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Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. Through the Integrated Solutions platform, West is ideally positioned to provide this data.
Andrea Straka, Senior Technical Account Specialist, will present “Sterilization Effects on Elastomer Characteristics and Functionality in Sterile Parenteral Drug Products” at the PDA Annual Meeting in San Antonia, Texas, April 7-9, 2014.
Selecting the right package for a drug product is essential. To do this, it is necessary to understand the surface chemistry of the components of the package to determine if any unwanted interaction with the drug product is likely.
United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The original USP chapter for elastomeric components used in injectable drug packaging was <381> <em>Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems</em>, which addressed characterizing for biological reactivity, physicochemical testing and functionality testing. The new chapter, <em>USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em>, will become effective on December 1, 2025 and will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. While under USP <381> compliance was typically a supplier responsibility, under the new chapter it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system, including the container closure system and the drug.
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