Container closure systems chemical composition

While the tests and methods described in Table 4 allow one to provide data that the container closure system is suitable for its intended use, an application must also describe the quality control (QC) measures that will be used to ensure consistency in the packaging components. The principal considerations for the QC measures are the physical characteristics and the chemical composition. By choosing two or three of the tests done in the initial suitability study, a QC program can be established that will ensure the consistency of the container closure system (Table 4). 

The FDA guidance for industry suggests considering consistency in physical and chemical composition. Using a few simple tests, the quality of components and ultimately the container closure system can be monitored. 

Thus, it is no longer acceptable for the formulator to delay this compatibility testing until later in the development programme. The key message is for the formulator to test early and ensure equivalence of the whole product throughout the development cycle. Leachables are specifically mentioned data on their identity and concentration in the product and placebo are required through the shelf life and also under accelerated stability test conditions. Information should be submitted on source, chemical composition and physical dimensions of the container closure system, together with control and routine extraction tests. Acceptance criteria are also required. 

The stability of finished pharmaceutical products depends, on the one hand, on environmental factors such as ambient temperature, humidity and light, and, on the other, on product-related factors, e.g., the chemical and physical properties of the active substance and of pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the nature of the container-closure system and the properties of the packaging materials. 

An elastomeric closure is a packaging component that is, or may be, in direct contact with a drug product. Elastomer selection for parenteral packaging principally involves consideration of chemical, physical, and biological properties, with emphasis on the stability profile of the drug/container system. Typical elastomeric closure compositions are listed in Tables 1 1. Although certain packaging applications frequently call to mind certain elastomer types, it is not feasible to prescribe specific... 

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