What are the Correct Criteria for Assessing the Risk of Glass Delamination?
In 2010, the pharmaceutical industry witnessed the first major recall due to glass delamination. As a result, regulatory bodies and pharmaceutical companies focused research activities on understanding the root cause, and thus elaborate solutions to reduce the risk of glass delamination. Simultaneously, suppliers of primary packaging containers worked on minimizing the manufacturing-related delamination propensity. Initial approaches, however, were restricted to qualitative recommendations. A first attempt to define quantitative measures focused on using containers with reduced surface (...)