Moisture Considerations for Lyophilized Drug Products
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:
- permeation of water through elastomer stopper
- release of residual water in the elastomer stopper
- permeation of water through the stopper/vial interface
- permeation of water through vial (polymer vial)
- release of residual water in the vial
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:
- compatible vials comprising either glass or Daikyo Crystal Zenith® cyclic olefin polymer
- stoppers designed and laminated to work in lyophilization chambers
- polymer seals (LyoSeal™ and Daikyo PLASCAP® products) that enable closure in the lyophilization chamber – minimizing risk of water ingress through mishandling of the system prior to application of the final seal.
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.