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What does it mean to have package integrity for your container closure system? It means an absence of breaches that can lead to product loss or ingress. Container closure integrity testing should not be just a “one and done” study. It should be understood throughout the life cycle of the product.
There are many considerations when determining the best type of integrity testing for your product. Microbial ingress testing is probabilistic and can be difficult to predict, control and measure for critical leakage. There are many factors that can affect testing and some tests can give false positive results, and no ingress method is definitive. A thorough study for your product should be designed based on reliable tests, then checked for defects and monitored over time.
While United States Pharmacopeia (USP) chapters above are not mandatory, they are intended to provide guidance, definition and description on a particular subject. The USP will release a guidance Sterile Product Package-Integrity Evaluation in 2014 as a guidance for pharmaceutical companies. Chapter will describe leak test methodologies as well as different useful tests, both probabilistic and deterministic , for sterile product package integrity verification.
West Technical Support and Analytical Services can work with customers to select components and design the appropriate test protocol and test for container closure integrity. Contact West today for more information.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.