How to Meet Container Closure Integrity (CCI) Requirements of ChP 2025

To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the guidance “Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections” (21 October 2020), which indicates the beginning of injection consistency evaluation. This guidance clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc.
Container Closure Integrity (CCI) is one of the key factors for the quality and safety of the entire product lifecycle of pharmaceuticals. To better address this topic, NMPA issued “Technical Guide for Research on Package Integrity of Chemical Injections (Trial)” on 21 October 2020. And 4 years later, “9650 Guidelines for Research on Pharmaceutical Package Integrity” is published as Chinese Pharmacopoeia (ChP) 2025 chapter on 19 Feb 2024. This new publicity helps to guide the implementation of CCI of pharmaceutical packaging materials and provides effective ways to comprehensively assure the quality of drugs.

One of the references of ChP <9650> is USP <1207>. Both chapters mention the below requirements on CCI:

• CCI should be validated with proper methodologies in the process validation;
• CCI can replace sterility testing at other time points excluding the beginning and final stages during stability study – physical testing methods are encouraged to be applied with methodology validation

With 100 years of elastomeric closure manufacturing experience, West also has extensive knowledge of the associated regulations affecting pharmaceutical drug manufacturers. Anticipating publication of this ChP chapter, West evaluated CCI of stoppers in elastomer 4031/45 Gray with various ISO-compliant vials. USP<1207> endorsed methods were used – 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).

Stoppers in elastomer 4031/45 Gray within the AccelTRA® offer deliver packaging quality, speed, and simplicity to affordable medicine manufacturers. These stoppers should be the first choice for affordable medicine manufacturers because:

1. Quality:
• A choice of Ready to Sterilize Qualities to suit the market need.
2. Speed:
• Product held in stock to offer shortened product delivery lead times and a free of charge robust extractables package to help truncate drug development timelines.
3. Simplicity:
• A next-generation elastomer with broad application suitability offered in designs compatible with blowback and straight-walled glass vials

These stoppers were developed based upon West’s extensive knowledge and experience in drug packaging systems. Stoppers within the AccelTRA offer facilitate risk mitigation and enable reduction in testing, which can help get your product to market faster.

To learn more, visit The AccelTRA Offer 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.