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USTR 2832
Validation Guide
PallSep™ Biotech Encapsulated Modules
with Supor®Polyethersulfone Membrane
2
CONTENTS
1. Purpose of This Document .........................................................................................................................4
2. Product Specification Summary .................................................................................................................4
2.1 Specifications ..........................................................................................................................................4
2.2 Part Number Structure ............................................................................................................................4
2.3 Materials of Construction ........................................................................................................................5
2.4 Operating Parameters..............................................................................................................................5
2.5 Shelf Life Data ........................................................................................................................................5
2.6 Cleaning Solutions ..................................................................................................................................5
3. Summary of Test Conclusions ....................................................................................................................6
3.1 Burst Testing............................................................................................................................................6
3.2 Operating Temperatures ..........................................................................................................................6
3.3 Extractables Testing ................................................................................................................................6
3.4 Membrane Plate Material (Polyolefin) Compatibility Test with Typical Process Solutions ..........................6
3.5 Encapsulant Compatibility Test ................................................................................................................6
3.6 Shell Coating Compatibility Test ..............................................................................................................6
3.7 Compatibility with Cleaning Solution ........................................................................................................6
3.8 Biological Safety Tests ............................................................................................................................7
4. Maximum Pressure Limit.............................................................................................................................7
4.1 Introduction..............................................................................................................................................7
4.2 Summary of Methods ..............................................................................................................................7
4.3 Results ....................................................................................................................................................7
4.4 Conclusions ............................................................................................................................................7
5. Operating Temperature................................................................................................................................7
5.1 Introduction..............................................................................................................................................7
5.2 Summary of Methods ..............................................................................................................................8
5.3 Results ....................................................................................................................................................8
5.4 Conclusions ............................................................................................................................................8
6. Extractables Testing ....................................................................................................................................8
6.1 Introduction..............................................................................................................................................8
6.2 Summary of Methods ..............................................................................................................................8
6.3 Results ....................................................................................................................................................9
6.4 Conclusions ............................................................................................................................................9
7. Membrane Plate Material (Polyolefin) Compatibility Test with Process Solutions...................................9
7.1 Introduction..............................................................................................................................................9
7.2 Summary of Methods ..............................................................................................................................9
7.3 Results ....................................................................................................................................................9
7.4 Conclusions ............................................................................................................................................9
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8. Encapsulant Compatibility Test ..................................................................................................................9
8.1 Introduction..............................................................................................................................................9
8.2 Summary of Methods ............................................................................................................................10
8.3 Results ..................................................................................................................................................10
8.4 Conclusions ..........................................................................................................................................10
9. Shell Coating Compatibility Test...............................................................................................................10
9.1 Introduction............................................................................................................................................10
9.2 Summary of Methods ............................................................................................................................10
9.3 Results ..................................................................................................................................................10
9.4 Conclusions ..........................................................................................................................................10
10. Compatibility with Cleaning Solution......................................................................................................11
10.1 Introduction........................................................................................................................................11
10.2 Summary of Methods ........................................................................................................................11
10.3 Results ..............................................................................................................................................11
10.4 Conclusions ......................................................................................................................................11
11. Biological Safety Tests ............................................................................................................................11
11.1 Introduction........................................................................................................................................11
11.2 Summary of Methods ........................................................................................................................12
Systemic Injection Tests .....................................................................................................................12
Intracutaneous Tests ..........................................................................................................................12
7 Day Muscle Implantation with Macroscopic Evaluation....................................................................12
11.3 Results ..............................................................................................................................................12
11.4 Conclusions ......................................................................................................................................12
12. Appendix 1 ...............................................................................................................................................13
13. Appendix 2 ...............................................................................................................................................14
14. Appendix 3 ...............................................................................................................................................15
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1. Purpose of This Document
This report summarizes the results of test work performed to substantiate the suitability of the PallSep
Biotech encapsulated module (also called encapsulated stack) with 0.2 µm Supor polyethersulfone
membrane for operation under conditions typical for biotech processes.
The test program included:
• Burst testing for maximum pressure limit of installed module
• Operating temperatures
• Extractables testing
• Membrane plate material (polyolefin) compatibility test with typical process solutions
• Encapsulant compatibility test
• Shell coating compatibility test
• Compatibility with cleaning solution
• Storage fluid trial
• Biological safety tests
Pall Life Sciences offers technical support and validation services. Please contact your local Pall repre-
sentative for specific services.
2. Product Specification Summary
Important preliminary remark: PallSep Biotech modules with part numbers VMFPSM20BXX (where XX
varies with the module membrane area) are designed to be used exclusively in the PallSep Biotech sys-
tems with the PallSep PS50 base machine. They are not designed to be used with any other machine.
Any other use is hazardous and Pall declines responsibility when modules are not used in combination
with PallSep Biotech systems supplied by Pall.
Please refer to the following documentation:
- PallSep Biotech Modules Instructions for Use
- PallSep Biotech System Documentation Package (delivered with the PallSep Biotech system) for instal-
lation, operation, and maintenance instructions
2.1 Specifications
Nominal Wet
Nominal Dimensions Weight (kg)
diameter x height Nominal (water-wet –
Part Number Area m² mm (inch) Weight (kg) after drainage)
VMFPSM20B02 0.2 311 x 23 (12.25 x 0.91) 1.17 1.20
VMFPSM20B10 1.0 311 x 53 (12.25 x 2.07) 2.83 3.05
VMFPSM20B50 5.0 311 x 200 (12.25 x 7.88) 11.0 12.1
2.2 Part Number Structure
Each PallSep Biotech module is identified by lot and serial number for traceability:
Lot number structure outline CAXXXX
CA = specific prefix dedicated to the PallSep Biotech modules products
XXXX = sequential lot number in the series from 0001 to 9999
Serial number structure outline CAXXXXYYYY
CAXXXX = lot number
YYYY = specific number of the filter produced within that particular lot
Example:
CA00100001 would correspond to the first (0001) encapsulated module produced in the tenth
lot (0010) of PallSep Biotech modules
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2.3 Materials of Construction
PallSep Biotech Module Materials of Construction
Membrane 0.2 µm Supor polyethersulfone (PES)
Membrane support plate Polyolen copolymer
Membrane drainage layer Polyolen
Spacers Polyester fully encapsulated in epoxy resin
Encapsulant Epoxy resin
O-rings/gaskets Ethylene propylene diene monomer (EPDM)
Housing Fiber reinforced plastic (non-product contact)
Core Polysulfone
2.4 Operating Parameters
Pressure
Maximum operating pressure 4.2 barg (60 psig)
Maximum transmembrane pressure (TMP) 3.5 barg (50 psig)
Maximum reverse pressure 0.0 bar (0 psig) [no reverse pressure allowed]
Temperature
Maximum operating temperature 45 ºC during process
50 °C during cleaning
Minimum operating temperature 4 °C
Feed ow rate
Maximum feed ow rate 3.5 L/min/m²
Oscillation amplitude
Maximum amplitude 19 mm (0.75 in), peak-to-peak amplitude as measured at the
outer diameter of the lter module, at 50 Hz nominal operating
frequency
Recommended vibration amplitude 17 mm (0.67 in)
during the process
2.5 Shelf Life Data
Shelf life, time and conditions Expected shelf life:
3 years stored dry, unused, in original packaging when
stored between 16 ºC and 29 ºC
2.6 Cleaning Solutions
Pre-use treatment 0.5 M NaOH ush @ 45 °C for 60 minutes, followed by deionized
water ush
Cleaning method A cleaning solution of 0.5 M NaOH and 300 ppm NaOCl at a
maximum temperature of 45-50 °C and a maximum time of
25 hours (5 cycles of 5 hours maximum)
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3. Summary of Test Conclusions
Remark: the test conclusions are valid for the PallSep Biotech modules with part numbers listed below:
Part Number Area (m²) Product Description
VMFPSM20B02 0.2 0.2 m² PallSep Biotech module
VMFPSM20B10 1.0 1.0 m² PallSep Biotech module
VMFPSM20B50 5.0 5.0 m² PallSep Biotech module
3.1 Burst Testing
The PallSep PS50 base machine used with a 5 m2PallSep Biotech module with Supor
polyethersulfone membrane has a recommended maximum operational pressure of 4.2 barg
(60 psig) at 45 °C, based on test results with a safety factor of greater than 5 times.
3.2 Operating Temperatures
The PallSep Biotech module with Supor polyethersulfone membrane has been evaluated at a
minimum operating temperature of 4 °C for a total of 75 hours (cycles of about 15 hours each)
and at a maximum operating temperature of 45 °C for a total of 25 hours (cycles of about
6 hours).
3.3 Extractables Testing
A PallSep Biotech module assembly was tested for extractables. Over two consecutive 4 hour
extraction periods with purified water at ambient temperature, a single PallSep Biotech 0.2 m2
encapsulated module demonstrated a reduction in the rate of release of extractable material.
The analysis gave results of 16 mg and 7 mg/m² for the NVR. It is expected that additional
extraction periods will not exceed these values.
3.4 Membrane Plate Material (Polyolefin) Compatibility Test with Typical Process Solutions
No significant change in the physical properties of the test samples was observed when
compared to the control sample. Therefore, it can be concluded that the typical process
solutions of deionized water, 4 M guanidine HCl, 8 M urea and 0.5 M NaOH with 300 ppm
NaOCl are compatible with the membrane plate material (polyolefin).
3.5 Encapsulant Compatibility Test
The data shows no significant change in the dimensions and compressive yield strength of the
samples following a 72 hour soak in test solutions of deionized water, 4 M Guanidine HCl, 8 M
Urea and 0.5 M NaOH with 300 ppm NaOCl. It can be concluded from the data that the epoxy
resin used in the manufacture of the PallSep Biotech module is compatible with these test solutions.
3.6 Shell Coating Compatibility Test
No physical changes occurred to the test samples following exposure to formaldehyde and
ammonium carbonate. It is therefore considered that routine use of these chemicals in the clean
room environment will not compromise the PallSep Biotech module’s polyurethane coating.
3.7 Compatibility with Cleaning Solution
The PallSep Biotech module with Supor polyethersulfone membrane may be cleaned with a
solution of 0.5M NaOH in deionized water with 300ppm NaOCl at 45-50 °C for a maximum
of 25 hours (5 cycles of 5 hours maximum).
3.8 Biological Safety Tests
Representative samples of all product contact components of the PallSep Biotech module
have met the specifications for biological tests listed in the current revision of the United States
Pharmacopoeia (USP) for Class VI – 50 °C plastics in vivo.
4. Maximum Pressure Limit
4.1 Introduction
The purpose of this test was to determine the hydrostatic burst pressure of a 5 m2PallSep
Biotech module installed in a PallSep PS50 base unit at the maximum operating temperature
of 45 °C.
4.2 Summary of Methods
The perimeter length and center bolts were measured before and after testing. Height and
diameter measurements of the PallSep Biotech module were taken in three marked locations
pre- and post-test. The module was then assembled in accordance with the PallSep PS50
base unit manual. The outer diameter (OD) flange-to-flange height was marked and measured
at 4 locations pre- and post-test. The module was then flushed with warm tap water until the
effluent temperature reached 45-50 °C. The inlet and outlet ports were then capped and the
complete assembly was immersed in 45-50 °C water for 20 minutes. A pressure hold test
was performed at 4.2 barg (60 psig) to confirm correct module assembly. The module was then
pressurized with a hand hydro-pump until the module failed to maintain pressure. The module
was then removed and a low water pressure (0.35-1.4 barg or 5-20 psig) was applied and the
module was checked for leaks.
4.3 Results
The module was successfully tested for ten times at a pressure greater than 21 barg (300 psig),
i.e., more than five times the maximum operating pressure of 4.2 barg (60 psig). There was no
visible damage to the outer shell.
4.4 Conclusions
The PallSep PS50 base unit with 5 m2PallSep Biotech module did not burst at a pressure the
5 times above the operating limit for the plastic filter housing.
The PallSep PS50 base unit with 5 m2PallSep Biotech module is recommended for operation
at a maximum pressure of 4.2 barg (60 psig) and 45 °C, in accordance with component design
specifications.
5. Operating Temperature
5.1 Introduction
The purpose of this study was to determine if the PallSep Biotech module would maintain
membrane and structural integrity after being exposed to:
- a minimum operating temperature of 4 °C for 75 hours
- a maximum operating temperature of 45 °C for 25 hours
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5.2 Summary of Methods
A PS50 PallSep base machine equipped with a 5 m2module was run with filtered deionized
water to remove any air bubbles. The integrity of the system as well as the integrity of the
module were confirmed prior to the tests with fluid at minimum and maximum temperature.
A 48% glycerin and water solution was prepared in a holding tank. The solution was then chilled
and maintained to approximately 5 °C while recirculated through the system running at ¾”
(19 mm) peak-to-peak amplitude and the flow rate adjusted so that retentate and permeate
total flow was corresponded to a feed flow rate of 2-3.2 L/min/m².
The solution was recirculated at approximately 5 °C during 6 runs for a total duration of 75 hours.
Between these runs, the solution was again recirculated through the system and slowly heated
to 47-50 °C to avoid thermal shocking of the module (less than 0.75 °C/min rate of temperature
increase). The solution was recirculated at 47-50 °C during 5 runs for a cumulative total of 25 hours.
During all these runs, time, flow rates (retentate and permeate), temperature and frequency
were recorded.
The integrity of the PallSep Biotech module was confirmed at a test pressure of 2.8 barg
(40 psig) after the last run and deionized water rinsing.
5.3 Results
The PallSep Biotech module maintained structural and membrane integrity after all these runs
corresponding to a total of 75 hours at approximately 5 °C and a total of 25 hours of operation
at 47-50 °C with the solution.
5.4 Conclusions
The PallSep Biotech module with Supor polyethersulfone membrane may be used at a minimum
operating temperature of 4 °C for a total of 75 hours (cycles of about 15 hours each) and at a
maximum operating temperature of 45 °C for a total of 25 hours (cycles of about 6 hours).
6. Extractables Testing
6.1 Introduction
The purpose of this testing was to quantify the material extracted from a 0.2 m² PallSep Biotech
module using purified water. Testing was performed to quantify the non-volatile residue (NVR)
material.
6.2 Summary of Methods
To prepare the PallSep Biotech module, a clean-in-place (CIP) cycle was performed on the
module at 45 °C for a period of 60 minutes using a recirculating solution of 0.5 M sodium
hydroxide with 300 ppm sodium hypochlorite, followed by a purified water rinse.
Extraction tests were performed in a known volume of deionized water at ambient temperature:
• Extraction sample 1: obtained by recirculation of 2 L of purified water for 4 hours through the
test equipment including the PallSep Biotech module with a transmembrane pressure of 1 bar
(14.5 psig).
• Extraction sample 2: obtained under the same conditions as extraction sample 1 using a fresh
2 L sample of purified water.
Blank samples were determined as appropriate for method and result controls.
Following the extraction period, the 2 L sample volume of the extraction liquid was evaporated
to dryness and the NVR was determined gravimetrically. An extrapolation was made to the NVR
value to get the values per square meter of membrane area.
6.3 Results
Sample NVR (mg/m²)
1 16*
2 7*
* Total extractables per extract (baseline correlated and maximum error value)
6.4 Conclusions
Over two consecutive 4-hour extraction periods, a single 0.2 m2PallSep Biotech module
demonstrated a reduction in the rate of release of extractable material. The initial analysis gave
results of 16 mg and 7 mg/m² for the NVR analysis. It is expected that additional extraction periods
will not exceed these values as a second extraction cycle gave a result of 7 mg/m² for the NVR.
7. Membrane Plate Material (Polyolefin) Compatibility Test with Process Solutions
7.1 Introduction
The purpose of this test was to determine the chemical compatibility of the membrane plate
material (polyolefin) after soaking in solutions of guanidine hydrochloride, urea, sodium hydroxide
with hypochlorite solution, and deionized water.
7.2 Summary of Methods
The solution concentrations were made up as below:
1. Deionized water at ambient temperature
2. 4 M guanidine hydrochloride at ambient temperature
3. 8 M urea at ambient temperature.
4. 0.5 M NaOH with 300 ppm NaOCl at 50 °C
Three membrane plate material (polyolefin) ASTM standard tensile bar samples were soaked in
each of these solutions for 48 hours. The samples were removed from the solution, rinsed, dried
and immediately tensile tested to failure. The ASTM standard tensile bar samples from solution
#4 were allowed to cool to room temperature before testing.
The standard tensile properties were recorded, and the width and thickness of each sample
was measured.
7.3 Results
No significant differences in the physical properties of the test samples were observed when
compared to the control sample.
7.4 Conclusions
Based upon the test results, it can be concluded that the membrane plate material (polyolefin)
is compatible with the typical process solutions tested.
8. Encapsulant Compatibility Test
8.1 Introduction
An epoxy resin is the encapsulant used for the PallSep Biotech encapsulated filter module. The
epoxy resin was exposed to several different chemicals during the course of operation. The
purpose of this study was to establish the chemical compatibility of the epoxy resin with
these substances.
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8.2 Summary of Methods
Fifteen (15) epoxy resin samples were measured at room temperature. Three pieces of the
epoxy were then exposed to each of the following solutions for 72 hours at 35 °C.
A. Deionized water
B. 4 M guanidine HCl
C. 8 M urea
D. 0.5 M NaOH with 300 ppm NaOCl
Three pieces were retained as a control and not exposed to any chemicals or water. Following
exposure, the samples were removed from the solutions, dried and allowed to cool. Each
sample was then measured and any physical changes in appearance were recorded. Finally, a
compression test where the sample was put under a compressive load was conducted on each
sample to failure. The estimated compressive failure load was approximately 3390 Nm (2500 lb-f).
8.3 Results
No significant change (<0.25 mm or < 0.01 in) in dimensions of the samples following a 72 hour
soak in the test solutions and no significant change (within 5% of original value) in compressive
yield strength were observed.
8.4 Conclusions
Based upon the test results, it can be concluded that the epoxy resin used in the manufacture
of the PallSep Biotech module with Supor polyethersulfone membrane is compatible with the
test solutions.
9. Shell Coating Compatibility Test
9.1 Introduction
The purpose of this study is to determine if the polyurethane module coating is affected by ex-
posure to formaldehyde and ammonium carbonate during sanitisation in the processing room.
The outer ring of the PallSep Biotech module is a fiberglass wound tube with a polyurethane
clear-coat on the outer circumference, top and bottom. During sanitization, the room and con-
tents are exposed to nebulizer formaldehyde at 4 g/m3for 6 hours followed by neutralization for
2 hrs with 3 g/m3of ammonium carbonate.
9.2 Summary of Methods
Two 51 mm (2 in) sections were cut from the fiberglass wound tube using a band saw. (Control
and Test sample). One section was exposed for 6 hours in the formaldehyde solution. Upon
completion, the test sample was inspected and then place into the ammonium carbonate
solution for an additional 2 hours. The sample was removed and inspected for any changes
in appearance.
9.3 Results
The sample remained visually unchanged following exposure to formaldehyde and ammonium
carbonate when compared to the control sample.
9.4 Conclusions
No physical changes occurred to the test samples following exposure to the formaldehyde
and ammonium carbonate solutions. It is therefore considered that the routine use of these
chemicals in the clean room environment will not compromise the PallSep Biotech polyurethane
module coating.
10. Compatibility with Cleaning Solution
10.1 Introduction
The purpose of this study was to determine if the PallSep Biotech module would maintain
membrane and structural integrity after being exposed to a 0.5 M NaOH with 300 ppm NaOCl
cleaning solution for a 25 hours exposure.
10.2 Summary of Methods
A PS50 PallSep base machine equipped with a 0.2 m2module was run at a 19 mm (¾ in) peak-
to-peak amplitude with filtered, deionized water to remove any air bubbles. Initial “zero” readings
of the feed, permeate and retentate pressure gauges were recorded before a water flux test at
differential pressures (retentate – permeate) of 0.35 barg (5 psig), 0.7 barg (10 psig) and.1 barg
(15 psig) were carried out. The integrity of the module was then confirmed at test pressures of
1 barg (15 psig) and 2.8 barg (40 psig).
A 0.5 M NaOH with 300 ppm NaOCl solution was prepared in a holding tank. The solution was
then heated to and maintained at 50 °C. The cleaning solution was then passed through the
system and the flow rate was adjusted so that retentate and permeate total flow was corre-
sponded to the maximum feed flow rate of 3.5 L/min/m² (worst case conditions). Time, pressure
(feed, retentate, and permeate), flow rate (retentate and permeate), temperature, amplitude and
power consumption were then recorded.
The 0.5 M NaOH with 300 ppm NaOCl solution was recirculated for approximately 5 hours and
then the system was rinsed with deionized water. The water flux was measured and the integrity
of the PallSep Biotech module was confirmed at test pressures of 1 barg (15 psig) and 2.8 barg
(40 psig) after each run of cleaning solution testing and deionized water rinsing. This cycle was
repeated to a total of 25 hour exposure time to the cleaning solution.
10.3 Results
Over the different cycles, the PallSep Biotech module maintained structural and membrane integrity
after 25 hours of operation at 50 °C to the cleaning solution. Integrity tests confirm the module
remained integral after exposure to the 0.5 M NaOH with 300 ppm NaOCl cleaning solution.
10.4 Conclusions
In conclusion, the PallSep Biotech module with Supor polyethersulfone membrane can be
cleaned with 0.5 M NaOH in deionized water with 300 ppm NaOCl at 50 °C for a maximum
of 25 hours (5 cycles of 5 hours maximum).
11. Biological Safety Tests
11.1 Introduction
The purpose of these tests was to evaluate the biological suitability of the materials of construction
of the PallSep Biotech Supor polyethersulfone modules, against current USP Class VI Plastics test
procedures. The materials of construction are as follows:
• PallSep Biotech module plates:
– Plates – membrane plate material (polyolefin)
– Drainage layer – polypropylene/polyethylene
– Intermediate layer – non-woven polyolefin
– Membrane – Supor polyethersulfone 0.2 µm
• PallSep Biotech polyester spacer material for epoxy resin wicking
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11.2 Summary of Methods
Tests were performed according to current USP methods for Class VI-50 °C plastics in vivo.
All tests were performed by STS, Rush, NY, USA, and consist of:
• Systemic injection test
• Intracutaneous (intradermal) reactivity test
• 7 Day muscle implantation with macroscopic evaluation
The four extracting media listed in the USP simulate parenteral solutions and body fluids.
These include:
• USP saline
• 1:20 alcohol:USP saline
• Polyethylene glycol
• Vegetable oil
Tests were conducted to USP standard conditions of 50 ±2 °C for 72 hours ± 30 minutes.
Systemic Injection Tests
An acute systemic injection test was performed to evaluate the potential of a single injection
of en extract to produce systemic toxicity. Saline and alcohol:saline injections were performed
intravenously. Vegetable oil and polyethylene glycol injections were performed intraperitoneally.
Intracutaneous Tests
An intracutaneous test was performed to evaluate the potential of a single injection of an extract
to produce tissue irritation. All four extracts listed above were used for these tests.
7 Day Muscle Implantation with Macroscopic Evaluation
Implantation tests were also performed, in order to subject the component materials of the
PallSep Biotech module to the most stringent conditions included in the USP. Each component
was implanted separately.
All observations to the above tests were made by comparing test components to a
suitable control.
11.3 Results
The PallSep Biotech membrane plate and the PallSep Biotech polyester spacer (inner and outer)
passed all of the tests specified. Appendices 1 and 2 show a copy of the test certificates.
11.4 Conclusions
Components of the PallSep Biotech module meet the requirements of the USP for Class VI-
50 °C Plastics.
12. Appendix 1
Copy of Biological Safety Test Certificate for the PallSep Biotech Membrane Plate
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13. Appendix 2
Copy of Biological Safety Test Certificate for the PallSep Biotech Spacer Material for Epoxy Wicking
14. APPENDIX 3 :
Quality Assurance Certificate
www.pall.com/biopharm 15
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Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia,
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Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit
www.pall.com/contact.
The information provided in this literature was reviewed for accuracy at the time of publication. Product data
may be subject to change without notice. For current information consult your local Pall distributor or contact
Pall directly.
© 2012, Pall Corporation. Pall, , PallSep, and Supor are trademarks of Pall Corporation.
® indicates a trademark registered in the USA and TM indicates a common law trademark.
Filtration.Separation.Solution. is a service mark of Pall Corporation.
3/12, PDF, GN12.7720 USTR 2832
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