Stability Chamber - GMP & NON-GMP Model

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
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  • Double wall construction
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  • Fulfills storage conditions of 25° C - 60% RH, 40° C - 75% RH, 30° C - 65% RH, 25° C - 40% RH, 30° C - 35% RH
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  • Designed for testing product shelf – life, Packing and Electronic test.
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  • Specially designed to meet ICH, WHO & USFDA requirements.
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  • Full size polycarbonate sheet inner door to inspect samples without affecting the control parameters.
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  • Electrical wiring as per CE Compliances
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  • Illuminated working area
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  • User friendly and tactfully designed chamber door and locking mechanism
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  • Forced air circulation for uniform temperature and RH Distribution
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  • Ensures smooth air-flow pattern to improve the Temp & Humidity distribution across the chamber
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  • U-Shaped tubular heaters as heating element.
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  • Unit mounted on castor wheels for easy movement.
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  • Uniformity module with 4 + 4 RH & Temp Sensors (Optional)
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  • Password protected door access and monitoring (Optional)
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  • GSM module for SMS Alert (Optional)
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  • Serial port for PC interface with 21-CFR Compliant software (Optional software)
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  • Standby Humidity control system and Standby refrigeration system (Optional)

 

Insulation

70mm polyurethane insulation (PUF)/ fiberboard to ensure thermal loss

 

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 60 °C
  • Humidity Accuracy: ± 2% RH
  • Temperature Accuracy: ± 0.2 °C
  • Humidity Uniformity: ± 3% RH
  • Temperature Uniformity: ± 1°C
  • Supply: 230V Ac, 50 Hz, Single Phase
  • Humidity Range: 40% RH to 95% RH

 

Trays for samples

  • Removable perforated trays
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  • Can withstand heavy load
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  • Offer better air circulation

Safety Features

  • High temperature safety cut off
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  • Low water level boiler cut off
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  • Electrical overload cut off
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  • Time delay for compressor switch ON
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  • Electrical circuit breaker

 

Salient Features

  • 21-CFR Compliance software with PC Communication
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  • Highly advanced HMI & PLC Control system
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  • GSM Alert through SIM Card
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  • Data logger with 4 temperature + 4 Humidity sensors
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  • Spare RH Sensor for validation purpose
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  • Spare PT-100 Sensor for validation purpose
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  • Standby Humidity System
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  • Standby Refrigeration System
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  • Biometrics Magnetic Door Access for Secured Door opening with software to maintain log
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  • On-Site Validation (mapping) for 24 hours on Empty, Half and Full load condition

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Selection Guide

Working chamber sizes (CM) (H x D x W) Overall dimensions (CM) (H x D x W) Volume (Liters) No of trays Power ratings (KW) Weight (KG) Digital Model Numbers (EIE-106RP) Digital GMP Model Numbers (EIE-106RG)
45 x 45 x 45 cm 119 x 74 x 66 92 2 1.5 115 EIE-106RP92 EIE-106RG92
70 x 50 x 50 cm 145 x 76 x 71 175 3 1.5 135 EIE-106RP175 EIE-106RG175
60 x 60 x 60 cm 135 x 84 x 81 216 3 2.0 150 EIE-106RP216 EIE-106RG216
90 x 60 x 60 cm 165 x 84 x 81 324 3 2.0 157 EIE-106RP324 EIE-106RG324
125 x 60 x 60 cm 201 x 84 x 81 450 4 2.5 175 EIE-106RP450 EIE-106RG450
125 x 70 x 70 cm 201 x 94 x 91 612 4 2.5 198 EIE-106RP612 EIE-106RG612
125 x 80 x 80 cm 201 x 104 x 102 800 5 3.0 220 EIE-106RP800 EIE-106RG800
125 x 90 x 90 cm 201 x 114 x 112 1000 5 3.0 245 EIE-106RP1000 EIE-106RG1000

R : Refrigerated   |   G : GMP   |   P : Powder coating

EIE Instruments Pvt. Ltd.

EIE Instruments Pvt. Ltd.
Manufacturer
India

Primary focus area

Analytical Products & Services

Packaging Equipments

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