CLIMATIC CHAMBER FOR PHARMACEUTICAL STABILITY TESTS, CM ICH SERIES

CM ICH series has an accuracy temperature and humidity control in order to ensure stability parameters of these variables according with the directive ICH Q1A (R2) Stability Testing of New Drug Substances and Products and US FDA 21 CFR part 11. These equipments comply with the three studies in those directives: large and middle duration or accelerated.
It’s possible to adapt the chamber the chamber for the photostability test according with the directive: ICH Q1B Photostability Testing of New Drug Substances and Products, option 2.

Our laboratory, LCIS, is the responsible to do the qualification of the chambers: DQ, IQ, OQ or PQ.

Features:

• Volumes: 250, 600 or 1.200 liters
• Temperature range: +10ºC till +50ºC
• Humidity range: From 50% to 90% RH.
• Temperature Stability: ± 0,1ºC to ± 0,5ºC
• Temperature Uniformity: ±0,5 ºC to ±1,5ºC
• Humidity stability: ±1%RH
• Humidity Uniformity: ±1%RH to ±3%RH

Standard:

– High accuracy double regulator to control temperature and humidity.
– Methacrylate box with safety key to avoid manipulation.
– High precision temperature probe and humidity capacitive sensor.
– Interior and exterior made in Stainless Steel AISI 304.
– Lock with key in door.
– Magnetic weather-strip.
– Shelves (3 in 250, 600 liters model and 6 in 1200 liters model)
– 80 mm Access-ports.
– Height adjustable legs or casters.
– Air cooled condenser unit.

Optional:

– HMI control with touch screen.
– Auxiliary water supply tank (80 litre tank).
– Illumination system for photostability studies.
– Extended temperature range (-20 ºC).
– Doors with tempered glass.
– 4 wheels for chamber movement.
– Water-cooled condensing unit.
– Additional shelves.
– White lacquered exterior.
– Demineralisation system (reverse osmosis, mixed bed ion exchange, decalcification).
– Validation according to DQ, IQ, OQ, PQ.