Together with the industry, the pharmacopeias are currently working on new approaches for the inner surface hydrolytic test and the light transmission test (for amber glass). Additionally, efforts are being made to develop a new description of the autoclave procedure for the glass grains and the surface tests to eliminate ongoing questions associated with the autoclave cycle and to establish a global standard.
At the USP - Ph. Eur. - ECA Joint Conference GLASS meets PHARMA from 6-7 June 2018 in Berlin, Germany, the latest news regarding glass packaging were presented by 13 speakers from FDA, EDQM, USP and Industry, including:
An Update of USP General Chapters <660>, <1660>, including proposed revisions regarding the hydrolytic resistance test and the light transmission test
An Update of Ph. Eur. Chapter 3.2.1 (specific topics: delamination / hydrolytic resistance)
Glass Delamination (What is delamination – What‘s it like?) and Product Recalls caused by Delamination
Glass Particles (Particle Contamination in Parenterals) including USP´s approach to glass particulates: Proposed New General Chapter <667> Sub-Visible and Visible Particulates in Packaging and Manufacturing Components and Systems
Risk Evaluation of Elemental Impurities (EIs) from Glass in view of ICH Q3D and mitigation strategies to reduce extractables with surface treatment and coatings (for example by siliconization of the container inner surface)
Glass formulations with enhanced chemical stability - for example Aluminosilicate glass (e.g. Valor Glass®) which is not covered by the pharmacopoeias yet.
These topics were highly discussed by the audience and the participant´s comments will now be considered during the revision process of the pharmacopoeias regarding the chapters on glass packaging materials.