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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:
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.