Tests (by SABIC) USP 26 / NF21, here <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.
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
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.