Secondary packaging component

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... 

Secondary Packaging Component A packaging component that is not and will not be in direct contact with the dosage form. 

A primary packaging component is one that is or may be in direct contact with the dosage form. A secondary packaging component is one that is not and will not be in direct contact with the dosage form [4],... 

Secondary packaging components are not intended to make contact with the dosage form. Examples are cartons, which are generally constructed of paper or plastic, and overwraps, fabricated from a single layer of plastic or from a laminate made of metal foil, plastic, and/or paper. In special cases, secondary packaging components provide some additional measure of protection to the drug product. In such cases it could be considered a potential source of contamination and the safety of the raw materials should be taken into consideration. 

Migrants from secondary packaging components, such as inks and label adhesives. 

Chemical entities from the storage environment (i.e., very secondary packaging components), such as volatiles from cardboard shipping containers or plastic storage bags. 

Although the types of test procedure will broadly continue to follow the stages identified in this and other chapters, the ultimate intensity of the procedure must be related to (and vary with) the type of product and the route by which it is administered etc. The use of a declared food grade plastic is usually the minimum standard that would be used for a pharmaceutical product, either for a secondary packaging component or where extraction between product (solid items) and the plastic may seem unlikely. Reference to toy regulations may also provide useful information, especially where coloured materials are employed. 

The primary and secondary aluminum industry produces ingots of pure (greater than 99%) aluminum that serve as feedstock for other materials and processes. Within the U.S., the leading end-users of aluminum come from three industries containers and packaging, transportation, and building and construction. Examples of materials produced with aluminum are sheet metal aluminum plate and foil rod, bar, and wire beverage cans automobiles aircraft components and window/door frames. 

The sections below review the coordination chemistry of the most important classes of extractants used commercially. Particular attention is paid to the importance of secondary bonding between extractant components. This facilitates the assembly of ligating packages which match the coordination requirements of particular metal cations or their complexes and enhances both the selectivity and strength of extraction. Flydrogen bonding between ligands—e.g., esters of phosphorus(V) acids (see Section 9.17.4.3)—is particularly prevalent in the hydrocarbon solvents commonly used in industrial processes. 

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