Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

2019 ◽  
Author(s):  
Ravi Vital Kandisa

Advancement in technology made the medical device manufacturing industry prominent among all the industrial sectors. Most health care products and medical devices require sterilization. Due to the heat sensitivity of the medical devices, Ethylene Oxide (ETO) sterilization is recommended but ETO is an expensive and long process. Now, there is a need to find an efficient, minimal cost and a lesser amount of time for sterilization process. In this present study, we developed and validated a minimum time, low cost, and efficient ETO sterilization process that can be used at an Industrial scale.


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