Lyophilization is a complex process that presents many manufacturing challenges, one of which is ensuring good container closure integrity (CCI) of the finished product. The vial stoppering process, involving the raising and lowering of the freeze dryer shelves, and the potential of ‘stopper pop-up’ during unloading of the freeze dryer, both introduce possible risk to the CCI of freeze dried product. A leading contract manufacturer suspected a raised stopper issue in several commercial batches of lyophilized product. This Case Study describes how automated headspace inspection for 100% CCI testing was used to identify the leaking vials. Today, many manufacturing sites have implemented, validated, and registered automated headspace inspection machines to perform 100% CCI inspection of freeze dried product
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