Pall Powder Handling Bags Validation Guide

Type
Validation Guide
USTR3239
Validation Guide
Pall® Powder Handling Bags with PSD Film
2
Contents
A. General Description of the PSD Film and Articles .................................................................................... 4
B. Properties of the PSD Film ........................................................................................................................ 4
B1. Mechanical Testing ................................................................................................................................. 4
B1.1. Gelbo Flex ..................................................................................................................................... 4
B1.2. Thickness ...................................................................................................................................... 4
B1.3. Strength and Elongation ................................................................................................................ 4
B1.4. Puncture Resistance ..................................................................................................................... 4
B1.5. Dart Impact ................................................................................................................................... 5
B1.6. Tear Resistance ............................................................................................................................ 5
B2. Physical Testing ...................................................................................................................................... 5
B2.1. Surface Resistivity ......................................................................................................................... 5
B3. Chemical and Biological Testing ............................................................................................................. 5
B3.1. Biological Reactivity – In Vitro ISO 10993-5 and USP <87> Elution Test .................................... 5
B3.2. Biological Reactivity – In Vivo USP <88> Class VI Plastics ......................................................... 5
B4. Physicochemical Tests .......................................................................................................................... 6
B4.1. Tests on Plastic Materials and Components Used to Package Medical Articles USP <661> ........ 6
B5. Functional Testing on Powder Handling Bag .......................................................................................... 6
B5.1. Functional Weight Test .................................................................................................................. 6
B5.2. Powder Transfer Efciency ............................................................................................................ 6
B5.3. Functional Drop Test ..................................................................................................................... 6
B6. Overview Testing Results ........................................................................................................................ 6
B6.1. Mechanical Results ....................................................................................................................... 6
B6.1.1. Gelbo Test ........................................................................................................................ 7
B6.1.2. Thickness .......................................................................................................................... 7
B6.1.3. Strength and Elongation .................................................................................................... 7
B6.1.4. Puncture Resistance ........................................................................................................ 7
B6.1.5. Dart Impact ....................................................................................................................... 7
B6.1.6. Tear Resistance ................................................................................................................ 8
B6.2. Physical Testing ............................................................................................................................ 8
B6.2.1. Surface Resistivity ............................................................................................................. 8
B6.3. Chemical and Biological Testing .................................................................................................... 8
B6.3.1. Biological Reactivity – In Vitro – ISO 10993-5 and USP <87> Elution Test ....................... 8
B6.3.2. Biological Reactivity – In Vivo – USP <88> Class VI Plastics Test .................................... 8
B6.4. Physicochemical Test Results ....................................................................................................... 8
B6.4.1. Tests on Plastic Materials and Components Used to Package Medical Articles
USP <661> ...................................................................................................................... 8
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B6.5. Functional Tests on Powder Handling Bag .................................................................................... 9
B6.5.1. Functional Weight Test ..................................................................................................... 9
B6.5.2. Powder Transfer Efciency ............................................................................................... 9
B6.5.3. Functional Drop Test ...................................................................................................... 10
B6.5.4. Conclusion ..................................................................................................................... 11
C. Aging Test Study- Accelerated Shelf Life Study .................................................................................... 11
C1. Aim of the Study ................................................................................................................................... 11
C2. List of Tested Materials ......................................................................................................................... 11
C3. Storage Conditions ............................................................................................................................... 11
C4. Testing Frequency ................................................................................................................................ 12
C5. Analytical Method and Specications .................................................................................................... 12
C6. Results ................................................................................................................................................. 12
C7. Conrmation of the Results with 240 μm Film ....................................................................................... 13
C8.Conclusion ............................................................................................................................................. 13
D. Aging Test Study- Refrigerator Conditions ............................................................................................. 13
D1. Aim of the Study ................................................................................................................................... 13
D2. List of Tested Materials ......................................................................................................................... 13
D3. Storage Conditions ............................................................................................................................... 13
D4. Analytical Method and Specications .................................................................................................... 13
D5. Results ................................................................................................................................................. 14
D6. Conclusion ............................................................................................................................................ 14
E. Statement on TSE/BSE and Animal Derived Components .................................................................... 14
4
A. General Description of the PSD Film and Articles
All of the layers in PSD are made from “medical grade” materials, meaning that they comply with
industry standards and are subject to strict change controls. The entire structure of PSD is totally free of
any animal derived components (ADCF). Pall has also created PSD with dual sourcing and contingency
planning in mind, to ensure security of supply. The structure of the lm is as follows:
Contact layer 45 µm LDPE + permanent antistatic
Inner layer 150 µm LDPE/ULDPE
Outer layer 45 µm LDPE + permanent antistatic
This composition allows permanent antistatic properties without any migration of antistatic additive in the
content of the bag.
Figure 1
Pall powder handling bags made of PSD lm.
B. Properties of the PSD Film
B1. Mechanical Testing
Test Type and Test Summary Description
General Description Reference of Test Reference
B1.1 Gelbo Flex ASTM F392 This test covers the ex crack resistance of materials
Determines the ex resistance of by the formation of pinholes. Specimens (=sealed
materials by the formation of pinholes. lm tube) are twisted and horizontally folded at a
constant rate and at different test cycles 500,
1000, 5000 or 10.000 test cycles. The number of
pinholes is measured by lling the tube with H2O.
B1.2 Thickness Pall Life Sciences The lm is placed in a calibrated digital system that
Determines the thickness of the lm. measures the thickness of the lm.
B1.3 Strength and Elongation ASTM D882 This test method covers the determination of tensile
A measure of the force required to properties of plastics in the form of thin sheeting,
stretch a material to its breaking point. including lm, less than 1.0 mm (0.04 in.) thick.
B1.4 Puncture Resistance FTMS 101B A pressing bar with a xed diameter will be pushed
Puncture resistance testing predicts through the lm at a constant speed. The pressure
the durability of the lm while in use. force, needed to break the lm, will indicate the
Films with high puncture resistance puncture resistance of the lm.
correspond with material that can
absorb the energy of an impact by
both resistance to deformation and
increased elongation. Puncture
resistance, measured in energy units,
evaluates the lm strength and
extensibility properties.
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Test Type and Test Summary Description
General Description Reference of Test Reference
B1.5 Dart Impact ASTM D1709 Described are two testing methods depending on
Test method covers the determination the size of the striker, which are determined by the
of the energy as part of mechanical impact resistance of the material. The standard
properties that causes plastic lm to technique is a staircase method to drop a weight
fail under specied conditions of and increase or decrease depending in pass or fail.
impact of a free-falling dart. Standard apparatus and striker has been described.
B1.6. Tear Resistance Test is designed to measure the force to initiate
Determines the tear resistance of tearing.
exible plastic lm and sheeting at
very low rates of loading.
B2. Physical Testing
Test Type and Test Summary Description
General Description Reference of Test Reference
B2.1. Surface Resistivity ASTM D257 Antistatic properties refer to the material ability to
resist to tribocharging. The surface resistivity of
a material is numerically equal to the surface
resistance between 2 electrodes forming opposite
sides of a square. The size of the square is
immaterial. The surface resistivity gives information
on discharge. The surface resistivity is measured on
inside and outside surface.
B3. Chemical and Biological Testing
Test Type and Test Summary Description
General Description Reference of Test Reference
B3.1. Biological Reactivity – In Vitro USP <87> Class VI Extracts are obtained by placing the test and control
Evaluates the response of mammalian ISO 10993-5 materials (extracts) in separate cell culture media
cell cultures to extracts of polymeric under standard conditions. Cells are observed for
materials. visible signs of toxicity (such as change in size or
appearance of cellular components or a disruption
in their conguration) in response to the test and
control materials.
B3.2. Biological Reactivity – In Vivo USP <88> USP Biological Reactivity Test – in vivo for Class
Evaluates the response in animals to VI Plastics, is a series of three tests: systemic
exposure of polymeric materials. toxicity, intracutaneous reactivity and implantation.
The rst two are designed to determine the systemic
and local, respectively, biological responses of
animals to plastics and other polymers by the single
dose injection of specic extracts prepared from
a sample. The implantation test is designed to
evaluate the reaction of living tissue to the plastic
and other polymers by the implantation of the
sample itself into animal tissue.
6
B4. Physicochemical Tests
Test Type and Test Summary Description
General Description Reference of Test Reference
B4.1. Tests on Plastic Materials USP <661> Material dependent: measures the properties of
and Components Used to Package impurities extracted from plastics when leached
Medical Articles with extraction medium over a specied period and
Evaluates the physical and chemical temperature. Includes the following: heavy metals,
properties of plastics and their extracts. buffer capacity and non-volatile residue.
B5. Functional Testing on Powder Handling Bag
Test Type and Test Summary Description
General Description Reference of Test Reference
B.5.1 Functional Weight Test N/A A lled bag hangs on a round or a at hook for
Provides information how long the several days. Bending of the handle is measured.
handle can hold a certain mass of
powder without a lot of bending of
the handle.
B.5.2 Powder Transfer Efciency N/A A rst bag is lled with powder and this powder is
Provides information how much then transferred to a second bag. The rst bag is
powder is remaining in a bag when weighed before lling and after being emptied.
the content of one bag is transferred.
B.5.3 Functional Drop Test ASTM 5276-2009 A lled bag is dropped and then checked if it is
Gives information if a lled bag intact. A hanging drop test and a at drop test are
is intact after being dropped. performed.
B6. Overview Testing Results
B6.1. Mechanical Results
The following mechanical properties were investigated; ex crack resistance,
thickness, tensile strength and elongation, lm modulus, puncture resistance,
dart impact and tear resistance. The tests were carried out before and after
gamma irradiation. The gamma irradiation dose was min 50 kGy.
B6.1.1. Gelbo Test
Before Gamma After Gamma
PSD Lot Number PSD Lot Number
41412 41562 41563 41412 41562 41563
Results after 500 cycles
Average # 0 Not done 0 0 0 Not done
pinholes
Results after 1000 cycles
Average # 0.7 0 1.3 0.7 0.3 0
pinholes
Results after 5000 cycles
Average # 8.7 3 2.7 5.3 4.7 1.7
pinholes
Results after 10 000 cycles
Average # Not done 7.7 Not done Not done Not done 11
pinholes
These results are the average of 3 measurements.
www.pall.com/biopharm 7
B6.1.2. Thickness
Before Gamma
PSD Lot Number
41412 41562 41563
Thickness (μm) 235 231 240
These results are the average of 40 measurements.
Release Specication: 240 ± 30 μm
B6.1.3. Strength and Elongation
Before Gamma After Gamma
PSD Lot Number PSD lot number
41412 41562 41563 41412 41562 41563
Tensile and elongation
Max strength (MPa) – MD1 19 19 19 21 23 20
Max strength (MPa) – TD2 20 19 20 23 23 20
Elongation at break (%) - MD 940 890 860 940 860 830
Elongation at break (%) - TD 1060 1070 1080 1010 960 1040
Young Mod (MPa) - MD 220 150 210 180 180 230
Young Mod (MPa) - TD 210 180 240 210 190 250
1MD = machine direction, which is the direction that the lms moves through the machine
from start to nish.
2TD = transverse direction, which is the direction perpendicular to the machine direction.
These results are the average of at least 5 measurements.
Release specication:
Max strength: Not lower than (NLT) 15 MPa (MD and TD)
Elongation at break: NLT 700% (MD)
NLT 800% (TD)
B6.1.4. Puncture Resistance
Before Gamma After Gamma
PSD Lot Number PSD lot number
41412 41562 41563 41412 41562 41563
Puncture resistance
Max load (N) 78 74 72 81 78 71
Deection at max load (mm) 34 33 31 32 32 30
These results are the average of 10 measurements.
B6.1.5. Dart Impact
Before Gamma After Gamma
PSD Lot Number PSD lot number
41412 41562 41563 41412 41562 41563
Dart impact (g) 630 670 630 850 880 832
www.pall.com/biopharm 7
8
B6.1.6. Tear Resistance
Before Gamma After Gamma
PSD Lot Number PSD lot number
41412 41562 41563 41412 41562 41563
Tear resistance
Avg force (N) - MD 21 20 20 21 21 18
Avg force (N) - TD 22 22 21 22 21 24
Initial max load (N) - MD 22 21 21 22 22 19
Initial max load (N) - TD 24 23 21 23 22 26
These results are the average of 5 measurements.
B6.2. Physical Testing
B6.2.1. Surface Resistivity
Before Gamma After Gamma
PSD Lot Number PSD lot number
41412 41562 41563 41412 41562 41563
Surface resistivity (Ohm/square)
Inside 109 109 109 1010 1010 109
Outside 1011 1010 1011 1012 1012 1011
These results are the highest results of 2 measurements.
Release Specication: Not more than (NMT) 1012 Ohm/square
B6.3. Chemical and Biological Testing
B6.3.1. Biological Reactivity – In Vitro – ISO 10993-5 and USP <87> Elution Test
Description Standard PSD Lot Number 37174
Biological reactivity in vitro USP <87> PASS
ISO 10993-5 PASS
B6.3.2. Biological Reactivity – In Vivo – USP <88> Class VI Plastics Test
Description Standard PSD Lot Number 37174
Biological reactivity in vivo USP <88> PASS, USP Class VI
B6.4. Physicochemical Test Results
B6.4.1. Tests on Plastic Materials and Components used to Package Medical
Articles USP <661>
Description Standard PSD Lot Number 37174
Test on plastic materials and USP <661> PASS
components used to package
medical articles
www.pall.com/biopharm 9
B6.5. Functional Tests on Powder Handling Bag
B6.5.1. Functional Weight Test
Test method: Gamma irradiated (min 50 kGy) bags are lled with different
weights. The test has been done with 3 samples per bag for gamma
irradiated bags. A lled bag hangs on a round hook for 7 days by
its handle.
Weight Test Gamma (min 50 kGy)
Volume Connector Weight # of Samples
5 L 2 in. 5 kg 3
15 L 4 in. 15 kg 3
30 L 4 in. 30 kg 3
40 L 6 in. 40 kg 3
50 L 6 in. 50 kg 3
100 L 6 in. 100 kg 3
Result: The irradiated bags can hold max 25 kg per handle. During the
holding time there has been no bending of the handle, no peel or no
visual seal elongation.
B6.5.2 Powder Transfer Efciency
Test method: The empty bags with tment and the gasket, clamp and
sanitary clamps are weighed. The bags are lled with powder (3 kg in
15 L bags and 6 kg in 30 L bags). The bag is rst closed with a pinch
and then with a gasket, cap and sanitary clamp. The bag is shaken so
that the powder reaches all sides of the bag. The gasket, clamp and
sanitary clamp are removed. The pinch is removed and the bag is
emptied in another bag. The empty bag with tment and the closing
system is weighed. The amount of powder that remained in the rst
bag and on the closing system is calculated.
The test was performed with sucrose, salt, lactose, diatomaceous earth
(Celite) and medium on 15 L – 4 inch bags. The test with salt has also
been replicated on the 30 L bag.
The % powder transfer for all types of powder is very high and > 99.9%.
The residues are mainly located at the 60° seal, followed by the connector
seal and the double bottom seal. On the lm itself, only a residue is left for
the very thin powders like lactose and diatomaceous earth.
The % transfer data on the gamma irradiated bag are in line with the data
measured on the non-gamma bags. The % transfer of all powders is
again very high and above 99.9%.
10
B6.5.3 Functional Drop Test
A bag lled with NaCl is dropped from a hanging and from a vertical lying
position and then checked if it is intact as described in ASTM 5276-2009
and 49 CFR (Code of Federal regulations) Chapter 1 part 178.
Before gamma irradiation
The drop test was carried out on 4 different volumes of bags (5 L, 15 L,
30 L and 50 L, respectively lled with 5 kg, 15 kg, 30 kg and 50 kg salt).
Two types of tests were performed: the at drop test and the hanging
drop test.
5 L Bag Bag 1 Bag 2 Bag 3 Bag 4 Bag 5
1.2 m at drop PASS PASS PASS - -
1.5 m at drop - - PASS - PASS
1.2 m hanging drop - - - PASS PASS
15 L Bag Bag 2 Bag 2 Bag 2 Bag 3 Bag 4 Bag 5 Bag 6
1.2 m at drop PASS PASS PASS PASS PASS - -
1.5 m at drop - - - - PASS - -
1.1 m hanging drop - - - - PASS PASS 1 cm
seal
break
30 L Bag Bag 1 Bag 2 Bag 3 Bag 4 Bag 5
1.2 m at drop - - PASS PASS PASS
1.5 m at drop - - - - PASS
0.8 m hanging drop PASS 4.5 cm PASS - -
seal break
50 L Bag Bag 1 Bag 2 Bag 3
1.2 m at drop PASS PASS PASS
1.5 m at drop PASS PASS PASS
All bags passed the 1.2 m at drop test up to 50 L bag (lled with 50 kg
salt). This test was repeated on 3 different bags. At least one of these 3
bags was tested again at 1.5 m. All bags passed again the test at 1.5 m
at drop.
The most critical test was the hanging drop test. Only the 5 L bag
passed this test. For the 15 L and 30 L bags, this test failed for 33%.
The failure was due to the 60° seal break. The breakage occurs at the
area at which the connector touches the 60° seal after the drop.
Based on these results, it will be recommended to customers to
transport the lled, higher weight bags in a at position.
After gamma irradiation (min 50 kGy)
The drop tests on gamma irradiated bags were only performed on the
highest weight bags: 30 L and 50 L (respectively lled with 30 kg and
50 kg salt).
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30 L Bag Bag 1 Bag 2 Bag 3 Bag 4 Bag 5 Bag 6
1.2 m at drop PASS PASS PASS - - -
1.5 m at drop PASS PASS PASS - - -
0.8 m hanging drop - - - PASS PASS PASS
50 L Bag Bag 1 Bag 2 Bag 3
1.2 m at drop PASS PASS PASS
1.5 m at drop PASS PASS PASS
The at drop test was repeated for each volume on 3 bags. If the test at
1.2 m was positive, the same bag was tested at 1.5 m. All bags up to
50 L (lled with 50 kg) passed the at drop test at 1.2 m and 1.5 m. So
data are in line with the drop test results before gamma.
The hanging drop test was only performed on the 30 L irradiated bag.
The 30 L bag passed the test for 100%. This is not the case for the 30 L
bag before gamma.
The gamma irradiated 60° seals seem to be superior the to 60° seals of
the non-gamma CPTB in terms of hanging drop test.
B6.5.4. Conclusion
Powder transfer bags may be lifted and supported by their integral
handle alone, provided they contain not more than 15 kg of material. If
loads above 15 kg are anticipated, Pall recommends using an external
support device such as a tray, tank, support rod or overbag to avoid the
risk of the handle becoming distorted. Loads above 50 kg are not allowed.
As with all single-use containers, care must be taken at all times not to
allow any hard/sharp objects to puncture the bags while they are being
used or transported.
C. Aging Test Study - Accelerated Shelf Life Study
C1. Aim of the Study:
An accelerated study has been performed in order to prove that lm and product has minimum
a shelf life of 3 years.
The study was conducted on irradiated material as a worse case, to cover both irradiated and
non-irradiated product.
One year will be given to intermediates, resulting is a 2 years shelf life for nished goods starting
from their manufacturing date.
C2. List of Tested Material
Batch number 39115
This batch is made in 150 μm lm.
C3. Storage Conditions
Accelerated study has been performed at 55 °C on gamma irradiated material (min 50 kGy).
12
C4. Testing Frequency
For accelerated study, the period is estimated based on an accelerated aging time (AAT)
estimated based on ASTM 1980-2 formula:
AAT (1 year) = 365 days/AAF
With AAF= Q10 (TAA-TRT)/10
With Q10= 2.0 and TAA of 55 °C
AAT: Accelerated aging time
AAF: Accelerated aging factor
Q10: The aging factor for 10 °C increase or decrease in temperature
TAA: Accelerated aging temperature
TRT: Room or ambient temperature
Batch Number Set Down Date 3 Months 6 Months 1 Year 2 Years 3 Years
39115 26/Feb/09 6/Mar/09 14/Mar/09 31/Mar/09 2/May/09 3/Jun/09
C5. Analytical Method and Specications
Test Standard/Method Specications1
Tensile strength ASTM D882 (MD) NLT 15 MPa (CD2) NLT 9 MPa
Sealing strength ASTM F88-06 NLT 15 N/15 mm
Elongation at break ASTM D882 (MD) NLT 300% (TD) NLT 300%
Surface resistivity ASTM D257 NMT 1012 Ohm/sq
1Specications have been set for a 150 µm lm.
2CD: Cross-direction, which is the direction perpendicular to the machine direction.
C6. Results
Test T=0 3 Months 6 Months 1 Year 2 Years 3 Years Specications1 Conclusion
Tensile strength (MPa)
MD 24 22 25 23 21 16 NLT 15 Mpa Conform
TD 18 21 21 19 19 14 NLT 9 Mpa Conform
Elongation at break (%)
MD 620 720 740 680 690 640 NLT 300% Conform
TD 700 970 930 850 850 930 NLT 300% Conform
Sealing strength (N)
Film-lm 22 23 23 24 24 24 NLT 15 N/15 mm Conform
Film-connector 23 24 24 22 25 25 NLT 15 N/15 mm Conform
Surface resistivity (Ohm/sq)
Inside 109 109 1010 1010 1010 1010 NMT 1012 Ohm/sq Conform
Outside 1011 1010 1011 1011 1012 1011 NMT 1012 Ohm/sq Conform
1Specications have been set for a 150 µm lm.
www.pall.com/biopharm 13
C7. Conrmation of the Results with 240 μm Film
Tests were also performed on the 240 μm 50 kGy gamma irradiated lm to conrm the results.
Test T=0 3 Years Specications1 Conclusion
Tensile strength (MPa)
MD 21 24 NLT 15 MPa Conform
TD 23 20 NLT 15 MPa Conform
Elongation at break (%)
MD 940 1020 NLT 700% Conform
TD 1010 960 NLT 800% Conform
Sealing strength (N)
Film-lm 40 36 NLT 20 N/15 mm Conform
Surface resistivity (Ohm/sq)
Inside 1010 1011 NMT 1012 Ohm/sq Conform
Outside 1011 1012 NMT 1012 Ohm/sq Conform
1Specications for 240 μm lm.
C8. Conclusion
After 3 years accelerated testing, all data conform to specications. We can conclude that PSD
lm has a shelf life of minimum 3 years. In order to take into account intermediate storage, we
give a shelf life of 2 years on nal product (starting at manufacturing date).
D. Aging Test Study - Refrigerator Conditions
D1. Aim of the Study
A refrigerator study has been performed in order to prove that the quality of the product remains
after storage at 4-6 °C for several weeks.
D2. List of Tested Material
Batch number 36609
This is a 150 μm lm.
D3. Storage Conditions
Study has been performed between 4 °C and 6 °C on gamma irradiated material (min 50 kGy).
D4. Analytical Method and Specications
Test Standard/Method Specications1
Tensile strength ASTM D882 (MD) NLT 15 MPa
(CD) NLT 9 MPa
Sealing strength ASTM F88-06 NLT 15 N/15 mm
Elongation at break ASTM D882 (MD) NLT 300%
(TD) NLT 300%
Surface resistivity ASTM D257 NMT 1012 Ohm/sq
1Specications have been set for a 150 µm lm.
14
D5. Results
Test T=0 1 Week 2 Weeks 6 Weeks Specications1 Conclusion
Tensile strength (MPa)
MD 24 24 24 23 NLT 15 MPa Conform
TD 18 21 19 21 NLT 9 MPa Conform
Elongation at break (%)
MD 620 710 720 680 NLT 300% Conform
TD 700 900 810 960 NLT 300% Conform
Sealing strength (N)
Film-lm 22 23 23 22 NLT 15 N/15 mm Conform
Film-connector 22 22 20 23 NLT 15 N/15 mm Conform
Surface resistivity (Ohm/sq)
Inside 109 1010 109 109 NMT 1012 Ohm/sq Conform
Outside 1011 109 1012 1012 NMT 1012 Ohm/sq Conform
1Specications have been set for a 150 µm lm.
D6. Conclusion
After 6 week storage at 4-6 °C, all properties conform to the specications. Overall, it can be
seen that there is no trend of degradation with time.
E. Statement on TSE/BSE and Animal Derived Components
The entire PSD lm structure is animal derived component free (ADCF).
Therefore this material is considered safe to use in respect with BSE and TSE transmissions according
the Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents
via human and veterinary products (EMEA/410/01 rev. 3 –July 2011) and U.S. Code of Federal
Regulations, Title 21 of part 189.5.
Corporate Headquarters
Port Washington, NY, USA
+1.800.717.7255 toll free (USA)
+1.516.484.5400 phone
European Headquarters
Fribourg, Switzerland
+41 (0)26 350 53 00 phone
Asia-Pacic Headquarters
Singapore
+65 6389 6500 phone
International Ofces
Pall Corporation has ofces and plants throughout the world in locations such as: Argentina, Australia, Austria,
Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico,
the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major
industrial areas of the world. To locate the Pall ofce 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.
© 2017, Pall Corporation. Pall and 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.
9/17, PDF, GN17.06899 USTR3239
Visit us on the Web at www.pall.com/allegro
E-mail us at [email protected]
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Pall Powder Handling Bags Validation Guide

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