Furthering understanding and expertise in pharmaceutical delamination and performance

Glass Technology Services has joined the International Commission on Glass’ (ICG) Technical Committee (TC12) for Pharmaceutical Packaging in order to share their knowledge and experience dealing with a wide range of pharmaceutical glassware and exchange understanding, skills and learn from a wider group of peers and technical experts. The overall aim of the technical committee is to work collaboratively to increase understanding, standards and, ultimately, the prevention of the ‘phenomena’ of glass surface delamination.

This move builds upon existing knowledge and consultancy services, which already sees them working across a wide range of clients operating throughout the pharmaceutical supply-chain – from glass manufacturers to those developing, manufacturing, filling or processing the finished dosage form (FDF) products. The Glass Technology Services laboratory already provides a range of related services.

Daniel Capon, Laboratory Manager, at Glass Technology Services, said:

“We are proud to be working with a consortium of esteemed technical experts to further understanding, analysis and control of pharmaceutical packaging defects across the supply-chain. The objectives of this technical committee are well aligned with a range of work already underway in our laboratories, so it was a logical move for our nominated expert to join the group to share our experiences as well as expand our own understanding."

Senior Technologist, Amy Meysner, who takes a lead on chemical migration, durability and delamination analysis in our laboratory, is the nominated expert joining TC12 to represent Glass Technology Services.

Previously provided as an ad-hoc consultancy service, Glass Technology Services formalised its delamination services in 2013 in line with the adoption of the United States Pharmacopoeia (USP) chapter <1660> - providing pharmaceutical clients clear options for assessing delamination probability. These include both analysing suspected cases and a number of delamination study options. Initial screening is provided to help with the initial selection of packaging for specific drug products - including how primary packaging resists delamination and the migration of major constituent ions into drug products or supporting solutions. In addition, long-term exposure scenarios, accelerated attacks and formal propensity studies are all available – often conducted with a range of drug products, supporting solutions and simulants - providing scientific data and technical reports to support companies in their formal drug application and approval processes.

Glass Technology Services provides analysis, consultancy, testing and research and development support to all parts of the glass supply chain – from raw materials to the end consumer. GTS prides itself on its confidentiality and independence and is accredited to ISO 9001 and ISO/IEC 17025 standards. For more information please visit www.glass-ts.com , email enquiries@glass-ts.com or telephone +44 (0) 114 290 1801.