PharmaTainer PET Bioprocess Container Features
Features & Benefits
- Estar™Certified PET:
- High clarity, gamma stable,
- Good chemical resistance to most medical solvents.
- Excellent gas barrier properties.
- Tests (by Eastman Chemical): to FDA Modified ISO-10993, Part 1 “Biological Evaluation of Medical Devices” tests with human tissue contact time of 30 days or less.
- Contains no animal derived products.
- Container tests (post-sterilization):
- Container and closure were 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.
- Certified to meet USP <788> Particulate Matter in Injections.
- Double-seal closure system; seal integrity tested.
- Sterile SAL 10-6.
- Other Features
- On-bottle tracability by lot & serial number.
- Graduations ±1% in black.
- Vacuum-pack provides proof of package integrity 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.
ESTAR is a trademark of the Eastman Chemical Corporation.