Integrity™ TK8 Film
ATMI 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 ATMI's "one film" philosophy, giving users access to a single film capable of serving in the full range of bioprocess single-use applications, from storage to mixing and even bioreactor processes. This approach can yield significant savings in validation effort, time and cost.
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 ATMI under cleanroom conditions (0.2μm filtered air), ensuring the cleanest possible product-contacting surface. Lamination is also performed under controlled, ultra-clean conditions. Lastly, TK8 film is converted into ATMI 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). ATMI has also created TK8 with dual sourcing and contingency planning in mind, to ensure security of supply.
- TK8 film complies with USP Class VI (USP<87>, USP<88>, and USP<661>)
- ULDPE resin complies with EP 3.1.3
- Shelf life is supported by aging validation studies.
- Certified ADCF.
- Bioburden evaluation available (ISO 11737)
- Particle count data available (EP 2.9.19 or USP<788>)
- By performing blow extrusion in-house, ATMI maintains full control and traceability of the contact film composition, from resin through to finished bag product.
