PharmaTainer Bioprocess PC Container Features
Features & Benefits
- Lexan® HPS series PC:
- High clarity, gamma stable, broad temperature tolerance.
- Tests (by SABIC) USP 26 / NF21, <661> Containers physico-chemical tests and <88> Class VI Biological Test for Plastics.
- Container no animal derived products.
- Container tests (post-sterilization):
- Container and closure tested by independent laboratories: USP 37 / NSF 29, <88> Biological Reactivity, in vivo and <87> Biological Reactivity, in vitro (MEM), ISO 10993-4 indirect Hemolysis, Leachables in WFI and in 20% ethanol in WFI.
- Certified negative for endotoxin testing.
- Certified to meet USP <788> Particulate Matter in Injections.
- Double-seal closure system; seal integrity tested.
- Seal integrity during freeze/thaw from ambient to -80°C and back to ambient.
- Drop tests at -80°C.
- Sterile SAL 10-6.
- Other Features
- On-bottle tracability by lot & serial number.
- Graduations ±1% in black.
- Vacuum-pack provides proof of package integrity and sterility at point of use.
- Validation CD: a compilation of test reports, data sheets, drawings and other information to support the use of PharmaTainer products. This information is free, but is only provided under a non-disclosure agreement.
LEXAN is a trademark of SABIC (Saudi Basic Industries Corporation).
PharmaTainer is a trademark of Cellon SA