REQUALIFICATION

Periodic requalification is recommended to verify correct functioning at regular intervals and ensure functional and process safety. The time interval for requalification is determined based on your risk assessment and may need to be justified to supervisory authorities.

In some cases, specific intervals for requalification are prescribed. As an example, ISO/TS 17665-2 (EN ISO 17665-1 and IFS Food 6) require for autoclaves that “routine reevaluation of performance should be carried out annually.

Requalification can be combined with the necessary recurring calibration of the device sensors in coordination with the device manufacturer. Requalification may also be necessary when certain changes are made to the device. Examples include:

• Changes to device parameters (e.g., changing sterilization temperature and/or time for an autoclave)
• Changes to loading configuration
• Changes to packaging for packaged goods
• Repairs to the device and replacement of components
• Updates to device software

Any change must be assessed for its impact on process functionality and safety and may require requalification.

We are happy to provide you with advice on this topic and conduct the requalification of your device for you.