In many countries there are legal requirements for autoclave validation. Autoclave validation / qualification is mandatory in FDA, WHO and EU controlled areas. Main purpose of autoclave validation is to show the success of the sterilization process.
With autoclave validation we provide the following information:
- Choosing the correct validation cycle
- Choosing the correct load configuration
- Demonstrating the worst case load and determining the cold points
- Determining the acceptance criteria
- Documantation of the protocol
We carry out our tests according to EN 285 and ISO 17665-1 standards.