All parenteral products are required to be free of microbial contamination throughout their shelf life. Sterility testing alone does not provide sufficient assurance of product sterility. Container closure integrity (CCI) addresses the maintenance of integrity to prevent microbiological ingress in sterile product packaging during storage, shipment and prior to opening. CCI testing is required by health authorities and compendial monographs. To guarantee patient safety, it is essential that CCI is ensured prior to first human use. Regulatory expectations for CCI globally differ and should be considered during the development of a holistic CCI control strategy.
Currently, there is neither a universally accepted test method nor a gold standard for conducting CCI Testing (CCIT). With the recent revision of USP monograph <1207>, CCI tests can be categorized into deterministic methods (e.g. helium leakage) or probabilistic methods (e.g. dye ingress). Whereas test sensitivity is one obvious selection criterion, the choice of a CCI method can vary depending on scope and intended purpose -- for example, whether the application is for an initial container-closure-system qualification or for routine GMP testing purposes.
The use of artificial leaks is important to assess method sensitivity and method controls which can help compare physical CCI tests and microbial ingress. However, these artificial leaks do not completely simulate actual defects from, for example, irregularities in shapes and pathways in a container closure system. There is also a high variability depending on the method used to create artificial leaks making it difficult to correlate these to leak sizes. Finally, Drug Product manufacturing unit operations, such as capping, may impact CCI and should be adequately assessed.
Hosted in conjunction with the American Association of Pharmaceutical Scientists (AAPS), this webinar is scheduled for Wednesday, October 19, 2016 at 12:30 pm EDT.
*All attendees must have an AAPS account in order to register. If you do not have an account with AAPS, please click here to sign up.