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Moisture-sensitive drug products are commonly lyophilized to enhance their shelf life and to prepare them for storage and transport. Maintaining a constant moisture level in a lyophilized drug product “cake” ensures product quality. Not only is proper selection of a container closure system (vial, stopper, seal) necessary, but sealing conditions are as well. This is achieved through demonstration of container closure integrity (CCI).
CCI is an essential performance requirement of any container closure system. A holistic approach to achieving this has been published by F. DeGrazio: Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity. A key element is achieving CCI that meets the specific maximum allowable leakage limit (MALL) for the drug product and closure system.
USP guidance Chapter <1207> Package Integrity Evaluation – Sterile Products presents numerous types of CCI measurement methods with various sensitivities. West's Analytical Lab Services has the facilities, staff, and detailed procedures to perform all of them.
The most sensitive CCI method is tracer gas leak detection with helium. Sealed closure samples are prepared by flooding with 100% helium via a metal cannula inserted through the stopper. After cannula removal, the punctured stoppers are sealed with epoxy. Samples are placed in a vacuum chamber, then vacuum applied continuously, and chamber helium concentration measured by mass spectrometry. Literature has correlated helium leak rates to defect size*. Historically, leak rates lower than 6.0 x 10-6 cm3/s (sometimes called Kirsch level) are considered acceptable. West closure systems typically do far better, with rates lower than 2 x 10-7 cm3/s for 20 mm stoppers, and lower than 7 x 10-8 cm3/s for 13 mm stoppers. This method is also suitable to other container types, such as syringe systems, cartridges and blister packs.
For more on how West can support CCI studies click here or contact an Account Manager or Technical Customer Support (TCS) representative.
<span style="color: #000000;">Container closure integrity is defined as the ability and quality of a container closure system to provide protection and maintain efficacy and sterility during the shelf life of a sterile drug product. The ability of rubber components to prevent microbial ingress of parenteral containers can be measured by seal integrity.</span>
<em>General chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em> is slated to become official on December 1, 2025. This allows five years from the date of publication in December of 2020 for stakeholders to implement the new testing requirements for full compliance. While that date seems to be far off in the future, there has been interest in early adoption of the new chapter and implementation of the various tests it requires.
USP General Chapter<382> <em>Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em> is slated to become official on December 1, 2025. This allows five years from the date of publication in December of 2020 for stakeholders to implement the new testing requirements for full compliance. While that date seems to be far off in the future, there has been interest in early adoption of the new chapter and implementation of the various tests it requires.
In 2017 there were many changes in the Chinese pharmaceutical industry. China Food and Drug Administration (CFDA) has published several new regulations and guidelines – for example, <em>Technical Requirements for Consistency Evaluation on Marketed Chemical Generic Drugs (Injection) (Exposure Draft)</em> by Center for Drug Evaluation, CFDA. This addresses the point that consistency evaluations of drugs have been extended from oral medicines to injectable medicines. This will further help to improve pharmaceuticals quality in China, and of course, be of great interest to generics suppliers.<br />
We are pleased to announce our recent publication in the November/December 2019 Issue of the International Journal of Pharmaceutical Compounding. In the article “How to Qualify Container Closure Systems, Part 1,” we address how compounding pharmacies (503Bs) can qualify systems for intended use via container closure integrity (CCI) to meet FDA Guidance requirements.<sup>1</sup>
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