Carrying out the different qualification phases (IQ, OQ y PQ) allows us to confirm that our equipment is working correctly. Qualipharma performs this thermal equipment qualification to ensure the equipment is properly installed according to the manufacturer’s specifications and your internal procedures. As part of qualification, Qualipharma calibrates control and registration instruments and implement temperature mappings. Different tests can be included upon request, such as power failure, door opening, etc.
Any thermal equipment which is part of your critical process is subject to certification and therefore the required tests must be implemented.
This qualification can be applied to all the thermal equipment, from conservation equipment such as deep freezers, freezers, and cold or stability chambers to the sterilization equipment such as autoclaves, sterilizers, tunnels or sterilization ovens.
Once your thermal equipment has gone through this qualification process, you can rest assured that you know its actual state.
We are specialists in:
Thermal mapping of autoclaves.
Thermal mapping of freeze-dryers, sterilization ovens and tunnels.
Mapping of equipment with controlled temperature: vacuum ovens, dehydrators and incubators, fridges, freezers and deep freezers.
Thermal mapping of warehouses and transports.
In each case, we develop controlled cycles of the equipment parameters (humidity, pressure, CO2) and carry out the key OQ and PQ tests such as opening of doors, power cuts, alarm triggers, etc…
- Complete support including the OQ and PQ tests execution
- Comprehensive project management
- Direct contact with your suppliers to improve documentation
- On-site or external implementation
- The only supplier for your thermal equipment qualification
- Control equipment that conforms to CFR21 section 11