Stability/photostability walk-in test chambers and rooms for
New active substances, medical products and similar applications
Key specifications and features
Working space from 2 m2 up to 1,000 m2
Temperature range 10~65 °C and humidity range 40~95 %RH, with stability up to
±0.2 °C and ±3 %RH
Full range of features to support ICH Q1A (R2) Guidelines for temperature testing, humidity testing, accelerated testing and long-term testing
Choose between geothermal energy refrigerated heat pump system and forced-air condensing system as applicable
Available with terminals of radiant heating and cooling by water-carrying capillary tube mats and ducted air heat exchanger where applicable
Patented stepper valve hot gas by-passing and dynamic temperature and humidity control for stability up to ±0.1 °C and
±2.0 %RH
Humidifier of non-condensing instant evaporating with automatic level control and low level protection
7 in high resolution true color TFT touch screen for data input for equipment opera-tion, programming data of temperature, humidity, alarm history and operating status, in text, graphic symbols and curves
Record and alarm system to meet require-ments of GMP, cGMP, GLP & GSP including alarm and alert through email and SMS
Available with documentation for IQ, OQ and PQ, certificates for calibration and materials, manuals for installation, operation, maintenance and service and, drawings for wiring, refrigerating and construction
Options for power backup, standby refrigerating and humidifying system
Options for lower temperature as low as
6 °C and minimum humidity down to
20 %RH
Options for visual daylight exposure and UVA exposure light canopies and, accumulative exposure measurement and control to meet requirements of ICH Q1B
Options for data transmitters, data acqui-ring & logging system and software kit for download & analysis of data, electronic signature & record, audit and administra-tion compliance to FDA 21 CFR Part 11
Options for fresh air intake and ventilating, low and medium efficiency filters
Options for racks, shelves and trays, water supply kit, water purifying kit, draining pump kit, interface of USB and EtherNet