Knowledge Center
Circular machine in a factory setting, equipped with vials capped with blue lids arranged on a rotating platform and mechanical arms positioned above.

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.

Download this case study

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.