Case Study
100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine
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).
A leading contract manufacturer approached LIGHTHOUSE with a concern about the container closure integrity of vials in several commercial batches of lyophilized product. Each batch consisted of approximately 30,000 vials stoppered at 200 mbar of nitrogen. A suspected raised stopper issue motivated the manufacturer to place several batches into quarantine and a decision was made to perform 100% container closure inspection of the product vials.
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