Our department of Thermal Equipment Services is specialist in the qualification and validation of autoclaves and other devices.
In order to guarantee the sterilization process, Qualipharma carries out the following tests:
- Bowie-Dick Test
- Vacuum Test (Tightness Test)
- Empty Chamber Heat Distribution (Temperature Mappings)
- Loaded Chamber Heat Distribution and Penetration
- Estimation of the F0 Value achieved during the sterilization hold period
Qualipharma carries out autoclaves validation including the calibration of temperature sensors and the execution of temperature mappings according to our client’s needs.
Thanks to our data acquisition systems, we can validate steam and formaldehyde sterilizers, hydrogen peroxide, ethylene oxide sterilizers and washing machines.
- Measuring instruments KAYE VALIDATOR, recommended by FDA
- CFR21 Part 11 compliance
- Detection of deviations and possible reasons
- Documentation for audits procedures