Sterilization is a process that is mandatory for the majority of medical devices quite often required by regulatory authorities.
Medical device sterilization process.
Medical devices made.
If review of the device history records including process control and monitoring records acceptance activity records etc reveals that the sterilization process is outside the firm s tolerance.
The materials and techniques used for packaging must allow the sterilant to contact the device during the sterilization process as well as to protect the device from contamination during storage and handling before it is used.
For many medical devices sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process.
It is a process to make the product free from bacteria and any other microorganism that cannot be eliminated by regular cleaning processes.
Atrophaeus spores 10 6 are used to monitor eto and dry heat and g.
Eto gamma steam shelf life validation 275 00 255 00 this live webinar course will provides guidance on medical device sterilization processes.
While eto is a very effective sterilant cd has many benefits over eto for a variety of applications.
Medical device sterilization chlorine dioxide gas clo 2 cd has been providing true sterilization similar to eto for medical devices for over 25 years.
Spores used to monitor a sterilization process have demonstrated resistance to the sterilizing agent and are more resistant than the bioburden found on medical devices 179 911 912.
However since 1950 there has been an increase in medical devices and instruments made of materials e g plastics that require low temperature sterilization.
Power ranges above 35 kw are available but are seldom used in medical device sterilization applications because of the difficulty of precision control at such high process rates for additional information and a comparison of current stand alone system design alternatives please refer to page 29 of medical plastics and biomaterials july august.
Medical device sterilization process.
Stearothermophilus spores 10 5 are used to monitor steam sterilization hydrogen.
For many medical devices sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process.