USP Republishes Metal Packaging Drafts

Following comments received, the USP republished the following two proposed new chapters on metal packaging materials in Pharmacopeial Forum (PF) 51(5): 

• <662> Metallic Packaging Systems and Their Materials and Components
• <1662> Materials and Manufacturing Processes for Metallic Packaging Systems

The new chapter proposals are based on the versions published last year in PF 50(4). The previous proposal for <662> has been canceled and is being replaced by the updated version. Chapter <1662> is intended to support the new chapter <662>, by providing information on the materials of construction, manufacture, and processing of metallic packaging containers used in pharmaceutical packaging/delivery systems. However, no revisions are being proposed to <1662> based on the PF 50(4) proposal, but the USP General Chapters—Packaging and Distribution Expert Committee (GC-PDEC) has requested that it be republished along with <662> to give stakeholders another opportunity to provide feedback (the deadline for comments is 30 November 2025).

Background and Outline

Due to their lightness and impermeability to light and moisture metal packaging systems were amongst the first used packaging materials for pharmaceutical products. However, up to now, there are still no harmonized regulatory or compendial standards for metal packaging systems. To ensure the safety, suitability, and compatibility of metal packaging systems, the USP GC-PDEC is therefore proposing the new general chapters to address the characterization of metal materials, components, and systems used to package pharmaceutical products.

The new chapter <662> outlines testing procedures and relevant 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 the proposed new general chapters, the USP GC-PDEC has committed to a delayed implementation of the chapters for five years to allow adequate time for industry to implement it. Furthermore, the USP will develop stakeholder engagements to allow open dialogue on the new chapters to facilitate use and support understanding. More information is available following registration to the Pharmacopeial Forum.