Strategies To Evaluate CCI Of Vial And Syringe Systems Over Time And Temperature

By Amy Gindhart, Louis Brasten, Amy Kim, and Jennifer Roark, West Pharmaceutical Services, Inc.

Proper characterization of container closure integrity (CCI) of vial and syringe systems is essential. This helps to aid pharmaceutical manufacturers to determine if a system is suitable for a drug product and determine if a system can meet the maximum allowable leakage limit (MALL). No single method is suitable for all systems, and a proper characterization strategy should employ multiple methods.

Combining techniques, such as Residual Seal Force, tracer gas analysis, and headspace analysis, enables a more complete and quantified measure of CCI for vial and syringe combinations to enable judgement if the MALL can be met.