Revised USP Elastomeric Components Chapters

The USP wants to revise the general chapters on elastomeric components. The Notice of Intent to Revise has been posted on May 31, 2019. The previous proposals that were published in PF 43(3) were canceled. Therefore, USP´s General Chapters–Packaging and Distribution Expert Committee (GC-PDEC) provides new proposals for:

  • <381> Elastomeric Closures for Injections (New proposed title: ELASTOMERIC COMPONENTS IN INJECTABLE PHARMACEUTICAL PRODUCT PACKAGING/DELIVERY SYSTEMS)
  • <382> Elastomeric Component Functional Suitability in Parenteral Products Packaging /Delivery Systems
  • <1381> Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems
  • <1382> Assessment of Elastomeric Component Functional Suitability in Parenteral Products Packaging /Delivery Systems

GC-PDEC proposals for new chapters

The GC-PDEC is proposing new versions of these chapters with the following key changes:

  • Emphasize baseline requirements on the selection of thermoset and thermoplastic elastomeric components in <381>.
  • Expand the scope of <381> to include all elastomeric components in injectable product packaging/delivery systems (e.g., components used in systems intended for transient product storage and/or delivery for specific pharmaceutical products, like co-packaged single-use syringes and infusion set components for specific products).
  • Delete Table 1 in <381>.
  • Delete the washing and boiling step prior to and include a temperature monitoring probe in the autoclave cycle for preparation of sample solution in 4.2 Physicochemical Tests of <381>.
  • Delete the Heavy Metals and Extractable Zinc tests in <381>. According to the proposal, it is left up to the component user to evaluate the need for performing extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished (an example of extractable elements testing strategy is provided in <1381>).
  • Include a new informational chapter <1381>, which is meant to support the current chapter <381> revision by:
    - Describing elastomeric components and their materials of construction,
    - Providing a high-level introduction to elastomer chemistry, manufacturing technology, and the post-processing of components,
    - Discussing identification testing,
    - Discussing extractable elements.

Timelines

According to the USP, the changes outlined above will become official via the usual implementation time frame (i.e. six months from publication in the USP). The new USP general chapters  <382> and <1382> address the fitness-for use functional suitability requirements of packaging / delivery systems that are intended for parenteral dosage forms and that include primary packaging components partially or completely made of elastomeric materials. Due to the scope of the proposed new chapter <382> and the industry impact, the GC-PDEC is proposing a 5-year delayed implementation to allow industry adequate time to implement <382>. Once <382> becomes fully implemented, the functionality test in <381> will be omitted.

USP Monographs and / or chapters with reference to general chapter <381>

USP Monographs and / or chapters that reference general chapter <381> and require revision to keep those references accurate are:

  • Parenterals - Product Quality Tests <1>,
  • Packaging and Storage Requirements <659>,
  • Ophthalmic Products - Quality Tests <771>,
  • Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants <1031>,
  • Quality Assurance in Pharmaceutical Compounding <1163>,
  • Package Integrity Testing in the Product Life Cycle - Test Method Selection and Validation <1207.1>,
  • Assessment of Extractables <1663>,
  • Assessment of Leachables <1664>,
  • Mandelic Acid monograph.

According to the USP, the proposed revisions will be published in Pharmacopeial Forum (PF) 45(4) [Jul.–Aug. 2019]. The objective of this pre-posting is to give stakeholders sufficient time to review the proposals and comment by September 30, 2019 (deadline). In the absence of any adverse comments the chapters are anticipated to be published in USP 43-NF 38, Second Supplement (the targeted official date is December 1, 2020).

Prior to the end of the comment period, the ECA will conduct a conference on "Plastic/Elastomeric Materials for Pharmaceutical Packaging and Production" with members of the USP GC-PDEC in Barcelona on 25/26 September 2019.

More information can be found in USP´s Revisions to Elastomeric Components for Injections Chapters <381>, <382>, <1381> and <1382> .

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