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Product and Package Stability Studies: The Application of FDA Guidance

来源: | 作者:pmo90dc87 | 发布时间 :2018-08-15 | 2403 次浏览: | 分享到:
The United States Food and Drug Administration provides guidance on physical tests to employ to demonstrate that packaging maintains the sterility of products throughout their shelf life. This article discusses what this means in practice for medical device manufacturers.
M. TUrNEr,
MEDicAl ENGiNEEriNG
TEchNoloGiES lTD,
FolkESToNE, Uk
The challenge The United States Food and Drug Administration (FDA) expects “products labelled as sterile to be free of viable microbial contamination” throughout their shelf life.1 A major role of packaging is to maintain this sterility during shipping and storage. The challenge is in demonstrating this and it is not an easy task. Microbial contamination in a pack may be impossible to detect visually and the majority of the tests (physical and microbial) that are available for assessing pack quality are destructive. Furthermore, if a product has a claimed shelf life of five years, it is not commercially viable to wait for the full period before testing. Therefore, validation techniques are used to ensure that the packs are robust and the production processes reliable.2 Validation depends on establishing the pack performance during the “design outputs” phase of a project, followed by regular quality analysis (QA) and process monitoring on validated equipment to ensure that this performance is maintained. The obvious way to check for sterility is to open a pack and perform a microbiological  analysis of the contents. But this is an attempt to demonstrate a negative. Proving that something is not there is not easy in practice. Testing for sterility can produce false negatives and false positives. False negatives result from the possibility that although there may be a fault in the pack, the viable organism in the selected culture medium has not entered the pack. To overcome this, the outside of the pack can be sprayed with an aerosol (or dust) that contains known microbes and then the contents of the pack analysed for those known organisms. However, this presents a different problem. It is extremely difficult to access the pack contents without contaminating them, even if the outside of the pack is treated chemically following exposure and prior to opening. This method increases the likelihood of false positives caused by the transfer of microbes to the product when the pack is opened. The FDA guidance document discussed here, “Container and Closure  System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability  Protocol for Sterile Products”1 helps to address this challenge by accepting physical testing in place of sterility testing.