Sterilisation Validation for Cleaning and Sterilisation Processes

Thermal validation of sterilisation processes and controlled storage

Agidens Life Sciences has the experience and knowledge to support you in the validation of both thermal processes (e.g. stream sterilisation, dry heat sterilisation, ...) and controlled thermal units (from refrigerators to storage warehouses).

Thermal validation of your disinfection and sterilisation processes

We check the correct operation of autoclaves in comparison with international regulations and standards (ISO-EN- 17665-1, EN-285, ISO-EN-15883). The following services are included:
  • 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 Agidens 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
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).

Thermal validation test equipment is fully validated and calibrated to NIST traceable standards.

Our customers return to Agidens again and again because of:
  • Our technical knowledge
  • Flexibility, commitment and professionalism of our consultants
  • Our support in finding solutions together with our customers

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