Recent revisions on pharmacopoeia standards for glass containers have led to simplification and cost saving for customers across the pharmaceutical supply chain, according to test house, Glass Technology Services (Glass Technology Services). "Although plastic has seen increased use for primary and secondary packaging of many pharmaceutical preparations, glass remains essentially the container material of choice for parenteral and other sensitive products" said Glass Technology Services Technologist, Margaret Flower. "Hydrolytic stability testing of those containers is clearly critical to maintaining that position and ensuring confident use of glass across the pharmaceutical, laboratory and medical sectors. The US Pharmacopoeia (USP) and European Pharmacopoeia (EP) remain the most widely used in the global market and recent revisions to the USP have brought harmonisation between the two - bringing welcome simplification and in many cases, cost savings for customers that regularly test to both USP and Ph Eur standards." Key changes include replacement of the USP powdered glass test by the Ph Eur glass grains test, deletion of the USP water attack at 121 deg C test, incorporation of the Ph Eur surface glass test into the USP and the recent inclusion of a chapter (1660) to the USP for delamination propensity pre-screening. Glass Technology Services has been offering this service in advance of the chapter's publication. Margaret Flower believes the partial harmonisation will be well received, both by glass manufacturers and pharmaceutical and medical companies, who are increasingly using Glass Technology Services services to achieve product certification. "One set of tests for hydrolytic stability makes the process much simpler and more cost-effective and for an industry which is heavily regulated and where development and innovation is constant, that has to be very welcome news.
