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About Sterilization of Plastics


One of the greatest difficulties with sterilization of medical devices is the range of plastics used in any given device or kit. A simple device or kit may contain up to 10 different plastics for a range of uses, e.g. housings, tubing, connectors, valves, and seals. The plastics used may be chosen for a variety of reasons such as transparency, mechanical strength, or inertness depending on the application. The difficulty is that every plastic behaves in a different manner to the various sterilization methods used. Manufacturers can easily find that the completed device cannot be effectively sterilized. If manufacturers make unwise material choices, then it may be impossible to adequately sterilize the completed device.


The possible sterilization methods therefore need to be considered as an integral and early part of the materials selection process for all medical devices using plastics. An additional complication in the materials selection process is the multiplicity of grades available, even for a nominally identical plastic material. For example, PVC is available in several different major materials families depending on the production method, (e.g. suspension PVC, emulsion PVC and mass polymerized PVC, and in tens of thousands of different grades which will vary according to plasticizers), fillers and other additives.

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