Achieving the absence of viable microorganisms on Medical Devices is something that the industry has spent much effort on over the years, and various ISO standards are in place that address how to assure the microbiological quality of products to be placed on the market and labelled as ‘sterile’.

Because of the exponential nature of microbial inactivation, the models being used to validate the use of sterilization processes that involve, for example, Ethylene oxide (ISO 11135) or Radiation (ISO 11137), do not guarantee the complete absence of viable microorganisms. Rather, they allow the manufacturer to demonstrate that the probability of a viable microorganism surviving the application of a particular process to a defined device has reached an acceptable level, referred to as the ‘SAL’ (Sterility Assurance Level).

We have been actively involved in the writing, review and application of relevant standards and have trained personnel in both manufacturing companies and Regulatory Authorities in the theory and practice of successful implementation of them.