Parenteral container closure systems are in direct contact with the drug product formulation and can significantly impact the product quality. The interaction between the drug product formulation and the primary packaging components may also impact adequate delivery of the product to the patient. Therefore, primary packaging development should be fully integrated into parenteral drug product development. This book chapter describes the basic function and requirements of a parenteral container closure system, advantages, and challenges with commonly used container closure system materials and components and the key benefits of combination products compared to traditional vial systems.

by Roman Mathaes, Ph.D, Associate Director, Pharmaceutical Services
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