 in the nanogram levels. The table below outlines a summary of the results achieved.
Sample Set
N
Personal Sample
Breathing Zone
PSBZ – with outlier
event
12
PSBZ – without
outlier event
10
Mean
Range
Lowest
Range
Highest
Standard
Deviation
Standard
Error
Coefficient
of
Variation
95%
Confidence
Interval for
Population
Mean
0.077 μg/m3 0.014 μg/m3
0.50 μg/m3
0.136 μg/m3
0.039
1.8
-0.00980 to
0.163 μg/m3
0.032 μg/m3 0.014 μg/m3
0.084 μg/m3 0.023 μg/m3
0.0074
0.72
0.0156 to
0.0490 μg/m3
WHY USE THIS OVER OTHER TECHNOLOGIES?
The cost of ownership, ergonomic advantages, and speed of delivery benefits of this flexible solution
far outweigh those of rigid isolation systems
O T H E R P O T E N T I A L A P P L I C AT I O N S
This technology is applicable for charging and offloading most vessels. This includes, but is not limited
to, reactors (charging only), dryers, blenders and granulators.
Uses ILC Dover’s Patented Technology
26
G2Pac - <100μg/m³ Containment Powder Transfer
Features:
Durable ArmorFlex® liner with
groundable restraint (type C)
Individual necks with bag-out sleeve
to support charging and offloading
operations
Secure, dust-free hardware interface
to process equipment
Sized to interface with standard pallet
Interfaces with ILC contained
separation crimps
Benefits:
Economical containment
Supports dust-free operation
Reduced cross contamination risks
Protects operator
One-person operation
Eclipsing the traditional FIBC, the G2Pac is
engineered to address the issues that arise from
uncontrolled processes, including compromised
facility cleanliness, cross contamination risks
and employee exposure to unnecessary
hazards. G2Pac supports cGMP operations.
Feature
Restraint and Liner
Yes
Charge/Offloading Neck
Yes
ArmorFlex® 104
Yes
Sizing
700L, 560L,
185L
Integral Bag-Out Sleeves
for Contained Changeover
Yes
Interfaces with Contained
Separation Crimps
Yes
27
DoverPac® Continuous Liner 23” Dia - Contained Powder Discharge to Drums
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
23”(584 mm)
Diameter Continuous
Liner Systems
Contained processing to
protect the operators
cGMP processing in a
completely closed operation
to protect the product
One person operation
Pre-loaded liner material
minimizes processing time
Inert atmosphere offloading
of products.
System Description
This easy-to-use system has been proven effective in containing
active pharmaceutical ingredients and other hazardous compounds
to assure a safe and effective transfer of powders – an operational
requirement that cannot be achieved with a standard drum liner.
The 23” (584 mm) diameter continuous liner system is designed to
allow continuous offloading of powders into drums. This contained
powder transfer system consists primarily of a set of hardware that
fits the flange of a vessel and a factory packed kit of liners that
are delivered in a pack ready to install on the canister. Standard
systems are supplied in continuous sleeves. Sample sleeves are
often added as custom applications.
28
Significant reduction in
cleaning time, waste, and
validation expenses
The system is available
in the following sizes:
Pack Length
Number of Drums
per Pack*
50’
10
100’
20
150’
30
* assumes 5’ of liner per drum to
accommodate drum height and
crimping. Actual usage will
depend on the drum height
DoverPac® Continuous Liner 23” Dia - Contained Powder Discharge to Drums
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
The basic steps for operating
this easy to use system are
shown in these continuous
liner process steps
Materials
ArmorFlex® is ILC Dover's proprietary family of films used exclusively in
the DoverPac® family of high potency flexible containment products.
These films pass incendivity testing and are designed and manufactured
using FDA & EU compliant materials.
Continuous Liner Kit
Versatile
hardware easily
mounts to vessel
discharge port
Continuous liner
pack is installed
The Continuous Liner Kit includes:
• Canister
• Cage
• Shroud
• Pack Protector
• 12” Band Clamp
• Sanitary Clamp and Gasket
• FlexLoc Clamp
• 23” Crimp Kit
• Turn Table
• Continuous Liner Pack
The canister will attach to the vessel using a transition adapter. The
transition adapter has a nitrogen purge/vent to discharge into an inert
atmosphere (if required).
Continuous Bag-in/Bag-out System
Sleeve is pulled
into drum and filled
This system can be supplied with an alpha/beta port interface to allow
attachment to an isolator as depicted in the drawing. This allows the
contained removal of product containers, samples, or waste from the
isolator.
Unique DoverPac®
crimping system is
used to separate
filled drum
Next sleeve is
pulled into drum
29
DoverPac® Continuous Liner 23” Dia - Contained Powder Discharge to Drums
Containment
Systems
Containment
Systems
Crimp Separation Kit
The 23” crimp separation kit is used to separate the filled drum from
the unused pack. The 23” Crimp Separation (start-up) Kit includes:
• 200 Crimps
• 1 Crimp Hand tool
• 1 Cutter
ILC crimps have been
designed and tested
to compress standard
diameter liners made
with ArmorFlex® film
• 100 Cable Ties (7” Nylon)
• 1 User's Manual
Additional spare items can be ordered separately by their individual
model/part numbers.
Load crimp into installation tool
The crimps have been designed and tested to compress the standard 23”
diameter liners made with ArmorFlex® film. Use on any other system
will preclude the crimps from closing correctly, which could result in
operator and product exposures.
The hand tool applies two crimps at once. The cutter is then used to cut
between the two crimps, and the cap is slid onto the closed crimp body.
Position crimp
FlexLoc Clamp
The FlexLoc clamp is used to secure the neck
of the liner to the canister. Construction of the
molded clamp is of FDA compliant elastomer with
integrated stainless steel band clamp. The clamp
has a molded ridge along one surface to help
install it in the correct orientation.
FlexLoc Clamp
The FlexLoc functions to prevent powder from going between the inside
of the liner and the outside of the canister to minimize cleaning operations. The clamp is designed to operate in the offloading and the charging operations.
Squeeze tool until crimps are engaged
-- then release tool
Containment Levels
While specific powders react differently due to their particle size, customer
testing has shown that these systems are capable of providing containment levels to below 1 µg/m3 in applications around the world.
Cut and separate
Install crimp cap on crimp body
30
DoverPac® Continuous Liner 23” Dia - Contained Powder Discharge to Drums
Containment
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Systems
Continuous Liner Discharge Arrangement
Other System Components and Accessories
Other system components and accessories developed by ILC Dover
to support contained pharmaceutical ingredient processing include:
• Wash In Place Enclosure
• Clean In Place System
• In Line Filter Kit
Applications
• Product offloading from sifters, mills, blenders, centrifuges,
dryers and other process equipment.
• Bag-in/Bag-out
31
DoverPac® Continuous Liner 14” Dia - Contained Powder Discharge to Drums
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
14” (355.6mm)
Diameter Continuous
Liner Systems
<1µg/m3 contained processing to protect the operators
with results in the 250
nanogram/m3 range
cGMP processing in a
completely closed operation
to protect the product
One person operation
System Description
This easy-to-use system has been proven effective in containing
active pharmaceutical ingredients and other hazardous compounds.
Inert atmosphere
offloading of products
This system uses a five-liner canister, which will allow up to five
contained changes of the 30' packs before cleaning or canister
recovery is required. This system also provides the 30’ liner packs
pre-bundled, which reduces operator time. Its use assures a safe
and effective transfer of powders, tablets, vials, tools, and trash.
Uses ILC Dover’s Patented Technology
Uses ILC Dover’s Patented Technology
32
Significant reduction in
cleaning time, waste, and
validation expenses
DoverPac® Continuous Liner 14” Dia - Contained Powder Discharge to Drums
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
Materials
ArmorFlex® is ILC Dover's proprietary family of films used exclusively
in the DoverPac® family of high potency flexible containment products.
These films pass incendivity testing and are designed and manufactured using FDA & EU compliant materials.
System Components
The system components for contained discharging as pictured
here consist of:
• 8” Sanitary Flange Five Liner SS Canister (used to make
Attach neck of continuous liner
to canister
Install a band clamp
Slide the pack onto the canister
Install the outer shroud
Unsnap the retaining snaps on
the pack
•
•
•
•
•
•
•
•
contained connection of DoverPacs®)
30’ Continuous Liner Pack
Fabric Outer Shroud
Pack Protector
8” Stainless Steel Band
8” Sanitary Clamp
8” Sanitary Gasket
14” Crimp Kit
8” FlexLoc Clamp
This system can be supplied with an alpha/beta port interface to
allow attachment to an isolator as depicted in the drawing. This
allows the contained removal of product containers, samples, or
waste from the isolator.
Continuous Bag-in/Bag-out System
Pull down liner material to start
processing
33
DoverPac® Continuous Liner 14” Dia - Contained Powder Discharge to Drums
Containment
Systems
Containment
Systems
Crimp Separation Kit
The 14” crimp kit is used to separate the filled drum from the unused pack.
The 14” Crimp Separation (start-up) Kit includes:
• 200 Crimps
ILC crimps have been
designed and tested to
compress standard diameter
liners and sleeves made
with ArmorFlex® film
• 1 Crimp Hand tool
• 1 Cutter
• 100 Cable Ties (7” Nylon)
• 1 User's Manual
Load crimp into installation tool
Additional spare items can be ordered separately by their individual
model/part numbers.
The crimps have been designed and tested to compress the standard 14”
diameter liners made with ArmorFlex® film. Use on any other system will
preclude the crimps from closing correctly, which could result in operator
and product exposures.
Position crimp
The hand tool applies two crimps at once. The cutter is then used to cut
between the two crimps, and the cap is slid onto the closed crimp body.
This system has been proven effective in containing active pharmaceutical
ingredients and other hazardous compounds to assure a safe and effective transfer of powders, tablets, vials, tools, and trash – an operational
requirement that cannot be achieved with a standard drum liner.
Squeeze tool until crimps are engaged
-- then release tool
Containment Levels
While specific powders react differently due to their particle size, customer
testing has shown that these systems are capable of providing containment
levels to below 1 µg/m3 on a task basis in applications around the world.
Cut and separate
Install crimp cap on crimp body
34
DoverPac® Continuous Liner 14” Dia - Contained Powder Discharge to Drums
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
Containment
Systems
FlexLoc Clamp
The FlexLoc clamp is used to secure the neck of the liner to the canister.
Construction of the molded clamp is of FDA compliant elastomer
with integrated stainless steel band clamp.
The clamp has a molded ridge along one surface to help install it
in the correct orientation.
FlexLoc Clamp
It functions to prevent powder from going between the inside of the
liner and the outside of the canister to minimize cleaning operations.
The FlexLoc clamp is designed to operate in the offloading and the
charging operations.
Other System Components and Accessories
Other system components and accessories developed by ILC Dover
to support contained pharmaceutical ingredient processing include:
• Wash In Place Enclosure
• Clean In Place System
• In Line Filter Kit
Applications
• Product offloading
• Tablet offloading
• Bag-in/Bag-out
35
Continuous Liner Bag in Bag out - Contained Transfer
Containment
O verview
Systems
The DoverPac® Bag In/Bag Out (BIBO) system is a family of contained transfer designs
for multiple processes. The primary components for this validated operation consist of multiple
groove canisters, docking interface hardware, and softgoods in either continuous liner form or
discreet liners as illustrated below in the continuous liner application.
Isolator
14” Continuous
Bag-Out/Bag-in
System
23” Continuous
Drum Liner
System
This system can be applied to any rigid isolator. The use of multiple size canisters allows a
broad range of needs to be met, systems can be retrofit to existing assets, and the BIBO
system requires a low capital outlay.
O peration
By utilizing the patented multi o-ring and flexible containment techniques developed by ILC
Dover, this system builds on proven DoverPac® designs. The hardware is docked to the containment enclosure either by using the existing alpha/beta port hardware or bolting directly to the
wall of the rigid isolator. The liner is then extended over the item to be introduced or removed
from the enclosure and then crimped off to complete the contained transfer.
Continuous Liner being attached to isolator
Operator shown “bagging in” a tool
Operator shown “bagging out” a sample
Uses ILC Dover’s Patented Technology
36
Continuous Liner Bag in Bag out - Contained Transfer
Containment
Systems
Accessories and support equipment include a lifting stand to help support the larger
canister size, crimps and the FlexLoc™.
Crimping tool/crimps
Lifting Stand
FlexLoc™
A pplications – C urrent and P otential
Current applications: tool pass through on 22 rigid isolators at one international Pharma
manufacturer’s site, trash bag out, sample bottle transfer, tablet transfer for testing/analysis,
pre-packaged seed/API processing after tare weight process
Other potential applications: document transfer, gamma irradiated for sterile transfer
operation, wall mounted in process suite for contained pass thrus.
C ontainment L evel
Nanogram containment levels demonstrated during task based operations – see data below.
Sample*
Location
Duration of
Operation
(mins.)
Measured Airborne
Concentration
(µg/m3)
Source Sample (AS-0BH)
At Bagout Port
31
<0.017
Operator #1 (PSBZ)
On Shoulder
31
0.017
Operator # 1 (PSBZ)
On Shoulder
30
<0.017
Operator # 2 (PSBZ)
On Shoulder
30
<0.018
Source Sample (AS-0BZ)
At Bagout Port
30
<0.017
* Finished Product, raw materials, cleaning materials, waste materials
F eatures
BENEFITS
Validated system
•
Minimizes risk during operation
Proven and tested softgoods
•
ArmorFlex films are regulatory compliant
Disposable
•
Eliminates concern of cross contamination due
to “pneumatic” effect of low end films leaking
•
Reduced cleaning and cleaning validation costs
•
Reduced process time and cost by eliminating
multiple RTP canisters
•
Eliminates RTP seal maintenace
•
•
•
Bolt on or RTP Interfaces available
•
37
Antistatic Drum Liners
Containment
Systems
Static Dissipative
Drum Liners
Features
Clear durable film
Chilworth tested– passes
incendivity testing
Available in all ArmorFlex® films
Up to 5 year shelf life based
on film selected
DoverPac® static dissipative drum liners provide
you with the confidence to safely transfer and
store a wide range of API’s and other powders.
As the pioneer of flexible containment systems
for the pharmaceutical industry, ILC Dover
offers drum liners constructed from our
durable ArmorFlex® film–the same
material used in our DoverPac®
API containment system.
38
Contained Processes - Flexible Enclosures / Glovebags
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
Flexible
Enclosures
Allows operators to work in shirt
sleeve environment – increases
efficiency
3rd party validated Nanogram
containment levels using
SMEPAC guidelines
Economical
Fast turnaround/installation
Fit check on lab scale
fluid bed dryer
ILC Dover’s flexible enclosures take the concept of a traditional
flexible glove bag to a new level. Using the same reliable
fabrication techniques and proven containment design
features found on our DoverPac® family of products, we’ve
produced a line of flexible enclosures adaptable to a wide
range of existing equipment. These enclosures save time
and money by allowing you to retrofit existing processing
equipment while achieving nanogram containment levels. All
materials meet FDA standards and the design accommodates
cGMP as well as operator ergonomics.
Compatible with a wide range of
existing equipment for retrofit
Design makes use of existing
DoverPac® containment details
such as crimps, bag/out sleeves,
and o-ring interface canisters
Ergonomics are improved with
an increased range of motion
Designs support separation of
process and technical areas
Where applicable, entire piece of
equipment can be contained
39
Contained Processes - Flexible Enclosures / Glovebags
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Containment
Systems
Tablet Press/Deduster Flexible Enclosure
• Powder added using a DoverPac® and canister interface
• A series of glove sleeves permit easy press operation
• Continuous bag-out sleeve supports tablet sampling/analysis
• Unexpected maintenance can be performed using bag out
sleeve and gloves
Unique base design/interface
• Eliminates the need for zippers
• Stainless steel construction
• Utilities can be plumbed
through base
• Fork lift compatible allows for
easy repositioning
• Base can be used to connect to
wash-in-place (WIP) system
Enclosures designed
to work with:
• Blending
• Milling
• Tableting
• Weighing
• Subdividing
More cost effective than:
• Rigid isolators
• Downflow booths
Lab Scale Analytical/Blending Process Train
• New equipment
• Product enters through bag-in sleeves
• Operation of equipment accommodated via glove sleeves
• Integration of process steps through ILC Dover canister
interface
• Process train can be expanded to include sub-dividing,
milling, tableting, etc.
40
Contained Processes - Flexible Enclosures / Glovebags
Containment
Systems
Containment
Systems
Weighing and Dispensing
• Utilities through pan
• Used with standard lab equipment
Mill Flexible Enclosures
L1A Fitzmill
• Powder added at top using DoverPac® addition technique
or scooped in by hand
• Milled powder discharged into DoverPac®, IBC or vessels
Granulator
Overdrive Mill enclosure with
shroud removed and fully deployed
to allow use of glove sleeves for
cleaning and maintenance
• Mobile frame allows use in multiple suites
• Clear film and bungee attachments optimize ergonomics
ILC Dover...pioneers of flexible containment.
41
Contained Processes - Flexible Enclosures / Glovebags
Containment
Systems
F L E X I B L E C O N TA I N M E N T T E C H N O L O G I E S
Contain
Sy
Tablet Coater Enclosure
• Tablets bagged in/out through sleeve
• Glove sleeves allow full
operator access
IBC Transfer
• Milled powder or finished product
• Tare weighing in process transfer
Dispensing device
enclosure with
transfer sleeve to
IBC or downstream
process
42
Document Transfer Enclosure
Containment
O verview
Systems
The Flexible Document Transfer Enclosure is designed to allow paperwork used in
pharmaceutical processing to be handled in a contained way so that powders are not
transferred onto the documents and to areas or individuals that are not protected.
The enclosure can be manufactured from a clear ArmorFlex® or polyurethane film that will allow for
room light to illuminate the inside of the enclosure for easy viewing and writing on the documents.
H ow does the system work ?
Documents, writing implements, and baggies for enclosing the finished paperwork are
preloaded into the enclosure.
A set of glove sleeves (left hand and right hand) are integral to the front of the enclosure at
an approximate height of 48”. Due to the flexibility of the enclosure, the operators will be
able to work at heights approximately +/- 5” from the glove sleeve centerline. This flexibility
is provided by the nature of the films employed and the use of bungee cords that allow the
enclosure to move with the operator.
On the side opposite of the Glove Sleeves will be a zipper
that is used as a pass-through for the documents.
A bag in/bag out (BIBO) canister can also be provide
as an optional method for transfer (as shown in the
photograph).
Space is also available to store plastic bags that can be
used to contain the documents once all work is completed.
A stainless steel frame is used to support the enclosure which includes casters to make the unit portable.
The frame will include a rigid plate to use for support
during writing.
The top half of the frame can be provided as a table
mounted system.
Frames are typically available in 304 or 316L Stainless
Steel. Other materials can be provided as required.
The typical document transfer enclosure is sized
for dimensions of 24” wide x 24” high x 24” deep.
Custom sizes are also available.
F eatures
Clear film allows use of existing light from the suite
•
Passive system meets ATEX and Ex ratings
•
Re-usable for extended campaigns
•
Portable
•
Small footprint does not take up a lot of floor space
•
43
Document Transfer Enclosure
Containment
Systems
B enefits
No cross contamination transfer to documents and then to other parts of the plant
•
Ergonomics are maximized with flexible materials
•
Reduced cleaning and cleaning validation
•
Low capital and operating cost
•
Speed of implementation
•
Production and Lab processes supported
•
W hat containment level provided ?
OEB 5 with results in the nanogram range. This is anticipated given third party test results
from similar designs and the 100% inflation tests performed on the deliverable enclosures.
W hy use this over other technologies ?
The cost of ownership, ergonomic advantages, and speed of delivery benefits of
this flexible solution far outweigh those of rigid isolation systems.
O ther potential A pplications
Sampling
•
Dispensing
•
Product Analysis
•
44
Drum Transfer System - Contained Drum Dispensing
Containment
Systems
O verview
Flexible Containment for offloading drummed materials in a safe and efficient
manner is provided by the Drum Transfer System (DTS) platform, at fixed and varying heights.
1
2
1. Flexible Enclosure
2. Outer Drum Sleeve
3. DTS Enclosure Frame
4. DTS Base Frame
5. Outlet Canister
6. Lifter
3
5
6
4
Figure 1a – Fixed Height Lifter
Figure 1b – Variable Height Lifter
The DTS consists of an enclosure attachment frame, a support stand, a drum lifter, an
enclosure, an outer drum sleeve, and discharge softgoods that are dependent upon your
process equipment.
The basic process steps include:
Attach the enclosure to the frame.
•
Stretch the bottom opening of the Drum Sleeve over the drum and attach the sleeve to
the ring on the back of the frame.
•
Pull the drum slightly into the enclosure and open the inner drum liner using the integral
gloves on the enclosure.
•
Scoop/pour powder into the process equipment to be utilized.
•
Put trash in the empty drum and move the drum back out of the ring with the
translating arm of the lifter.
•
Twist and crimp the Drum Transfer Sleeve for disposal of the drum.
•
Attach a new sleeve to a new drum and attach the sleeve over the stub remaining from
the previous drum. Pull the stub into the enclosure to allow a clear pass through for the
drum and repeat the process steps above.
•
45
Drum Transfer System - Contained Drum Dispensing
H ow does the system work ?
The Enclosure Frame sits on a series of bases offering a modular approach to processing drums in a contained fashion. This provides the benefit of processing into various mills, DoverPacs® and other vessels.
The entire assembly is mobile and can be wheeled over the piece of process equipment to be charged.
The castors used here are conductive. Two wheels are locking while the other two pivot for steering.
The enclosure functions as a flexible isolator. It is attached to the frame at the drum inlet ring and the
outlet canister. Bungee cords are used to attach the enclosure to the frame and allow the enclosure
to move with the operator to take advantage of the system’s built in flexibility.
Hepa Filters
The drum’s inner liner can then be accessed from the enclosure after the outer drum liner is removed as depicted here.
Glove Sleeves
Multi Use
Sleeve
The drum lifting unit is provided as part of the system.
The lifter is pneumatic powered to lift and tilt the drum into
position. The unit is a stainless steel construction and meets
cGMP requirements.The maximum lift capacity of the
standard unit is 100 Kg though larger lifts can be provided.
The outlet canister supplied with the frame is typically our
5 liner, multiple o-ring groove system. For transfer direct to
a process vessel a Transfer Sleeve is used. If filling with a
DoverPac® is required, the canister supports interface to
this containment technology.
Bungi
Cords
Figure 2
W hat containment level provided ?
OEB 5 with results in the nanogram range. This is based on proven applications, third party testing to
the “SMEPAC” protocols, and the 100% inflation tests performed on the deliverable enclosures.
W hy use this over other technologies ?
The cost of ownership, ergonomic advantages, and speed of delivery benefits of this flexible solution
far outweigh those of rigid isolation systems.
A pplications
Given the modularity features designed into the Drum Transfer System, contained transfer of drummed
powders for the following applications is possible:
M illing
In the application pictured in Figure 3, powder is processed from
a drum, through a mill (a Quadro Sifter in this example), into a
stainless steel Intermediate Bulk Container (IBC).
An interface to the mill is provided at the outlet of the Enclosure frame
using a transfer sleeve. A similar sleeve is used to go from the outlet
of the mill to the inlet of the IBC.
Figure 3
46
Drum Transfer System - Contained Drum Dispensing
In Figure 4, the milled powder is processed into a DoverPac®
for future charging into a vessel. The example pictured uses
a Quadro overdrive mill. This same approach has been accomplished with the Quadro under drive mill as well as other
mills.
In this application, a transfer sleeve would be attached to the
discharge canister of the DTS frame and to the inlet canister
on the mill.
S ubdividing
Using the DTS, a scale can be placed either inside the
enclosure or just underneath it between the support tray
and the enclosure. In this approach, the discharge canister
was moved to the side to allow room for the scale.
Figure 4
On a larger size system, like the BNL repackaging effort
discussed in the next paragraph, the DTS was placed around
a floor scale so that a tare weight was measured. In this
instance a Sartorius scale was used but others can be
accommodated. In this type of application it is important
to confirm the interface sizes.
R epackaging
Figure 5
We have worked recently with a repackaging company, BNL
Labs, for an application with one of our customers in Ireland.
In this application, drums and bags of intermediate materials
were transferred directly into DoverPacs®. These were for
185L, 400L and 700L sizes.
The customer would have rejected any lot of repackaged
materials if any powder were seen on the outside of the
restraint. In order to be successful, BNL adopted our
Drum Transfer Station.
C harging to vessels
The Transfer Sleeve between the bottom of the DTS and the
inlet of the next piece of equipment is depicted in Figure 6.
This uses our standard technology of multiple groove o-rings
and bag out techniques.
The Transfer Sleeve between the enclosure outlet and the
process equipment inlet will be sized using our standard 12”
hardware. In this case, we will be able to use our unique
crimp system for contained separation.
Figure 6
After processing, the Transfer Sleeve will be twisted and
crimped closed using the red, 14” crimps. The hand tool
applies two crimps at once. The cutter is then used to cut
between the two crimps and the cap is slid onto the closed
crimp body.
In addition, the DoverLoc™, a molded clamp that secures
the liner at the bottom interface point of the canister, supports the twisting/crimp operation and minimizes cleaning.
47
Drum Transfer System - Contained Drum Dispensing
Feature
Benefit
Flexible enclosure follows operator’s
movements
Ergonomic performance is better than rigid system
Fits a wider range of operator sizes without ergonomic
issues of rigid designs
Lightweight, portable design
Can move to process area when needed, freeing room in
process suite when not in use unlike a rigid, fixed system
Better utilization of facilities
Disposable
Significant operational cost savings in cleaning time
and validation
Third Party proven containment
Engineered process control
Protection of operator
No product loss of expensive APIs
Reduced capital cost over rigid systems
Significant savings of capital budget leaving
money for other priorities
Maximized use of contained processing
commonality
Operator training minimized across multiple processes
Time to manufacturing readiness is
shorter than capital intensive systems
Improved speed to market
cGMP system
No cross contamination
Modular frame design
Allows attachment to a process specific frame
Improved interface to multiple pieces of process
equipment and DoverPac® sizes
Proven in customer applications
This is a validated system
48
Mill Containment System
Containment
Systems
O verview
Milling is a common operation throughout the Pharmaceutical Manufacturing Process. Sizing of
powders is a dusty operation and with more potent powders being processed the need for containing
this operation becomes even more critical from safety and cross contamination avoidance purposes.
In addition to contained powder throughput, it is imperative that access to the interior of the
mill be made available without breaking containment in case the screen blinds, for changing
to a different mesh, impeller change, or cleaning.
1.
2.
3.
4.
5.
2
Underdrive Mill
DoverPac®
Charging Canister with Transition Adapter
Screen Access Enclosure Hardware
Outlet Canister
HOW DOES THE SYSTEM WORK?
The configuration shown in Figure 1 consists of the
basic mill with modifications to support the attachment
hardware needed for the standard DoverPac® charging
and offloading systems. In addition, a flexible enclosure
interface is provided between the base of the charging
canister and the mill’s inlet housing.
3
4
1
5
Safety is maintained as provided in the base mill design.
Safety Grids are included in the inlet and outlet canisters.
In addition, the interlocks are relocated to the Charging
Canister and Screen Access Enclosure Ring.
In the event that a screen blinds during operation, the mill
is turned off and the screen is accessed using the enclosure shown in Figures 2, 3, and 4. This is accomplished
by:
•
Applying the Lifting Shroud to the canister
•
Removing the protective shroud from around the
enclosure (used when the enclosure is in the stowed
position only, not shown in this document)
•
Inserting hands in the integral glove sleeves in the
enclosure and opening the tri-clamp
•
Hoisting the canister and using the glove sleeves
again to remove the impeller and screen
Figure 1
The enclosure is manufactured from clear ArmorFlex® film that will allow room light to illuminate
inside the enclosure for easy viewing. It is also equipped with a bag in/bag out sleeve which is used
for housing the tool needed to loosen the bolt that secures the impeller and bagging out the screen
as required.
The opening at the top of the enclosure includes an encapsulated o-ring that is clamped onto the
bottom groove of the canister. The bottom of the enclosure has a similar arrangement that is
clamped to the interface ring shown in Figure 3.
49
Mill Containment System
Figure 3. Grooved interface ring
Figure 4. Integral glove sleeve for
manipulating screen.
F E AT U R E S
BENEFITS
Validated containment
technology
• Clear film
•
•
•
•
•
•
•
Figure 2. Shroud used to hoist canister.
Passive system
Flexible materials
Disposable components
Retrofit to existing mills
Adaptable to other mills
and size reduction
designs
Nanogram containment
levels achieved
• Supports visibility for
maintenance
• Does not affect ATEX
and Ex ratings
• Ergonomics maximized
Reduced cleaning and
cleaning validation
• Low capital and
operating cost
• Speed of implementation
•
W H AT C O N TA I N M E N T L E V E L P R O V I D E D ?
OEB 5 with results in the nanogram range. This is based on proven applications, third party testing
to the “SMEPAC” protocols on similar designs, and the 100% inflation tests performed on the
deliverable systems.
WHY USE THIS OVER OTHER TECHNOLOGIES?
The cost of ownership, ergonomic advantages, and speed of delivery benefits of this flexible
solution far outweigh those of rigid isolation systems.
O T H E R P O T E N T I A L A P P L I C AT I O N S
Continuous liner hardware on outlet of mill for contained filling in drums
•
Transfer Sleeve on outlet of mill for direct transfer to IBCs or other vessels
•
Transfer Sleeve on inlet of mill with drummed materials being introduced using the DoverPac®
Drum Transfer System (Flexible Containment Solution Guide # FCSG 003)
•
50
Drum Sampling Enclosure System
Containment
Systems
O verview
Sampling of active pharmaceutical ingredients, sensitizers, and other highly hazardous compounds
for quality assurance purposes is a process that is performed on a routine basis. The ability to
perform this work in a warehouse or other parts of the facility, on a task operation basis, and
without having to make significant capital expenditures are key in meeting this operational need.
The Drum Sampling Enclosure (DSE) system, a proven containment solution, supports accessing
drummed materials - with the drum fully contained. Some processes advocate the safety of removing the drum lid before placing the drum inside the containment device. Experience proves the risk
exists, even with a dual inner liner, that cross contamination and operator exposure can occur when
the lid can not be removed within a robust flexible enclosure.
H ow does it work ?
The DSE System consists of a Flexible Enclosure and Support
Stand. Sampling to an integral flexible sleeve, bottles or a thief
are all proven capabilities.
The enclosure includes one pair of integral glove sleeves, a
storage sleeve and sampling sleeve. Loops for supporting
the enclosure by the stand are added to provide the attachment
mechanism for the bungee cords. The combination of HEPA
filters and bungee cords support the flexibility of the ergonomic
design.
Operationally, the following basic steps are employed:
1. Sampling tools are preloaded into the 14”/350mm diameter
sleeve and the open bottom of the enclosure is stretched
over the drum and then taped to the drum wall.
2. The integral grommets on the top of the enclosure are
connected to the support frame to provide the operator
with space to work using the supplied bungee cords.
3. The drum lid is removed and placed along side of the
drum but remains inside the containment area. The inner
drum liners are then opened.
4. The sample is taken via the 4”/100mm sleeve using the
process desired scooping directly into the sleeve or a
sample bottle that is placed in the sleeve or using a standard sample thief and depositing that
sample in the sleeve or a sample bottle. The samples can then be removed from the enclosure
through the 4”/100 mm diameter sleeve by using the ILC Dover developed Crimping process.
5. The inner drum liner is resealed and the drum lid is put back into place without breaking
containment.
51
Drum Sampling Enclosure System
Containment
F eatures
Systems
Clear film allows use of existing light from the process area
•
Static dissipative film
•
Re-usable for repeated sampling
•
Tamper Proof sampling
•
Portable
•
Small footprint does not take up a lot of floor space
•
Enclosure is attached to drum wall allowing lid to be contained
•
Stretch on enclosure interfaces with common size drums but can also be customized
•
One person operation
•
B enefits
Can be used in any part of the facility
•
No cross contamination transfer to other parts of the plant
•
Ergonomics and secure operations are maximized with the integrity of ArmorFlex® materials
•
Low capital, depreciation and operating costs maximizes true cost of ownership
•
Immediate implementation supports Production and Lab processes in any part of the plant
•
Reduced cleaning and cleaning validation
•
Drums can be moved freely without breaking containment
•
W hat containment level provided ?
OEB 5 with results in the nanogram range. Even lower to non-detectable levels would be
expected if the system were to be used in conjunction with an existing down flow booth.
This is anticipated given actual customer feedback and third party IH test results from similar
designs as well as the 100% inflation tests performed on the deliverable enclosures.
W hy use this over other technologies ?
The cost of ownership, ergonomic advantages, ease of use, integrity of the ArmorFlex
material and speed of delivery benefits of this proven flexible solution far outweigh those
of rigid isolation systems.
O ther potential A pplications
This technology is applicable for multiple process steps and includes, but is not limited to:
cGMP access to buffer prep powders
•
Liquid sampling
•
Dispensing
•
52
Drum Sampling Enclosure FAQ’s
Containment
Systems
High performance features:
Clear film allows use of existing
light from the process area
Static dissipative film
Reusable for repeated sampling
Portable
Small footprint utilizes small amount
of floor space
Enclosure is attached to drum wall
allowing lid to be contained
Stretch on enclosure interfaces
with common size drums but can
also be customized
One person operation
Crimp separation for containment
and sample security
Benefits:
At ILC Dover we are always “creating what’s next” by
Drum lid can be opened after drum
is contained
listening carefully to our customers. In some cases,
Can be used in any part of the facility
we are continually improving our offerings using this
No cross contamination transfer to
other parts of the plant
same voice of the customer commitment.
The Drum Sampling Enclosure (DSE) is just such an
example. ILC first starting supplying drum sampling
enclosures internationally in 2002. Based on our
patented flexible containment transfer technology,
we have evolved those original designs to the DSE
system that we offer today.
Ergonomics are maximized with
flexible materials
Low capital, depreciation and
operating costs offers best cost
of ownership
Speed of implementation. It supports
Production and Lab processes in any
part of the plant
Reduced cleaning and cleaning
validation
Drums can be moved freely without
breaking containment
Crimping with DoverPac® system
confirmed as the best possible
containment
Tamper proof sampling achieved
53
Drum Sampling Enclosure FAQ’s
Containment
Q:
Systems
A:
How is the flexible liner removed
from the drum after use? Seems
like containment would be lost
once the tape is removed.
The containment level stated was for operation and leaving the
enclosure on (original customer’s operation). To remove the
enclosure, the Twist/Tie/Tape/Cut (TTTC) method would need to
be employed due to the film used for the body of the enclosure
and the material thickness. While the TTTC method can be slightly
variable in how tight the bundle is, the amount of powder that
becomes airborne inside the enclosure will be very minimal. If the
sampling is done with care, the enclosure and the TTTC area should
have very little powder and so the containment level should still be
excellent with expectations in the nanogram range.
Have you thought about a DoverLoc
type of clamp to give you a positive
seal without taping?
We looked at a flexible strap originally but were concerned that the
enclosure might slip out from that type of attachment.
Does it work equally well with
plastic and steel drums (you show
a fiberpacks in the brochure).
This works as well with plastic or SS drums.
Specifically, what level of containment are you reaching (there is
mention to nanogram ranges; what
are they, <50 ng/m3, better, worse?).
Do you have test data that would
be available for review?
We have not tested this specific design in ILC’s SMEPAC test facility.
Our intent is qualification by similarity to other enclosures that
we have tested (like the Drum Transfer Station) where our results
ranged from non detects to under 500 nanograms. We do perform
an inflation dwell test on this design as we do with all of our high
containment systems.
Does the size of the drum matter
(i.e. 30 gallon, 50 gallon, etc.)?
We currently have three standard sizes that cover a range of drums
(15” to 17.5” (381mm – 445mm) diameter – Model FE8615S; 17” to
19.5”(432mm – 495mm) diameter – Model FE8615M; 19” to 21.5”
(483mm – 546mm) diameter – Model FE8615L). Custom sizes can
also be accommodated.
How is the drum lid supported
inside of the liner? Seems like
it would get in the way.
The lid is set up vertically on the side. Since this is not a long term
application, we felt the trade off of leaving it set inside was more
cost effective than supporting it with a stand. The good news is that
you can remove the lid inside the enclosure rather than risking a
potential exposure by removing the lid first.
Is the stand support adjustable
regarding height?
The stand is three lengths of square SS stock that are connected by
push pins. Sections can be removed for gross height adjustment.
Which film are you using for
this system?
The body is AF113, a clear PE film that has been formulated to meet
FDA and the new EU regulations but not tested to date. The sleeves
are AF110.
For removal and disposal, I assume
the HEPA filter allows the liner to
collapse; where is the filter, how is it
mounted to the liner, what size, etc.?
The HEPA filter is attached via a screw attachment to a fitting that is
welded to the enclosure on the top panel. This is one of our standard
85L/m (3 cfm) HEPA filters.
What size crimps does the sampling
sleeve use (red, yellow or blue)?
Yellow
54
DoverPac® SF
Containment
O verview
Systems
The original DoverPac® SF was launched to be used in conjunction
with Split Butterfly valves (Figure 1). This system replaces rigid bottles.
H ow does the system work ?
The basic DoverPac® SF is used either unrestrained (Figure 2), with an
integral restraint (Figure 3) or with a reusable restraint.
The system can be filled and emptied through a standard 4” (100mm)
DN100 or DN150 integral sanitary flange. The design is set up so that
the SF can be used with any Split Butterfly Valve. Filling and emptying
the liner is accomplished by attaching the passive half of the valve to
the liner which then docks with the active half of the valve. Other
sizes have been accommodated as well.
The sanitary flange is injection molded and then thermally
welded to the liner. This is done with a blended lap weld
which keeps all of the load in shear and eliminates any
possibility of powder hangup or bioburden build up in an
otherwise raised lip at the seal area.
Figure 1
The unrestrained design uses a separate lifting bar when
it is supported for vessel charging. This is significantly
more robust than an encapsulated plate.
The restrained version is provided when a concern over
back pressure exists. This design uses an integrated
restraint that has been proven to withstand pressure
Figure 2
excursions of 0.499 bar with a 2X safety factor.
A window is included in the restraint so the operator
can see that all powder has been discharged into the vessel.
Figure 3
A variety of configurations are
available including
Sizes from 1L, 5L, 10L, 15L, 25L,
30L, 50L, and 100L.
•
An integral tube for addition of
liquids creating slurry within the
liner or for rinsing out the liner to
recover any remaining powder
(Figure 4)
•
The DoverPac® SF has also been
adapted for cGMP and higher
containment applications. For
cGMP, a dual tied/S-folded neck
is incorporated. (Figure 5). For
containment needs past that
of split butterfly valves, a model
that attaches to our patented
multi O-ring system can be
used. (Figure 6).
Figure 4
55
DoverPac® SF
W hat are the applications ?
This system has been proven to be of value in:
Dispensing from Isolators
•
Reactor Charging
•
Tank charging for mixing creams
•
Creating a slurry for later charging into a tank
•
W hat are the features / benefits ?
Figure 5
Features
Flexible
•
Clear
•
Sanitary Flange
•
•
Range of Sizes
•
ArmorFlex Family of Films
Benefits
Can be manipulated to overcome bridging,
also achieves over 99.5% product discharge
•
Figure 6
Operators can see product without breaking containment
•
Interfaces with any Split Butterfly Valve
•
Supports Lab scale through Bulk production
•
Assures ruggedness, static dissipation and material
of contact compliance
•
W hat containment level I S provided ?
The containment level achieved is that of the Split Butterfly
Valve selected.
If a configuration is selected that interfaces with a DoverPac®
multiple o-ring canister as in Figure 6 above at the right, containment
to the OEB5 levels in the nanogram range can be achieved.
W hy use this over other technologies ?
Reduced cost of ownership
•
Eliminates cleaning and cleaning validation
•
Eliminates waste treatment of cleaning solutions
•
Best product recovery
•
Visual access to drug product being manufactured
•
Liner can be manipulated to overcome bridging
•
56
DoverPac® SF (BioPharmaceutical) From Lab Scale Through Production Processes
O verview
Containment
The DoverPac® SF (BioPharmaceutical) consists of a series of standard and
customized applications based on the DoverPac® SF (Split Flange) technology (FCSG 007).
This expansion of single-use manufacturing is designed to meet the needs of speed of
implementation, ease of facility design, reduced validation, cost savings over cleaning
and cleaning verification, and reduced capital costs to the operation.
Systems
H ow does it work ?
The DoverPac® SF can be attached to a variety of process vessels with by an integral sanitary
flange (either sealed or clamped to the liner) or via our patented multi o-ring technology.
Materials of Contact
The ArmorFlex® Film is utilized to provide structural integrity, as well as meet the
rigorous demands for materials of contact. Using existing and specific reference,
monographs, key needs, such as no animal derived components, extractable/
leachable limits, and food contact compliance, to name a few, are addressed.
The Sanitary Flange Interface
The sanitary flange is injection molded and then thermally welded to the liner.
This is done with a blended lap weld which keeps all of the load in shear and
eliminates any possibility of powder hang-up or bioburden build up in an
otherwise raised lip at the seal area.
Figure 1 shows the
basic design with
a 4 inch/100mm
sanitary flange.
The unrestrained design uses a separate lifting bar when it is supported for
vessel charging. This is significantly more robust in larger volumes and
supported weights than an encapsulated plate. In fact, customer testing
has shown the 100L version to hold 165 pounds/75 kgs. Reusable restraints
are also available for added support.
The DoverPac® SF is also available with an optional S-fold on the neck as
shown in Figure 2. This functions as an integral “clamp” to shut off powder
flow when making the connection to the vessel.
Figure 2
Multi O-ring Canister Attachment
The interface to the vessel can also be supplied in our
patented multiple o-ring technology. This configuration
is shown in Figure 3. Attachment of the first liner to the first
groove in the canister is made. The powder transfer operation is completed and the neck attached to the
vessel is then removed using our crimp separation method.
The subsequent liner is then attached to the next groove
above the stub and the stub is then bagged out.
Standard solutions are also available for DN 100 and 150
flange interfaces. A variety of configurations are available
including 1L, 5L, 10L, 15L, 25L, 30L, 50L, and 100L.
Figure 3
W hat are the applications ?
Use of powder transfer devices within existing buffer prep processes whether new or existing
operations, is gaining momentum as well. Figure 4 illustrates just such an example during the
Factory Acceptance Test (FAT) stage of the project at METO where dispensing to weight operations
were being trialed. Now that this has been successfully completed, process installation efforts
are underway.
57
DoverPac® SF (BioPharmaceutical) From Lab Scale Through Production Processes
Since this was a dispense to weight operation within a tightly controlled
tolerance, the need to separate the support frame and scale from the
drum inverter was needed. Figures 5 and 6 show the application of a
flexible sleeve with molded sanitary flanges as a method for achieving
this need.
F eatures
Flexible
•
Clear
•
Sanitary, DN and multi o-ring flange interfaces
•
Range of Sizes
•
ArmorFlex® Family of Films
•
Gravity feed
•
No capital
•
Reduced cleaning and disposal
•
Figure 4
B enefits
Can be manipulated to overcome bridging, also achieves
over 99.5% product discharge
•
Operators can see product without exposing product
•
Interfaces with any vessel interface
•
Supports clinical through production scale up
•
Assures ruggedness, static dissipation and material of
contact compliance
•
No expensive mechanical systems, eliminates validation
of mechanical components, simple to use
•
Figure 5
Best overall cost of ownership, small footprint
•
Supports Green Initiatives
•
W hat containment level provided ?
Often applied for cGMP containment, however, if a configuration is
selected that interfaces with a DoverPac® multiple o-ring canister
as in Figure 3, containment in the nanogram range can be achieved.
W hy use this over other technologies ?
Reduced cost of ownership
•
Eliminates cleaning and cleaning validation
•
Eliminates waste treatment of cleaning solutions
•
Best product recovery
•
Visual access to drug product being manufactured
•
Liner can be manipulated to overcome bridging
•
58
Figure 6
DoverPac® Tray Dryer Enclosure Technology
Containment
Systems
O verview
Tray Dryers are a common method of drying wetcakes and granulated drug products. This is especially true in the early product
development phase. The issue of containment for this type of
process equipment is unique in that open scooping of powder onto
multiple trays that get slotted into the dryer one at a time prohibits
a mass, single transfer as with charging a vessel through a nozzle.
1
2
3
There are many styles of Tray Dryers that drive the Engineering
Control here to a custom design. However, containment is accomplished with a standard set of interface and design techniques.
The various styles of dryers, interfaces, door types, volumes,
ergonomics, and life cycle costs must all be taken into account
in order to meet the need of containing the dryer. Included here
is whether the dryer is portable or a fixed installation.
H ow does the system work ?
The final design may vary from operation to operation but a typical installation
includes adding a flange to the face of the dryer to the outside of the door.
An enclosure made from the rugged ArmorFlex® family of films is then attached
to the flange and a supporting frame assembly. The door is within an enclosed
environment when loading and unloading the trays with the drug product.
4
5
The trays, drug product and associated process tools can either be preloaded
into the enclosure or bagged into the isolated area via bag in/bag out (BIBO)
canisters or larger drum ring attachment canisters. The steps outlined below
represent a typical example of this type of process:
1.Attach the enclosure to the support frame using the bungee cords
supplied. Also attach the enclosure to the BIBO canister.
2.Preload trays into the enclosure (or bag in after the enclosure is attached).
3.Attach the enclosure to the flange on the dryer using the tape and
V-Groove trim method developed by ILC and open the dryer door.
4.Load the bags of wet cake material into the enclosure through a
bag-in sleeve.
5.Scoop material from the bags onto the dryer trays, load the trays into
the dryer and close the dryer door for processing.
6.After the drying process is complete, open the door, remove the trays
within the enclosure and scoop the powder into plastic bags which in
turn will be placed into a bag-out sleeve. Alternatively, the powder can be
scooped directly into a DoverPac®, Continuous Liner, or Transfer Sleeve.
7.Crimp, cut a remove the contained materials for further processing.
After processing is completed, spray mist the inside of the enclosure as part
of the overall wash down. The flexible enclosure will then be removed from
the dryer while wearing personal protective equipment (PPE) as part of the
wash down process.
6
Portable Tray Dryer
1 Enclosure
2 Frame
3 BIBO Canister
4 Portable Tray Dryer
5 V groove trim
attachment to flange
6 Flange
Frames are typically supplied in 304 Stainless Steel with a 2b mill finish.
Other materials can be provided as required.
59
DoverPac® Tray Dryer Enclosure Technology
W hat are the applications ?
Portable and permanently installed Tray Dryers have been fitted
with this type of flexible containment technology.
Features
Clear film allows use of existing light from the process area
Bungee cords and HEPA filters allow the enclosure to move
with the operator
• Static dissipative film supports ATEX and Ex operations
• Re-usable for repeated processing of same drug product
• Portable or permanent installations supported
• Customized to specific process and equipment without
change to drug product drying process
•
•
Benefits
Ergonomics maximized for visibility, operator height and reach
No cross contamination transfer to other parts of the plant
• Low capital, depreciation and operating costs maximizes true
cost of ownership
• Speed of implementation supports Lab and Production processes
in any part of the plant
• Reduced cleaning and cleaning validation
• Product can be transferred between operations without breaking
containment
• No change in validation
•
•
W hat containment level I S provided ?
OEB 5 with results in the nanogram range. This is anticipated given
actual customer feedback and third party IH test results from similar
designs as well as the 100% inflation dwell tests performed
on the deliverable enclosures.
W hy use this over other technologies ?
The cost of ownership, ergonomic advantages, and speed of delivery
benefits of this flexible solution far outweigh those of rigid isolation
systems.
60
Mill Containment System - Bohle BTS 100
61
Mill Containment System - Bohle BTS 100
62
Tablet Coater Containment System - O’Hara LCM Tablet Coater
O verview
Recently delivered for lab scale operations
at an International Pharma manufacturer, the
installation described in this Containment
Guide takes the idea of retrofits to another
level. Here, a new piece of equipment
was needed but cost savings were realized
by modifying an existing design. Flanges
added to the unit by the original equipment
manufacturer (OEM) allow this end user to
process contained when needed and to use
existing procedures when containment is not
required.
Containment for the O’Hara LCM Tablet
Coater is provided by two individual rectangular enclosures. One enclosure surrounds the
pan access door and the second the exhaust
plenum access door.
The enclosure is manufactured from clear
ArmorFlex® film that allows room light to illuminate inside the enclosure for easy viewing.
This rugged film provides a safe working environment while enabling the enhancements
developed through numerous installations
using this flexible containment technology.
1
2
3
4
Coater
Enclosure Support Frame
BIBO Canister Support Frame
Coater Enclosure
with HEPA Filters
5 Filter Change Out Enclosure
with HEPA Filters
6 BIBO Sleeve
7 BIBO Canister
H ow does I T work ?
The pan access enclosure is used for product charging and removal as well as sampling, cleaning and
spray gun maintenance. It has one pair of glove sleeves. A single entry/removal point provides a means
for moving product and supplies in and out of the enclosure. This entry/removal point supports the use
of a bag-in/bag-out sleeve or interface with ancillary containment devices such as an in-process isolator.
The enclosure is mounted in such a way that it can be collapsed inward toward the front of the coater.
This simplifies loading and unloading product through the circular door on the coater. The enclosure is
fully extended to provide clearance when opening the larger pan access door for cleaning operations.
The exhaust plenum enclosure is mainly used for cleaning operations. It has a pair of glove sleeves and
a cleaning wand sleeve. It can also be equipped with a storage/waste sleeve if desired. Both enclosures
also include HEPA filters to balance the pressure in the enclosure and allow it to move freely as the
operators perform various operations.
Attachment flanges running outward from the cabinet around each of the access doors provide a
means of attachment for the enclosures. This allows for containment to be applied to the process
area of the equipment with the technical area segregated from any contamination. A bag-in canister
is mounted on a mobile stand with integral product staging table. An external enclosure support
frame supports the enclosures without need of ceiling attachment.
The enclosure also includes a spray-wand cleaning sleeve to allow misting of the interior of the
enclosure during cleaning. Spray mist of the inside of the flexible enclosure and surfaces of the
equipment within the contained area eliminates airborne contaminants prior to removing the
containment. Cleaning of the surface of the equipment is done following normal practices.
63
Tablet Coater Containment System - O’Hara LCM Tablet Coater
W hat are the F eatures and B enefits of this technology ?
Features
•
•
•
•
Retrofit to existing equipment design
Process and Technical areas separated
Validated containment technology
Clear film
•
•
Passive system
Flexible materials
Disposable components
Adaptable to other process equipment
•
•
•
Nanogram containment levels achieved
Supports visibility for maintenance
Does not affect ATEX and Ex ratings
Ergonomics maximized
Speed of implementation
•
•
Benefits
Provides the lowest overall cost of process ownership through low capital and
operating cost including reduced cleaning
and cleaning validation
• Fastest turnaround of a processing suite
for subsequent manufacturing campaigns
• Process is contained without contamination of motor, drive shaft, and controls
•
•
•
W hat containment level I S provided ?
OEB 5 with results in the nanogram range. This
is based on customer test data, other proven
applications, third party testing to the “SMEPAC”
protocols on similar designs, and the 100%
inflation tests performed on the deliverable systems.
W hat are the applications ?
This containment technology can be applied to any Oral Solid
Dosage (OSD) type of processing equipment. Applications
to myriad Tablet Presses, Coaters, Dedusters, Blenders,
Granulators, Mills, Roller Compactors, Spheronizers, Extruders,
Fluid Bed Dryers, and weighing/subdivision processes have
been demonstrated successfully.
W hy use this over other technologies ?
The cost of ownership, ergonomic advantages, and speed
of delivery benefits of this flexible solution far outweigh
those of rigid isolation systems.
Tools such as Lean Manufacturing come into play more
and more. For example, the time to clean and validate the
cleaning are major bottlenecks for processing efficiencies in
the plant. Being able to minimize this part of the process results
in getting products to market faster and at an overall reduction
in operating costs when considering labor, utilities, and waste
disposal costs. It also supports getting multiple products to
market faster within an existing facility without risking product
safety.
64
Contained Offloading of Aurora Filters - Processing from Nutsche Filters
Containment
Systems
O verview
Nutsche Filters are a mainstay in processing in the Pharmaceutical and Chemical industries. They
typically function by keeping the slurry contents fluidized until most of the mother liquor is filtered
through. When filtration is complete, the cake can be washed by reslurrying the cake. After washing,
the mother liquor can be refiltered and the cake can then be discharged.
AURORA FILTERS, a Division of ALL-WELD Company Limited, designs and fabricates a line of Nutsche
filters for the pilot scale production of active pharmaceutical ingredients. These designs typically
combine a glove box with a single plate vacuum Nutsche under an inert gas blanket to ensure operator
safety and product integrity.
Each filter has seven process connections - Slurry Inlet, Nitrogen Inlet, CIP Wash Inlet, Vent,
Nitrogen Inlet for Drying, Final Vacuum Outlet, and Filtrate Vacuum Outlet.
•
Each filter has a large viewing window on the Upper Chamber as well as a small sight glass on
the Lower Chamber.
•
A Heating/Cooling Jacket designed for 50 to 75psi and registered to ASME Code surrounds the
cake collection area. This jacket is for use with heat transfer fluids only, such as cooling brine,
hot water, Dowtherm, Silthane, Glycol, or similar liquids.
•
The remainder of the filters are not considered a registered pressure vessel. The Upper Chamber
is designed for atmospheric conditions only and the Lower Chamber is designed for atmospheric
to full vacuum conditions.
•
The CIP Spray ball assembly is designed such that the entire spray ball assembly can be
extracted from the nozzle without disassembly within the filter. The spray ball components
are either Teflon or equivalent to the wetted material of choice.
•
However, the outlet of the filter is not typically contained. This Flexible Containment Solutions
Guide outlines several methods of achieving a contained discharge from the Aurora Filter.
1
H ow D O E S T H E C O N T A I N E D O F F L O A D I N G S Y S T E M W O R K ?
There are a variety of methods that can be used to achieve contained offloading
of an Aurora Filter. The designs of the filters are varied so the applications below
represent a few of the installed solutions. Some customization may be needed
depending on the specific filter.
Offloading to DoverPacs®
2
3
The key components in The DoverPac® system include:
4
Transition adapter between the vessel and the DoverPac® canister
•
Multiple o-ring canister (typically separate from the Transition Adapter but
these can be combined into one piece of hardware)
•
DoverPac® which is a combination of inner liner and outer Type C restraint
•
The new FlexLoc clamp (an improvement over the original DoverLoc
clamp that replaced the original cir-clip)
•
The Crimp Separation System (the replacement for the original twist, tie,
tape and cut system for repeatable separation of the liner from the vessel
without breaking containment)
•
1 Fill neck with o-rings 4 Body
5 Bag Out Sleeve
2 Bag Out Sleeve
6 Discharge neck
3 Sample Sleeve
with o-rings
5
6
DoverPac Liner (shown
without Restraint)
65
Contained Offloading of Aurora Filters - Processing from Nutsche Filters
The basic operational steps are performed for offloading the filter:
1 Attach the fill neck of the DoverPac® to the ILC Dover supplied multiple o-ring canister and shuffle up
some of the neck to create a clean zone for crimp separation
2. Bag out the stub from the previous liner
3. Open the valve on the vessel and use the sample sleeve to take a sample if required by the process
4. Finish filling
5. Pull down the clean zone, twist the neck, and apply the crimps.
6. Cut between the two crimps and close the caps on the crimps. Note that this leaves the stub that will
be bagged out with the next DoverPac®
7. Repeat steps 1 – 6.
The same process is used to charge the next vessel except there is no sampling sleeve at
that point.
In the application below, an offset canister with the capability to offload to three 110L
DoverPacs® was installed on the sanitary flange of the 8” (200mm) Cora Valve on the
discharge chute of the vessel. Once the filtration process is complete, the valve is opened
and the Operator scoops powder through the chute and into the DoverPac® using the glove
ports that are supplied as part of the Aurora Filter.
The DoverPac process outlined above is then followed.
After processing, a Clean In Place (CIP) tundish is attached to the sanitary flange on the
canister by bagging it in with the CIP sleeve.
Offset canister
DoverPac®
66
Contained Offloading of Aurora Filters - Processing from Nutsche Filters
Flexible Enclosure Offloading
Flexible Enclosures are a proven alternative to rigid gloveboxes. These can be provided in
either a passive system or with a Ventilation System included.
The enclosure is manufactured from clear ArmorFlex® film that will allow room light to
illuminate inside the enclosure for easy viewing. It is also equipped with a bag in/bag out
sleeve which is used for introducing product and tools to and from the enclosure without
breaking containment.
In this application, a standard 8” multiple o-ring canister is attached to the outlet of the
filter. The enclosure is then attached to the same canister to provide a contained connection during the transfer of powder.
A 14” Continuous Liner is connected to the canister inside of the enclosure. This is a
factory packed, 35’ long liner. Once the Continuous liner is filled, it is crimped and the
bagged out using the BIBO Sleeve on the side of the Enclosure.
3
1
4
5
2
Isometric View
1 Mobile Frame
2 Flexible Enclosure
3 Glove ports
View from the Glove port side
4 Attachment to Filter Outlet
5 BIBO Canister
67
Contained Offloading of Aurora Filters - Processing from Nutsche Filters
The basic process steps include:
1 pull a length of the Continuous Liner
down from the pack
2 open the valve on the filter outlet to
allow powder transfer to the liner
3 when filled, twist and crimp the liner
4 place the filled section of the liner into
the bag out sleeve and then twist and
crimp the BIBO Sleeve. This is then
moved to the next step of the process.
F E AT U R E S
BENEFITS
•
•
•
•
•
•
•
Validated containment technology
Clear film on enclosures
Passive and ventilated systems available
Flexible materials
Disposable components
Retrofits to existing filters
•
•
•
•
•
•
nanogram containment levels achieved
visibility during operation
Containment to a broad range of requirements
Ergonomics maximized
Reduced cleaning and cleaning validation
Low capital and operating cost
Speed of implementation
W H AT C O N TA I N M E N T L E V E L P R O V I D E D ?
OEB 5 with results in the nanogram range. This is based on proven applications, third party
testing to the “SMEPAC” protocols on similar designs, and the 100% inflation tests performed
on the deliverable systems.
WHY USE THIS OVER OTHER TECHNOLOGIES?
The cost of ownership, ergonomic advantages, and speed of delivery benefits of this flexible
solution far outweigh those of rigid isolation systems.
O T H E R P O T E N T I A L A P P L I C AT I O N S
AURORA FILTERS are designed primarily for the applied research, development and pilot scale
operations within the pharmaceutical and chemical industry. Containment for offloading in
addition to the applications outlined above can be applied via:
Continuous liner system on outlet for contained filling in drums
Transfer Sleeve on the outlet for direct transfer to IBCs or other vessels
•
•
68
Mill Containment System - Jet Mills
O verview
The process for this application consists of the controlled feeding of a mill through a feeder.
The powder is introduced into the feeder using a Drum Transfer System. After the particle
reduction is complete, the powder is passed through a Cyclone housing and collected in a
continuous liner system.
The Jet Mill, or Micronizer as this style of mill is also called, used in this application is a
Jet Pulverizer 8” Micron Master. In this process, air drives the particles which are
reduced in size when they impact upon each other. Smaller particles flow up the
transfer tube to the Cyclone housing while the larger particles continue to be
impacted on each other until they are reduced to the desired size (see
Figure 1 at right).
The Feeder in this application is the K-TRON Model number K-PH-MV-KT20 feeder.
This is a 20L, twin screw, volumetric feeder with a separate control system.
Figure 1
This equipment was on site prior to this effort. Some modifications were required
by the customer which included, but were not limited to, modification of the piping
going to the Cyclone and mounting the equipment on the ILC supplied cart.
5
HOW DOES IT WORK?
This system (Figure 2 at right) provides a contained method
of transferring the complete or partial contents of drums to
a variety of processes including milling. The design will
accommodate the charging of several different types of
mills with various sizes and shapes though the Jet
Pulverizer 8” Micron Master was used in this application.
In the case of partial transfers, the system provides
a contained method of resealing the drum for return
to stock. The system consists of a flexible enclosure
mounted on a mobile stainless steel frame (see
Figures 3 and 4 on next page).
Product drums are over-sleeved with disposable drum
attachment sleeves. The sleeves are stretched over the
drum and taped to the drum. The opposite end of the
sleeve is attached to the 23” diameter stainless steel
bag-in ring using a band clamp and integrated O-rings.
This provides a connection interface to attach the
sleeve and introduces the drum into the enclosure.
3
6
2
4
1
Figure 2
1
2
3
4
5
6
Mill Containment Cart
Feeder Inlet Canister
Drum Lifter
Drum Transfer System Frame and Platform
Drum Transfer System Enclosure
23” Diameter Continuous liner (not shown)
The enclosure containing the Mill and Feeder is mounted on a tray integral to the cart provided
by ILC Dover. All air and electrical lines are passed through the tray. The milled product feed pipe
to the Cyclone passes through a single interface ring which includes a groove for enclosure attachment. This ring is mounted to the cart. The feed hopper is fitted with a grooved canister to also
allow enclosure attachment for the Drum Transfer Station and the Mill.
The mill enclosure includes three butyl gloves. A right and left pair are on the front of the enclosure.
The third is a bidirectional glove on the opposite side on the enclosure. HEPA filters and bungee cords
allow for the enclosure to move with the operator which is an ergonomic benefit that is not achieved
with a rigid system.
69
Mill Containment System - Jet Mills
The milled powder is collected from the bottom of the cyclone via a 23” diameter, 50 foot continuous
liner in this application. This interface is fitted with a valve to prevent inflation of the liner. DoverPacs®
could be used instead if contained powder transfer to the next step in the process were required.
W hat are the applications ?
In addition to the Jet Pulverizer system, containment has been proven on other Micronizers.
Fielded applications include, but are not limited to, the Microtech Midas Mikronizer – 200.
Enclosures that separate the process and technical areas as well as systems
that encapsulate the entire Jet Mill have been supplied.
5
W hat are the features / benefits ?
Features
Process and technical areas separated
Clear film
4
Flexible materials
Retrofit to existing equipment
3
Validated containment technology
Benefits
Process is contained without contamination of motors
and controls
Visibility optimized and use of room lighting achieved
Ergonomics maximized
Figure 3
Capital equipment costs minimized
Reduced cleaning and cleaning validation
W hat containment level provided ?
The Occupational Exposure Level for this application was set to be less
than 1 μg/m3. The flexible containment technology utilized in this application has been proven to be capable of being below this level in third
party and customer testing. Test results on a variety of powders have
shown that containment in the 250 to 500 nanogram range is achievable.
W hy use this over other technologies ?
The cost of ownership, ergonomic advantages, and speed of delivery
benefits of this flexible solution far outweigh those of rigid isolation
systems.
Figure 4
70
Granulator Containment Technology
O verview
In the pharmaceutical industry, granulation is used to create bonds between multiple particles as
part of the oral solid dosage manufacturing process. Two types of granulation technologies are
employed, Wet Granulation and Dry Granulation.
The containment systems described in this guide center around wet granulation which involves the
massing of a mix of dry primary powder particles using a granulating fluid. The powders can range
in properties and potency and are subjected to a variety of additional steps including sieving, drying
and milling.
Used for lab scale and production operations at multiple International Pharma manufacturers, our
contained Granulator applications take the idea of retrofits to another level. Here, a broad range
of existing and new equipment are supported as a tool to eliminate the risk of contained powder
processing.
H ow does it work ?
Two methods of containment have been applied. One uses
flanges that are added to the piece of process equipment that
then have a flexible enclosure attached to the flange in operation. The second is to totally encapsulate the granulator with a
pan mounted flexible enclosure.
Equipment Mounted Enclosures Separate the
Process and Technical Areas
The use of stainless steel flanges added to the granulator
enables the containment of the process area. The enclosure
is attached to the flange and includes glove sleeves, bungee
cords, and HEPA filters. These features support access to
the equipment while maximizing ergonomics and support
operators from the 5th percentile female to the 95th
percentile male.
Pan Mounted Enclosures Encapsulate the
Entire Granulator
Pan mounted enclosures allow the entire piece of process
equipment to be contained. This is beneficial for equipment
that can not be modified to use the flange mounted
approach.
Flange Mount Style
Again, the enclosure is supported by bungee cords,
attached to the pan, and includes glove sleeves for
access to the equipment. The enclosure “moves”
with the operator, as is the case with all of our flexible
enclosure systems, to maximize ergonomics as noted
above.
Pan Mount Style
71
Granulator Containment Technology
1
W hat are the applications ?
The enclosures are manufactured from clear ArmorFlex® 113 film that allow room light to illuminate inside
the enclosure for easy viewing. This rugged film provides a safe working environment while enabling the
enhancements developed through numerous installations. Transfer Sleeves are made from another version
of ArmorFlex® film. This is the same monolayer film
used in our DoverPacs® and as such brings regulatory
pedigree for materials of contact.
4
3
5
2
Figure 1
The use of flexible containment allows the end user to
process contained when needed or to follow existing,
open processing procedures when containment is not
required.
1 Enclosure
2 Pan
3 BIBO canister
4 Support frame
5 Glove Sleeves
FluidAir PharmX Model PX-1
In this design, containment is achieved by encapsulating the entire granulator inside a pan mounted flexible
enclosure (see figures 1). In this case the pan is 33”
(838 mm) x 60” (1524 mm). Space beside the granulator is maintained inside the enclosure for staging of
product and materials to support the overall process.
Three ambidextrous gloves are incorporated into the
flexible enclosure to support ease of operations when
loading and unloading the granulator and operating
the controls. A bag-in bag-out (BIBO) interface allows
materials to be passed in and out of the enclosure
without breaking containment. The entire unit is supported on a frame that includes conductive casters
which make the system portable.
Glatt GPGC2 Fluid Bed Granulator
In the application shown in figure 2, flanges were
added to an existing design that allows the attachment
of the flexible enclosures. The two enclosures allow for
access to the bowl of the granulator and the filters. A
telescoping frame supports the enclosure when charging and offloading the equipment. This frame can be
collapsed on itself to allow the enclosure to be folded
out of the way when not being operated.
1 Support
Frames
2 Enclosure
3 Filter
Change Out
Enclosure
4 BIBO
Canister and
Sleeve
2
4
3
Figure 2
Collette High Sheer Granulator – 10L and 20L
Figures 3 and 4 depict this containment system which
also uses the flange mount feature to achieve containment while separating the process and technical
areas. A roll away frame supports the enclosure. This
frame also includes a platform that functions as a
table to support the bags of material.
Figure 3
72
1
Granulator Containment Technology
This style of granulator includes a separating cover as part of
the top-driven mixer and chopper with a removable bowl. The
enclosure and flange are elongated on the lower front face of
the equipment to support the movement of the process area
without breaking containment.
ProCepT Mi Pro 1900
Containment of the Mi-Pro Mixer/Granulator, figure 5, is
achieved by a flexible enclosure surrounding the process
chamber and staging area forward of the control system connection column. A single pair of glove sleeves is provided to
charge and collect product from the process vessel. A single
entry/removal point using replaceable bag-in sleeves provides
a means for moving product and supplies in and out of the
enclosure. The enclosure also includes integral HEPA filters
to balance the pressure in the enclosure and allow it to move
freely as the operators perform various operations.
Figure 4
The enclosure is
attached to a stainless
steel base pan with
vertical attachment
flanges. A small
attachment canister
with liquid tight connectors provides a method
of introducing utilities
into the contained area.
An external frame
supports the enclosure
and the bag-in canister.
RapidMix 100
Granulator
This granulator is a
fixed installation as opposed to a mobile design. As seen in figures
6 and 7, the granulator
is placed on a floor pan
Figure 5
that is 85” (2159 mm)
by 54” (1372 mm).
The overall height of the enclosure is 88.5” (2248 mm) to
allow clearance for the opening of the lid of the granulator.
Seven glove sleeves are located to support opening of the
lid, access to the controls, discharge of the materials, and
bag in/bag out of raw materials and the processed powder.
The frame is used to support the enclosure during
operations and can be wheeled out of the way for
storage when not in use.
Figure 6
Figure 7
73
Granulator Containment Technology
W hat are the F eatures and B enefits of this T echnology ?
Features
Benefits
Retrofit to existing equipment design
Provides the lowest overall cost of process
ownership through low capital and operating cost
including reduced cleaning and cleaning validation
Fastest turnaround of a processing suite for
subsequent manufacturing campaigns
Process is contained without contamination
of motor, drive shaft, and controls with
flange mount design
Nanogram containment levels achieved
Supports visibility for maintenance
Does not affect ATEX and Ex ratings
Process and Technical areas separated
Validated containment technology
Clear film
Passive system
Flexible materials
Disposable components
Adaptable to other equipment
Ergonomics maximized
Speed of implementation
W hat containment level provided ?
OEB 5 with results in the nanogram range. This is based on customer test data, other proven
applications, third party testing to the “SMEPAC” protocols on similar designs, and the 100%
inflation tests performed on the deliverable systems.
OEB 1
OEB 2
10,000 to 1000
1,000 to 100
OEB 3
100 to 50
OEB 4
50 to 10
10 to 1
OEB 5
1 to 0.1
0.1 to 0.01
Occupational Exposure Levels above are in μg/m3.
W hy use this over other technologies ?
The cost of ownership, ergonomic advantages, and speed of delivery benefits of this
flexible solution far outweigh those of rigid isolation systems.
Tools such as Lean Manufacturing come into play more and more. For example, the time
to clean and validate the cleaning are major bottlenecks for processing efficiencies in the
plant. Being able to minimize this part of the process results in getting products to market
faster and at an overall reduction in operating costs when considering labor, utilities, and
waste disposal costs. It also supports getting multiple products to market faster within
an existing facility without risking product safety.
74
Process Area Barrier Curtains
O verview
Process Area Barrier Curtains are a useful tool in improving the
containment levels in existing installations as a method to reduce
operational exposure risk and to restrict access. Examples of these
types of applications include, but are not limited to, down flow
booth curtains and room access barriers.
Down flow booths, for example, work by pulling air across a drum
or piece of processing equipment which typically provide a
containment level of 100 μg/m3 on an 8 hour time weighted
average (TWA). While this draws the powder into a set of filters,
the airflow is disrupted when an operator is working at this type
of station. When that occurs, eddy currents of air and entrapped
powder start to swirl which disrupts containment. The barriers
described in this guide are a tool in improving this type of application.
Bungee Cord
included with
Enclosure
3 Pair Butyl
Glove Sleeve
Similarly, restricting access to another part of a processing suite has been
a demonstrated need as well. Here, a barrier can be added to a doorway,
for example, to restrict the flow of personnel between the suites.
H ow does it work ?
By isolating the operator’s breathing zone
from the point of exposure with this form
of secondary containment the operator is
protected from the product and vice versa.
The curtains are manufactured from clear
ArmorFlex® 113 film that will allow room
light to illuminate inside the barrier and
not restrict visibility. This rugged film
provides a safe working environment
while enabling the enhancements
developed through numerous
installations using this flexible
containment technology.
Typically, the ArmorFlex® 113 is
patterned to interface with the
opening to be contained. This can
be a flat sheet or a three dimensional
design. The barrier is attached using
flanges and U-Groove channel
as a locking mechanism or by grommets.
Cord to secure Panel
in rolled up position
Rolled up Panel
of Curtain
Zipper to close or open
Panel of Curtain
Closed Panel of Curtain
Doorway
Vinyl Trim can be removed to
roll up one or both Curtain sides
Glove sleeves are incorporated into the panel as needed by the specific process.
These can include right handed, left handed, or ambidextrous gloves.
There are myriad flow booths installed and as such no one curtain design fits everyone’s
needs. As such, customization is provided to make sure the process and ergonomics are
covered correctly.
75
Process Area Barrier Curtains
W hat are the A P P L I C A T I O N S ?
This type of containment can be an extension of down flow, cross flow, and laboratory fume hoods.
In addition, doorway restrictions have also been designed to prevent access from one part of a suite
to another.
The use of flexible containment allows the end user to process contained when needed or to
follow existing, open processing procedures when containment is not required. In both cases,
cost savings are realized by modifying an existing design or using an existing piece of equipment
with no modifications.
W hat are the features / benefits ?
Features
Benefits
Retrofit to existing equipment designs
Clear film
Passive system
Flexible materials
Disposable components
Provides the lowest overall cost of process
ownership through low capital and operating cost
including reduced cleaning and cleaning validation
Supports visibility for maintenance
Does not affect ATEX and Ex ratings
Ergonomics maximized
Speed of implementation
W hat containment level provided ?
These types of barriers are designed to enhance the capabilities of the booths and facilities
installed and rely on the airflow from the primary source of containment.
W hy use this over other technologies ?
The cost of ownership, ergonomic advantages, and speed of delivery benefits of this flexible
solution far outweigh those of rigid isolation systems.
Tools such as Lean Manufacturing come into play more and more. For example, the time to
clean and validate the cleaning are major bottlenecks for processing efficiencies in the plant.
Being able to minimize this part of the process results in getting products to market faster
and at an overall reduction in operating costs when considering labor, utilities, and waste
disposal costs. It also supports getting multiple products to market faster within an existing
facility without risking product safety.
76
Contained Blending - Transfer Sleeve, DoverPac®, Continuous Liner Technology
O verview
Two methods of containing blenders have been
demonstrated. Included here are the use of flexible enclosures and separate, disposable powder
transfer systems.
Area of
detail
The systems described in this containment guide
center around bin blending and V-Blender applications
in Oral Solids Dosage (OSD) manufacturing using
Transfer Sleeves, DoverPacs® and Continuous Liners.
Blending involves the controlled mixing of dry primary
powder particles and excipients. The powders can
range in properties and potency and, if not contained,
can present cleaning and exposure issues.
Figure 1a
1
Dry mixing of granular and other processing
constituents includes a significantly high number
of blending steps. This includes potent and highly
hazardous compounds, excipients, and materials
such as lubricants as processing aids.
As demonstrated by the Risk-MaPP principles,
both current good manufacturing practices (cGMP)
and Industrial Hygiene (IH) needs can be met by
containing the process at the source. By employing
flexible containment and using the logic diagrams from
the Risk-MaPP process, cleaning is minimized and the
operator is protected with this Engineering Control. As
such, processes in multi product facilities can be safely
performed without the risk of cross contamination.
Used for lab scale and production operations at
multiple International Pharma manufacturers, our
contained Blending applications take the idea of
retrofits to another level. Here, existing and new
equipment are supported as a tool to eliminate the
risks posed by uncontrolled powder processing. At
no time are the blenders’ angle of repose affected so
as to change the blending performance.
2
Figure 1b
1 Vac/Purge Port
2 DoverLoc®
Note that the powder containment applications
described below are based on proven designs
supported for customers based on the process
equipment that they specified. ILC Dover does not
have any specific ties to these equipment suppliers and does not recommend one type of blender
over another. Rather, this guide depicts a sampling
of flexible containment applications to a variety of
styles of equipment as standard and customized
containment solutions.
77
Contained Blending - Transfer Sleeve, DoverPac®, Continuous Liner Technology
H ow does it work and what are the applications ?
Three methods of flexible containment using powder transfer systems have been applied to blenders. These include charging and offloading with transfer sleeves, charging and offloading with
DoverPacs® and offloading with a continuous liner system.
This rugged film provides a safe working environment while enabling the enhancements developed
through numerous installations using this flexible containment technology.
The Transfer Sleeves, Continuous Liners and DoverPacs® are made from ArmorFlex® film. This rugged monolayer film brings regulatory pedigree for materials of contact as well as proven use from
multiple process applications.
The use of flexible containment allows the end user to process contained when needed or follow existing, open processing procedures when containment is not required. In both cases, cost savings are
realized by modifying an existing design or using an existing piece of equipment with no modifications.
Charging and offloading with transfer sleeves
A transfer sleeve is essentially a flexible chute that attaches to the blender and the piece of process
equipment being used to fill or offload the blender. Contained attachment is achieved through the
use of a multiple groove canister on the blender and on the IBC, for example. The sleeve is then
clamped onto the blender and IBC to support powder flow.
In the case of a bin blender, the bin can be attached to the tablet press or to an interface in the floor
of the suite where powder transfer to a piece of equipment on a lower floor is part of the process.
Gemco V-Blender to IBC
In the example shown in figures 1a and 1b, a 30 cubic foot Gemco blender is being emptied to a
rigid IBC. The application posed a challenge in lining up for docking with the IBC and in clearances
while the blender rotates.
The system includes a 5 groove multiple o-ring canister attached to the V-Blender, a 2 groove canister
clamped to the IBC, the Transfer sleeve, the DoverLoc®, and the crimp components. The transfer sleeve
is also made with an ArmorFlex® film.
Charging and offloading with DoverPacs®
DoverPacs® are a proven method for contained transfer from vessel to vessel. This system consists
of a liner that is attached to a multiple o-ring groove canister. By incorporating a fill and discharge
neck the same liner can be filled at one process point and discharged into another.
DoverPacs® utilize the crimping system and ArmorFlex® family of films developed by ILC. Various
standard and custom designs are available to fit any process need from lab scale to full production.
Conta Bin Blender Charging and Discharging
While DoverPacs® can be used for charging and discharging any type of blender, the wall mounted
Bin blender shown is an example of an application with this flexible containment technology. In this
design, the process is supported by the installation of a single, 8”(200 mm) multiple o-ring groove
canister on the bin which allows for contained powder transfer through one port for charging, figure
2a, and offloading, figure 2b, the bin. This minimizes the capital expense versus a rigid isolator even
further and allows for existing bins to be used without modification.
Following this step the filled 20L DoverPac® is used to charge a capsule filler.
78
Contained Blending - Transfer Sleeve, DoverPac®, Continuous Liner Technology
Offloading with a continuous liner system
Utilizing a similar multiple o-ring groove canister, ArmorFlex® film, and crimping technique
as above, this system allows contained offloading into drums. Liners are factory packed
with standard bundles of 150’ (45 m), 100’ (30
m), and 50’ (15 m). Custom lengths are also
provided.
1
Gemco V-Blender to Continuous Liners
Figure 3 is an example of offloading a 30 cubic
foot V-blender with a Continuous Liner system
to drums. In this case the rotational clearance
did not allow the Continuous Liner canister to
be installed directly on the blender as in other
applications.
2
Figure 2a
Figure 2b
1 Bin
2 DoverPac®
To account for the clearance, a three groove
canister was mounted on the blender and the
standard canister was mounted on the Transfer
Stand shown. In addition, the stand allows the
Operator to reach the valve on the outlet of
the blender and the transfer sleeve since this
interface is 92” (2337 mm) above the floor in
this installation.
A transfer sleeve is then used as the contained
chute to direct the powder from the blender
to the Continuous Liner. The Continuous Liner
is pulled into a drum that sits on the existing
scale in the floor between the blender supports. This allows for the drum to be weighed
as part of the process.
1
2
3
Input from the operation of this system included “this saved us significant cleaning time
as we no longer need to hose down the entire
suite”. This is a key in the Risk-MaPP logic for
supporting operations in a multi process facility
by eliminating cross contamination concerns.
4
Figure 3
1 Blender Mounted
Canister
2 Transfer Sleeve
3 Transfer Stand
4 Continuous Liner
System
79
Contained Blending - Transfer Sleeve, DoverPac®, Continuous Liner Technology
W hat are the F eatures and B enefits of this T echnology ?
Features
Benefits
Retrofit to existing equipment design
Complies with the Risk-MaPP initiative
Process and Technical areas separated
Provides the lowest overall cost of process
ownership through low capital and operating
cost including reduced cleaning and cleaning
validation
Validated containment technology
Passive system
Flexible materials
Fastest turnaround of a processing suite for
subsequent manufacturing campaigns
Disposable components
Adaptable to other process equipment
Process is contained without contamination
of motor, drive shaft, and controls
No blender shape modifications
Nanogram containment levels achieved
Does not affect ATEX and Ex ratings
Ergonomics maximized
Speed of implementation
No affect on blend uniformity
W hat containment level provided ?
OEB 5 with results in the nanogram range. This is based on customer test data, other proven
applications, third party testing to the “SMEPAC” protocols on similar designs, and the 100%
inflation tests performed on the deliverable systems.
OEB 1
OEB 2
10,000 to 1000
1,000 to 100
OEB 3
100 to 50
OEB 4
50 to 10
10 to 1
OEB 5
1 to 0.1
0.1 to 0.01
Occupational Exposure Levels above are in μg/m3.
W hy use this over other technologies ?
One of the driving forces of this technology is that it reduces the risk of cross contamination in
multi process facilities and it provides safety to the operators in both multi process and dedicated
facilities. By using this disposable Engineered Control, highly hazardous powders are contained
at the source which significantly reduces cross contamination risks and cleaning of process suites
and rigid containment devices.
The cost of ownership, ergonomic advantages, and speed of delivery benefits of this flexible
solution also far outweigh those of rigid isolation systems.
Tools such as Lean Manufacturing come into play more and more. For example, the time to clean
and validate the cleaning are major bottlenecks for processing efficiencies in the plant. Being
able to minimize this part of the process results in getting products to market faster and at an
overall reduction in operating costs when considering labor, utilities, and waste disposal costs.
It also supports getting multiple products to market faster within an existing facility without
risking product safety.
80
Contained Blending - Flexible Enclosure Technology
O verview
Two methods of containing blenders have been
demonstrated. Included here are the use of flexible
enclosures and separate, disposable powder
transfer systems.
The systems described in this containment guide
center around bin blending and V-Blender applications
in Oral Solids Dosage (OSD) manufacturing using
Flexible Enclosures. Blending involves the controlled
mixing of dry primary powder particles and excipients.
The powders can range in properties and potency and,
if not contained, can present cleaning and exposure
issues.
Dry mixing of granular and other processing constituents includes a significantly high number of blending
steps. This includes potent and highly hazardous
compounds, excipients, and materials such as
lubricants as processing aids.
As demonstrated by the Risk-MaPP principles,
both current good manufacturing practices (cGMP)
and Industrial Hygiene (IH) needs can be met by
containing the process at the source. By employing
flexible containment and using the logic diagrams
from the Risk-MaPP process, cleaning is minimized
and the operator is protected with this Engineering
Control. As such, processes in multi product facilities
can be safely performed without the risk of
cross contamination.
Used for lab scale and production operations at
multiple International Pharma manufacturers,
our contained Blending applications take the idea
of retrofits to another level. Here, existing and new
equipment are supported as a tool to eliminate the
risks posed by uncontrolled powder processing. At
no time are the blenders’ angle of repose affected
so as to change the blending performance.
Note that the powder containment applications described below are based on proven designs supported
for customers based on the process equipment that
they specified. ILC Dover does not have any specific ties to these equipment suppliers and does not
recommend one type of blender over another. Rather,
this guide depicts a sampling of flexible containment
applications to a variety of styles of equipment as
standard and customized containment solutions.
81
Contained Blending - Flexible Enclosure Technology
H ow does it work and what are the applications ?
Three methods of flexible containment using enclosures have been applied to blenders. These include
containing the entire blender in an enclosure, using an enclosure and flanges attached to the blender
to separate the process and technical areas, and charging and offloading a blender with an enclosure
attached to the valve on the blender.
The enclosures are manufactured from clear ArmorFlex® 113 film that allows room light to illuminate
inside the enclosure for easy viewing. This rugged film provides a safe working environment while
enabling the enhancements developed through numerous installations using this flexible containment
technology.
The Bag-in/Bag-out (BIBO) Sleeves and DoverPacs® are often used to transfer powders into and out of
the enclosure. The Sleeves and DoverPacs® are made from another version of ArmorFlex® film and as
such brings regulatory pedigree for materials of contact.
The use of flexible containment allows the end user to process contained when needed or follow
existing, open processing procedures when containment is not required. In both cases, cost savings
are realized by modifying an existing design or using an existing piece of equipment with no
modifications.
Separating the Process and Technical Areas of the Blender
In this method, flanges are added to the piece of process equipment, usually by the original
equipment manufacturer (OEM). A Flexible Enclosure is then attached to the flange.
The use of stainless steel flanges added to the blender enables the containment of the process area.
This then keeps the controls, motors and other components of the technical section of the equipment
away from the powder being processed to avoid contamination. The enclosure is attached to the flange
and includes glove sleeves, bungee cords, and HEPA filters. These features support access to the
equipment while maximizing ergonomics for operators from the 5th percentile female to the 95th
percentile male.
Globe Pharma Blend Master V-Blender
1
In the application shown in figure 1, flanges
were added to an existing design that allows
the attachment of the flexible enclosures.
The frame is included to support the enclosure.
This frame is on casters so it can be moved
out of the processing suite and stored when
not being operated. The overall enclosure is
58” (1473 mm) x 44” (1118 mm) x 70”
(1778 mm) tall.
2
3
4
5
Figure 1
1 Enclosure
2 Support Frame
3 Attachment Flange
82
4 Glove Sleeves
5 BIBO Canister
and Sleeve
Contained Blending - Flexible Enclosure Technology
Containing the Entire Blender
1
Pan mounted enclosures contain the entire
piece of process equipment. This is beneficial for
equipment that can not be modified to use the
flange mounted technology described above.
The enclosure is supported by bungee cords,
attached to the pan, and includes glove sleeves
for access to the equipment. The enclosure
“moves” with the operator, as is the case
with all of our flexible enclosure systems,
to maximize ergonomics as noted above.
2
3
5
Chitra V- Blender
4
In this design, the containment is achieved by
encapsulating the entire blender inside a flexible
enclosure. The enclosure is of the pan mounted
style, see figure 2, where the pan is situated on
the floor of the process suite. In this case the
pan is 53.5” (1359 mm) x 74.5” (1892 mm).
The enclosure height is 75.5” (1918 mm).
Multiple sets of gloves are incorporated into the
flexible enclosure to support ease of operations
when loading and unloading the blender and
operating the controls. A Bag-in Bag-out (BIBO)
interface is included to allow materials
to be passed in and out of the enclosure
without breaking containment. The entire unit
is supported on a frame.
PK Blendmaster
A similar design contains the PK Blendmaster
in Figure 3. The pan is 56” (1422 mm) x 61”
(1549 mm) and the overall height is 81” (2057
mm). Operational features such as integral glove
sleeves located at key process points, a BIBO
canister, HEPA filters, and bungee cords are
incorporated into the design.
Figure 2
1 Enclosure
2 BIBO Canister
3 Support Frame
4 Pan
5 Glove Sleeves
1
3
2
5
4
6
7
Figure 3
1
2
3
4
5
HEPA Filters
ArmorFlex® Enclosure
Glove Sleeves
Bag-in Canister
PK Blender Existing
6 Enclosure Support
Frame
7 Base Tray and
Enclosure
Mounting Flange
83
Contained Blending - Flexible Enclosure Technology
PK Blendmaster Yoke Blender
The Yoke Blender provides a tumble blending operation
for free flowing materials in small volumes. As such, it
can be cart mounted using a pan mount design, figure
4. The pan is mounted on a frame asembly with conductive casters. Overall dimensions of this portable system
are 54” (1372 mm) x 42” (1067 mm) x 73.3” (1861 mm)
tall.
Standard features carried over to this design include
a BIBO canister for introducing raw materials into the
enclosure and passing blended product out for processing to the next step, HEPA filters and bungee cord
attachment to support a range of operator heights, and
integral glove sleeves at optimal processing locations.
1
2
3
5
4
Flexible Enclosure loading and offloading
By attaching a multiple groove canister directly to the
valve on the blender, small volumes of powders can
be charged and removed from a blender using a Flexible Enclosure. Typically used in Lab Scale and Clinical
Development trials, this process supports processing in
early stages where the acceptable daily exposure (ADE)
and Occupational Exposure Level (OEL) are often not
known yet.
Double Cone Blender Mounted Flexible
Enclosure System
Here a small volume of powder is charged into the
blender from a bottle. In order to contain this transfer
a flexible enclosure is attached to the blender. In this
design a 6” (150 mm) multiple groove o-ring canister
is attached to the valve on the double cone blender. A
custom enclosure was developed based on this process
that included a bag in/waste sleeve, an ambidextrous
glove sleeve, a HEPA filter, and an encapsulated o-ring
for securing the enclosure to the canister.
84
Figure 4
1 HEPA Filters
2 ArmorFlex® Enclosure
3 Glove Sleeves
4 Frame Mounted Pan
5 BIBO Canister (sleeve not shown)
Contained Blending - Flexible Enclosure Technology
Figures 5a and b illustrate the charging process.
These steps include attaching the enclosure to
the canister, bagging the powder into the sleeve
on the enclosure, bagging out the stub from the
previous enclosure, pouring the powder from the
jar into the blender, placing the waste product
back in the sleeve, and crimping off the sleeve.
The enclosure is then folded and placed inside a
fabric support shroud while still attached to the
blender. This protects the enclosure during the
tumbling operation and saves the enclosure for
use when offloading the blended product.
Offloading the blender, figure 5c, includes
removing the support shroud, unfolding the
enclosure, opening the valve to discharge the
product, and crimping off the enclosure so that
the contained powder can be taken to the next
processing step.
1
2
3
4
5
7
6
Figure 5a
1
2
3
4
Collection Area
Blender Enclosure
HEPA Filter
Bag-in Sleeve
5 Glove Sleeve
6 Blender Canister
7 Band Clamp
1
Figure 5b
Figure 5c
1 Bin
85
Contained Blending - Flexible Enclosure Technology
W hat are the F eatures and B enefits of this T echnology ?
Features
Benefits
Retrofit to existing equipment design
Complies with the Risk-MaPP initiative
Process and Technical areas can be
separated
Provides the lowest overall cost of process
ownership through low capital and operating cost
including reduced cleaning and cleaning validation
Validated containment technology
Fastest turnaround of a processing suite for
subsequent manufacturing campaigns
Clear film
Passive system
Disposable components
Process is contained without contamination
of motor, drive shaft, and controls using
flange attachment design
Adaptable to other process equipment
Nanogram containment levels achieved
No blender shape modifications
Supports visibility for maintenance
Flexible materials
Does not affect ATEX and Ex ratings
Ergonomics maximized
Speed of implementation
No affect on blend uniformity
W hat containment level provided ?
OEB 5 with results in the nanogram range. This is based on customer test data, other proven
applications, third party testing to the “SMEPAC” protocols on similar designs, and the 100%
inflation tests performed on the deliverable systems.
OEB 1
OEB 2
10,000 to 1000
1,000 to 100
OEB 3
100 to 50
OEB 4
50 to 10
10 to 1
OEB 5
1 to 0.1
0.1 to 0.01
Occupational Exposure Levels above are in μg/m3.
W hy use this over other technologies ?
One of the driving forces of this technology is that it reduces the risk of cross contamination in
multi process facilities and it provides safety to the operators in both multi process and dedicated
facilities. By using this disposable Engineered Control, highly hazardous powders are contained at
the source which significantly reduces cross contamination risks and cleaning of process suites
and rigid containment devices.
The cost of ownership, ergonomic advantages, and speed of delivery benefits of this flexible
solution also far outweigh those of rigid isolation systems.
Tools such as Lean Manufacturing come into play more and more. For example, the time to clean
and validate the cleaning are major bottlenecks for processing efficiencies in the plant. Being able to
minimize this part of the process results in getting products to market faster and at an overall reduction in operating costs when considering labor, utilities, and waste disposal costs. It also supports
getting multiple products to market faster within an existing facility without risking product safety.
86
DoverPac® SF Powder Transfer Systems
Containment
Systems
Designed for your process,
Delivered on time,
Supported by the ILC Dover Team!
Combining flexible technology with
manufacturing expertise to deliver
economic disposable solutions to
the biopharm industry
Robust construction using ArmorFlex®
to assure integrity even when dropped
Powder transfer containers
for media and buffer prep
Custom designs to meet your specific
process needs including turnkey systems
for weighing powders
Inventory programs to assure you will
always have the right product available
at the right time
ILC Dover – global experts in powder transfer
systems which meet cGMP requirements and
control cross contamination
ArmorFlex® – a unique anti-static film meeting
global product contact requirements including
stringent USP Class VI and other regulatory
directives
Compliance – Certificates of Conformance
to comply with your Quality program
Ask how our options can
be combined to solve your
specific process needs.
100 L DoverPac® SF prior to and following
sanitary flange interface
Gamma Irradiation of 25 – 50 KGy
High containment using patented
technology
Complete Range of DoverPac® Products
DoverPac®
SF sizes
Vessel Connection
options
5 Liter
1.5” Sanitary Flange
10 Liter
2” Sanitary Flange
20 Liter
3” Sanitary Flange
30 Liter
4” Sanitary Flange
50 Liter
DN 100 Sanitary Flange
100 Liter
DN 150 Sanitary Flange
6” Sanitary Flange
8” Sanitary Flange
87
Sentinel Clear™
Sentinel Clear™
with ArmorFlex® Material
NIOSH Approved TC-21C-0848
and TC-23C-2537
Benefits of the Panoramic Hood
Clear hood provides 320˚panoramic
field of view.
APF of 1000 provided.
Panoramic Hood
The 8 scfm (230 lpm) of air supplied is
above the NIOSH minimum of 6 scfm
(170 lpm)
Air distribution plenum improves
comfort.
clear vision
for the future
Adhesive tab system keeps hood in
place even while bending. Patent
pending.
Unique Skirt/exhaust system fully
inflates suit to deliver improved
protection and comfort.
Safety glasses and hard hats
are readily accommodated.
Elimination of neckdam improves
comfort.
Sentinel XL™ Blower
No suspension system increases
comfort and eliminates sizing concerns.
Sentinel XL
TM
POWERED AIR PURIFYING
RESPIRATOR
www.doverpac.com [email protected]
Ph 302.335.3911, X506 or 800.631.9567
ONE MOONWALKER RD., FREDERICA, DELAWARE USA 19946-2080
88
Sentinel Clear™
Sentinel XL™ Blower
Integrated blower and battery pack reduces bulk and eliminates
“battery falling off” and snagging issues
Quick-Loc™ belt greatly simplifies adjustment and cleaning
Blower with HP Filters and Quick-Loc™ Belt
Operation with two P100 filters (vs. 3) provides excellent protection
while reducing operating costs
NIOSH-approved OV/CD/CL/HF/SD/HE filter operation available.
Low voltage alarm – flashing LED and continuous beep alert wearer
OV/AG/HE Filters
ILC Dover has been “creating what’s next” for over 60 years.
MKT-0050 Rev C
Adhesive tab system keeps hood in place
even while bending
To “create what’s next” ILC Dover listens to its customers. Our skilled engineering
staff, building on years of experience with NASA, military, and commercial customers,
translates those needs into high performance products. We look forward to hearing
from you so we can continue to “create what’s next”.
www.doverpac.com [email protected]
Ph 302.335.3911, X506 or 800.631.9567
ONE MOONWALKER RD., FREDERICA, DELAWARE USA 19946-2080
89
Sentinel Clear™ Hood FAQ’s
Sentinel Clear™ Hood FAQ’s
Sentinel XL
TM
POWERED AIR PURIFYING
RESPIRATOR
Q:
A:
What user operations are approprate
for the Sentinel Clear™ hood?
The Sentinel Clear™ hood supports the broad range of pharmaceutical
processing operations. The hood is designed for comfortable, non-encumbering use over long operating periods. When combined with the Sentinel
XL™ PAPR blower and NIOSH-approved cartridges, it provides protection
from airborne particulates, aerosols, and organic and acid gas vapors.
What is the difference between Sentinel
Clear™ Hood and HP head tops?
The Clear Hood covers the head and neck and includes bibs that get
tucked into coveralls. The HP hood covers the head and face only.
What are the major advantages
to the Sentinel Clear™hood?
First and foremost is the field of view, the Sentinel Clear™ offers
a 320 degree field of vision. Attention to ergonomic detail has also
resulted in a system that does not require a headband, thus no
uncomfortable mechanism riding on your head and no neck dam
which eliminates any chocking feeling.
Are the Sentinel XL™ Clear Hood
and HP systems NIOSH approved?
Yes, both have NIOSH approvals.
What are the assigned protection
factors for these designs?
The Clear Hood system has been rated with an assigned protection
factor (APF) of 1000 and the HP system is rated with an APF of 25.
How many sizes of hoods are there?
The hood is designed and NIOSH approved as a one size system.
Can I wear standard personal
protective gear in the hood?
Yes, the head top supports the use of equipment such as hard
hats, hearing muffs, and safety glasses as needed.
What types of filters are available?
The system has NIOSH approvals for the option of using two High
Efficiency Particulate (HE) or three OV/CD/CL/HC/HF/SD/HE filters.
What airflow does the PAPR provide?
The powered air purifying respirator (PAPR) delivers 8 scfm
(230 LPM) of filtered air. This is 33% more than the minimum
flow required by NIOSH.
What is the advantage of all this
added air flow?
Aside from increased protection for the worker, the added flow
provides additional prevention of lens fogging as well as cooling
to the head and torso as the air passes from the internal duct in
the hood, across the breathing zone and down into the Tyvek suit.
What keeps the hood from rising
up when it is inflated?
The outer bib includes four adhesive tabs. These tabs adhere to the
Operator’s Tyvek suit creating a shear mode resistance to any lifting
load. Additionally, a portion of the air from the blower is exhausted
to the room which balances the comfort and protection features of
the system.
90
Sentinel Clear™ Hood FAQ’s
Sentinel XL
TM
POWERED AIR PURIFYING
RESPIRATOR
Q:
A:
What type of batteries are used with
the Sentinel XL™ system?
Nickel metal hydride (NiMH) rechargeables which do not exhibit
“memory effects” like NiCad batteries.
How long does the charge last?
8 hours.
Will I get the same flow as the battery
charge runs down during use?
Yes, the PAPR is equipped with an integrated circuit board that is
designed to maintain a steady flow during operation.
Does the PAPR incorporate a low
voltage alarm?
Yes, both an audible and visible alarm are included.
How much does the PAPR weigh?
The integrated blower and battery weigh 2.75 pounds.
How is the PAPR worn?
The PAPR is supported on the Quick-Loc™ comfort belt. The integrated system sits comfortably on the Operator’s hips and does not
present any snag hazards.
What is the advantage of an
integrated blower/battery system?
An integrated battery is ergonomically more suitable to the wearer
with the weight distributed over the Quick-Loc™ comfort belt versus having the blower riding on the back and the separate battery
riding on the hip, thus two points where one has to carry weight. An
integrated system also does not require a separate cable to attach
the blower and battery, which can be a snag hazard.
How rugged is the system?
The entire system has been designed and tested to support vigorous use in a plant environment. One example is the Breathing Tube.
The Breathing Tube is a reinforced design that resists crushing when
an operator needs to be working on their back.
How do I decon my system after use?
Your typical cleaning SOPs would be used, however, there is an
approved list of cleaning materials that should be followed.
What documentation is available?
System Level User Instruction Manuals, Filter User Instructions,
Battery Charging Instructions, Recommended Cleaning Solution
list, Donning Posters, and a Training presentation.
91
Weigh and Dispense System
Containment
A NEW era in dispensing technology
Systems
O verview
W eighing C apability
This modular design is developed to allow
weighing or subdividing materials in a highly
contained way while maintaining weighing
accuracy. The system can be used for weighing
and then directly charging into a process vessel
or other equipment.
•
•
•
B enefits
•
•
•
•
•
Modular design to meet specific process
demands using proven containment and
weighing technology
Improved ergonomics over hard wall
isolators by utilizing the comfort of the
flexible wall system
Low capital cost to purchase and install
Accurate weighing system designed for the
application and process typically to +/- 5 grams
depending on scale capacity (higher accuracy
available with custom design and scale selection)
Proven containment using the static or dynamic
Flexible Isolator System to less than 1.0 µg/m3
The unique drum
attachment method
provides high containment and ease
for the operator to
dock a drum
Versatile design to use balance, load cell
system or floor scale systems
Accurate weighing along with tare removal
of packaging for net weight accuracy
Weighing accuracy is determined by the
scale capability and the weights being
handled
D rum D ispensing
•
•
•
•
•
The system is primarily designed to dispense
from drums
Easily attach drums using the ILC Dover drum
attachment ring technology
Standard design for drum diameters up to 23”
Drums can be completely or partially discharged and then removed from the system
maintaining containment for subsequent
discharging
ILC Dover Crimping System completes the
safe and secure process
The scale can be
located outside of the
containment area so
cleaning is not required
The System can discharge
to a continuous liner system, DoverPac, or other
packaging. This frame can
include load cells or use
a floor scale to assure
accurate net weights.
92
Weigh and Dispense System
S tatic F lexible I solator
•
•
•
•
This passive system is proven for high
containment
Using our robust ArmorFlex® 113 flexible
film, the integrity of the system is secure
Testing results consistently report an OEL
below 1.0 µg/m3 TWA
Systems have been provided up to 200”
long with no limit on size capacity
P rocess E xamples
•
•
•
•
•
Dispense to DoverPac’s for charging
Dispense to Continuous Liner
Subdivide drums of potent materials
Sampling from drums
Weigh and dispense directly to the process
D esign O ptions
•
•
•
•
•
•
N2 inerting of the system
Low humidity control
Alternate transfer options including RTP
units and transfer valves
Wash-in-place cleaning
Adjustable height base
Collapsible frame for storage
A rmor F lex ®
•
D ynamic F lexible I solator
•
•
•
Designed with a fan and HEPA filter system to
provide an additional level of containment protection while reducing the risk of any breach
Pressure control is maintained and monitored
by PLC System
Breach control to sense and indicate a
pressure drop while changing the operating
parameters to maintain a negative pressure
•
•
The ArmorFlex® family of films has been
developed for the specific needs of the
pharmaceutical industry including FDA
approval for product contact
The flexible isolator is manufactured from
ArmorFlex® 113 film and is typically 8 mil
thick. This robust material will resist against
damage from typical use and is more
functional than a hard wall type design
ArmorFlex® is developed to be resistant to
most solvents, environmentally friendly for
incineration with no chlorides, and has a
5-year shelf life
93
CrimpLoc™ System
Containment
Systems
The Premier Closure System In
Pharmaceutical Processing
New CrimpLoc™ System From ILC Dover
ILC Dover pioneered flexible containment for the pharmaceutical industry and continues to innovate processes for
better performance. We invented the original crimping
system and now we have created the CrimpLoc™ System.
This NEW system is the next generation to provide
high containment and a secure closure when using
the DoverPac®, Continuous Liner, and other ArmorFlex®
film solutions.
Less hand force and more ergonomic
One Tool for all Crimp Sizes
Uses the same Crimps as the existing
ILC Dover Crimp System
Light weight
Key factors to consider for closure of
in process pharmaceutical packaging
Containment
Quality
Ergonomics / Safety
No plastic shards from separation cut
Validation
Operator Ease of Use
94
CrimpLoc™ System
Innovation Timeline of Film Closures
ILC Dover
”creating what’s next“
1997 Twist and Tie
2004
ILC Dover Crimping
2011
CrimpLoc
Future
Automated Crimping
The CrimpLoc™ System is a complete kit to
provide the secure closure for ArmorFlex® film
packages. Current users can upgrade to the
CrimpLoc and realize the benefits of the new
design. New kits are available including the
CrimpLoc™ tool, Cutting Tool, and Crimps.
One CrimpLoc™ tool is needed for the range of
ArmorFlex® closures offered by ILC Dover:
ArmorFlex® size
Crimp Designation
23” Diameter
Blue
14” Diameter
Red
4” Diameter
Yellow
CrimpLoc™ Kit
Crimp Removal Tool - The latest
innovation for safe removal of
the crimp. The crimp remains in
one piece so no risk of contamination upon opening.
95
ArmorFlex® Family
Containment
Systems
ArmorFlex® Family of Films
Meeting Your Current And Future
Process Requirements
ArmorFlex® 114 - The latest addition
to the ArmorFlex® Family
Complies with FDA 21 CFR
Fully compliant to 2002/72/EC and
amendments
Meets test parameters of EP 3.1.3
Passes USP <661> Physicochemical
Tests for Plastics
Passes USP <88> Class VI (7 day
implant)
Passes <87> biological reactivity,
in vitro
At ILC Dover we are always “creating what’s next”
by listening carefully to our customers.
In response to customer input and emerging
regulations, we’ve developed a robust new
film to support our DoverPac® Containment
Systems. This revolutionary film,
ArmorFlex® 114, delivers permanent
static dissipative properties while
meeting FDA and 2002/72/EC
requirements for food contact
and EP 3.1.3 test conditions.
96
No animal derived components
5-year shelf life
Permanent antistat replaces
migrating additives
Passes Chilworth incendivity tests
Tested for solvent resistance
DMF filed with FDA
ArmorFlex® 104 - Continuing to be
the most used ArmorFlex® film
This space age film continues to be used for
meeting process and regulatory needs throughout the pharmaceutical industry. With over
150,000 containment solutions completed from
ArmorFlex® 104, this high tech film is a proven
standard. DoverPacs, continuous liners, and
other containment solutions will be available
using ArmorFlex® 104 for years to come.
ArmorFlex® Family
Containment
ArmorFlex® 114 Solvent Resistance
Solvent Contact Recommendations
Systems
Chemical
Resistance
Acetone
Excellent
Acetonitrile
Excellent
Anisole
Good
Butyl Acetate
Good
Cyclohexane
Excellent
Cyclohexane –
Ethyl Acetate (50/50)
Excellent
Dichloromethane
Excellent
Diethylether
Excellent
Dimethylacetamide Excellent
Dimethylformamide Excellent
Ethanol
Excellent
Ethyl Acetate
Excellent
HCL (37.4%)
Very Good
n-Heptane
Very Good
HMDS
Excellent
ILC Ireland operating since 2007
Isopropanol Excellent
KOH (50%)
Very Good
Methanol
Excellent
2-Methoxyethanol
Excellent
Methylethyketone Excellent
n-Methylpiperazine
Excellent
n-Methypyrrolidone
Excellent
Methyl-tert-butylether Excellent
Mineral Oil
Excellent
Reagent (3A) Alcohol
Excellent
NaOH (50%)
Excellent
ILC Ireland located in County Cork
has been providing standard products
from this facility for 4 years. Established to support the pharmaceutical
industry in Ireland, the facility warehouses all standard products offered
by ILC Dover. DoverPac’s, continuous
liners, crimps, etc. are readily available for immediate delivery with the
convenience of all customs clearance
completed. ILC Ireland is committed
to providing superior service with
quick responses for process needs
locally in Ireland.
Tetrahydrofuran Very Good
Toluene
Fair
Water, Distilled
Crimp Separation
ILC Ireland facility
Continuous Liner System
DoverPac®
Excellent
Criteria
% Change in
Physical Properties
Resistance
0 - 10
Excellent
10 - 20
Very Good
20 - 30
Good
> 30
Fair
97
Process Train Containment in CMO Operations
Flexible Containment Technologies are critical to
Pharmatek’s CMO Operations
Containment
Systems
O verview
Pharmatek Laboratories, Inc. is a premier pharmaceutical chemistry development organization
supporting the pharmaceutical and biotechnology industries.
Pharmatek offers development and manufacturing services for
highly-potent and cytotoxic (HP/C) compounds including:
• Analytical methods development
• Preformulation testing
• Formulation development
• GMP manufacturing of phase I/II clinical supplies
• Stability storage and testing services
(all ICH storage conditions)
• Technical transfer for commercialization
• Clinical distribution and fulfillment
Handling HP/C compounds requires highly specialized facilities and controls. As part of Pharmatek’s overall
corporate safety program, they have chosen after careful consideration to integrate ILC Dover Flexible
Containment Solutions into their HP/C facilities. Wet Granulation, Dry Granulation, Oven Drying, Fluid
Bed Drying, Milling, Blending, Encapsulation, Tableting and De-dusting are all examples of manufacturing
processes in which Pharmatek has integrated the ILC Dover containment technology.
Pharmatek’s focus on pharmaceutical chemistry development, combined with their state-of-the-art
HP/C facilities, ensures their customer’s molecules move efficiently from discovery to clinical trials.
Pharmatek focuses on preclinical and early-phase development & manufacturing of small molecules and peptides
Late Stage
Discovery
Pre-Clinical
Development
Phase I
Phase II
Phase III/
Commercial
IND
Compound Selection
Preformulation
API Method Development
Method Qualification
GLP Formulation Support
Formulation Development
Drug Product Methods/Specification
Prototype Stability
cGMP Manufacturing/Packaging/Labeling
Release & ICH Stability
CTM Storage & Distribution
H ow do F lexible enclosures work ?
Flexible Containment Enclosures are designed
using two basic methods – flange mount and total
encapsulation.
The flange mount approach is used for the tray dryer
where the flange is added to the face of the dryer
outside of the door. An enclosure made from the
rugged ArmorFlex® family of films is then attached
to the flange and a supporting frame assembly. The
door is within an enclosed environment when loading
and unloading the trays with the drug product.
Flange Mount Flexible Containment Selected for Tray Dryer
98
Process Train Containment in CMO Operations
The trays, drug product and associated process tools can
either be preloaded into the enclosure or bagged into the
isolated area via bag in/bag out (BIBO) canisters or larger
drum ring attachment canisters.
For the wet granulation process, Pharmatek selected the total
encapsulation method by working with ILC Dover engineers.
Solid pan mounted enclosures allow the entire piece of process
equipment to be contained. The enclosure is supported by an
elastic suspension system, attached to the pan, and includes
glove sleeves for access to the equipment and integrated
HEPA filters. Based on the suspension system, the operator
is able to get in close proximity to the process, as if
containment wasn’t even present.
Solid Pan Mount Total Encapsulation
Selected for Granulator
W hat are the applications ?
Flexible Containment enclosures have applicability across Pharmatek’s entire high potency process train.
W hat are the K E Y B enefits of this T echnology ?
• Prevents cross contamination – the enclosures are single-use and are dedicated to a specific
compound to prevent cross contamination, which is of extreme importance to their customers.
• Supports lean manufacturing – with over 100 product runs per year, Flexible Containment supports
easy product changeover and helps Pharmatek meet stringent EH&S requirements and project timelines.
• Superior operator protection – proven nanogram level containment (reference table below)
Additional advantages
• Durability – manufactured using puncture resistant ArmorFlex® films, the enclosures
hold up during the most demanding operations.
• Improved ergonomics – the flexibility of the enclosures in terms of configuration
(glove sleeves, ports, and passthrus configured for the equipment), the film clarity,
and the elastic suspension attachments simplify the process for their operators.
• Custom designed – with ILC Dover’s engineering expertise, Pharmatek custom
designs enclosures for each process train unit.
W hat containment level I S provided ?
ILC Dover
Enclosure System
Test
Material
OBZ-TWA*
(µg/m3)
Comment
(No. of operators)
Operation (2)
Granulator
Lactose
0.0026-0.0027
Granulator
Lactose
0.0027-0.0331
Cleaning (2)
Drying Oven
Lactose
0.0026-0.0028
Operation (2)
Drying Oven
Lactose
0.0026-0.0037
Cleaning (3)
Based on surrogate monitoring
testing conducted by Kasai Consulting,
Pharmatek’s facilities in San
Diego achieved the nanogram
containment values shown at left.
*Operator Breathing Zone - 8 Hour Time Weighted Average
W hy F L E X I B L E ?
Flexible Enclosures prevent cross contamination and help assure operator safety
in Pharmatek’s development and manufacturing operations.
99
EZ BioPac™
State-of-the-Art Powder Transfer for Biotech
Applications Typically for Media Prep and Buffer Prep
O verview
ILC Dover has developed a new powder transfer
process to solve issues related to contamination
and reduce the fill time of each powder bag.
The EZ BioPac™ is proven to reduce contamination that typically occurs during filling a powder
transfer bag or, more importantly, when it is
discharged at the reactor or mix tank.
benefits
• Open fill design provides an easy target
for manual filling without spillage
• Significantly less time required per
dispense cycle
• Minimizes cleaning with fold over neck
• Additional parts eliminated
• Eliminates the need for additional tools and
fixtures. It is self standing and self supporting
• Custom designs to meet specific process
requirements
• ArmorFlex® 114 film is the standard material
for the product contact area. This unique
antistatic film meets FDA, USP, and EU
regulatory compliance standards
Complete Range of DoverPac® Products
EZ BioPac™
Vessel Connection
flange sizes
options
• 1liter thru 100 liter capacity
5 Liter
1.5” Sanitary Flange
• 1.5” thru 6” sanitary ferrule reactor
charge connections
10 Liter
2” Sanitary Flange
20 Liter
3” Sanitary Flange
• Rinse ports, vent filters and other
process features available
30 Liter
4” Sanitary Flange
50 Liter
DN 100 Sanitary Flange
• Smaller sizes have a handle for manual
lifting, and larger sizes have lifting loops
100 Liter
DN 150 Sanitary Flange
F E AT U R E S
6” Sanitary Flange
8” Sanitary Flange
100
Containment
Systems
FlexiVac™
Containment
Systems
O verview
F E AT U R E S
In an effort to provide a better solution for
containment to the standard PTS / DCS system,
FlexiVac™ was developed along with our partners
CSV Life Sciences in Italy and Micro-Macinazione
S.A. The resulting innovative solution improves
the ergonomics of the system while containment
levels have been verified to <1.0 µg/m3 on a TWA.
Operator is aided visually in the wanding
process, as the flexible wall allows for clear
sight into the drum.
B enefits
Integral Bag-Out sleeves are included which
can be used for samples or for the spent
liners after a transfer is complete.
A choice of Allen-Bradley or Siemens control
platforms are available.
• Operator motion is less restricted with a flex-
ible isolator compared to using a hard box style.
• The “Flexi” system can be provided stand alone
FlexiVac™
to work with an existing powder pump. The filter
design and the wand support are designed to
work with typical installations.
• Integrated FlexiVac™ with powder pump is a
turnkey system available in non-rated electrics
or Ex-Proof.
•
• Can be operated with nitrogen inerting or
the stand-alone static filters which allow for
air flow, thus balancing the pressure in the
flexible enclosure.
101
FlexiVac™
Containment
Systems
S ystem F unctional D escription
FlexiVac™ features an ArmorFlex 113 flexible isolator that can be attached within minutes. This safe
isolator system is designed to minimize cleaning requirements while providing high containment. The
flexible isolator is robust for use on many drums and then disposed. The improved ergonomics and head
space above the drum allows operators, while dispensing, to easily take a spent drum liner with its residual
level of powder and stow it until the next drum is attached. The residual powder is easily emptied into the
next drum (maintaining high containment) eliminating batch shrinkage.
®
A stretch fit ArmorFlex® sleeve is used to dock the standard drum o’ring canister with the product
drum. This is a fast and effective process to make a contained connection. After the powder is
vacuumed from the drum, a high containment separation process using the CrimpLoc™ is performed.
The drum and the FlexiVac™ remain contained and are ready to attach the next drum. This process
has been used with isolators in many applications and proven effective. Designed for operator
ergonomics, the drum connection has a pivoting position to allow the drum to be easily moved into
position, connected, and then removed when empty.
The FlexiVac™ system is available with or without a powder pump for compatibility with existing
PTS units or other vacuum systems. The fully integrated FlexiVac uses dilute phase conveying
technology for the best powder transfer possible.
A rmor F lex ® F ilms
ArmorFlex® 113 film’s superior visual clarity
makes this the clear film of choice for flexible
enclosures and flexible isolators.
• Polyethylene base film provides excellent
solvent resistance
• Permanent antistat provides better than
1 x 1011 Ohms per square surface resistivity
• No incineration off-gassing concerns
• ArmorFlex® is designed for high strength and
has a 500% elongation before failure, assuring
safety from tearing during typical use.
ArmorFlex® films contain no animal derived
components and have a 5-year shelf life.
ArmorFlex® 114 film delivers permanent static
dissipative properties while meeting FDA and
2002/72/EC requirements for food contact and
EP 3.1.3 test conditions.
• Complies with FDA 21 CFR • Passes USP <661> Physicochemical Tests
for Plastics
• Passes USP <88> Class VI (7 day implant)
• Passes <87> biological reactivity, in vitro
• Passes Chilworth incendivity test to assure the
static dissipative qualities of the flexible isolator
• Tested for solvent resistance
• DMF filed with FDA
contained D rum T ransfer options
DTS-Drum Transfer System
VTS-Contained Drum Transfer
DSE-Drum Sampling Enclosure
102
Ventilated Enclosure System
FLEXIBLE CONTAINMENT TECHNOLOGIES
Containment
Systems
Ventilated Enclosure
System
User friendly control system
Stable running conditions
Automatic breech condition protection
with audible and visual alarms
Provide EC GMP Grade A internal
conditions
Enclosures available in static dissipative
Polyurethane, PVC or ArmorFlex® 113
Polyethylene film
System can be offered to provide
negative or positive pressure operation
Capable of 30 air changes per hour
(minimum)
The Ventilated Enclosure System combines the benefits of
Flexible Containment with a unique, light weight ventilation
unit. This system provides all the advantages of a negative or
positive pressure isolator providing reduced costs for cleaning
and validation with the disposable enclosure that is utilized.
Typical pharmaceutical process operations with this system
include, but are not be limited to, dispensing, sampling, milling, mixing, and processing potent compounds. Containers,
solvents, and raw material containers can be opened, used,
sealed, and cleaned, within the enclosure.
Incorporates Bag In/Bag Out multiple
O-Ring canister capability
Incorporates a visual pressure indicator
Incorporates Exhaust Filter pressure
drop monitoring
Transportable by one person
Available in ATEX and Non ATEX
rated versions
103
Ventilated Enclosure System
T echnical S pecifications
Operates on standard European power of 220/240V, 50 Hz
and United States Power of 110V, 60 Hz
3
Automatically operates and maintains an enclosure negative
pressure of -15 Pa (nominal)
Audible and visual alarms are set at -25 Pa and -3 Pa to
notify operator in case of pressure change outside of the
safe operating range or in case of excessive exhaust filter
pressure drop
5
6
Complies with the following Regulatory Requirements:
GAMP 5
21CFR Part 11
Machinery Directive 2006/42/EC replacing 98/37/EC
IEC 60529
1
CE Marking available
1.
2.
3.
4.
5.
6.
Inlet Filter and BIBO Canister Location
104
4
Frame Assembly
Bag In/Bag Out (BIBO) canister
Fan and Controls Assembly
Flexible Enclosure
Inlet Filter
Outlet Filter (behind BIBO canister)
2
105
ILC Dover has been “creating what’s next” for over 60 years.
To “create what’s next” ILC Dover listens to its customers. Our skilled engineering staff,
building on years of experience with NASA, military, and commercial customers, translates
those needs into high performance products. We look forward to hearing from you so we
can continue to “create what’s next”.
www.doverpac.com | [email protected]
O N E
M O O N WA L K E R
R D . ,
F R E D E R I C A ,
|
PH
1.302. 335. 3911 | 1. 800. 631. 9567
D E L AWA R E
U S A
1 9 9 4 6 - 2 0 8 0
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