Primary packaging components

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. 

Identification of the materials of construction (i.e., plastics, paper, metal, glass, elastomers, coatings, adhesives, and other such materials) should be identified by a specific product designation (code name and/or code number) and the source (name of the manufacturer) alternate materials of construction should be indicated postconsumer recycled plastic should not be used in the manufacture of a primary packaging component, and if it is used for a secondary or associated component, then the safety and compatibility of the material for its intended use should be addressed appropriately... 

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. 

For liquid (e.g., solution, suspension, elixir) and semisolid (e.g., creams, ointments) dosage forms, a change to or in polymeric materials (e.g., plastic, rubber) of primary packaging components, when the composition of the component as changed has never been used in a CDER-approved product of the same dosage form and same route of administration. For example, a polymeric material that has been used in a CDER-approved topical ointment would not be considered CDER-ap-proved for use with an ophthalmic oinhnent. 

A change in the primary packaging components for any product when the primary packaging components control the dose delivered to the patient (e.g., the valve or actuator of a metered-dose inhaler). 

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] ... 

The production of sterile products is profoundly impacted both by formulation and the selection of primary packaging components. Design parameters for a facility and selection of appropriate manufacturing technologies for the product require that the formulation process and packaging components be chosen and evaluated in advance. 

Desiccants or other absorbent materials are primary packaging component. The components should differ in shape and/or size from the tablets or capsules with which they are packaged. Their composition should be provided and their inertness should be proved through appropriate tests, and acceptance criteria should be established. 

Primary Packaging Components, which are or may be in direct contact with the dosage form. These include containers (e.g., ampules, vials, and bottles), container liners, closures (e.g., screw caps, stoppers, and metering valves), closure liners, stopper overseals, container inner seals, administration ports, overwraps, etc. 

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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