USP´s Intent to Revise and to Develop Elastomeric Packaging Chapters

The U.S. Pharmacopeial Convention (USP) proposes to revise and to develop the following general chapters:

  • <381> Elastomeric Closure for Injections (revision), 
  • <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (new),
  • <1381> Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems (new),
  • and <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (new).

The USP posted a notice regarding the revision of these chapters on December 30, 2016. Suppliers of elastomeric materials and components used for packaging systems (primary packaging components) and drug product manufacturers using elastomeric component and system primary containers are invited to give their input regarding the proposed revision of the general chapters. Input deadline was just January 30, 2017, and the final draft chapters are estimated to be published in Pharmacopeial Forum PF 43(3) [May–Jun. 2017].

The General Chapters—Packaging and Storage Expert Committee proposes the revision of <381> to provide baseline requirements (e.g. component screening in view of the elastomer’s biological reactivity, physicochemical properties and extractable metals) for the selection of elastomeric components to be further qualified for use in a given system. The same principles can be applied to elastomeric components used in medical devices and combination products, with consideration of the appropriate guidances and regulations.

Determining the suitability of a component to function properly will need consideration of the complete system. Testing must be designed to meet the requirements for intended use as is described in Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems <1381>. The chapter is meant to support <381> and the major revision to be proposed for that chapter.

If components comply with requirements outlined in the chapter, studies should then be designed to determine safety and compatibility as recommended in Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems <1663> (e.g. worst-case controlled extraction study) and Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems <1664> (actual-case measurement of confirmed leachables).   

General chapter <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems will address the functionality requirements of packaging/delivery systems intended for injectable dosage forms that include primary packaging components partially or completely made of elastomeric material. The functionality tests outlined in the chapter are intended to evaluate the fitness of a closure as part of its specific final product packaging system. In addition to the assessment of package integrity the chapter includes specific tests depending on the intended use of the individual packaging/delivery system, such as, for example, break force, glide force, and plunger seal integrity tests (plunger functionality tests), and penetrability, fragmentation and self-sealing capacity (needle and spike access functionality tests).

Information and guidance to assist in the functionality assessment of elastomeric closures as part of packaging/delivery systems intended for injectable dosage forms outlined in <382> will be provided in general chapter <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems. Proper selection and design of functionality assessment studies is based on sound and justifiable scientific principles that are consistent with the nature of the packaging system and packaged drug product, the clinical use of the packaged drug product, and the perceived safety risk associated with the packaging system and drug product.

To initiate an open dialogue with stakeholders regarding this revision, the Expert Committee will host a workshop at USP Headquarters in Rockville, MD, on June 19-20, 2017. The input received during this Workshop will provide input to the revision of the general chapters.

For more information please visit the USP website under "Notices/General Chapter Prospectus".

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