Harmonization of Pharmacopoeial Standards Stresses on Delamination

November 5, 2015
Pharmaceutical Technology Editors

The latest revisions to the international pharmacopoeia standards for glass pharmaceutical packaging have emphasized the importance of assessing delamination propensity of pharmaceutical glassware, including bottles, vials, cartridges, and syringes.

The latest revisions to the international pharmacopoeia standards for glass pharmaceutical packaging have emphasized the importance of assessing delamination propensity of pharmaceutical glassware, including bottles, vials, cartridges, and syringes, notes independent research and development, consultancy and testing facility, Glass Technology Services Ltd (GTS).

“The United States (USP) and European (Ph. Eur.) Pharmacopoeias remain the most widely used in the global market and recent revisions to both monographs continue to harmonize requirements between the two-bringing welcome simplification and, in some cases, savings for customers that regularly test to both the USP and Ph. Eur. Standards,” GTS laboratory manager, Daniel Capon, said in a press statement.

According to Capon, the latest revisions, USP 38-NF33 and Ph. Eur 8.3, emphasize recommendations for propensity and stability studies-with direct references now being included within both USP <660> and Ph. Eur 3.2.1 for the first time. “This ongoing harmonization is another positive step forward and builds upon significant unification between USP 37-NF32 and Ph. Eur 8.0 in 2014-which saw the USP adopt the Ph. Eur. glass grains and surface tests,” he said.  

Other key changes include: stricter autoclave programs within respective glass grains and surface tests across both monographs, with additional requirements for the time-temperature profiles that must be achieved in both heating and cooling of samples and the required use of external thermocouples for temperature logging; and mechanical sieve-shakers/sieving machines now allowed within glass grains preparation in both the USP and Ph. Eur.

There is consequently a growing need for glass surface delamination evaluation, propensity and stability studies among drug manufacturers operating in the EU and US. GTS provides accredited testing services for pharmaceutical and medical companies as well as glass manufacturers. In addition to USP and Ph. Eur., GTS also tests to British, Russian, and Japanese Pharmacopoeia standards and provides a comprehensive range of chemical analyses, performance testing, quality assessment, and consultancy services.

Source: Glass Technology Services