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包装容器密封完整性检测参考文献

Evaluating Pharmaceutical Container Closure Systems

来源: | 作者:pmo90dc87 | 发布时间 :2018-08-16 | 2664 次浏览: | 分享到:
The use of qualitative and quantitative methods can help packaging professionals determine the presence of extractables and leachables.
David E. Albert, NAMSA (Northwood, OH)
The United States Pharmacopeia (USP) and FDA have been and continue to be the driving force behind the safety evaluation of materials and container closure systems in the United States. An important step in such evaluations is characterizing the materials and the chemicals that can migrate or extract from container closure system components to the drug product. Figure 1 shows the various types of chemicals that can migrate from polymeric materials1. Such basic information is critical to understanding the biological safety and suitability of a container. A number of tests can be used to establish initial qualification of the container closure system, and a quality control plan can help ensure compatibility and safety.

Background
 
Establishing the safety of container closure systems is of key importance to the medical and pharmaceutical industries. It is no less important than the contents themselves. FDA�s guidance document, �Container Closures System for Packaging Human Drugs and Biologics,� makes this point clear2. This document, which stands as the latest reference evaluating drug product packaging materials, is the primary governing standard. Understanding the principles presented is imperative, and implementing them is an essential part of establishing product safety. This paper defines what the document requires and what qualitative and quantitative tests can be used to satisfy the requirements with an emphasis on leachable and extractable chemicals to satisfy compatibility and safety.