The upcoming changes to USP <382> in December 2025 represent a significant shift in the regulatory landscape for injectable and parenteral products. Ensuring that elastomeric components meet the functional suitability requirements will be essential for maintaining product integrity and compliance. USP <382> provides a detailed framework for assessing the functional suitability of packaging and delivery systems for parenteral products. Sections 5-7 of the chapter outline essential tests for needle and spike access, plunger functionality, and tip cap and needle shield effectiveness.
Key Aspects of USP <382>
Functional Suitability Tests: These evaluations ensure that packaging components—such as needles, plungers, and caps—operate correctly and preserve the integrity of the drug product.
Package/Delivery System Integrity: Section 5 highlights two critical aspects:
- Maximum Allowable Leakage Limit (MALL): Defines the acceptable leakage threshold to maintain product safety.
- Inherent Integrity: Assesses the intrinsic robustness of the packaging system. Both aspects reference USP <1207> for package integrity evaluation.
Alternative Testing Methods:
USP <382> permits the use of alternative testing methods if scientifically justified. A thorough rationale must be provided for the selected approach, and findings must be well-documented to ensure compliance and reliability.
Adhering to USP <382> ensures that packaging and delivery systems for parenteral products meet stringent functional suitability and integrity standards. This adherence is critical for maintaining product safety, efficacy, and regulatory compliance. Gateway Analytical is here to support your compliance with USP <382>. Our expertise in pharmaceutical packaging and delivery systems ensures that your products meet the highest 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.
