BioCold Environmental

FDA/ICH Stability Rooms

Stability testing today represents a growing segment of the environmental room market, as regulatory requirements in pharmaceutical, nutritional supplements and cosmetic manufacturing mandate accelerated, intermediate, and long-term stability testing.

stability roomAt BioCold we have developed our stability rooms specifically to meet FDA/ICH stability requirements, providing exceptional control and uniformity of both temperature and humidity for rooms from 100 to 1,000 sq. ft. Multiple, independent zone controls gives us the ability to maintain precise control of 0.3°C or better throughout large areas. Our center-mount, low velocity air handler provides an "umbrella airflow" pattern which envelopes the room with conditioned air, providing maximum uniformity (1.0°C or better) without the need for lay-in ceiling tiles which are difficult to clean and represent a prime location for mold and spore growth over time.

All stability rooms are equipped with precision 100 ohm, 3-wire platinum RTD (Band 5) temperature sensors and thin-film polymer capacity humidity sensors with hermetically sealed microprocessor transmitters, representing the latest in sensor technology.

Principles of Operation

stability roomsBalanced against a small refrigeration load, resistive heaters are finitely pulsed with a PID controller to maintain precise temperature control even at near-ambient temperatures, while maximizing energy efficiency. Humidification works on a similar principle: While the evaporator coil provides a small, but constant, dehumidification effect, ultrasonic transducers pulse water vapor back into the room for finite control. BioCold rooms do not use steam boilers, which are subject to corrosion over time, represent a high energy load, and introduce and independent and uncontrolled heat source within the room, disrupting uniformity performance.

Contact BioCold at (636) 349-0300 for more information or to discuss options and pricing.