In December 2025, significant changes will impact injectable and parenteral developers, as well as CMO/CROs, when USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems becomes enforceable in the United States. This chapter addresses the functional suitability requirements for packaging and delivery systems used for parenteral dosage forms, including injections and all elastomeric components in direct or indirect contact with the pharmaceutical product.
Key Focus of USP <382>
USP <382> establishes essential performance requirements for elastomeric components used in primary packaging systems for parenteral drug products. These components, such as vial stoppers, syringe plungers, and cartridge seals, play a critical role in maintaining drug stability, preventing contamination, and ensuring safe and effective delivery. To achieve these objectives, elastomeric components must not only be manufactured from suitable materials but also be designed and tested to function seamlessly within their respective packaging and delivery systems.
The performance of elastomeric components is highly dependent on their interaction with the full packaging system. Factors such as dimensional compatibility, material properties, and mechanical performance influence their ability to maintain container closure integrity and facilitate proper drug administration. Recognizing this, the latest updates to USP <382> emphasize the following key areas:
- Comprehensive Protection: Elastomeric components must prevent microbial ingress, particle contamination, and chemical interactions that could compromise drug safety and efficacy. Ensuring a robust seal and barrier function helps maintain the sterility and stability of the drug product throughout its shelf life.
- Product Safety: Beyond material composition, the functional performance of elastomeric components is essential. USP <382> sets criteria for mechanical properties such as compression, elasticity, and seal integrity to ensure that these components operate effectively in various packaging configurations. Proper functionality reduces the risk of failures such as leakage, plunger resistance, or improper drug dispensing.
- Regulatory Compliance: Adherence to USP <382> is not optional; it is a legally enforceable standard that manufacturers must meet to avoid regulatory setbacks. Compliance ensures consistency in testing methodologies, performance criteria, and quality control measures, streamlining approvals and reducing risks associated with non-conforming components.
By aligning elastomeric component standards with broader regulatory expectations, USP <382> enhances the safety, reliability, and effectiveness of parenteral drug packaging, ultimately benefiting both pharmaceutical manufacturers and patients. Gateway Analytical is ready to help you navigate these changes. With our expertise in pharmaceutical packaging and delivery systems, we can support your efforts to meet the new USP 〈382〉 standards. Contact us at (724) 443-1900 or info@gatewayanalytical.com, or visit our contact page to learn more about how we can assist you.
