Daniel Bantz

Manager, Scientific Communications, Self Injection Systems

November 20, 2020

New USP Chapters , , , and

Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.

Stoppers

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.

Diane and Dan's OnDemand Webinar on USP Elastomer Chapter Revisions

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.