Qualipharma can performance the required tests in order to verify the uniformity and stability of temperature of your equipment and therefore identify deviations and defined if they are accepted or not according to the client requirements. To keep the conditions while carrying out the qualifications tests, we use the cable and pipe transit system.
Qualipharma offers qualification services of thermal equipment such as freeze drying, autoclaves, tunnels and sterilization ovens, including the generation of the appropriate documentation and the execution of the qualification.
As part of freeze drying qualifications, Qualipharma has deep experience on monitoring the different lyophilization machine systems, including CIP (Cleaning In Place) and SIP (Sterilization In Place), in order to certify temperature and other essential parameters.
Some of the tests that we carry out in ovens and tunnels of depyrogenation are:
- Empty Chamber/Tunnel Heat Distribution studies with temperature mapping probe at different locations
- Load Chamber/Tunnel Heat Distribution and Penetration studies
- Filter Integrity Testing (HEPA and ULPA)
- Air Velocity
- Particle Count Test
- Measuring instruments KAYE VALIDATOR recommended by FDA
- CFR21 Part 11 compliance
- Detection of deviations and possible reasons
- Documentation for audits procedures