An evaluation of sterilisation processes

Abstract

A sterile environment is one of the basic elements of in vitro cell culture. When choosing an appropriate sterilisation method, the possibility that the physical and chemical properties of the sterilised material could be altered by the sterilisation process itself, should be considered. Avoiding any potential problems of toxicity arising as a consequence of the sterilisation process is essential, not only in in vitro cell culture procedures, but especially in the case of the sterilisation of medical devices which come into contact with human tissue (e.g. catheters, surgical tools, and containers used for transplant preparation and storage). As it is not possible to predict the potential effects of every combination of test material and sterilisation process, we have designed a simple test, which can be easily performed to ensure the absence of cytotoxicity. The test involves the culturing of a non-adherent cell line in direct contact with the test material, in micro-wells attached to the surface of the test device. By using this novel test method, three sterilisation procedures were compared for each material. The results indicated that, neither ionising irradiation nor ethylene oxide left toxic residues on the surface of polystyrene; and that, in the case of steel, neither steam sterilisation nor ethylene oxide left toxic residues on the metal. The cold plasma system, which left toxic residues on the surface of both materials, required a post-sterilisation period of 24 hours in the case of steel, and 10 days in the case of polystyrene, in order to eliminate toxic residues prior to their use.