Packaging Systems Components

Injectable Drug Delivery Systems Components Plastic Packaging Systems Components Elastomer Metal Components... 

Compatibility (for each component and/or the packaging system) component/dosage form interaction (USP methods are typically accepted), may also be addressed in... 

Available sizes range from shelf areas of 0.4 to 67 m" (4 to 726 ft"). These are available in several manufacturers standards, either as system components or with arrxihary gear as packaged systems. 

Container Closure System — The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system. 

A packaging system found acceptable for one drug product is not automatically assumed to be appropriate for another. Each application should contain enough information to show that each proposed container closure system and its components are suitable for its intended use. 

The quality control procedures of the manufacturer of a packaging component may sometimes rely in whole or in part on the quality control procedures of a manufacturer who makes an intermediate packaging component that is used to create the component. If so, each contributor to the final packaging system should provide a description of the quality control measures used to maintain consistency in the physical and chemical characteristics of the separate components and of the assembled packaging system that they provide. 

A typical container closure system is a plastic (usually HDPE) bottle with a screw-on or snap-off closure and a flexible packaging system, such as a pouch or a blister package. A typical closure consists of a cap — often with a liner — frequently with an inner seal. If used, fillers, desiccants, and other absorbent materials are considered primary packaging components. 

Chapter 3 describes the container closure systems again, this discussion would apply to all dosage forms. It is noteworthy that the regulatory agencies consider containers and packaging systems, all those components that... 

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