EtO Sterilisation Validation

Sterilisation is an example of a special process because process efficacy cannot be verified by visual inspection of the product. For this reason, sterilisation processes have to be validated before use, the performance of the process monitored routinely and the equipment maintained.  

carries out periodic validation of medical devices and other healthcare products in accordance with the international standard ISO 11135:2014 and guidelines of US FDA or as per the protocol for validation drawn out by customers.