BRIEFING
〈662〉 Metallic Packaging Systems and Their Materials and Components. This new chapter proposal is based on the version published in PF 50(4) [Jul.–Aug. 2024] with the title "Metallic Packaging Systems and Their Materials and Components of Construction". The previous proposal has been canceled and is being replaced by this updated version.
Metal packaging systems were first used to package pharmaceutical products in the early 1900s due to their lightness and impermeability to light and moisture. Common metal packaging components include aluminum and its alloys, stainless steel, tin-free steel, and tinplate. In the pharmaceutical industry, primary metal packaging systems can include aerosols, blister packs, canisters, collapsible tubes, drums, and gas cylinders, as well as secondary packaging systems such as overwraps and seals. Currently, there are no compendial standards for metal packaging systems. To ensure the safety, suitability, and compatibility of metal packaging systems 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
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Burst Pressure
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Particulate Matter
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Surface Coatings
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Tube Air Tightness
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Tube Deformation (Guillotine Test)
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Foil Pinholes
3.2 Chemical Analysis—Extractables
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Solvent Mediated Extractions
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Thermal Extraction
Due to the impact of this proposed new general chapter, the General Chapters—Packaging and Distribution Expert Committee has committed to a delayed implementation of the chapter for five years to allow adequate time for industry to implement it.
To facilitate use and support understanding, USP will 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-2299