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Lyophilization (freeze drying) is the process of dehydrating a drug product at low temperature and reduced pressure. Absent water, degradation processes are greatly reduced; thus, it helps to enhance drug product stability. Moisture-sensitive drug products are often marketed in lyophilized form. For a primary package system, the selection of appropriate components is essential to prevent risks associated with alteration of the lyophilized drug product prior to reconstitution and use.
One of the critical success factors for a primary package system is protection against product degradation caused by moisture. Moisture can reach a lyophilized drug product in a variety of ways, including:
To help reduce these possibilities, the following aspects should be considered:
West’s AccelTRA® components employ a newly developed elastomer formulation, 4031/45G, which has a low MVTR. Stopper components have excellent container closure integrity (CCI) performance with glass vials that comply with the ISO standard. For more information on how AccelTRA components can help to protect lyophilized drug products, contact an Account Manager or Technical Customer Support (TCS) representative.
AccelTRA® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.