Pharmaceutical Laboratory And Pharmaceutical Factory Medicine Stability Testing Chamber

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

• Selection Guide