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 Life Sciences also helps 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. 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).
With patient safety in mind, it’s recommended that temperature mappings are consistently repeated on a regular basis. By no means a sinecure, but our Senior GxP Compliance Engineers are happy to advise and assist you.