Page McAndrew

Director, Scientific Communication

February 09, 2018

Holistic Approach to Container Closure Integrity

Container closure integrity (CCI) is a fundamental requirement of every sterile drug package. Recently, the United States Pharmacopeia Convention (USP) published a guidance in this area that, among other key topics, addresses test methods in detail: Chapter <1207> Package Integrity Evaluation – Sterile Products. However, proper test method is only one aspect of achieving good CCI.

 Seal, Stopper and Vial stacked on top of each other

In the article Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity [PDA Journal of Pharmaceutical Science and Technology, 72 (1), 15-34 (2018)]  Fran L. DeGrazio, Vice-President of Scientific Affairs & Technical Services, presents a comprehensive strategy and best practices recommendations to achieve good CCI that comprises consideration of all critical aspects, including test methods. This strategy begins with an understanding of the maximum allowable leak limit (MALL) for the drug product. Following this is a science-based understanding of all critical aspects, namely:

  • materials
  • test methods
  • processes
  • people
  • environment
  • equipment  

Understanding the interplay among these aspects enables control and minimization of risk. Resultant from employment of this strategy is a package that provides proper CCI – by comprising the right components assembled the right way. More important, this strategy provides for patient safety.

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