Primary packaging 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. 

When information on a container closure system is submitted in an application, the emphasis would normally be on the primary packaging components. For a secondary packaging component, a brief description will usually suffice unless the component is intended to provide some additional measure of protection to the drug product. In this case, more complete information should be provided, along with data showing that the secondary packaging component actually provides the additional protection. 

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. 

A change in the container closure system of unit dose packaging (e.g., blister packs) for nonsterile solid dosage fonn products, as long as the new package provides the same or better protective properties and any new primary packaging component materials have been used in and been in contact with CDER-approved products of the same type (e.g., solid oral dosage form, rectal suppository). 

Packaging Component Any single part of a container closure system. Primary Packaging Component A packaging component that is or may be in direct contact with the dosage fonn. 

In addition to their use in large-volume parenterals and IV sets, thermoplastic polymers have also recently found utility as packaging materials for ophthalmic solutions and some small-volume parenterals [43], However, there are many potential issues with using these polymers as primary packaging components that are not major concerns with traditional glass container closure systems, including [44] ... 

This chapter introduces the basic aspects of small-volume injectable products—their use, types and primary characteristics of dosage forms, formulation ingredients, and packaging systems. Additional information is available in a variety of reference texts and book chapters. Only conventional SVI... 

Because many steps in lentiviral infection (reverse transcription, nuclear transport, and integration) depend on cellular cofactors (65, 66, 68-70), there may be serious limitations in the use of nonhuman lentiviral vectors in primary human tissues. Replication of lentivimses is highly adapted to their natural host, indicating that cross species variability of cellular factors essential for vims replication, and thus vector transduction, may impair the transduction efficiency of nonhuman lentiviral vectors in human cells. These restrictions may be overcome by the use of chimeric lentiviral vectors. Indeed, cross-packaging of FIVRNAby HIV-1 and SIV packaging systems has been demonstrated, and viral proteins were able to... 

A brief description and discussion of the container closure system for a drug substance is to include the identity of and specification for materials of construction of each primary packaging component. The suitability of each component should be summarized. 

A brief description of a drug product container closure system is to include the identity of materials of construction for each primary packaging component and their specifications. Where appropriate, noncompendial methods and their validation should be summarized. 

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