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100% Container Closure Inspection of Freeze Dried Product in Quarantine
Lyophilization is a complex process that presents many manufacturing challenges, one of which is ensuring good container closure integrity (CCI) of the finished product.
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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.