Sterilization Processes & Technologies

There is no single sterilization process that is suitable for all medical products. The diversity in sterilization processes—and of operating systems within each process - has arisen as a consequence of the efforts made to optimize medical sterilization and to meet the differing needs imposed by the vast range of products to be sterilized.

Traditional Processes

The sterilization processes that have traditionally been used for medical products include steam, ethylene oxide (EtO), ionizing radiation (gamma or E-beam), low-temperature steam and formaldehyde, and dry heat (hot air). These methods can be divided into three categories, based on the nature of the sterilant and its reaction with microorganisms: physical processes (ionizing radiation, dry heat); physicochemical processes (steam, steam/formaldehyde); and chemical processes (EtO, glutaraldehyde).

 New Processes

What do we mean by a new sterilization process? New is often a marketing description for the latest outcome in a gradual development and refinement of an existing process. Continued development or refinement in one area allows, and sometimes requires, development in another. This advance may be driven by the product, the sterilization process, the packaging, economics, or other external forces.

Over the past two or three years, the development of the art of sterilization seems to have accelerated, with the introduction of several new processes. At least one reason for this is the potential decline in the use of EtO in hospitals. This is a result both of increased concern over the toxicity of residuals and of the need to eliminate the use of chlorofluorocarbons (CFCs), which had previously been employed to minimize the flammability and explosion risks of the EtO. Another prominent trend is the proliferation of various minimally invasive therapies, and the need for appropriate sterilization protocols for the equipment used in these procedures.  

Disclaimer

The content of this issue is presented for general information only as perceived by the writer of the article. Reader should independently verify the correctness and accuracy of the material before using the same for any purpose whatsoever. The Company or Management or Staff of Puneet Industries or the Writer shall not be responsible for any inaccuracy or error in the article. 

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