| abstract |
This invention provides a process of sterilizing a medical device, and preferably the contents of a sealed container which comprises said medical device, comprising the step of exposing said medical device to monochromatic ultraviolet radiation whereby the D value of Bacillus stearothermophilus (ATCC 7953) is at least 23.7 mJ/cm 2 monochromatic ultraviolet radiation at 257 nm to the spore. Further, this invention provides a process of sterilizing a medical device comprising the step of subjecting said medical device to monochromatic ultraviolet radiation wherein the minimum total energy density of said monochromatic ultraviolet radiation at 257 nm which reaches the microorganisms present on said medical device is at least 284 mJ/cm 2 . n This invention further provides an apparatus for delivering UV radiation to a medical device for sterilization comprising a laser and a scanner for the laser such that at least 284 mJ/cm 2 at 257 nm is applied to a treatment area for said medical device. This invention provides a process and apparatus in which sterilization can be achieved in less than 20 seconds, preferably less than 15 seconds, more preferably in less than 5 seconds. The process and apparatus are efficient and continuous. |