PharmaTainer PET Bottles & Carboys

PharmaTainer™ sterile PET bottles and carboys meet today’s requirements for safe, rigid, disposable containers for biomanufacturing storage and transport. We believe these are the best bioprocess containers available today for mini-bulk storage of biologics.

PharmaTainer containers at PharmaTainer General Information. Features specific to PET Copolyester containers are listed below.


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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.