Drug packaging materials containers, types

The application (or Type II DMF) should include a detailed description of the complete container closure system for the bulk drug substance as well as a description of the specific container, closure, all liners, inner seal, and desiccant (if any), and a description of the composition of each component. A reference to the appropriate indirect food additive regulation is typically considered sufficient to establish the safety of the materials of construction. The tests, methods, and criteria for the acceptance and release of each packaging component should be provided. Stability studies to establish a retest period for bulk drug substance in the proposed container closure system should be conducted with fillers or desiccant packs in place (if used). Smaller versions that simulate the actual container closure system may be used. 

Paper, paperboard, and cardboard containers are used ubiquitously in pharmaceutical manufacturing. Because these types of containers are rarely designed to interact with the drug product itself, they are not as comprehensively validated in most compendial evaluations. Paper, paperboard, and cardboard are very inexpensive easy to print identification, instructions, or advertising materials and easily adhered to other packaging components. Furthermore, paper is a key component in several designs implemented to comply with tamper-resistant packaging mandates. ... 

Containers used for topical administration include plastics, glass, and metals. Most topical preparations are packaged in plastic jars, metal tubes, glass jars or, in some cases, a combination of these materials. Suitable tests are performed to ensure that drug products do not leach or react with the proposed containers. The various types of topical formulations are discussed in Pharmaceutical Dosage Forms (1151) of the USP/NFP ... 

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