Thermal validation of sterilisation processes and controlled storage
The current health economics guidelines require processes to be demonstrably controlled. Whether it is sterilization, disinfection, thermally controlled storage or distribution, microbial cultures, etc., companies and organizations in the life sciences sector must guarantee that processes comply with the required conditions. Agidens offers bespoke solutions for this.
Thermal validation of disinfection and sterilisation processes
We check the correct operation of o.a. autoclaves in comparison with international regulations and standards (ISO-EN- 17665-1, EN-285, ISO-EN-15883).
- Measurement of F0 (steam sterilisation) or A0 (disinfection)
- Cycle optimisation
- Worst case loading patterns
- Wet loads
Is the 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 cold rooms, sites and storage areas
Agidens Life Sciences also helps with thermal validation of cold rooms such as freezers, refrigerators, cryogene tanks. We analyse your systems and areas by execution of temperature mappings and if applicable relative humidity mappings to see whether they meet your acceptance criteria. This is done by means of an independent measurement with calibrated and validated equipment based on a pre-approved protocol. These studies can be carried out on large areas (warehouses) and on refrigerators, freezers (up to -80°C) and transport vessels.
With these studies we can determine the temperature distribution of the system to calculate the most representative and/or worst case locations for your monitoring system and to determine the most suitable locations for storage of time and temperature sensitive pharmaceutical products.
If applicable, open door tests and a power failure test are executed to determine the impact on the system.
Agidens Life Sciences formulates qualification protocols in close consultation. These describe for example what guidelines are used, what tests are included in the qualification, who is responsible for what, and what materials are used.
An Agidens expert will take care of the implementation. Calibrated and validated material is used for this. We have different measuring systems, with a temperature range from -196 °C to 1250 °C. In addition to temperature, other parameters are measured depending on the application (e.g. pressure, volume, mass, relative humidity, etc.). Critical faults are immediately reported to the responsible party for their immediate resolution.
Our report includes the measured data, an analysis of the acceptance criteria per test performed, comments, recommendations, and a conclusion. We discuss the report face-to-face so that we can go through the entire process and explain any comments or recommendations.
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