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As one of the most critical factors in the evaluation of drug packaging, Container Closure Integrity (CCI) is mentioned in these new technical requirements:
These new components were developed based upon West’s extensive knowledge and experience in drug packaging systems. Anticipating publication of the Exposure Draft, West evaluated CCI of AccelTRA stoppers with various ISO-compliant vials, using the USP 1207 endorsed methods – tracer gas and headspace analysis (Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by Multiple Methods. PDA Journal of Pharmaceutical Science and Technology, 74 (1), 147-161 (2020)(https://journal.pda.org/content/74/1/147). Excellent performance was demonstrated.AccelTRA components facilitate risk mitigation and enable reduction in testing, which can help getting to market faster.
To learn more visit our AccelTRA component program page or contact an Account Manager or Technical Customer Support (TCS) representative.
AccelTRA® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.