(Treffer aus pharmind, Nr. 05, Seite 727 (2019))
Assessing and Navigating Testing for Parenteral Packaging and Delivery Systems / Riter • Parenteral Packaging and Delivery · Riter J · West Pharmaceutical Services, Inc., Exton, USA
As combination products evolve, new and complex interactions among packaging components and delivery systems have arisen. For pharmaceutical manufacturers, it is critical to understand the compatibility and performance of the primary packaging system with both the drug product and the delivery systems for successful development of the drug product. Applying a systematic approach and strategy for component and system qualification is critical to ensure drug product quality, safety and efficacy. Understanding the physical, functional, and chemical compatibility of these components and systems requires assessment of several key areas during development, namely: extractables and leachables, container closure integrity (CCI), performance and ...