Webinar
Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging: USP <381> and <382>
This on-demand webinar provides a detailed technical briefing on the 2020 revisions to USP <381> and the introduction of USP <382>, <1381>, and <1382> — covering scope changes, new functional suitability testing requirements for container closure systems, and what pharmaceutical and packaging teams must do to maintain compliance across vials, syringes, and cartridge systems.
Status
Published
Format
Webinar
Language
English
Access
Registration Required
Resource Overview
About this Webinar
The June 2020 Second Supplement to USP 43 introduced the most significant restructuring of the primary pharmacopoeial framework for elastomeric closures in injectable drug packaging in decades. This on-demand webinar — the second session in Datwyler's 2020 "Path to Patient Safety" series — provides pharmaceutical regulatory, quality, and packaging professionals with a precise technical walkthrough of the changes to USP <381>, the new functional suitability standard USP <382>, and the informational companion chapters <1381> and <1382>. Key topics include the shift from component-level suitability testing in the current <381> to system-level fitness-for-intended-use testing in <382>; the removal of the washing and boiling pre-extraction step and the deletion of heavy metals and extractable zinc tests from <381>; the expansion of <382> scope beyond vial systems to cover prefilled syringes, cartridges, pen injectors, and BFS systems; new fragmentation testing methodologies using USP <788> microscopic particle count procedures; the introduction of in-use system integrity and maximum allowable leakage limit concepts for needle self-sealing capacity; and the December 2025 implementation date for functional testing under <382>. The session also addresses how European Pharmacopoeia 3.2.9 aligns or diverges from the revised USP framework.
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