Sterilization Cycle Study of Medical Device

Project Description

Microbiology Laboratory needed for the following Sterilization Cycle Study of a Medical Device according to EN 13060 Small steam sterilizers and ISO 14937 Sterilization of health care products ? General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

. Sterilization cycle with the sterilizer chamber empty.
Place the inoculated carrier into the helix challenge device.
Close and seal the device. Wrap the device in a sheet of textile.
Check that the plateau period time does not exceed the specified response time of the biological indicator.
If necessary, adjust the plateau period.
Place the helix challenge device into the usable chamber space according to the user instructions provided with the sterilizer, using the sterilizer furniture. Immediately start the sterilization cycle.
At the end of the sterilization cycle remove the process challenge device from the chamber.
Remove the inoculated carrier from the helix challenge device.
Incubate the sterilized inoculated carrier and the positive control non-sterilized indicator according to EN ISO 11138-3.
After the incubation time, check for growth and report results. (the results are to be reported as Pass/Fail, based on pH color change in the growth medium, not quantitatively).