药物分析学报

抽象的

Basic Considerations for Container Closure Selection of Parenteral Drug Products

Lakshmi Prasanna Kolluru

By definition, container closure system encompasses all components of the packaging system that hold and protect the drug product. It includes primary packaging system (components with which the drug product comes in direct contact) and secondary packaging system (components that offer additional protection to the system but do not come in direct contact with the drug product). This article focuses on primary packaging components as they have a significant effect on the critical quality attributes of the drug product throughout the product shelf-life. Selection of an appropriate container closure system for a parenteral drug product is of utmost importance as Food and Drug Administration (FDA) classified that the probability of interaction of the drug product with the packaging component is high and the risks associated from such interactions are highest for injections administered via parenteral route [1]. Impeachment of container closure integrity leads to compromised sterility of the drug product system, which in turn is one of the major reasons for FDA drug product recalls in 2016 [2].