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Many parenteral drug products, such as monoclonal antibodies, are susceptible to degradation over time. To enable a longer shelf life, such drugs are often stored in a lyophilized state. Lyophilization (freeze-drying) is a process by which water is removed from a drug product. In the absence of water, all metabolic processes stop, making lyophilized drug products far more stable.
In considering the container closure integrity (CCI) performance of a vial/stopper/seal system for a lyophilized drug product, a key element is resistance to exposure to water. It is often wrongly assumed that exposure to water occurs only as a result of residual water in the elastomer stopper. However, there are several possibilities, including:
To help reduce these possibilities, it is very important to consider the material properties of the vial, stopper and seal, and their treatment prior to use. For example, stoppers are often sterilized by autoclaving (steam at approximately 120°C), so it is necessary to ensure stoppers are properly dried before use to minimize risk of releasing residual water.
West offers vials, stoppers and seals well-suited for lyophilized drug products, including:
PLASCAP® and Daikyo Crystal Zenith® are registered trademarks of Daikyo Seiko, Ltd.
LyoSeal® is a registered trademark of West Pharmaceutical Services Deutschland, GmBH, a subsidiary of West Pharmaceutical Services, Inc.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.