Specialist, TCS, Jurong
April 09, 2019
Prior to the mid-90s, sterility testing itself was the "go-to" approach. That changed in 1994, when US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, which promoted the importance of verification of microbial barrier properties of a parenteral product package (i.e., CCI). Sterility testing alone was determined to be insufficient.
In 2008, US FDA published: Guidance for Industry on Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. This further guidance reiterated the importance of CCI tests, vis-a-vis sterility tests, and enumerated the limitations of sterility tests, e.g., possibility of false positive readings due to interference from adventitious microbial contamination introduced at the time of testing, destructive nature – not allowing opportunity to reexamine samples in the event of either positive or negative findings.
Recently published guidance USP <1207> Package Integrity Evaluation – Sterile Products discusses CCI methods in detail, in particular promoting the use of deterministic methods, and emphasizing the importance of pharmaceutical companies understanding the maximum allowable leak limits (MALL) of their drug products. At West, CCI is thrust area for Analytical Lab Services – having the staff, expertise, and facility to design and execute those methods specified in <1207>. Please feel free to contact your West Account Manager and Technical Account Specialist (TCS) for more.