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There are different types of studies recommended to be conducted during development of the product packaging system and to support filling and final assembly operations.
The purpose of this information is to enable recommendations and provide evidence for the types of the components that can be matched, quality of seal and container closure integrity.
Each component material, with its critical dimensional tolerances, directly affects the intended integrity of the final packaged product. Assurance of package integrity originates from the use of appropriate materials, accurate and optimum closing properties, matching dimensional fit and consistent control of processes used to assemble the closed package.
During the drug product development phase a rigorous set of data is needed to provide evidence that the container closure system will be fit for use. A combination of different variables and components should be considered; for example, different component configurations, glass configurations, components that have been coated, washed and sterilized.
The process for evaluating vials and elastomeric closures can show suitability of a system for use. Initial assessments can be conducted to identify systems that serve as optimal candidates for model test systems along with negative and positive controls.
Seal quality can be determined from an initial dimensional exercises along with container closure integrity for the i) presence of a leak, ii) the potential for microbial ingress, iii) package leak rate and iv) seal integrity vs. time. Data will show evidence of system fit, acceptable capping pressure and allowable leak rate.
Manufacturers of elastomeric closures for parenteral packaging systems can support the pharmaceutical industry in complying with the responsibility of ensuring that CCI is maintained throughout the shelf life of a drug. Through the use of different test approaches when selecting the components to use, to the testing of the components on the drug products, a partnership with packaging manufacturers can help pharmaceutical companies select and test proper components for their drug products.