How To Bring Delamination Under Control
Sponsored by: SCHOTT
Date: 7 May
Time: 3PM London/10AM New York
A new generation of pharma vials minimizes the risk of delamination and increases patient safety
The problem of delamination has been around for a long time. It refers to the detachment of glass flakes from the inner surface of a vial as a result of drug/container interaction. Recent drug recalls, however, have given new impetus to this issue. As a result, the US drug authority FDA is explicitly requiring that pharmaceutical companies manage this risk more closely.
Packaging manufacturers have devoted a great deal of energy to new solutions that help reducing the risk of delamination. A new generation of vials can now reliably lower the risk of delamination thanks to a more homogenous inner surface. This is achieved by combining high quality glass with an optimized production process – and with a newly developed test method that allows for the delamination tendency to be determined and managed during production for the first time ever.
To confirm this effect, predictive screening studies were conducted with systems for which recalls for glass delamination have been reported. The results showed that the new vials remained stable even after many month of storage, while conventionally manufactured vials showed delamination or at least early indicators for delamination.
In this webinar you will learn how to lower the risk of delamination by choosing an improved packaging product, and we will also present the result of several screening studies.
Dr. Bernhard Hladik ,
Product Management, SCHOTT Pharmaceutical Systems
Dr. Bernhard Hladik has been leading SCHOTT’s Product Management group for ampoules, vials and cartridges for several years. His tasks include trend mapping, innovations and strategic projects like the prevention of delamination, which he is currently focusing on. Bernhard holds a diploma in chemistry and gained a Ph.D. in physical chemistry from the institute of applied thermodynamics at the University of Heidelberg.
Key Learning Objectives
- Root cause â€“ Why does delamination occur
- Reducing delamination by means of coating
- An alternative to coated vials: SCHOTT Vials DC
- How the SCHOTT Delamination Quicktest works
- C Levels
- Heads of R&D
- Drug Developers
- Heads of Packaging
- Packaging Developers
- R&D or Packaging Project Managers
- Head of Production (filling)
- Production Managers