FlexAct® BT (Bag Tester)

FlexAct® BT (Bag Tester)
Point-of-use Leak Test of Flexboy® 2D Bags
Product Information
FlexAct® BT is a Bag Tester solution for end user to control
the absence of leaks that could occur during transportation
and handling of 2D bags at the point of use. FlexAct® BT
features the Sartocheck® 4 plus Bag tester and a set of two
holders to perform pressure decay testing in a safe, fast,
easy and reliable way. FlexAct® BT is supplied with a complete validation package and on-site service to achieve
an easy validation.
Pressure Decay Leak Test Equipment
FlexAct® BT enables end user to perform a fast and easy leak
testing of Flexboy® 2D bag assemblies at the point of use.
FlexAct® BT increases the level of assurance of single-use container
closure integrity and significantly improves process integrity,
product sterility as well as patient and operator safety.
FlexAct® BT is equipped with two metal restraining plate holders
between which bags are easily inserted and securely maintained
during testing. The holders protect the bag from mechanical stress
and allow performing the leak test with a small inflating bag volume and at a high test pressure, thus increasing the test reliability.
The bags are separated from the metal plates by porous spacers to
avoid direct contact of the surface of the film and to prevent any
leak masking effect during the test.
The device has three shelves on which bag testers can be placed.
The Sartocheck® 4 plus Bag tester is placed on the upper shelf and
a Sartocheck® 4 plus Bag tester MultiUnit option is available to
increase test productivity by testing two bags simultaneously and
to allow filter integrity testing.
FlexAct® BT is designed to support the installation, inflation and
the pressure decay test of 2D bags from 50 mL to 50 L in less
than 10 minutes.
FlexAct® BT is supplied with a robust validation package and
on site validation service to facilitate implementation of bag
leak testing in critical drug substance and drug product cGMP
commercial productions.
FlexAct® BT features the Sartocheck® 4 plus Bag tester that serves
as the control unit for the pressure decay testing. The combination
of the well-established Sartocheck® technology and ASTM
F2095-011 pressure decay methodology provide end users with
a reliable and easy-to-validate leak test for Flexboy® 2D bags.
1 ASTM F2095-01: “Standard leak test for pressure decay leak test for
non-porous flexible packages with and without restraining plates”.
Fluid Management Systems
As bags require lower test pressures and therefore higher
measurement accuracies than membrane filters, the pressure
range of the Sartocheck® 4 plus Bag tester is reduced to optimize
the test pressure setting accuracy and the pressure decay
measurement accuracy.
The Sartocheck® 4 plus Bag tester software version 3.00 achieves
pressure decay measurement accuracy of +/-0,3 mbar with
a +/- 1 mbar reproducibility for non-defective bags.
Single-use 2D bag leak testing can be implemented with the
same fast, easy to implement, reproducible, accurate and sensitive
pressure decay test methods as already used for decades for
sterilizing-grade filters.
Using a MultiUnit filter tester connected to the Sartocheck® 4 plus
Bag tester allows filter integrity testing.
Using a MultiUnit bag tester connected to the Sartocheck® 4 plus
Bag tester provides parallel testing of two bag assemblies and thus
reduces testing time.
Pressure Decay Leak Test Method
The test method is derived from the ASTM2095-01: “Standard leak
test for pressure decay leak test for non-porous flexible packages
with and without restraining plates”.
After setting and stabilization of the test pressure, the pressure
decay is measured and compared to an acceptance criteria
determined during the validation of the method.
The validated test method can detect 30 µm defects and is compatible with a 100% point-of-use leak test: it is nondestructive,
safe, fast, easy to implement and to validate, reliable
and it maintains the sterility of the system during testing.
The inflation and pressure decay leak testing are performed
through a sterilizing grade vent filter line pre-assembled and
pre-sterilized with the single-use bag assembly to maintain the
closure integrity and the sterility of the bag to be tested.
The restraining plates and porous spacers integrated into the
FlexAct® BT provide a fast and easy installation, a safe inflation
and a reliable test of Flexboy® 2D bag assemblies. They also reduce
environmental heat transfers that could lead to erroneous leak
test results. Porous spacers avoid leak masking effect during the
test. The combination of the small and reproducible inflating
volume, less than 3 L for a 50 L bag, the high test pressure, up
to 300 mbar, the +/-1 mbar measurement reproducibility for
non-defective bags and +/-0.3 mbar measurement accuracy
of Sartocheck® 4 plus Bag tester provides a highly reproducible,
accurate and sensitive leak test.
FlexAct® BT is validated to detect 30 µm leaks across the volume
range from 50 mL to 50 L in less than 10 minute total installation
and test time, providing a high level of safety, which is far below
the potential risk of defect size currently observed under normal
production and handling conditions.
The FlexAct® BT combines the benefits of well-established
Sartocheck® technology and ASTM F2095-01 pressure decay
methodology
Safe
Fast and easy to use
Reliable
Test pressure
stabilisation
Pressure decay
test
Pressure (mbar)
300
Pressure decay
limit 3,1 mbar
Easy to validate
200
Non-defective bag
Defective bag
100
0
0
4
7
– Avoids processing with leaking bags
– Improves patient safety by reducing
risks of sterility failures
– Improves process integrity and operator
safety by eliminating product loss
– Restraining plates maintain bag
integrity
–Well established Sartocheck® technology
and pressure decay method
– Less than 10 minute total installation
and test time
– Efficient equipment utilization with
MultiUnit Bag tester option for dual
testing and filter integrity testing
– Reproducible ± 1 mbar
– Accurate: ± 0.3 mbar
– Sensitive: 30 μm detection limit
validated with 640 tests and 6 sigma
confidence interval between defective
and non-defective bags
– Proven ASTM F2095-01 pressure decay
methodology
– Development in accordance with
GAMPS & full compliance with
21 CFR Part 11
– Test reliability validated with 640 tests
and 6 sigma confidence interval between defective and non-defective bags
– Expert on site validation support for
IQ, OQ, PQ, SOP development and
operator training
Fluid Management Systems
3
Both test parameters and test specifications have been validated
using 640 tests (defective and non-defective units) from multiple
batches of Flexboy® bags from 50 mL to 50 L.
Non defective test samples are taken from normal production
and defective test samples are deliberately achieved using 30 µm
calibrated defect film samples.
The leak detection is validated at 30 µm with a pressure decay
test time of 3 minutes for the range of Flexboy® 2D bags using
the worst case 50 L bag and the leak differentiation between
defective and non-defective samples is established with a 6 sigma
confidence interval.
This validation provides a robust and reliable leak test method,
i.e. reproducible, accurate and sensitive.
Validation study|240 s stabilization time / 180 s test time
100
n=32
n=32
n=32
n=32
n=32
n=32
n=32
n=32
n=32
n=32
+3σ
90
80
Mean
value
70
-3σ
Pressure drop [mbar]
Validation and Qualification
FlexAct® BT is supplied with a robust validation documentation
package. The Installation Qualification (IQ) and Operational
Qualification (OQ) of the equipment is performed by Sartorius
Stedim Biotech Service, both for the FlexAct® BT and the
Sartocheck 4 plus Bag tester. It provides full certified documentation to evidence that all tests are carried out with highest
reproducibility and accuracy. The Performance Qualification
(PQ) is performed by Certified Application Specialists. It guarantees the sensitivity and repeatability of the validated method on
the installed equipment as well as the training of the operators.
60
50
40
30
20
10
0
-10
No overlapping between defective and non defective bags with a 6 σ confidence interval
n=32
n=32
n=32
n=32
50
20
10
5
n=32
3
n=32
1
n=32
0.5
n=32
0.25
n=32
0.15
n=32
0.05
Bag volume [L]
Defective
Non-defective
The validated pressure decay leak test method with Flexact® BT
is compatible with a 100% point-of-use leak test at customer
production facilities: It is easy to implement and to validate
and non-destructive, maintaining the sterility of the system
during testing.
Configuration of Flexboy® 2D Bags for Point-of-use
Leak Testing
a. Application
Flexboy® 2D bags are used in a variety of process steps and
applications:
– Buffer and media storage
– Harvest and storage
– Process intermediate storage
– Drug substance purification and storage
– Drug product formulation, storage and filling
The requirement for point-of-use leak testing is more prevalent in
the critical process steps of drug substance purification in downstream processing and drug product formulation in final fill and
finish.
The design rules for Flexboy® 2D bags to be leak tested are therefore defined for meeting the requirements for these critical process steps and applications. The design namely requires the installation of a sterile vent filter line to allow performing the test
under conditions that maintain the integrity and the sterility of
the system.
b. Description of Flexboy® 2D Validated Design
Flexboy® 2D bags from 50 mL to 50 L intended to be pointof-use leak tested need to meet specific design requirements.
First, the handle currently present on Flexboy® 2D bags from
5 L – 50 L is not installed to allow the insertion of the bag
in between the restraining plates of FlexAct® BT.
Second, a sterilizing grade vent filter line is pre-assembled
to perform the point-of-use test without breaching the sterility
of the system. C-Flex®* tubing is used to disconnect the filter
line after testing, using a Biosealer®
Bag
Chamber
Volumes
Port tubes
Fittings
Multiple layer film construction,
including an EVOH gas barrier layer and
an EVA contact layer
50 mL – 50 L
EVA
Sampling line:
Needle-less Clave connector
with slide clamp
Filling line:
filter test line with Midisart® BV sterilizing
grade vent filter
Clear C-Flex®* 374 L500 mm
¾” Triclamp, pinch clamps
Custom line defined by end-user –
not in the scope of the validation
Sterilization
Draining line:
pinch clamp on EVA port tube
Custom line defined by end user –
not in the scope of the validation
Gamma irradiated 25-45 kGy
Design set up for the
30 µm leak detection
Filter Test Line
* C-Flex® is a registered trademark of Saint-Gobain Performance Plastics
Corporation.
Fluid Management Systems
5
Technical Data
Specifications
FlexAct® BT
Power requirements
Max. power Input
Operating pressure
Dimensions
(W × D × H1 × H2)
Weight
Sartocheck® 4 plus
Bag tester
100 – 240 V AC
100 – 240 V AC
50 | 60 Hz
50 | 60 Hz
400 VA
74 watts
4 – 10 bar g
4 – 10 bar g
1405 × 699 × 1043 460 × 390 × 140 ×
245
375 kg | 326 lbs
FlexAct® BT
Sartocheck® 4 plus
Bag tester
Measuring Ranges
Test pressure
na
Pressure drop
na
3 – 300 mbar | 0.044 - 4.350 psi
0.3 – 300 mbar | 0.004 – 4.350 psi
Measuring Accuracy
Pressure
na
Pressure drop
na
± 0.05% full scale
± 0.3 mbar
(0.004 psi)
Operating Conditions
Ambient temperature + 15 °C to 35 °C
Rel. humidity
10 – 80%
Front View
1
2
+ 15 °C to 35 °C
10 – 80%
Back View
3
4
1
2
5
6
3
4
Pos. Description
Function
Pos. Description
Function
1
Handle
for moving the device
1
Main switch
for turning the device on and off
2
Bag Holders
for inserting the bags to be tested
2
Cover unit
3
Non-woven fabric
holder
for inserting the non-woven fabric
into the bag holder
cover of the connector strip
(power connections)
3
Lockable castors
for moving the device and securing
it in place
4
Manufacturer’s ID
label
4
Upper shelf
®
to place the Sartocheck 4 plus
Bag tester on
®
5
Middle shelf
(can be pulled out)
to place the Sartocheck 4 plus
Bag tester MultiUnit on
6
Lower shelf
to place additional MultiUnits on
Ordering Information
Configured to Order Product
Equipment Supplied for 2D Bag testing
FlexAct® BT 2D
BT Fleece for FlexAct® BT 2D
Test tube 2D
Inlet tube BT on FlexAct® BT
Power supply
Installation and operating instructions FlexAct® BT
®
Sartocheck 4 plus Bag tester
Sartocheck® 4 plus Bag tester
Inlet tubing for compressed gas
Ribbon cassette
Rolls of printer paper
Power cord
Test certificate
Calibration certificate
Installation and operating instructions Sartocheck® 4 plus
Bag tester
Validation package Bag tester
Part No.
®
Accessories FlexAct BT
FlexAct® BT 2D
BT Fleece for FlexAct® BT 2D
Test tube 2D
Inlet tube BT on FlexAct® BT
Power supply FlexAct® BT to Sartocheck®
26288---BTFA
DZ050L---SIT
26288---BT2D
26288---BTIT
1EE---0001
Accessories Sartocheck® 4 plus Bag tester
Sartocheck® 4 plus Bag tester
Sartocheck® 4 plus Bag tester MultiUnit
Sartocheck® 4 plus Filter tester MultiUnit
External temperature sensor
Ribbon cassette
Rolls of printer paper
Inlet tubing for compressed gas
Serial Port Interface cable TU | TU
2m
5m
Network Cable
2m
5m
10 m
20 m
Power cord
26288---BT
26288---BM
16288---FM
26288---ETS
6982141
6982142
18104
1ZE---0009
1ZE---0010
1ZE---0029
1ZE---0030
1ZE---0031
1ZE---0032
Region specific
Validation Packages
Clean Room Venting Adapter
Validation package Bag tester
Validation package Bag tester MultiUnit
1ZE---0021
26288---VPBT
26288---VPBM
Fluid Management Systems
7
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Specifications subject to change without notice. Copyright Sartorius Stedim Biotech GmbH. Printed in the EU on paper bleached without chlorine.
Publication No.: S--2133-e151101 · Order No.: 85037-550-09 · Ver. 11 | 2015
Europe
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