There are many guidance documents and regulations that govern container closure integrity systems. While, secondary packaging components are those components that are vital to ensure correct package assembly, such as aluminum caps over stoppers (USP ). Primary packaging components are those components that come into direct contact with the product, such as a glass vial or syringe. et al., 2015).Ĭontainer closure systems consist of primary packaging components and secondary packaging components (USP ). Container closure systems should maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life (Ewan, S. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP ). OverviewĬontainer Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. This article describes recent changes to the United States Pharmacopeia (USP), guidance documents, regulatory observations, common container closure methods, and provides recommendations on developing and validating a compliant container closure integrity test. Understanding container closure integrity systems, reviewing past observations, and following the regulations and guidance documents are excellent ways to establish a compliant container closure integrity assay.
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