CLIMATE CHAMBER FOR PHARMACEUTICAL STABILITY TESTS, CM ICH SERIES
The CM ICH series offers precise temperature and humidity control in accordance with ICH Q1A (R2) and US FDA 21 CFR Part 11 for stability testing of drug substances. Qualification (DQ, IQ, OQ, PQ) is carried out by our laboratory, LCIS.
- Volumes: 250, 600 or 1,200 liters
- Temperature range: +10ºC to +50ºC
- Humidity range: 50 % to 90 % relative humidity
- Temperature stability: ± 0.1ºC to ± 0.5ºC
- Temperature uniformity: ±0.5ºC to ±1.5ºC
- Humidity stability: ±1 % relative humidity
- Humidity uniformity: ±1 % relative humidity to ±3 % relative humidity
Standard:
- Precise dual controller for temperature and humidity.
- Methacrylate box with security key.
- High-precision temperature probe and humidity capacity sensor.
- Made of AISI 304 stainless steel inside and out.
- Door lock with key.
- Magnetic weather seal.
- Shelves (3 in the 250, 600 liter model and 6 in the 1200 liter model).
- 80 mm access port.
- Height-adjustable legs or castors.
- Air-cooled condenser unit.
Optional:
- HMI control with touchscreen.
- Additional tank for water supply (80 liter tank).
- Illumination system for photostability studies.
- Extended temperature range (-20 ºC).
- Doors with toughened glass.
- 4 wheels for chamber movement.
- Water-cooled condenser unit.
- Additional shelves.
- White lacquered exterior.
- Demineralization system (reverse osmosis, mixed bed ion exchange, decalcification).
Validation according to DQ, IQ, OQ, PQ.