Furthering Understanding and Expertise

Furthering Understanding and Expertise in Pharmaceutical Delamination and Performance

Glass Technology Services Ltd (GTS) 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 GTS’ 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 GTS laboratory already provides a range of related services – including pharmacopoeia standards verification , quality assessment , mechanical performance testing , expert analysis of foreign bodies , defects and surface contaminants , technical failure analysis and a range of delamination services .

Daniel Capon, Laboratory Manager, at Glass Technology Services Ltd, 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 the GTS laboratory, is the nominated expert joining TC12 to represent Glass Technology Services Ltd.

Previously provided as an ad-hoc consultancy service, GTS 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 Ltd 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.

Notes to Editor

Image Credit: urfin/shutterstock.com

Delamination Propensity Screening; For further information about key changes to the United States Pharmacopoeia, including the introduction of <1660> delamination propensity screening, in December 2013, please see: www.glass-ts.com/news/harmonising-standards-across-international-pharmacopoeias-for-pharmaceutical-glasses

Further information about delamination, propensity screening and both accelerated and long-term studies, please see: www.glass-ts.com/delamination

Glass Technology Services Ltd (GTS) is a leading provider of analysis, mechanical and performance testing, quality assessment, failure analysis, glass research and development and a range of consultancy services - specialising in glass, raw materials and glass products. GTS is accredited to ISO/IEC 17025 and ISO 9001 quality standards and have an established reputation for their specialist knowledge in glass. Please see www.glass-ts.com. GTS provides regular updates and research news through its website, social media and newsletter – to receive updates or interact through social media, please see www.glass-ts.com/newsletter .

The International Commission on Glass (ICG) is a non-profit making international GLASS SOCIETY comprising 37 national organizations in glass science and technology. ICG promotes cooperation between glass experts through Technical Committee work (round robin testing, publication of scientific & technical papers) and conferences. Please see www.icglass.org

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