Featuring an introduction to glass, glass making processes, and key glass properties as well as both current and emerging regulatory requirements, the day will cover a range of factors to consider when specifying glass for use in pharmaceutical applications.
The day provides delegates with an introduction to glass - including an understanding of the manufacture and processing of tubular and moulded glass primary packaging. Fundamental glass topics include glass durability and the differences between types I, II and III glasses, quality control, glass performance, common defects and types of glass failure.
Key regulatory and due diligence topics will cover pharmacopoeial verification, performance, dimensional specifications and the importance of appropriate selection in terms of both specifications and durability. Emerging requirements, including as glass delamination and elemental migration will also be covered.
The day includes a tour of the Glass Technology Services laboratory facilities, including demonstrations of key analyses and services provided in this sector. The team will also discuss and demonstrate some of the cutting-edge research and developments underway. These include ‘dissolvable’ glasses designed for controlled release of ions, phosphate fibres for integration within the human body, 3D printing and additive manufacture and anti-bacterial glasses – all currently under development for use in the biomedical sector.
What you will learn about:
Glass manufacture and processing
USP update and recent developments
Meeting your legal requirements
Glass durability and selection
Glass types I, II and III and the uses for each
European Pharmacopoeia (Ph. Eur/EP) and United States Pharmacopoeia (USP) requirements for glass
Delamination - what is it, why does it occur and propensity studies
ICH Q3D elemental impurities
End use and appropriate selection
Ensuring packaging integrity
Glass strength, performance and causes of weakness
Common forces and breakage patterns
Steps to take if breakages or defects are discovered
Research and developments in glass