Process control, traceability, cleanliness · 2020. 7. 19. · Part Number 17_Table_Heads_PNPkg_2C...

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Allegro™ TK8 Film Process control, traceability, cleanliness Overview Pall Life Sciences is a technology leader in the manufacture of single-use systems and consumables for the life science industry. The Allegro TK8 film is capable of serving the full range of bioprocess single-use applications, from storage to mixing and even upstream cell culture applications that require a bioreactor. Allegro TK8 film consists of ultra clean polymer film extrusion and biocontainer manufacture that delivers performance to meet or exceed the expectation of the most demanding user. Allegro TK8 film can yield significant savings in cleaning validation, process setup time, and costs. USD2946a

Transcript of Process control, traceability, cleanliness · 2020. 7. 19. · Part Number 17_Table_Heads_PNPkg_2C...

Page 1: Process control, traceability, cleanliness · 2020. 7. 19. · Part Number 17_Table_Heads_PNPkg_2C Pkg 4631 18_Table_Text2c[Rule Above] 10/pkg 4632 19_Table_Text2c_.25 Rule 10/pkg

Allegro™ TK8 Film

Process control, traceability, cleanlinessOverviewPall Life Sciences is a technology leader in the manufacture of single-use systems and consumables for the life science industry. The Allegro TK8 film is capable of serving the full range of bioprocess single-use applications, from storage to mixing and even upstream cell culture applications that require a bioreactor. Allegro TK8 film consists of ultra clean polymer film extrusion and biocontainer manufacture that delivers performance to meet or exceed the expectation of the most demanding user. Allegro TK8 film can yield significant savings in cleaning validation, process setup time, and costs.

USD2946a

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Allegro TK8 Film StructureThe Allegro TK8 film is constructed from laminated layers of PA (polyamide), EVOH (ethylene vinyl alcohol polymer) and ULDPE (ultralow density polyethylene). The outer PA layer provides robust puncture resistance, strength, and excellent thermal stability. The EVOH layer minimizes gas diffusion across the film while maintaining a very good flex crack resistance. The ULDPE layers provide flexibility, integrity and an ultra-clean, ultra-pure, low-extractables product contacting layer. The combination of these layers results in a film that has outstanding optical clarity, is easy to handle, and performs well in a broad range of bioprocess applications. The inner ULDPE layer used in Allegro TK8 is blow-extruded in-house by Pall under cleanroom conditions (0.2 μm filtered air), ensuring the cleanest possible product-contacting surface. Lamination is also performed under controlled, ultra-clean conditions. Lastly, Allegro TK8 film is converted into Pall biocontainer products in our ISO Class 7 cleanroom.

Traceability and ComplianceAll of the layers in Allegro TK8 film are made from “medical grade” materials, meaning that they comply with industry standards and are subject to strict change controls. The entire structure of Allegro TK8 film is totally free of any animal derived components (ADCF). Pall has also created Allegro TK8 film with dual sourcing and contingency planning in mind, to ensure security of supply.

Allegro TK8 film complies with USP Class VI (USP<88>), USP<87>, and USP<661>

Allegro TK8 film complies with EP3.2.2.1

Shelf life is supported by aging validation studies

Certified ADCF

Bioburden evaluation available (ISO 11737)

Particle count data available (USP<788>)

By performing blow extrusion in-house, Pall maintains full control and traceability of the contact layer composition, from resin through to finished bag product

Leachables/Extractables and Chemical Compatibility Data (Tested on 50 kGy gamma irradiated film)An extensive dataset of leachables/extractables data is available upon request. Extractable testing was performed in CH2Cl2 (8 hours reflux). Leachable tests were performed at 40 °C over durations up to six months. Leachable solvents include:

WFI HCl (pH < 3)

Saline (1M NaCl) Ethanol (20%)

NaOH (pH > 11) DMSO (10%) (tested at -20° C)

Tween (0.1%)

Additional studies have demonstrated chemical compatibility with the following common bioprocess materials under various, process-typical conditions:

MgSO4.7H2O MnSO4.7H2O

Ethanol (55%) Riboflavin

Kanamycine sulfate Casein hydrolysate

Tromethanine Diethanolamine

Guanidine HCl Yeast extract

KH2PO4 NaOH (5M-50%)

Acetic acid NaClO (15°) ÷ NaOH (0.5M)

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Overview

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Integrity™ TK8 FilmProcess Control, Traceability, Cleanliness

Product Data

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TK8 Film Structure

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Traceability and Compliance

Outer Layer

PA 25 µm

50 µm

10 µm

100 µm

50 µm

ULDPE

ULDPE

ULDPE

EVOH

Tie Layer

Tie Layer

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Biocompatibility Data (Tested on 50 kGy gamma irradiated film)Test Biological Reactivity (In vitro) Biological Reactivity (In vivo)

Protocol USP <87> USP <88> ISO10993 part 5 ISO10993, part 11 ISO10993, part 10 I ISO10993, part 6Result PASS PASS- Class VI – 70 °C Physiochemical Data (Tested on 50 kGy gamma irradiated film)Test Non-Volatile Heavy Buffering Appearance Acidity or Reducing Residue Metals Capacity of Solution Alkalinity Substances Transparency Absorbance

Protocol USP <661> USP <661> USP <661> EP3.2.2.1 EP3.2.2.1 EP3.2.2.1 EP3.2.2.1 EP3.2.2.1Result PASS PASS PASS PASS PASS PASS PASS PASS Physical PropertiesProperty Test Method Typical Value

Film Thickness Pall Life Sciences 250 μmO2 Transmission Rate (Barrier properties) ASTM D1927, 23 °C, 50% RH outside, 0.37 cc/m²/day 90% RH inside Water Vapor Transmission Rate (Barrier properties) ASTM F1249 0.41 g/m²/day 23 °C, 0% RH outside, 100% RH inside CO2 Transmission Rate (Barrier properties) ASTM F-2476 – 23 °C, 0% RH < 1 cc/m²/day (below detection limit)Shelf Life (Post gamma irradiation at 50 kGy) 2 Years

Visit us on the Web at www.pall.com/biopharmE-mail us at [email protected]

© 2015, Pall Corporation. Pall, , and Allegro are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. Filtration.Separation.Solution.SM is a service mark of Pall Corporation.

10/15, PDF, GN15.6389 USD2946a

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: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, New Zealand, Norway, Philippines, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam. Distributors in all major industrial areas of the world. To locate the Pall office or distribu-tor 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.

The film is fed directly into Pall’s ISO Class 7 cleanroom to ensure the highest levels of cleanliness and bioburden control.

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Part Number 17_Table_Heads_PNPkg_2C Pkg

4631 18_Table_Text2c[Rule Above] 10/pkg4632 19_Table_Text2c_.25 Rule 10/pkg4634 19_Table_Text2c_.25 Rule 10/pkgTA4632 20_Table_Text2c_.[Rule Below] 10/pkg individually attached tubing for each filter device), sterile

21_HARD RETURN AFTER CHART

22_References Title

1. 23_Reference Copy. Character 02_Reference_Italics, 6:319-25.

2. Lehr, H.A. et al. (2002) Particulate matter contamination of intrave-nous antibiotics aggravates loss of functional capillary density in postischemic striated muscle. Am J Respir Crit Care Med, 165:514-20.

3. Trautmann, M. et al. (1997) Bacterial colonization and endotoxin contamination of intravenous infusion fluids. J Hosp Infect, 37:225-36.

4. Richards, C. & Thomas, P. (1990) Use of endotoxin retentive intravenous filters with pediatric total parenteral nutrition solutions. J Clin Pharm Ther, 15:53-8.

5. Richards, C. & Grassby, P.F. (1994) A comparison of the endotoxin-retentive abilities of two ‘96-h’ in-line intravenous filters. J Clin Pharm Ther, 19:199-202.

6. Coppa, G.F. et al. (1981) Air embolism: a lethal but preventable complication of subclavian vein catheterization. JPEN J Parenter Enteral Nutr, 5:166-8.