BRIEFING
〈660〉 Containers—Glass. This proposal is based on the version of the chapter official as of October 1, 2023. The Packaging and Distribution Expert Committee is proposing a revision to this chapter 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 These changes include the addition of new glass materials; the removal and replacement of outdated tests; the revision of existing methodologies to ensure better safety, efficacy, and performance of glass packaging in pharmaceutical applications; and a new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 being proposed are as follows:
-
Addition of New Glass Materials: Two new glass materials have been introduced—aluminosilicate glass and quartz glass. These additions aim to provide more options with varying properties for different pharmaceutical applications.
-
Removal and Replacement of Tests: The Glass Grains Test has been removed and replaced with a new identification test based on WDXRF (4.1 Elemental Composition by Wavelength Dispersive X-Ray Fluorescence). This modern method enhances the accuracy of identifying and characterizing glass materials. The Surface Etching Test has been eliminated, streamlining the testing process and removing redundancies.
-
Revision of Existing Tests: The Determination of Inner Surface Hydrolytic Resistance test is retained (4.2 Determination of Inner Surface Hydrolytic Resistance) with added guidance on the application of autoclave instructions based on new studies. This ensures precise and reliable testing procedures. A new extractable arsenic test (4.4 Extractable Elements) has been added using inductively coupled plasma (ICP) technology, providing a more sensitive and accurate measurement of arsenic levels. The Spectral Transmission Test for Colored Glass Containers has been revised (4.5 Spectral Transmission for Colored Glass Containers), incorporating data from both borosilicate and soda–lime–silica colored glass to refine the evaluation of light protection capabilities.
Due to the impact of this proposed new general chapter, the Packaging and Distribution Expert Committee is committed to ensuring industry has ample time to review and assess impact.
The supporting general information chapter Evaluation of the Inner Surface Durability of Glass Containers 〈1660〉 is also being revised and is published in this issue of PF.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(GCPD: D. Hunt)
Case ID—SUB-754