Significant regulatory updates are on the horizon. In December 2025, alongside revisions to USP <661>, USP <382>: Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems will become legally enforceable, impacting injectable and parenteral developers, as well as CMO/CRO organizations.
What is USP <382>?
USP <382> outlines functional suitability requirements for packaging and delivery systems used in parenteral dosage forms. It focuses specifically on primary packaging components made partially or entirely of elastomeric material, which are critical for maintaining the integrity and safety of injectables.
Key Focus Areas of USP <382>
- Functional Suitability
Ensures packaging and delivery systems maintain drug integrity and safety throughout their lifecycle.
- Elastomeric Components
Applies to components such as:- StoppersPlungersNeedle shieldsTip caps
- Packaging Systems Covered
Includes a wide range of systems:- Vial and bottle systems
- Blow-Fill-Seal (BFS) plastic containers
- Cartridge systems
- Prefilled and single-use syringe systems
Will These Changes Affect You?
If your products use any of the systems listed above, it is essential to evaluate whether they comply with the new USP <382> requirements.
How to Prepare for USP <382>
- Evaluate Your Systems
Review your current packaging and delivery configurations for compliance. - Update Testing Protocols
Implement or revise functional suitability testing to meet the new standards. - Stay Informed
Monitor USP updates and guidance to maintain regulatory alignment.
Partner with Gateway Analytical
The changes to USP <382> represent a critical regulatory shift. Ensuring compliance is essential for protecting product integrity and achieving regulatory approval. Gateway Analytical is here to help you navigate these changes. With deep expertise in pharmaceutical packaging and delivery systems, we offer the support you need to stay compliant.
(724) 443-1900
info@gatewayanalytical.com
Let’s ensure your systems are ready for December 2025.
