Evidencia GmbH services

A sterilization process for a defined product has to be requalified periodically. The intervals at which requalification is carried out is determined on the basis of your risk assessment and must, if required, be justified to the monitoring authorities.

Apart from the physical measurements we carry out during the performance qualification, we can also provide a direct proof required by several guidelines that the SAL (Sterility Assurance Level) aimed for/required has been reached which enables a correlation to be evaluated between the microbiological kill rate and the predicted microbiological kill rate derived from the temperature loading.

As the operator of a facility you would like to, or rather you must, prove the process safety and sterility of your products or laboratory waste at every location within the usable space of your facility.

Process safety and sterility of your products or laboratory waste at every location within the usable space of your facility. Before you can provide this proof, however, you will need to know which parts of your load within the usable space are particularly difficult to sterilize. For example, gas release from waste products, fluctuating quality of steam, the type of steam generation, the ventilation of the facility and the intake of steam into the usable space can greatly affect the results obtained.

A successful sterilization kills microorganisms or destroys infectious proteins, viruses etc. A sterilization process enables the sterilization probability to be increased almost at will. 0 microbes/part cannot however be reached.