USP Draft Chapters on Elastomeric Closures <381>, <382>, <1381> and <1382>

Recommendation

7/8 May 2024

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Challenges and Solutions for Packaging and Single Use Systems

As previously reported in "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 Closures for Injections (revision, proposed new title: Elastomeric Components used in Injectable Pharmaceutical Packaging/Delivery Systems), 
• <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (new),
• <1381> Elastomeric 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 drafts of these four chapters have now been published for public comment in Pharmacopeial Forum (PF) 43(3) [May–Jun. 2017]. Deadline for comments is July 31, 2017.

Together with the above mentioned proposed change of the title, the USP Packaging and Distribution Expert Committee is proposing the following revisions which will update and expand the scope of the current chapter <381>:

• Emphasize the baseline requirements for the selection of thermoset and thermoplastic elastomeric components;
• Expand the scope to include all elastomeric components used in an injection packaging system. Elastomeric components include, but are not limited to, those used for vials, bottles, prefilled syringes (plungers, needle shields, and tip caps), cartridges (plungers and seal liners), injection ports for flexible bags and infusion sets, and plungers for single-use syringes;
• Delete the Heavy Metals <231> testing and add a modern method for extractable element determination;
• Omit functionality tests and assessment from the chapter and move them to the two proposed new chapters: 
  
  A) Functionality tests appear in Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems <382>.   The proposed new general chapter will address the fitness-for-intended-use functionality requirements of elastomeric packaging/delivery systems that are intended for injectable dosage forms. When properly fitted with dimensionally compatible packaging/delivery systems, the closures are intended to protect and contain the drug product while enabling safe and effective in-use product access. The function being performed by any single elastomeric closure type is dependent on the packaging/delivery system and may cover more than one functional parameter.
  
  B) Baseline information for the assessment is provided in Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems <1382> to assist users in the functionality assessment of elastomeric closures as part of packaging/delivery systems intended for injectable dosage forms. Proper selection and design of functionality assessment studies is based on sound 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.
  
  According to the proposal, alternative testing strategies for functionality assessment may be appropriate in certain circumstances with proper justification. In chapter <1382>, a more complete discussion of fitness-for-intended-use testing, as compared to closure functionality assessment in early package development, is presented including guidance on test samples and their preparation, test sample population size, test procedures, test acceptance criteria (data interpretation), and test outcome reporting.
  
• Develop an additional informational chapter, Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems <1381>, to support the current chapter revision by:
  - Describing elastomeric components and their materials of construction for use in pharmaceutical packaging systems,
  - Providing a high-level introduction to elastomer chemistry, manufacturing technology, and the post processing of components,
  - Explaining basic functional characteristics of components,
  - Designating baseline requirements, 
  - Discussing identification testing. 

Additionally, minor editorial changes have been made to update the chapter to current USP style.

Furthermore, a workshop, Modernization of USP Packaging Standards for Glass and Elastomeric Components, will take place June 19–20, 2017 at the USP Meetings Center in Rockville, Maryland, to discuss these four proposals.

USP also provided a briefing list in PF 43(3) which includes monographs and/or chapters that both reference the general chapter <381> under revision and require revision to keep references to the General Chapter accurate. USP says that "other monographs and/or chapters may also be listed, even where the reference to the General Chapter remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in the general chapter itself to affect pass-fail determinations for particular monograph articles".

Following your registration on the Pharmacopeial Forum website you get access to the complete drafts of general chapters <381>, <382>, <1381> and <1382>.