USP Packaging Standards

An overview of USP´s current packaging standards-strategy has been provided in Pharmacopeial Forum`s September issue [PF 45(5)]. The stimuli article outlines the General Chapters—Packaging and Distribution Expert Committee’s (GCPD Expert Committee) current thinking. Comments can be submitted until 30 November 2019. Amongst others, the article covers general USP chapters related to plastics and elastomers.


Chapter <661> Plastic Packaging Systems and Their Materials of Construction consists of the two subchapters Plastic Materials of Construction <661.1> and Plastic Packaging Systems for Pharmaceutical Use <661.2>.

The purpose of <661> is to establish the rationale behind the testing requirements / acceptance criteria and the process by which suitability for use is established, for example by:

  • Material screening for potential extractables & leachables
  • System assessment (controlled extraction study, worst-case)
  • Product assessment (measurement of confirmed leachables)

The objective of <661.1> is to provide tests and acceptance criteria for plastic materials of construction used in packaging systems. According to the article, a material is deemed well characterized if its

  • identity can be definitively established (including identity of the extractables from that material),
  • biocompatibility (biological reactivity) and general physicochemical properties have been established,
  • additives have been quantified based on test procedures and acceptance criteria outlined in the chapter.

The intent of <661.2> is to establish the testing needed to produce the data required to establish the packaging component’s or system's suitability. A packaging component or system is chemically suited for its intended use if the following parameters are met:

  • general physicochemical properties have been established,
  • biocompatibility (biological reactivity) has been established,
  • the component or system has been established to be suitable by means of the appropriate chemical suitability,
  • the component or system is chemically compatible with the packaged product, as established by appropriate compatibility assessments (e.g., stability studies).

ELASTOMERS (Revision in process)

The USP chapters on elastomers are currently under revision (see also Revised USP Elastomeric Components Chapters).
According to the GCPD Expert Committee, the purpose of chapter <381> Elastomeric Closures for Injections (proposed new title: ELASTOMERIC COMPONENTS IN INJECTABLE PHARMACEUTICAL PRODUCT PACKAGING / DELIVERY SYSTEMS) is to provide baseline chemical and biological reactivity requirements for selecting injectable packaging / delivery system components. The proof of suitability involves multiple tests and testing procedures, including:

  • Component screening,
  • Worst-case, controlled extraction (simulation) study (determines the extent to which extractables may become probable leachables, for additional information, see <1663>)
  • Actual-case measurement of confirmed leachables in the pharmaceutical product in the packaging/delivery system intended for the commercial market (for additional information, see <1664>)
  • Biocompatibility (biological reactivity), and
    physicochemical tests outlined in <381> :
  • Appearance (turbidity/opalescence),
  • Color,
  • Acidity or alkalinity ,
  • Absorbance,
  • Reducing substances,
  • Volatile sulfides,
  • Ammonium.

In addition, a new draft chapter entitled Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems <382> has been developed, which addresses the functionality requirements, like, for example,

  • fragmentation,
  • penetration force,
  • self-sealing capacity,
  • spike retention for vials, 
  • plunger functionality tests for prefilled syringes.

Furthermore, two accompanying draft general chapters have been developed: Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems <1381> and Assessment of Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems <1382>.

The GCPD Expert Committee announced to publish another stimuli article (in a future issue of PF) entitled Elastomeric Components for Inhalation Packaging/Delivery Systems. The proposal will include tests to determine selected N-nitrosamines and polycyclic aromatic hydrocarbons in elastomeric components for inhalation packaging/delivery systems and acceptance criteria.

Access to the Pharmacopeial Forum (PF) online is free of charge. More information can be found in the stimuli article "USP Packaging Standards—Strategy and Overview".

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