During stability testing, a drug substance or drug product is evaluated
under the relevant International Conference on Harmonization (ICH)
storage conditions, testing its thermal stability and its sensitivity to
moisture
Double walled construction with inner chamber made of stainless
steel 304 and outer chamber made of mild steel duly powder coated.
Solid door with full view inner plexi-glass door or see through
double walled door with glass window enables inspection and monitoring
of inner chamber specimens without disturbing the process temperature.
Magnetic door gasket.
User – oriented design of shelves makes you adjust each space of shelves without difficulty
PUF insulation to ensure temperature stability & reduced energy consumption.
Micro-processor based PID temperature & humidity indicator cum control
Designed air flow system ensuring uniform temperature & humidity distribution
CFC free cooling system consisting of hermetically sealed compressor coupled with evaporator and condenser coil.
Heating done by long lasting SS air heater
Low water level cut off relay and metal ball float valve for automatic water level control
Fulfills Long Term, Intermediate and Accelerated storage condition as 25°C – 60% RH, 30°C – 65%
RH, 40°C – 75% RH, 25°C – 40% RH
PT-100 temperature sensor, Capacities type humidity sensors
SS water reservoir with immersion type heaters at the bottom provides up to 95% humidity
Illumination with the help of fluorescent lamps
Over temp cut off using safety thermostat and over current relay protection for compressor
Time delay for compressor switch on
Touch screen colour display HMI with data logging facility (Non GMP)
PID temp controller with 21 CFR Part 11 compliant software for electronic records and audit
trail
PLC controlled equipment with touch screen colour display HMI and 21 CFR Part 11 compliant
software for electronic records and audit trail
Uniformity logging, 4+4 with Channel Interface Module (Available along with 21 CFR part 11
compliant software)
MOC Outer body SS 304 and inner SS 316 for GMP models Validation – IQ, PQ & OQ documents
Ultrasonic humidification system instead on traditional heater system for humidity generation
Stand by refrigeration system and stand by humidification system for uninterrupted functioning
Audio visual temp deviation alarm and humidity deviation alarm
Audio visual power failure alarm and door open alarm
Low water level alarm for humidity generating bath Compatible voltage stabilizer Low RH range from 20 to 95%
Stability Chamber manufactured as per ICH guidelines.
Temp range 10 to 60 deg Celsius
Humidity range 40 to 90%
Inner chamber made of SS 304 and outer made of MS powder coated
Optional – Inner MOC SS 316 and outer MOC SS 304
Optional – 21 CFR compliant system
Capacity:
18″ x 18″ x 24″, 125 Liters
24″ x 24″ x 24″, 225 Liters
24″ x 24″ x 48″, 450 Liters
24″ x 24″ x 60″, 565 Liters
30″ x 30″ x 60″, 885 Liters
