The 60s Called & They Want Their Glass Packaging Tests BackThe 60s Called & They Want Their Glass Packaging Tests Back
Outdated procedures have prompted USP-NF to revise two glass packaging standards to improve the safety and efficacy of pharmaceutical glass packaging systems.

At a Glance
- Two USP-NSF chapters will change: “Containers—Glass” and “Evaluation of the Inner Surface Durability of Glass Containers."
- Expect "acceptance from some and pushback from others," says Desmond Hunt, PhD, senior principal scientist at USP.
The United States Pharmacopeia and the National Formulary (USP-NF) is updating General Chapter <660> to enhance the evaluation and standards for glass packaging systems used in pharmaceuticals. One of the revisions pertains to the chapter “Containers—Glass” and the other pertains to the supporting general information chapter “Evaluation of the Inner Surface Durability of Glass Containers.”
The current standards are being revised to reflect advancements in glass materials, update testing methodologies, and improve accuracy and efficiency. This ensures glass packaging meets the latest safety, efficacy, and performance requirements.
According to Desmond Hunt, PhD, senior principal scientist at USP, another key reason for the update is that many of the tests and procedures in the current chapters date back to the 1960s.
Out with the old, in with the new.
“Today, we have better analytical procedures that provide more robust and accurate data,” he says. “Modernizing these outdated methods allows the pharmaceutical industry to benefit from improved testing techniques, ensuring higher quality and compliance.”
Hunt outlines the major changes in the revision as follows:
Addition of new glass materials: Aluminosilicate and quartz glass are introduced, providing more material options with different properties for specific pharmaceutical applications.
Removal and replacement of tests:
The glass grains test is replaced with wavelength dispersive X-ray fluorescence (WDXRF), offering improved accuracy in identifying and characterizing glass materials.
The surface etching test has been removed, reducing redundancy and streamlining the testing process.
Revision of existing tests:
The inner surface hydrolytic resistance test includes updated guidance on autoclave procedures.
A new extractable arsenic test using inductively coupled plasma (ICP) technology ensures more sensitive and accurate arsenic measurements.
The spectral transmission test for colored glass containers has been revised to include both borosilicate and soda-lime-silica glass containers, refining light protection evaluation.
Is industry ready for these changes?
When asked how the industry will view this revision, Hunt told Packaging Digest it’s likely there will be acceptance from some and pushback from others.
“On one hand, the modernization of outdated testing procedures and the introduction of new glass material, along with more accurate testing methodologies, will likely be welcomed by many as they improve safety, efficacy, and data robustness,” he added. “On the other hand, pushback may come from those concerned about the implementation and time required to transition to the new methods. The removal of long-established tests may raise concerns about validation requirements and the impact on existing manufacturing practices.”
The deadline for submitting comments on the revision draft of USP <660> is November 30, 2024. Stakeholders have 90 days (starting September 3, 2024) to provide feedback.
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