Proposed Revisions to USP's Glass Chapters

The USP Packaging and Distribution Expert Committee (PDEC) is proposing revisions to the two USP glass chapters <660> Containers—Glass and <1660> Evaluation of the Inner Surface Durability of Glass Containers. The comment deadline is 31 July 2026.

Proposed Changes

The PDEC is proposing the revisions to enhance the evaluation and standards for glass packaging systems used in pharmaceuticals. These changes include the addition of new glass materials, the removal and replacement of outdated tests, revisions to existing methodologies to ensure better safety, efficacy, and performance of glass packaging in pharmaceutical applications, and a new title that better reflects the chapter content. The key changes to <660> being proposed are the following:

• New title "Glass Containers and Their Composition".
• Two new glass materials: Aluminosilicate and quartz glass.
• New identification test based on wavelength dispersive X-ray fluorescence (WDXRF) replacing the Glass Grains Test. 
• Deletion of the Surface Etching Test in order to streamline the testing process and remove redundancies.
• Revision of the Determination of Inner Surface Hydrolytic Resistance test by incorporating guidance on the application of autoclave instructions, based on new studies, to ensure precise and reliable testing.
• Addition of a new extractable arsenic test that uses inductively coupled plasma (ICP) technology to provide more sensitive and accurate measurement of arsenic levels.
• Revision of the Spectral Transmission for Colored Glass Containers test by incorporating data from both borosilicate and soda–lime–silica colored glass to refine the evaluation of light protection capabilities. 

In addition, the supporting general information chapter <1660> Evaluation of the Inner Surface Durability of Glass Containers is also being revised. The revised chapter, which is retitled "Glass Containers Used in Pharmaceutical Packaging/Delivery Systems—Manufacture and Evaluation of the Inner Surface Durability", provides comprehensive guidelines on the formation, processing, and testing of molded and tubular glass containers. Key topics include:

• Glass composition, i.e. aluminosilicate, borosilicate, quartz, and soda–lime–silica glass 
• Formation processes
• Surface treatments
• Factors affecting inner surface durability 

The chapter also introduces screening methods to detect glass particles and flakes, ensuring the durability and safety of glass containers. Moreover, it emphasizes the importance of collaboration between pharmaceutical manufacturers and glass vendors to maintain high-quality standards throughout the glass supply chain.

For more information please the the draft chapters published in Pharmacopeial Forum PF 52(3).