FDA/ICH Stability Examination Spaces

BioCold stableness compartments offer our customers with certain humidity and temperature control that exceeds FDA/ICH guidelines regarding long-term, advanced, and also faster stableness screening.

Almost all balance spaces are equipped for regular Q1A balance tests through 25°C to 40°C and from 60% in order to 75% RH. Lengthy temperature and humidity ranges can be found upon request.

The newest BioLogic™ touchscreen display software is now available on all of our ICH stability step designs, providing outstanding user-friendly operation along with integrated safe datalogging as well as distant Biotech corp operation ability.

Just about all BioCold stableness test spaces feature incorporated microprocessor-based PID regulates with AutoTune features, providing temperature control (at sensor) of ±0.2°C and humidity control of ±1.0% RH or even better, which makes them well suited for Food and drug administration governed studies. High-efficiency commutated lover engines, watery vapor submission plenum, plus a 3/4 duration raise wall structure plenum make sure optimistic ventilation throughout the balance step, reaching heat uniformity regarding ±0.8°C and also humidity steadiness regarding ±2%.

BioCold FDA/ICH balance chambers are also eco-friendly, including energy-saving layout features as well as high-efficiency parts with out sacrificing performance. The stability examination spaces incorporate high-efficiency commutated lover motors, ultrasound watery vapor era, higher denseness CFC-free urethane padding, as well as computerized shut off associated with thermoelectric cooling models at previously mentioned normal heat setpoints.

Much of our balance spaces has a 100% money-back approval be certain that the actual chamber will be validatable in order to FDA/ICH standards. All stability compartments are usually exposed to the very least 24-hour factory test and includes a complimentary IQ/OQ affirmation box, sensor confirmation document, as well as original temperature/humidity maps statement conducted using the Kaye Valprobe wireless affirmation method.


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