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For any drug, selection of the appropriate primary packaging components is essential to having a containment system that ensures quality, safety, and stability. The primary packaging components are selected based on various factors, which include chemical compatibility with the drug product ingredients and dimensional fit with mating packaging components. Optimized fit among mating packaging components is essential for flawless fill-finish processing.

When converting a drug product from its initial container closure system to a prefillable syringe system or device, component elastomer formulations and sterilization mode equivalency can help ease the transition, minimize regulatory filing times and mitigate risk for pharmaceutical manufacturers.

Dr. Heike Kofler, Amy Miller, Jennifer Riter
West Pharmaceutical Services, Inc.

One of the critical success factors for packaging lyophilized drugs is protection against product degradation caused by moisture. Moisture can be introduced into a lyophilized drug product cake from the elastomeric stopper and from the atmospheric headspace; it can also permeate through the stopper, a process known as moisture transmission.