T. Page McAndrew, Ph.D.
Director, Scientific Communications
March 04, 2020
Take, for example, United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products. Published in 2016, the chapter specifies methods to measure the container closure integrity (CCI) of container/delivery systems. In particular, it advocates the use of deterministic methods (e.g., trace gas leak detection), as opposed to probabilistic methods (e.g., dye ingress). Anticipating publication of <1207>, West equipped its laboratories with the facilities, and the staff, needed to perform the specified methods, and upon publication, West immediately offered public comment:
- A blog (> 1,000 reads to date) offering insight into what <1207> requirements meant for the industry,
- A journal article (Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity) describing how <1207> requirements fit as part of an approach to integral containment/delivery systems.
As a result of these and similar efforts, Customers know that West is by their side – not only for advice on what to do, but how to get it done. This supports the goal we all share – safe and efficient delivery of drug products to the patients who need them.