SCHOTT pharma services - Specialized analytics for pharmaceutical packaging

Despite the high level of chemical durability of Type 1 glass, in rare cases the interactions between the drug and container can lead to safety concerns. Typical problems are glass delamination, particle formation, or leachables from the container. Several recent market recalls occurred, conferences were dedicated to the topic, and an advisory letter was issued from the FDA. We offer screening packages using specialized analytics to assess potential risks and find strategies to avoid them. more

Glass breakage is a major concern for many pharmaceutical operations. With our long standing experience in fractographic investigations of broken containers we can support our customers to determine the root cause that led to breakage.  Our expertise in mechanical strength testing enables us to compare the fracture resistance of different container systems and determine expected fracture probabilities. This analytical data provides you the basis for selecting the packaging that best meets your specifications. more

In order to meet clients’ needs and the requirements of regulatory agencies, we have developed specialized tests for thorough characterization of pharmaceutical packaging. We can can provide pharmacopeia (US/EP/JP) and industry standard (ISO, DIN, ASTM) methods. Container closure integrity, functionality testing, analysis of tungsten levels, and free and total silicone oil quantification are among the most popular tests we carry out. Herewith we support our customers to better understand the performance of their pharmaceutical container systems. more