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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.
The challenge of assuring integrity of a sterile package is more complicated than many realize. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of the primary packages they select. A critical aspect to understand is container closure integrity (CCI) and leakage (i.e., failure of CCI or package integrity), is a major quality issue for sterile injectable products, as shown below.
In 2017 there were many changes in the Chinese pharmaceutical industry. China Food and Drug Administration (CFDA) has published several new regulations and guidelines – for example, <em>Technical Requirements for Consistency Evaluation on Marketed Chemical Generic Drugs (Injection) (Exposure Draft)</em> by Center for Drug Evaluation, CFDA. This addresses the point that consistency evaluations of drugs have been extended from oral medicines to injectable medicines. This will further help to improve pharmaceuticals quality in China, and of course, be of great interest to generics suppliers.<br />
Good container closure integrity (CCI) is an essential feature in preserving the sterility of a drug package over its shelf life. How sterility has been demonstrated, however, has changed substantially over the past 30 years.
<em>General chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em> is slated to become official on December 1, 2025. This allows five years from the date of publication in December of 2020 for stakeholders to implement the new testing requirements for full compliance. While that date seems to be far off in the future, there has been interest in early adoption of the new chapter and implementation of the various tests it requires.
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