Case Study

100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine

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Introduction
Lyophilization is a complex process that presents many manufacturing challenges, one of which is maintaining and monitoring container closure integrity of the finished package. Container closure integrity plays an important role in maintaining the sterility and stability of lyophilized products. Concerns over patient safety, customer complaints, and the cost of investigations and product recalls have recently resulted in revised regulatory guidance (e.g. the revised Annex 1 of the European Guidelines for the Manufacture of Sterile Products).

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