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.
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.
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.
The Double-Seal Closure
PharmaTainer closures seal at two points; on the inside of the neck and also on the top flat rim of the neck. Tests have demonstrated that the closure system holds seal very well. The seal inside the neck is readily achieved when applying the closure by hand. Certain engagement of the rim seal requires application of a known amount of torque.
Imprint and Unit Traceability
PharmaTainer bottles and carboys have black printed volume scales and traceability information.
Graduations: ±2% in appropriate increments to recommended capacity.
PharmaTainer packaging has been designed to pass through 3 levels of increasing clean environments and each level of packaging is clearly labeled with product identity, lot number, expiration date and a radiation indicator dot. The following packaging scheme is true for all PharmaTainer bottles and carboys.