In a laboratory setting, temperature-controlled units, such as fridges, freezers, incubators among many, must be qualified. It is necessary to check whether the instrument is suitable for the intended use. The qualification process includes three steps:
1) Installation Qualification (IQ)
2) Operational Qualification (OQ)
3) Performance Qualification (PQ)
Here is a list of what a basic controlled temperature chamber qualification (temperature mapping protocol) should contain:
Installation Qualification (IQ)
- Standard Operating Procedure Verification
- Equipment and Utility Installation Verification
- Documentation and Drawings Verification
- Calibration Status of Critical Instruments
- Test Instrument Calibration Information
Operational Qualification (OQ)
- Operational Controls and Setpoint Verification
- Alarm Verification
- Empty Chamber Temperature Mapping Study
- Additional qualification tests may include (as applicable – often for reference only): Open Door Verification test, Power Loss Temperature test
Performance Qualification (PQ)
- Loaded Chamber Temperature Mapping Study
Mapping is a set of tests used to verify that a temperature-controlled unit is accurate and repeatable. This is essential for ensuring optimal performance. When determining mapping locations, the potential storage location should be considered.
In the Operational Qualification phase, the equipment is tested to ensure it meets the necessary regulatory requirements and is capable of maintaining the required temperature range. This is essentially a "dry run" before the equipment is put into service. Finally, the Performance Qualification stage tests the equipment under real operating conditions, with a full load.
Related: Good Documentation Practice in Commissioning and Qualification
For quality purposes, laboratory equipment such as instruments, refrigerators, and incubators must be qualified. This involves defining the purpose, and evaluating and documenting that the equipment is suitable for the purpose. After successful qualification, mapping is used to verify the accuracy and repeatability of the instrument. This ensures the instrument is functioning optimally.
Read also: Validation, Qualification and Calibration in Pharmaceutical Industry
Resource Person: Filip Kozmer
