Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

2011 ◽  
2020 ◽  
Vol 54 (s1) ◽  
pp. 23-30
Author(s):  
Brian McEvoy ◽  
Hervé Michel ◽  
Daniel Howell ◽  
Philip Roxby

Abstract Following years of discussion and debate regarding the economics of X-ray radiation for sterilization of healthcare products, the benefits of the technology are now being realized. X-ray, like gamma radiation, is a process whereby energic photons penetrate to sterilize medical devices. Compared to gamma, photons in the bremsstrahlung spectrum from X-ray radiation allow for improved dose uniformity ratio, higher dose rates, and shorter process time, which provide additional opportunities for sterilization process enhancement. Such improvements may be realized in a number of ways: 1) economic, where more products may be processed on a carrier; 2) improved dose range fit; and/or 3) wider material compatibility. Despite noted benefits, X-ray sterilization has not yet been widely accepted and currently accounts for less than 5% of the contract sterilization market. This article brings X-ray sterilization into focus by sharing knowledge and experience gained over the past 10 years at the STERIS Däniken site, with an aim to identify opportunities for future medical device sterilization.


2019 ◽  
Vol 42 (5) ◽  
pp. 386-398 ◽  
Author(s):  
Sandy A. Thill ◽  
Marc Spaltenstein

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