Product Data Integrity™ TK8 Film Process Control, Traceability, Cleanliness Overview Outer Layer PA Pall Life Sciences is a technology leader in the manufacture of single-use vessels and consumables for the life science industry. Integrity TK8 film represents the culmination of over a decade of experience in ultra-clean polymer film extrusion and bioprocess vessel manufacture, and delivers performance to meet or exceed the expectations of the most demanding users. Integrity TK8 film embodies Pall Life Sciences “one film” philosophy, giving users access to a single film capable of serving in the single-use applications, from storage to mixing and even bioreactor processes. This approach can yield significant savings in validation effort, time and cost. 15 µm Tie Layer ULDPE 50 µm Tie Layer EVOH 10 µm ULDPE 100 µm ULDPE 50 µm TK8 Film Structure The 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 TK8 is blow-extruded in-house by Pall Life Science under cleanroom conditions (0.2 µm filtered air), ensuring the cleanest possible product-contacting surface. Lamination is also performed under controlled, ultraclean conditions. Lastly, TK8 film is converted into Pall Life Sciences bag products in our ISO Class 5 cleanroom. Traceability and Compliance All of the layers in TK8 are made from “medical grade” materials, meaning that they comply with industry standards and are subject to strict change controls. The entire structure of TK8 is totally free of any animal derived components (ADCF). Pall Life Science has also created TK8 with dual sourcing and contingency planning in mind, to ensure security of supply. • TK8 complies with USP <87>, USP Class VI (USP <88>) and USP <661> • 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 Life Sciences maintains full control and traceability of the contact film composition, from resin through to finished bag product Leachables/Extractables and Chemical Compatibility Data An extensive dossier 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 • Ethanol (20%) • Tween (0.1%) • HCl (pH < 3) • DMSO (10%) • NaOH (pH > 11) (tested at -20 °C) • Saline (1M NaCl) Additional studies have demonstrated chemical compatibility with the following common bioprocess materials under various, process-typical conditions: • • • • • • • MgSO4.7H2O Ethanol (55%) Kanamycine sulfate Tromethanine Guanidine HCl KH2PO4 Acetic acid • • • • • • • MnSO4.7H2O Riboflavin Casein hydrolysate Diethanolamine Yeast extract NaOH (0.5 M-50%) NaClO (15° ) ÷ NaOH (0.5 M) The film is fed directly into Pall Life Sciences ISO Class 5 cleanroom to ensure the highest levels of cleanliness and bioburden control. Biocompatibility Data (Tested on 50kGy gamma irradiated film) Test Biological Reactivity Test In Vitro Biological Reactivity Test In Vivo Protocol USP <87> ISO10993 part 5 Result PASS USP <88> ISO10993, part 11 ISO10993, part 10 I ISO10993, part 6 PASS- Class VI - 70°C Pysiochemical Data (Tested on 50kGy gamma irradiated film) Test Non-Volatile Residue Heavy Metals Buffering Capacity Appearance of Solution Acidity or Alkalinity Reducing Substances Transparency Absorbance Protocol Result USP <661> PASS USP <661> PASS USP <661> PASS EP3.2.2.1 PASS EP3.2.2.1 PASS EP3.2.2.1 PASS EP3.2.2.1 PASS EP3.2.2.1 PASS Biocompatibility Data (Tested on 50kGy gamma irradiated film) Property Test Method Typical Value Thickness Barrier properties O2 transmission rate Pall Life Science 250 μm ASTM D3895, 23 °C, 50% RH outside, 90% RH inside ASTM F1249 23 °C, 0% RH outside, 100% RH inside ASTM F-2476 - 23°C, 0% RH 0.37 cc/m²/day Water vapor transmission rate CO2 transmission rate Tested on 50kGy gamma irradiated film: Strength and Elongation Strength (machine direction) MD (transverse direction) TD Elongation MD TD Young Modulus MD TD Puncture resistance Max load Deflection at max load Dart drop (method B) Tear resistance Avg. force MD TD Initial Max Force MD TD Shelf life 0.41 g/m²/day < 1 cc/m²/day (below detection limit) ASTM D882-91 25 MPa 25 MPa 125% 100% 590 MPa 500 MPa ASTM D882-91 FTMS 101B 130N 9 mm 1100 g ASTM D1709-01B ISO 6383/1 17 N 32 N 18 N 32 N 3 years Visit us on the Web at www.pall.com/biopharm E-mail us at [email protected] Corporate Headquarters Port Washington, NY, USA +1.800.717.7255 toll free (USA) +1.516.484.5400 phone [email protected] e-mail European Headquarters Fribourg, Switzerland +41 (0)26 350 53 00 phone [email protected] e-mail Asia-Pacific Headquarters Singapore +65 6389 6500 phone [email protected] e-mail International Offices Pall 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 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. © 2014, Pall Corporation. Pall, , and Integrity 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. 3/14, PDF, GN14.9224 USD2946
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