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Featured Blogs
May 20, 2022
USP <382>: Think Systems, Not Components - Fragmentation, Penetration and Sealability of Vial Systems
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> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems. This addressed characterizing for biological reactivity, physicochemical testing and functionality testing and compliance was typically a supplier responsibility. The new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025. This will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. Under the new chapter, it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system.
April 07, 2022
Industry Preparedness for Meeting the Challenges of Essential Performance Requirements
Prefilled syringes, and prefilled syringes with auto-injectors, continue to dominate the landscape. However, there has been an uptick in the evaluation and use of cartridges in on-body injector systems. The growth of these kinds of products reinforces the need for solutions to deliver larger volumes of biologic products to patients in a simplified manner. The trend from intravenous administration to subcutaneous administration helps to facilitate this patient-friendly option.
May 20, 2022
USP <382>: Think Systems, Not Components - Fragmentation, Penetration and Sealability of Vial Systems
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> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems. This addressed characterizing for biological reactivity, physicochemical testing and functionality testing and compliance was typically a supplier responsibility. The new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025. This will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. Under the new chapter, it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system.
April 07, 2022
Industry Preparedness for Meeting the Challenges of Essential Performance Requirements
Prefilled syringes, and prefilled syringes with auto-injectors, continue to dominate the landscape. However, there has been an uptick in the evaluation and use of cartridges in on-body injector systems. The growth of these kinds of products reinforces the need for solutions to deliver larger volumes of biologic products to patients in a simplified manner. The trend from intravenous administration to subcutaneous administration helps to facilitate this patient-friendly option.