Folker Steden

Day 2: Wednesday, 16 October 2019

CASE STUDY: Extractables and Leachables profiles from glass tubing and container made out of pharmaceutical glass

• General overview of potential E&L from glass materials down to ppm level
• Primary packaging material for parenterals is getting an integral part of the whole drug formulation system
• Not every glass is equal – An overview about different E&L profiles of commonly used glass types (so called Type 1, Type 3, high, middle and low borosilicate glasses)
• Discussion of influencing factors like the converting, different buffer systems and chemical environments, different pH values, filling volumes and for example thermal sterilization

Day 2: Friday, 23 October 2020

CASE STUDY: Influencing factors on Extractables and Leachables at different glass materials.

As the complexity of modern drug products grows from a chemical and physical point of view, the evaluation of possible drug/container interactions are an increasing focus area in primary packaging material development. These interactions mainly depend on several factors: the chemical composition of the glass packaging material, the conversion process (namely the transformation of glass tubing into containers), possible additional surface treatments and, finally, the drug product itself. Regarding the first aspect, the composition of glass varies among different glass types as well as among different manufacturers. In consequence, the composition of a glass gives first indications for potential sources of extractables. A case study will be presented revealing differences in the extractables levels among different glass types, such as borosilicate glass and aluminosilicate glass. Furthermore, also the influence of the conversion process and possible surface treatments on the chemical stability of both glass types will be illustrated.