Definition: Comprehensive study to document temperature distribution within refrigerated space (cold room, vehicle) under defined operating conditions. Required for GDP qualification.
Process:
- Place calibrated data loggers at minimum 9 strategic locations
- Record temperatures for minimum 24-48 hours (typically 72 hours)
- Conduct under empty, partially loaded, and fully loaded conditions
- Simulate worst-case scenarios (door openings, maximum ambient temperature)
- Identify hotspots (warmest) and cold spots (coldest)
- Determine maximum safe setpoint that keeps all locations within +2°C to +8°C
- Document findings in validation report
Frequency:
- Initial qualification (before use)
- Annually (routine requalification)
- After equipment modifications or repairs
- When investigating temperature excursions
Equipment:
- Minimum 9 SANAS-calibrated data loggers
- Record every 5-15 minutes
- ±0.5°C accuracy
Cost: R15,000-50,000 depending on space size and complexity
Related Terms: GDP, IQ/OQ/PQ, Validation, Temperature Gradient
Find Services: Temperature mapping and pharmaceutical validation specialists