Introduction:
Stability Chambers are designed as per ICH Guidelines for precise monitoring of temperature and humidity conditions required for long term, intermediate & accelerated stability studies at chemical, pharmaceutical, agrochemical manufacturing facilities. These chambers are manufactured to comply with GMP requirements.
Salient Features:
- CE Certified
- Light weight Sandwich panel
- Fulfills storage conditions of 25° C – 60% RH, 40° C – 75% RH, 30° C – 65% RH, 25° C – 40% RH, 30° C – 35% RH
- Designed for testing product shelf – life, packing and electronic test.
- Specially designed to meet ICH, WHO & USFDA requirements.
- Main Door with observation window to inspect samples
- Electrical wiring as per CE Compliances
- Illuminated Working area
- Password protected door access and monitoring
- U-Shaped tubular heaters as heating element.
- Non Condensing steam injection type humidity system with standby heater & auto switch over
- Mains-Fail Detection & Automatic Change Over to Battery/Inverter
- High speed Ethernet communication
- Uniformity module with 4 + 4 RH & Temp Sensors
- Forced air circulation for uniform temperature and RH Distribution
- Ensures smooth air-flow pattern to improve the Temp & Humidity distribution across the chamber
- GSM module for SMS Alert (Optional)
- Serial port for PC interface with 21-CFR Compliant software (Optional software)
- Standby Humidity control system and Standby refrigeration system (Optional)
Humidity System:
Non-condensing type Steam injection system & reservoir tank with water level arrangement with indicator.
Cooling System:
Hermetically sealed compressor, which is CFC free and eco-friendly, utilizes the refrigerant (R-134A gas) to maintain chamber temperature within specified range.
Technical Specifications:
Temperature Range: 20 °C to 70 °C
Temperature Accuracy: ± 0.2 °C
Temp Uniformity: ± 1°C
RH Range: 40% RH to 95% RH
RH Accuracy: ± 2% RH
RH Uniformity: ± 3% RH
As per ICH Guidelines:
At 25°C: RH = 60%
At 30°C: RH = 65%
At 30°C: RH = 75%
At 40°C: RH = 75%
Trays for samples:
- Removable perforated trays
- Can withstand heavy load
- Offer better air circulation
Safety Features:
- High-temperature safety cut off
- Low water level boiler cut off
- Electrical overload cut off
- Time delay for compressor switch ON
- Electrical circuit breaker
Optional accessories at extra cost:
- 21-CFR Compliance software with PC Communication
- Highly advanced HMI & PLC Control system
- GSM Alert through SIM Card
- Data logger with 4 temperature + 4 Humidity sensors
- Spare RH Sensor for validation purpose
- Spare PT-100 Sensor for validation purpose
- Standby Humidity System
- Standby Refrigeration System
- Biometrics Magnetic Door Access for Secured Door opening with software to maintain log
- On-Site Validation (mapping) for 24 hours on Empty, Half and Full load condition
Selection Guide
| Working chamber sizes (Meter) (W X D X H) | Volume (Liters) | No of trays |
| 2.0 x 1.0 x 2.0 | 4000 | 8 |
| 2.0 x 1.5 x 2.0 | 6000 | 12 |
| 2.0 x 2.0 x 2.0 | 8000 | 24 |
| 2.0 x 2.5 x 2.5 | 12500 | 28 |
| 2.5 x 3.0 x 2.5 | 18750 | 36 |
| 3.1 x 3.0 x 2.5 | 23250 | 40 |
| 3.7 x 3.5 x 2.5 | 32500 | 66 |
| 3.9 x 3.9 x 3.0 | 45000 | 84 |
| 3.85 x 5.2 x 2.5 | 50000 | 100 |
| 6.4 x 5.0 x 2.5 | 80000 | 200 |