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USTR3239 Validation Guide Pall ® Powder Handling Bags with PSD Film

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Page 1: Powder Handling Bags with PSD Film,Powder Handling Bags with PSD … · 2021. 1. 6. · B. Properties of the PSD Film ... 11 C. Aging Test Study- Accelerated Shelf Life Study

USTR3239Validation Guide

Pall® Powder Handling Bags with PSD Film

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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 Efficiency ............................................................................................................ 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 Efficiency ............................................................................................... 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 Specifications .................................................................................................... 12

C6. Results ................................................................................................................................................. 12

C7. Confirmation 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 Specifications .................................................................................................... 13

D5. Results ................................................................................................................................................. 14

D6. Conclusion ............................................................................................................................................ 14

E. Statement on TSE/BSE and Animal Derived Components .................................................................... 14

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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 film 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 film.

B. Properties of the PSD Film

B1. Mechanical TestingTest Type and Test Summary Description General Description Reference of Test Reference

B1.1 Gelbo Flex ASTM F392 This test covers the flex crack resistance of materials Determines the flex resistance of by the formation of pinholes. Specimens (=sealed materials by the formation of pinholes. film 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 filling the tube with H2O.

B1.2 Thickness Pall Life Sciences The film is placed in a calibrated digital system that Determines the thickness of the film. measures the thickness of the film.

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 film, less than 1.0 mm (0.04 in.) thick.

B1.4 Puncture Resistance FTMS 101B A pressing bar with a fixed diameter will be pushed Puncture resistance testing predicts through the film at a constant speed. The pressure the durability of the film while in use. force, needed to break the film, will indicate the Films with high puncture resistance puncture resistance of the film. 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 film 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 film to technique is a staircase method to drop a weight fail under specified 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. flexible plastic film 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 configuration) 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 first 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 specific 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.

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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 specified 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 filled bag hangs on a round or a flat 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 Efficiency N/A A first bag is filled with powder and this powder is Provides information how much then transferred to a second bag. The first bag is powder is remaining in a bag when weighed before filling and after being emptied. the content of one bag is transferred.

B.5.3 Functional Drop Test ASTM 5276-2009 A filled bag is dropped and then checked if it is Gives information if a filled bag intact. A hanging drop test and a flat drop test are is intact after being dropped. performed.

B6. Overview Testing Results

B6.1. Mechanical ResultsThe following mechanical properties were investigated; flex crack resistance, thickness, tensile strength and elongation, film 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.

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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 Specification: 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 2501MD = machine direction, which is the direction that the films moves through the machine from start to finish.

2TD = transverse direction, which is the direction perpendicular to the machine direction.

These results are the average of at least 5 measurements.

Release specification:

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

Deflection 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

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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 Specification: 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

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B6.5. Functional Tests on Powder Handling Bag

B6.5.1. Functional Weight Test

Test method: Gamma irradiated (min 50 kGy) bags are filled with different weights. The test has been done with 3 samples per bag for gamma irradiated bags. A filled 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 Efficiency

Test method: The empty bags with fitment and the gasket, clamp and sanitary clamps are weighed. The bags are filled with powder (3 kg in 15 L bags and 6 kg in 30 L bags). The bag is first 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 fitment and the closing system is weighed. The amount of powder that remained in the first 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 film 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%.

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B6.5.3 Functional Drop Test

A bag filled 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 irradiationThe drop test was carried out on 4 different volumes of bags (5 L, 15 L, 30 L and 50 L, respectively filled with 5 kg, 15 kg, 30 kg and 50 kg salt). Two types of tests were performed: the flat drop test and the hanging drop test.

5 L Bag Bag 1 Bag 2 Bag 3 Bag 4 Bag 5

1.2 m flat drop PASS PASS PASS - -

1.5 m flat 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 flat drop PASS PASS PASS PASS PASS - -

1.5 m flat 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 flat drop - - PASS PASS PASS

1.5 m flat 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 flat drop PASS PASS PASS

1.5 m flat drop PASS PASS PASS

All bags passed the 1.2 m flat drop test up to 50 L bag (filled 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 flat 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 filled, higher weight bags in a flat 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 filled 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 flat drop PASS PASS PASS - - -

1.5 m flat drop PASS PASS PASS - - -

0.8 m hanging drop - - - PASS PASS PASS

50 L Bag Bag 1 Bag 2 Bag 3

1.2 m flat drop PASS PASS PASS

1.5 m flat drop PASS PASS PASS

The flat 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 (filled with 50 kg) passed the flat 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 film 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 finished goods starting from their manufacturing date.

C2. List of Tested Material

Batch number 39115

This batch is made in 150 μm film.

C3. Storage ConditionsAccelerated study has been performed at 55 °C on gamma irradiated material (min 50 kGy).

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C4. Testing FrequencyFor 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/AAFWith AAF= Q10 (TAA-TRT)/10With Q10= 2.0 and TAA of 55 °CAAT: Accelerated aging timeAAF: Accelerated aging factorQ10: The aging factor for 10 °C increase or decrease in temperatureTAA: Accelerated aging temperatureTRT: 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 SpecificationsTest Standard/Method Specifications1

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/sq1Specifications have been set for a 150 µm film.

2CD: Cross-direction, which is the direction perpendicular to the machine direction.

C6. ResultsTest T=0 3 Months 6 Months 1 Year 2 Years 3 Years Specifications1 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-film 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 Conform1Specifications have been set for a 150 µm film.

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C7. Confirmation of the Results with 240 μm FilmTests were also performed on the 240 μm 50 kGy gamma irradiated film to confirm the results.

Test T=0 3 Years Specifications1 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-film 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 Conform1Specifications for 240 μm film.

C8. ConclusionAfter 3 years accelerated testing, all data conform to specifications. We can conclude that PSD film 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 final product (starting at manufacturing date).

D. Aging Test Study - Refrigerator Conditions

D1. Aim of the StudyA 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 film.

D3. Storage ConditionsStudy has been performed between 4 °C and 6 °C on gamma irradiated material (min 50 kGy).

D4. Analytical Method and Specifications

Test Standard/Method Specifications1

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/sq1Specifications have been set for a 150 µm film.

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D5. ResultsTest T=0 1 Week 2 Weeks 6 Weeks Specifications1 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-film 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 Conform1Specifications have been set for a 150 µm film.

D6. ConclusionAfter 6 week storage at 4-6 °C, all properties conform to the specifications. 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 film 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 HeadquartersPort Washington, NY, USA+1.800.717.7255 toll free (USA)+1.516.484.5400 [email protected] e-mail

European HeadquartersFribourg, Switzerland+41 (0)26 350 53 00 [email protected] e-mail

Asia-Pacific HeadquartersSingapore+65 6389 6500 [email protected] e-mail

International OfficesPall Corporation has offices 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 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.

© 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/allegroE-mail us at [email protected]