Filters with Millipore Express® Membrane Notice

Filters with Millipore Express® Membrane
Wetting Instructions, Integrity Testing, Sterilizing and Drying Guidelines
The M mark, Opticap® and Millipore Express® are registered trademarks of Merck KGaA, Darmstadt, Germany.
© 2015 EMD Millipore Corporation. All rights reserved.
UG4224EN00 Rev. B 12/2015.
Notice
The information in this document is subject to change without notice and should not be construed as a commitment by EMD
Millipore Corporation or an affiliate. Neither EMD Millipore Corporation nor any of its affiliates assumes responsibility for any errors
that may appear in this document.
Contents
Filters with Millipore Express® Membrane.................................................................................................................................................................... 1
Notice........................................................................................................................................................................................................................................ 1
Contents.................................................................................................................................................................................................................................... 1
Wetting Instructions............................................................................................................................................................................................................. 2
Integrity Testing Guidelines................................................................................................................................................................................................. 4
Post Use 70/30 IPA Alcohol Reference Test.................................................................................................................................................................... 4
Sterilizing Guidelines............................................................................................................................................................................................................. 4
Drying Guidelines................................................................................................................................................................................................................... 5
Filter Storage Conditions...................................................................................................................................................................................................... 5
Troubleshooting ..................................................................................................................................................................................................................... 6
Warranty................................................................................................................................................................................................................................... 7
Technical Assistance.............................................................................................................................................................................................................. 7
To achieve optimal results, use this wetting procedure prior to conducting an integrity test. Please refer to the appropriate Validation Guide
or Certificate of Quality for specifications of the filter to be tested.
2
Wetting Instructions, Integrity Testing, Sterilizing and Drying Guidelines for Filters with Millipore Express® Membranes
Wetting Instructions
• The filter should be completely dry to ensure complete and
adequate wetting of the membrane.
• Use purified ambient temperature water or the product to be
filtered.
• CARTRIDGE FILTERS ONLY: Moisten the cartridge filter
O-ring with water to allow ease of insertion into the filter
housing.
Wetting with Pressure
(most efficient and preferred method)
Minimum Recommended Flow Rates for Water Wetting
Filter Length
cm (in.)
Differential
Pressure mbar (psi)
Minimum Flow
Rate (LPM)
Total Flush Volume
Required* (L)
Millipore Express® PHF 0.2 μm Membrane
<7.62 (3)
45 (<1)
1.5
7.5
12.5 (5)
45 (<1)
3
15
25 (10)
55 (<1)
6
30
50 (20)
50 (<1)
12
60
75 (30)
50 (<1)
18
90
*System void volumes (housing, piping , hoses, etc.) should be
additive to these minimum recommended flush volumes.
1. Set up the filtration system as shown in Figure 1 and close
all valves (V1, V2 and V3).
2. Set the inlet pressure at 2.8 bar (40 psig).
3. Gradually open the upstream valve V1.
4. Gradually open valve V2 to vent the filter housing from the
highest point until all upstream air has been released.
5. Allow some water to flow through the highest point (V2).
6. Partially close the vent valve (V2) and continue to maintain
2.8 bar (40 psig) for at least one minute to dissolve and
evacuate any residual gas within the filter
and ensure complete membrane wetting.
Cartridge Filter Set-up
Note:
The vent valve (V2) must be kept partially open during the
wetting procedure to allow continuous venting and ensure
the filter remains fully wetted.
7. After one minute, gradually open the downstream valve (V3) and
set the differential pressure (P1 - P2) to the corresponding flow
rate shown in the table. Continue to flow water through the filter
at the appropriate ∆P/flow rate for at least 5 minutes.
For Opticap® XL 150, 300 and 600 capsules: After 1 minute,
gradually open the downstream valve (V3) and continue
to flow the wetting fluid through the filter for another two
minutes at 5 psid.
8. Close V1 to stop the fluid flow and allow the upstream
pressure (P1) to drop to zero.
9. Fully open V2 and V3 to drain the wetting fluid from the
housing and vent the filter.
10. Depressurize pressure tank and open V1 to drain the wetting
fluid from the upstream side into the tank.
11. Close V1 and disconnect pressure vessel from system.
12. Connect an integrity tester to V2, ensure the downstream line
is vented at atmospheric pressure and, when required, perform
an air/water diffusion integrity test.
Capsule Filter Set-up
Figure 1.Typical setup for wetting with pressure.
3
Wetting Instructions, Integrity Testing, Sterilizing and Drying Guidelines for Filters with Millipore Express® Membranes
Wetting with a Peristaltic Pump
Using a peristaltic pump allows recirculating pure water through
the filtration system and reduces the volume of water required
to ensure proper wetting. Do not exceed the maximum pressure
rating for the pump tubing.
Minimum Recirculation Volumes for Water Wetting Using a Peristaltic Pump
Filter Length cm (in.)
Required Recirculation Volume (Liters)
<7.62 (3)
3
12.5 (5)
6
25 (10)
10
50 (20)
20
75 (30)
30
1. Set up the filtration system to meet the maximum pressure
rating for the tubing (as shown in Figure 2) and close all
valves (V1, V2 and V3).
2. Set the peristaltic pump at the correct setting and start the
system.
Note: When using a peristaltic pump, the liquid flow rate
should be set at the values shown in Table 1.
3. Gradually open the upstream valve (V1) and vent the filter
housing from the highest point (V2) until all upstream air
has been released.
4. Allow fluid to flow through the highest point (V2) for 20
seconds.
5. Partially close the vent valve (V2) and continue to maintain
the pressure for at least one minute to dissolve and evacuate
any residual gas within the filter and to ensure complete
membrane wetting.
Note:
The vent valve (V2) must be kept partially open to allow
continuous venting and ensure the filter remains fully
wetted.
6. After one minute, gradually open the
downstream valve (V3).
7. Regulate the peristaltic pump to set the differential pressure
at the appropriate flow rate (see Table 1) and continue to flow
water through the filter for at least 5 minutes.
8. Close V1 to stop the fluid flow and allow the upstream
pressure (P1) to drop to zero.
9. Fully open V2 and V3 to drain the wetting fluid from the
housing and vent the filter.
10. Close V2.
11. Disconnect pump and ensure V2 is fully closed.
12. Connect integrity tester to V2 and open the valve.
13. Ensure the downstream line is vented at atmospheric
pressure.
14. When required, perform an air/water diffusion integrity test.
Cartridge Filter
Set-up
Capsule Filter
Set-up
Figure 2.Typical set-up for wetting with a peristaltic pump.
Minimum Recommended Flow Rates for Water Wetting
Filter Length
cm (in.)
Differential Pressure
mbar (psi)
Minimum Flow
Rate (LPM)
Total Flush Volume
Required* (L)
Millipore Express® SHF 0.2 μm Membrane
<7.62 (3)
45 (<1)
1.5
7.5
12.5 (5)
45 (<1)
3
15
25 (10)
55 (<1)
6
30
50 (20)
50 (<1)
12
60
75 (30)
50 (<1)
18
90
Millipore Express SHC 0.5/0.2 μm or HPF 0.5/0.3 μm Membrane
®
<7.62 (3)
60 (<1)
1.5
7.5
12.5 (5)
60 (<1)
2.5
12.5
25 (10)
80 (1)
6
30
50 (20)
70 (1)
11.5
57.5
75 (30)
70 (1)
17
85
Millipore Express SHR 0.1 µm Membrane
®
<7.62 (3)
90 (<2)
2
10
12.5 (5)
105 (<2)
3.5
17.5
25 (10)
55 (<1)
7.5
37.5
50 (20)
55 (<1)
15
75
75 (30)
55 (<1)
22.5
112.5
Millipore Express® SHR 0.1 µm Membrane with Prefilter
<7.62 (3)
90 (<2)
1.5
7.5
12.5 (5)
105 (<2)
2.5
12.5
25 (10)
95 (<2)
6
30
50 (20)
95 (<2)
12
60
75 (30)
95 (<2)
18
90
*System void volumes (housing, piping , hoses, etc.) should be
additive to these minimum recommended flush volumes.
4
Wetting Instructions, Integrity Testing, Sterilizing and Drying Guidelines for Filters with Millipore Express® Membranes
Integrity Testing Guidelines
Sterilizing Guidelines
Integrity Testing Parameters
Autoclaving Parameters for Sterilizing Wet or
Dry Filters
• The recommended integrity test for hydrophilic filters is the
air/water diffusion performed with the cartridge filter in
a housing, or a capsule filter, isolated from the rest of the
system, with the outlet open to atmospheric pressure.
• Pre-test treatment conditions described are not a substitute
for filter sterilization validation.
• Please refer to the enclosed Certificate of Quality for the
maximum diffusion rate.
• Validate the autoclave cycle using thermocouples and
biological indicators. Contact Technical Service for more
information.
Post Use 70/30 IPA Alcohol Reference Test
Autoclave Parameters for Wet or Dry Filters
Millipore Express Membranes are not for use with alcohol.
Alcohol based integrity tests should only be performed post use.
To minimize the volume of alcohol required, a peristaltic
pump is recommended for wetting the filter (see Wetting with
a Peristaltic Pump).
Ensure that the unit is properly grounded. Use a nitrogen
pressure source to minimize flammability.
• The filter should be completely dry to ensure complete and
adequate wetting of the membrane prior to the procedure.
• Use 70/30 IPA (70% isopropanol 30% purified water).
• It is recommended that an IPA/Water integrity test be
performed one time post-use, prior to filter disposal.
• CARTRIDGE FILTERS ONLY: Moisten the cartridge O-ring
with water to allow ease of insertion into the filter housing.
1. Set up installation as shown in Figure 2 and close all valves
(V1, V2 and V3).
2. Open V1 and V2. Flow 70/30 IPA through the filter housing
until fluid flows through V2 and all air has been released.
Close V2.
3. Gradually increase the upstream pressure to 1 bar (15 psig).
Do not exceed the maximum differential pressure rating for
the filter unit. Maintain this pressure for a minimum of one
minute to dissolve any residual gas within the filter and to
ensure membrane wetting.
4. After one minute, gradually open the downstream valve
(V3) and continue to flow 70/30 IPA through the filter at the
minimum recommended flow rate and differential pressure
shown in Table 2 for five minutes.
For Opticap® XL 150, 300 and 600 capsules:After one
minute, gradually open the downstream valve (V3) and
continue to flow the wetting fluid for another two minutes
at 5 psid.
Maximum Autoclave Specifications
Filter Type
Temp (°C)
Time
(min)
No. Cycles
Millipore Express® PHF Membrane
Cartridge Filters
126
60
15
Millipore Express® SHC and SHRP High
Area Membrane Cartridge Filters
126
60
5
Millipore Express® SHC, SHRP, HPF, SHF,
SHR Membrane Cartridge Filters
126
60
25
Gamma compatible and Gamma Sterilized Opticap XL Capsules with Millipore
Express® Membrane
123
60
3
Autoclavable Opticap XL Capsules with
Millipore Express® Membrane
126
60
3
Recommended Flush Volume for Final Filling Operation per
10-inch filter post sterilization
Filter Type
Flush Volume to meet
USP TOC requirements
Cartridge Filters
20 liters
Capsule Filters
21 liters
Steam in Place Parameters for Sterilizing Dry
Cartridge Filters
• DO NOT STEAM-IN-PLACE CAPSULE FILTERS.
• TO AVOID EXCESSIVE DIFFERENTIAL PRESSURE, ENSURE
THAT FILTER IS THOROUGHLY DRY PRIOR TO STEAM
STERILIZATION.
• Please refer to the enclosed Certificate of Quality for steamin-place and maximum differential pressure specifications.
• Perform steam sterilization on a dry cartridge to ensure that
process sterility is not compromised during steaming.
5. Stop the fluid flow and allow the upstream pressure (P1) to
drop to zero.
• IF A PRE-USE INTEGRITY TEST IS REQUIRED, IT MUST BE
PERFORMED AFTER FILTER STERILIZATION.
6. Drain the wetting fluid from the housing.
• The recommended integrity test for hydrophilic filters is an
air/water diffusion test performed with the cartridge filter in
a housing, or with a capsule filter, isolated from the rest of
the system, with the outlet open to atmospheric pressure.
7. Disconnect pump and ensure V2 is fully closed.
8. Connect integrity tester to V2 and open the valve.
9. Ensure the downstream line is vented at atmospheric
pressure
10. When required, perform an integrity test.
5
Wetting Instructions, Integrity Testing, Sterilizing and Drying Guidelines for Filters with Millipore Express® Membranes
Drying Guidelines
Filter Storage Conditions
Cartridge Blow Down Drying Procedure for
Millipore Express® HPF, SHF or SHC Filters
Store filters in their original packaging, away from direct
sunlight, and at room temperature. Do not remove the filter
from its bag until ready to use.
DO NOT BLOW DOWN Millipore Express® SHR CARTRIDGE
FILTERS.
1. With the outlet open to atmospheric pressure, set
compressed gas pressure to 340 mbar (5 psig). Start
compressed gas flow into the filter. Slowly increase
pressure to 6.9 bar (100 psig).
2. As the filter dries, the air flow rate will increase and the
differential pressure will decrease.
3. Allow air flow through the cartridge until either the inlet pressure
decreases to < 340 mbar (5 psig) or, apply 6.9 bar (100 psig) pressure
to the cartridge until bulk air (physically detectable air flow through
the filter) is detected at the outlet. Continue to flow air through the
cartridge for an additional 30 minutes.
Oven Drying Procedure for Millipore Express®
HPF, SHF, SHC or SHR Cartridge Filter
A standard area cartridge may be dried in a ventilated oven for
4.5 hours at 80 °C (176 °F) or > 9 hours at 60 °C (140 °F).
A high area cartridge may be dried in a ventilated oven for 10.5
hours at 80 °C (176 °F).
Cartridge drying can be verified by weighing a dry unused
cartridge and comparing it to the cartridge weight measured
after oven drying.
Cartridge Filter Oven Drying Procedure
A cartridge may be dried in a ventilated oven for 4.5 hours at 80
°C (176 °F) or > 9 hours at 60 °C (140 °F).
Cartridge drying can be verified by weighing a dry unused
cartridge and comparing it to the cartridge weight measured
after oven drying.
6
Wetting Instructions, Integrity Testing, Sterilizing and Drying Guidelines for Filters with Millipore Express® Membranes
Troubleshooting
Drying and rewetting the filter prior to retesting can minimize
integrity test failure.
Integrity test values that are out of specification may be caused
by:
• Improperly or incompletely wet filter
• If a problem in encountered:
• Do not remove the cartridge from the housing (for a
post-use test).
• Check connections for leaks (if automatic integrity tester
is used).
• Contaminant or product residue on the filter
• Improper O-ring seal on cartridge filter
• Ensure that appropriate integrity test specifications are
used for the filter and housing.
• Improper upstream vent seal
• Temperature outside manufacturer’s recommended
temperature
• System hardware leak (if automatic integrity tester is used)
• Ensure the environmental and/or test fluid temperature
is within the manufacturer’s recommended specification.
• Ensure an appropriate test fluid is used.
Filter integrity test failure
Post-use
Filter integrity test failure
Pre-use (after sterilization)
Yes
Is it a
marginal
failure?
No
Yes
No
Is it a
marginal
failure?
No
Can the
cartridge be
reseated?
OR
Are both
upstream vents
completely
closed?
Yes
Retest
Retest
Retest
Yes
Yes
No
No
Retest
Yes
No
Yes
Record
the value
No
Record
the value
A marginal failure is defined as a diffusional flow rate less than approximately 150% of the specification.
7
Wetting Instructions, Integrity Testing, Sterilizing and Drying Guidelines for Filters with Millipore Express® Membranes
Warranty
Technical Assistance
The applicable warranty for the products listed in this
publication may be found at www.millipore.com/terms (within
the “Terms and Conditions of Sale” applicable to your purchase
transaction).
For more information, contact the office nearest you or
visit the Technical Service page at www.emdmillipore.com/
techservice. Worldwide contact information is available at www.
emdmillipore.com/offices.
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