Rigid Container Integrity Testing-Mass Extraction Simplified

摘要

There are many options available for Container Closure Integrity (CCI) testing of glass vials and syringes. From traditional probabilistic methods like Dye Immersion (tracer dye) or Bacterial or Microbial Challenge testing, to a variety of deterministic methods like Vacuum Leak, Headspace Analysis, Mass Extraction, Voltage Leak, and Tracer Gas there should be an option for any need. Each method has pros and cons that should be considered when choosing an appropriate test method for a particular container type. Not all options are suitable for all sample configurations and some methods particularly shine in certain applications, but fall short in others. With the newest edition of USP 1207, the pharmaceutical industry is moving away from traditional dye and bacterial immersion test methods and moving toward deterministic methods for CCI testing.