The term sterilisation is used to describe processes to free materials from living microorganisms as well as their resting stages through various influences, such as physical or chemical effects. This condition is generally referred to as sterile.
The main procedures for sterilising medical devices are:
Heat sterilisation
Radiation sterilisation
Gassing
Various influencing factors play a role in the choice of a suitable process and should be considered comprehensively. These include, for example, the compatibility of the material to be sterilised regarding the chosen sterilisation process, as well as possible risks to the safety and performance of the product. It is very important to validate the chosen sterilisation process, i.e., to make the results reproducible, and to carry out a risk analysis of its effects on the medical device itself as a 100% sterilisation is scientifically not possible and cannot be guaranteed. There will always be a residual risk that remains to be evaluated and diminished to the best of the manufacturer’s knowledge and possibilities.
In the healthcare sector, there are numerous, partly harmonised standards for the implementation of sterilisation procedures. These standards specify the requirements for the development, validation, implementation, and maintenance of the respective sterilisation process as well as associated parameters. Exempels of such standards are:
We have extensive knowledge of the various sterilisation processes that can be used depending on the product and area of application. The variety of possibilities and requirements demands a high degree of detailed knowledge. We will be happy to advise you about the appropriate procedure for your specific requirements. Our experts are on hand to help you select the right sterilisation process and ensure that your products are effectively sterilised.
