Manager, Scientific Communications, Self Injection Systems
November 20, 2020
Key elements of these changes are:
- The prior <381> (Elastomeric Closure for Injections, Heavy Metals and Extractable Zinc) heavy metals tests section was removed.
- The heavy metals tests from section of <381> (Elastomeric Closure for Injections, Heavy Metals), have been removed and in <1381> controlled extraction studies as described in USP <1663> are recommended.
- The most significant change in new <381> (Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems) is that elastomeric component combination product developers now are responsible for evaluating extractable testing needs, including justifications.
- The new <381> functionality tests section will be omitted after 5 years (2025), allowing industry-wide implementation of <382> (Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems).
- <382> includes fitness-for-intended-use elastomer functionality requirements for vial and bottle systems, pre-filled and single-use syringe systems, blow-fill sealed containers, dental cartridges, pen injectors, and plastic containers for IVs.
- <1382> (Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems) includes guidance for test sample preparation, test population, test procedures, ISO standards references, data interpretation, and reporting.
As a result, West is making changes to related quality certificates, which currently provide results for USP/EP combined chemical testing. As heavy metals and zinc belong to chemical testing, the reference to USP will be removed; testing will continue following EP 3.2.9 (Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders). <381> heavy metals and zinc update will be effective 01-Dec-2020; functional testing will continue harmonization with EP 3.2.9 until the 2025 expiration.
Specific West components will be evaluated to demonstrate USP <382> compliance. Additionally, West will offer product packaging and delivery systems contract testing services for <382> compliance and <1382> compatibility through its Integrated Solutions platform. For more information, watch West's On-Demand webinar.