USP Proposal for Metallic Packaging Systems

Although metal is one of the oldest materials for pharmaceutical packaging, there is currently no compendial standard available. In 2016 the USP Expert Committee "General Chapters-Packaging and Storage" announced to develop a new General Chapter <662> "Metal Packaging Components and their Materials of Construction". Additionally, a stimuli article (Metal Packaging Systems and Their Materials of Construction for Pharmaceutical Products) was published in PF 39(4) (2013). Now the anticipated USP draft chapter has finally been released in Pharmacopeial Forum PF 50(4). The deadline for comment is 30 September 2024.

USP Draft Chapters

The USP published the following two new General Chapters on metal packaging systems for pharmaceutical use:

  • <662> Metallic Packaging Systems and Their Materials and Components of Construction

  • <1662> Materials and Manufacturing Processes for Metallic Packaging Systems

Common metal packaging components include aluminum and its alloys, stainless steel, tin-free steel, and tin. The general information chapter <1662> is meant to support the general test chapter <662> by providing information on the materials, manufacture, and processing of metallic packaging containers used in pharmaceutical packaging/delivery systems. Chapter <662> outlines testing procedures and relevant defined acceptance criteria for the following functional and chemical tests:

Functional Tests

  • Burst Pressure
  • Particulate Matter
  • Surface Coatings
  • Tube Air Tightness
  • Tube Deformation
  • Foil Pinholes

Chemical Analysis - Extractables

  • Solvent Mediated Extractions
  • Thermal Extraction

Due to the impact of these two proposed new general chapters, the USP Packaging and Distribution Expert Committee has announced to republish the chapters after receiving stakeholder comments to ensure industry has sufficient time to review and assess impact. More information is available after registration to the Pharmacopeial Forum.

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