Introduction

EIE 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%

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