FDA/ICH Stability Test Chambers

Thermolab stability chambers provide our customers with guaranteed temperature and humidity control that exceeds FDA/ICH guidelines for long-term, intermediate, and accelerated stability testing.

All stability chambers are designed for standard Q1A stability testing from 25°C to 40°C and from 60% to 75% RH. Extended temperature and humidity ranges are available upon request.

The new “Thermo” touchscreen interface is now available on all of our ICH stability chamber models, providing exceptional user-friendly operation with integrated secure datalogging and remote operation capability.

All Thermolab stability test chambers feature integrated microprocessor-based PID controls with AutoTune functionality, providing temperature control (at sensor) of ±0.2°C and humidity control of ±2.0% RH or better, making them ideal for FDA regulated studies. High-efficiency commutated fan motors, shallow evaporative system, and a 3/4 length rear wall plenum ensure positive airflow throughout the stability chamber, achieving temperature uniformity of ±2°C and humidity uniformity of ±3%.

Thermolab FDA/ICH stability chambers are also environmentally friendly, incorporating energy-saving design features and high-efficiency components without sacrificing performance. Our stability test chambers incorporate high-efficiency commutated fan motors, shallow evaporative vapor generation, CFC-free refrigerant, and automatic shutoff of refrigeration units at above ambient temperature setpoints.

Each of our stability chambers comes with validation guarantee that the chamber is validatable to FDA/ICH standards. All stability chambers are subjected to a minimum 24-hour factory test and comes with a complimentary IQ/OQ validation packet, sensor verification certificate, and preliminary temperature/humidity mapping report conducted with the Imported calibrators.

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