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〈662〉 Metallic Packaging Systems and Their Materials and Components of Construction

BRIEFING

〈662〉 Metallic Packaging Systems and Their Materials and Components of Construction. A metal packaging system was first used to package pharmaceutical products in the early 1900s due to its lightness and its impermeability to light and moisture. Common metal packaging components include aluminum and its alloys, stainless steel, tin-free steel, and tinplate. Within the pharmaceutical industry, primary metal packaging systems can include aerosols, blister packs, canisters, collapsible tubes, drums, and gas cylinders, and secondary packaging systems such as overwraps and seals. Currently, there are no compendial standards for metal packaging systems. Thus, to ensure the safety, suitability, and compatibility of metal packaging system for pharmaceutical products, the General Chapters—Packaging and Distribution Expert Committee is proposing a new general test chapter to address the characterization of metal materials, components, and systems used to package pharmaceutical dosage forms such as aerosol cans, capsules, creams, emulsions, foams, lotions, ointments, pastes, suppositories, and tablets.

 This new chapter outlines testing procedures and relevant defined acceptance criteria for the following functional and chemical analysis tests:

 3.1 Functional Tests

  • Burst Pressure

  • Particulate Matter

  • Surface Coatings

  • Tube Air Tightness

  • Tube Deformation (Guillotine Test)

  • Foil Pinholes

 3.2 Chemical Analysis—Extractables

  • Solvent Mediated Extractions

  • Thermal Extraction

 Due to the impact of this proposed new general chapter, the Packaging and Distribution Expert Committee has committed to republishing this chapter after receiving stakeholder comments to ensure industry has ample time to review and assess impact.

 To facilitate the use and support the understanding of this new general chapter, USP will look to develop stakeholder engagements to allow open dialogue on this new general chapter.

 The supporting general information chapter Materials and Manufacturing Processes for Metallic Packaging Systems 〈1662〉 is also being published in this issue of PF.

 (GCPD: D. Hunt)

 Case ID—SUB-751

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