Qualifying Delamination Propensity of Tubular Glass Vials
Sponsored by: SCHOTT
- Tubular Glass Vials
Date: 28 November
Time: 3PM London/10AM New York
The occurrence of glass delamination during storing of pharmaceutical products in borosilicate glass vials is mainly determined by the interaction of pharmaceutical product and the chosen glass container. The phenomenon typically arises in the bottom near surface area, whose local chemical composition is influenced by the container forming process as well as the original glass composition.
Using vials produced with different parameter settings, the principal delamination propensity was qualified by a test procedure, which can be done in a laboratory within 1 working day. The test is meanwhile successfully applied for daily routine control and was used to optimize the vial production process and validate vial formats between 2ml and 50ml nominal volume to minimize the risk for delamination. The proof of concept will be shown by a countercheck using predictive screening studies according USP1660 for a wide range of common buffer solutions.
SCHOTT Vials DC comply with USP, EP and Jp and from a regulatory point of view no re-registration is required.
Predictive screening studies will show that there is no empirical evidence for low surface alkalinity to minimize the risk for delamination.
Dr. Bernhard Hladik,
Senior Business Development Manager, SCHOTT Pharmaceutical Systems
Dr. Bernhard Hladik gained a Diploma in Chemistry of the University of Duisburg and in 1996 a Ph.D. in Physical Chemistry from the Institute of Applied Thermodynamics at the University of Heidelberg.
Since October 2000 he has been working for the SCHOTT AG and from 2009 on his area of responsibility is pharmaceutical packaging holding different key-functions in Product Management/Business Development for the product group ampoules, vials and cartridges. This includes trend mapping, innovations and strategic projects like coated vials, ready to fill containers and the prevention of delamination.
Key Learning Objectives
- Root cause and mechanism for delamination
- Optimizing the production process to minimize the risk for delamination
- Setting a quantitative limit value and performing a parameter setting program
- Proof of concept performing predictive screening studies with commonly used buffers acc. USP 1660
- CSOs CEOs
- Heads of R&D
- Drug Developers
- Heads of Packaging
- Packaging Developers
- R&D Managers
- Packaging Project Managers
- Head of Production (Filling)
- Production Managers