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FDA/ICH Stability Test Chambers

BioCold stability chambers provide their 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 BioLogic™ touchscreen interface is now available on all of their ICH stability chamber models, providing exceptional user-friendly operation with integrated secure datalogging and remote operation capability.

All BioCold 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 ±1.0% RH or better, making them ideal for FDA regulated studies. High-efficiency commutated fan motors, vapor distribution plenum, and a 3/4 length rear wall plenum ensure positive airflow throughout the stability chamber, achieving temperature uniformity of ±0.8°C and humidity uniformity of ±2%.

BioCold FDA/ICH stability chambers are also environmentally friendly, incorporating energy-saving design features and high-efficiency components without sacrificing performance. Their stability test chambers incorporate high-efficiency commutated fan motors, ultrasonic vapor generation, high density CFC-free urethane insulation, and automatic shutoff of thermoelectric refrigeration units at above ambient temperature setpoints.

Each of their stability chambers comes with a 100% money-back validation guarantee that the chamber is validatable to FDA/ICH standards. All stability chambers are subjected to a minimum 24-hour factory test and come with a complimentary IQ/OQ validation packet, sensor verification certificate, and preliminary temperature/humidity mapping report conducted with the Kaye Valprobe wireless validation system.