What are the Benefits of using X-ray for Terminal Sterilization of Medical Devices?
- Cost control – bringing a Rad Source unit in house provides protection against annual price increases, the rising cost of cobalt, and fluctuating transportation costs
- Because it is a form of ionizing radiation it’s effects on materials, packaging, and microorganisms is the same as gamma
- Industry accepted in ISO 11137:2006, EN 552
- Just in Time (JIT) supply chain – Process product when you need it
- Better control of dose delivery – Min/Max ratio of 1.1
How is a Radiation Sterilization Validation performed?
A validation for medical devices sterilized by radiation is governed by ISO 11137:2006. A basic outline of the steps involved in the validation process are below, however it is highly recommended that you speak with a sterilization expert to fully understand the validation process.
The development of new 4 pi X-ray tube technology makes it possible to evaluate the development of new useful plants through the use of ionizing radiation without the high costs and security concerns of nuclear materials or chemicals. Ionizing radiation is needed for asexually propagated materials because chemicals work poorly. Mutating with radiation speeds the development of new clones.