USP Published New Drafts for General Chapters on Plastic Materials

In the current issue of Pharmacopeial Forum (PF) 45(2) [March-April 2019] the following general USP chapters have been re-published for comment (the comment deadline is May 31, 2019): 

  • <661> Plastic Packaging Systems and Their Materials of Construction,
  • <661.1> Plastic Materials Of Construction,
  • <661.2> Plastic Packaging Systems for Pharmaceutical Use,
  • <1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction With Respect to Their User Safety Impact,
  • <665> Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products,
  • <1665> Characterization of Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products.

Proposed revision of <661>, <661.1>, <661.2>, and <1661>

  • As reported before, the 2017 draft for <661.1> introduced the requirement to test on extractable elements. The requirement for extractable elements testing is now proposed to be removed from chapter <661.1>. According to the new draft "it is being left up to the material user to evaluate the need for extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished". An example of an extractable elements testing strategy is provided in <1661>.
  • In addition, the implementation date for <661.1> and <661.2>, is being changed from May 1, 2020 to December 1, 2025.
  • The four chapters are also being revised to align with each other and to describe all of the plastic materials that are included in <661.1>, including the process of materials assessment, along with the applicability and application of <661.1>.
  • Furthermore, four new polymer descriptions [polyamide 6; polycarbonates; poly(ethylene-vinyl acetate); and polyvinyl chloride] have been added. 

Proposed revision of <665> and <1665>

A previous proposal for the new USP chapter <665> was published as Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products <665> in PF 43(3). On the basis of comments received, that proposal was cancelled and is replaced by the current proposal with the following significant changes:

  • Include sufficient information in the chapter to allow for its execution.
  • Clarify the scope with respect to components, drug substances, and drug products.
  • Delineate the hierarchical relationship between component and materials testing.
  • Remove the concepts of compatibility and grandfathering exemption.
  • Provide for flexibility regarding the design of the risk evaluation matrix.
  • Generate a set of baseline chemical and biological tests for materials of construction.
  • Revise the risk-based chemical and biological reactivity testing requirements for components.
  • Revise the extractable elements testing to align with other USP chapters.

In addition, there have been comments regarding the applicability of <665> and the mechanism by which this will occur within the USP–NF. According to USP, "the expert committee will work with stakeholders, via comments submitted to this proposal, an upcoming workshop, and other stakeholder engagement activities to determine how best to incorporate this chapter into the USP–NF". To facilitate the use and support the understanding of <665>, a new informational chapter <1665> has been proposed. The new chapter discusses material characterization, selection and qualifications of plastic components and systems used to manufacture active pharmaceutical ingredients, biopharmaceutical drug substances, and biopharmaceutical and pharmaceutical drug products.

Furthermore, it has been announced in Pharmeuropa that new Ph. Eur texts on plastic/ elastomeric materials will be elaborated:

  • 3.1.17 Cyclo-olefin copolymers (COC),
  • 3.1.18 Styrene block copolymers (SBC) for containers and closures for parenteral preparations and ophthalmic preparations.

Following your online registration to Pharmacopeial Forum, you will have acces to the full texts of the published USP packaging chapters.

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