White paper “Sterilization of medical devices: Validation of radiation sterilization”

For many medical devices such as implants, dressings, surgical material, and laboratory diagnostic products, sterility is a mandatory requirement for marketing and safe use on patients.

Attributable to the special technology as well as due to the expense for the operation of the corresponding facilities, sterilization processes are generally outsourced to specialized service providers. Overall, a trend towards radiation sterilization has become apparent in Germany in the past years. Sterilization is carried out particularly frequently using gamma rays and increasingly also beta rays. As with all sterilization methods, the steps necessary to validate radiation sterilization are complex and often associated with numerous questions on the part of the manufacturer.

Therefore: request our whitepaper free of charge now and learn

• how sterilization with beta and gamma rays functions,
• which benefits the method offers and where its limits are set,
• which validation steps are necessary in detail and how they are carried out,
• what to do if the product is to be validated for a second facility, and
• what to consider when switching from another method of sterilization to radiation sterilization.