Biomedical Engineering Reference
In-Depth Information
most manufacturers are likely to continue using these additives, and thus,
the user may not have to alter the composition at a later stage as these com-
pounds and the art of using them is likely to survive obviating the need for a
change control step as significant changes in the process need to be reported
back to the FDA.
Commercially supplied plastic films are proprietary formulations and
arrangements; for example, Advanced Scientific produces its bags utilizing
two films. The fluid contact film is a 5.0 mm polyethylene. The outer is a
5-layer 7 mil co-extrusion film that provides a barrier and durability. A typi-
cal test report is given in
Table 2.1
.
ATMI offers its proprietary TK8 film, which is constructed from lami-
nated layers of polyamide (PA), ethylene vinyl alcohol polymer (EVOH), and
ultralow density polyethylene (ULDPE). 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, ultrapure, 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 (0.2 μm 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 an ISO Class 5 cleanroom. 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 con-
trol and traceability of the contact film composition, from resin to
finished bag product.
Testing
Polymers used in medical and pharmaceutical applications should comply
with the appropriate USP guidelines, and it is recommended that they meet
