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:
- test methods
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.