Sterilisation validation for cleaning and sterilisation processes

Egemin Automation has the experience and knowledge to support you in all your thermal validations of your cleaning and sterilisation processes, and of areas such as cold rooms. We work for hospitals, pharmaceutical and biotechnological companies in Belgium, the Netherlands and Switzerland.

Thermal validation of your processes

We check whether your disinfection and sterilisation programmes meet the European norms or GAMP:

• ISO-EN 17665-1
• EN-285
• ISO-EN-15883
• Measurement of your F0 (steam sterilisation) or A0 (disinfection)
• Cycle optimisation
• Worst case loading patterns
• Wet loads

Is your autoclave properly registered, or do you need an adjustment to be made to your system? We would like to prepare an annual programme for you, to enable you to use your systems practically yet reliably. If desired Egemin Automation will also provide you with protocols and test scripts for your microbiological control measures.

Thermal validation of your cold rooms, sites or storage areas

We can also help with thermal validation of cold rooms such as freezers, refrigerators or even cryogene tanks. We analyse your systems and areas to see whether they meet your acceptance criteria. This is done by means of an independent measurement based on a pre-approved protocol.

By means of power failure and door open/door closed tests we measure how your alarm settings can best be set.

• Worst case loading
• Recovery tests (power failure)
• Large areas
• Cleanrooms
• Freezers (up to -80°C)
• Cryogene tanks (for level alarms)

These studies can be carried out on large areas (warehouses) and on refrigerators, freezers (up to -80°C) and on cryogene tanks (for your level alarms).