Glass Technology Services is holding a series of one-day workshops for the pharmaceuticals industry to discuss key regulatory, specification and quality assurance topics concerning glass primary packaging.
Leading USP expert Dr Desmond Hunt, Principal Scientific Liaison at the USP, has confirmed that the next workshop will be on 9 October 2019.
Hunt will provide delegates with an update on the current status and developments of the US Pharmacopoeia, with regard to key glass chapters (USP <660>, 'Containers - Glass' and <1660>, 'Evaluation of the Inner Surface Durability of Glass Containers').
Workshop content
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.
Course summary
- 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
- Pharmacopoieal verification
- 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
- Handling considerations
- Steps to take if breakages or defects are discovered
- Research and developments in glass
- Laboratory demonstrations
Who should attend?
Whether you make, sell, process or use glass packaging – this workshop will give you an understanding of how glass is processed, quality control, appropriate selection in terms of specification and durability and how to meet your legal responsibilities. There will also be a chance to discuss your specific requirements in our one to one surgeries.
Professionals in the pharmaceutical supply chain that work with glass packaging:
- Quality assurance and control
- Packaging specification and development
- Regulatory affairs
- Manufacturers
- Contract fillers
Location:
Glass Technology Services Ltd
9 Churchill Way, Chapeltown, Sheffield, S35 2PY, United Kingdom
Free, on-site, parking is available.
For further information or to book visit the website.
