Installation Qualification (IQ): Documented verification and confirmation that installed or modified equipment or systems comply with the approved design, manufacturer’s recommendations, or user requirements.
Operational Qualification (OQ): Documented verification and confirmation that the installed or modified equipment and systems operate correctly within the entire range of anticipated operational conditions.
Process Qualification (PQ): Documented verification and confirmation that the equipment and supporting systems, integrated into a functional whole, can operate effectively and consistently according to the approved process method and specifications.
NOTICE OF THE MINISTER OF HEALTH of October 17, 2013
As part of the qualification procedure, we perform measurements for the following devices:
-
autoclaves
- climatic chambers
- incubators
- heating cabinets
- drying ovens
- sterilizers
- refrigerators
- cooling units
- freezers
Qualification Procedures IQ, OQ, PQ Qualification (Validation):
- Thermostatic and climatic chambers in the temperature range of -80…+200°C and relative humidity range of 10…+90%,
- High-temperature furnaces in the temperature range of 100…+1100°C
- Operational and Performance Qualification (OQ, PQ) of autoclaves up to 140°C
Location of procedures: at the User’s location