The delamination of pharmaceutical glass is a serious issue, as it can cause glass lamellae to appear in vials, a problem that leads to several drug product recalls in recent years. The first stage of delamination is always the formation of an altered layer due to the glass-liquid interactions that may lead, after a long period, to the separation of thin glass layers that appear as shiny, needle-shaped particles floating in the filling liquid.
After an extensive investigation on the chemical performance of the inner surface of vials and on the critical glass forming process parameters that influence the final delamination propensity of vials performed by SG Lab, OMPI launched LDP Vials in both bulk and ready-to-use configuration; a result of an optimized forming process that minimizes the surface inhomogeneity formation ensuring patient safety and product quality.
In this webinar you will learn how to minimize the risk of delamination thanks to an optimized packaging product that also combines the flexibility offered by the EZ-fill® platform.
Lorenza Bonaldi,
Product Specialist Strategic Support
With a Master’s Degree in Bioengineering at the University of Padua, Lorenza Bonaldi boasts a vast knowledge in physics, biomaterials, biomechanics, biomedical instrumentations, biology, physiology, chemistry, informatics, mathematics, electronics, electro technology. She entered Stevanato Group in 2015 as Technical and Quality Front End for Ompi, gaining experience in the glass primary packaging and injectable delivery fields. Now she is Product Specialist Strategic Support in Ompi, responsible for developing and implementing strategies for ready to use syringes, cartridges and vials, expert in fill&finish machines
- Factors leading to delamination – consequences and risks
- Ompi solution to delamination: an optimized forming process
- EZ-fill® LDP Vials: the perfect solution to be managed both during clinical trials and during the industrialization phase
- SG Lab studies: the results on EZ-fill LDP Vials
- Project Managers
- Product Manager
- Product Specialist
- Heads of Packaging
- R&D Managers
- R&D Engineers
- Operations Managers
- Fill & Finish Mangers
- Pharma Engineering Managers
- Early Phase Drug Development and Quality Engineers
- Product and Process Development
