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- Title
Surface Hydrolytic Resistance Test or Delamination Quicktest: What are the Correct Criteria for Assessing the Risk of Glass Delamination?
- Authors
Hladik, Bernhard; Rupertus, Volker
- Abstract
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 hydrolytic resistance (HR) according USP <660> or EP 3.2.1 so called �low EP� vials or vials with compressed HR. Yet more recent research activities have shown that the �low EP� approach is limited to specific conditions, and that a review of these activities reveals a decision to fully abandon this route. Today, the manufacturing-related mechanism for delamination is allegedly well understood and broadly accepted in the pharmaceutical industry. Experts argue that strategies to minimize the manufacturing-related risk for glass delamination need to focus on avoiding changes in chemical durability in the inner surface of the wall near bottom area. With the results of predictive screening studies serving as benchmark, this article highlights various criteria which define delamination resistance and discusses a number of delamination prediction approaches. The results show that the propensity of delamination can be minimized by an automated 100 % control of critical process parameters in combination with a quick test routine adapted to quantify the delamination propensity (Delamination Quicktest).
- Publication
TechnoPharm, 2017, Vol 7, Issue 6, p1547
- ISSN
2191-8341
- Publication type
Trade Publication