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Surface Hydrolytic Resistance Test or Delamination Quicktest
What are the Correct Criteria for Assessing the Risk of Glass Delamination?
Analytik
Introduction
Influencing Factors for Glass Delamination According to USP <1660>
How to Validate a Vial Manufacturing Process for Minimizing the Delamination Propensity
Principles of Tubular Vial Manufacturing with Minimized Delamination Propensity
Results of Predictive Screening Studies According to USP <1660> for Proof of Concept
Arguments against the Use of the Surface Hydrolytic Resistance Test Minimizing the Manufacturing-related Glass Delamination Propensity
Conclusion
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Influencing Factors for Glass Delamination According to USP <1660>
How to Validate a Vial Manufacturing Process for Minimizing the Delamination Propensity
Principles of Tubular Vial Manufacturing with Minimized Delamination Propensity
Results of Predictive Screening Studies According to USP <1660> for Proof of Concept
Arguments against the Use of the Surface Hydrolytic Resistance Test Minimizing the Manufacturing-related Glass Delamination Propensity
Conclusion
Anzeigen
Dr. Bernhard Hladik and Prof. Volker Rupertus · SCHOTT Pharmaceutical Systems, Mainz
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 (...)
