WALK IN STABILITY CHAMBER

Walk-In Stability Test Chamber - GMP Model

Model Number : EIE-106WG40

Designed as per ICH guidelines to meet, WHO and USFDA requirement. Fulfills storage conditions of 25° C - 60% RH, 40° C - 75% RH, 30° C - 65% RH, 25° C - 40% RH, 30° C - 35% RH. Chamber equipped with PLC & Touch screen HMI system. Interior fabricated from mirror polished Stainless Steel (S.S. - 304). Exterior body is fabricated from Stainless Steel (S.S. - 304). Equipped with Magnetic Door Lock Mechanism. Supplied complete with 21-CFR (PART-11) Compliance PC Software.

WALK IN STABILITY CHAMBER VOLUME CAPACITY
  • 2000 LTR
  • 4000 LTR
  • 6000 LTR
  • 8000 LTR
  • 12500 LTR
  • 18750 LTR
  • 23250 LTR
  • 32500 LTR
  • 45000 LTR
  • 50000 LTR
  • 80000 LTR
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  • Technical specification
  • Accessories
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Construction Details:
  • CE Certified
  • Designed as per ICH guidelines to meet, WHO and USFDA requirement
  • Fulfills storage conditions of  25° C - 60% RH, 40° C - 75% RH, 30° C - 65% RH, 25° C - 40% RH,  30° C - 35% RH
  • Chamber equipped with PLC & Touch screen HMI system
  • Highly accurate Individual control Loop for precise control of temp and humidity
  • Interior fabricated from mirror polished Stainless Steel  (S.S. - 304)
  • Exterior body is fabricated from Stainless Steel (S.S. - 304)
  • Toughened glass wondow to inspect samples without affecting the chamber temperature.
  • Prefabricated Puf Panels with cam-locks to avoid thermal leakage
  • Electrical wiring as per CE Compliances
  • Chamber illumination by LED light with door switch.
  • User friendly and tactfully designed chamber door and locking mechanism
  • Facility to open chamber door from inside, in case of emergency
  • Aesthetic outer appearance and high quality
  • Supplied complete with IQ/OQ/PQ Documents, Calibration certificates and Instruction manual.
Following advance features are available:
  • Equipped with 7" Touch screen HMI Controller and PLC System
  • Equipped with GSM MODULE (Mobiler alert configuration) system for parameter deviation
  • Equipped with Magnetic Door Lock Mechanism 
  • Password protected door access system
  • Supplied complete with 21-CFR (PART-11) Compliance PC Software
  • Audit trail generation in PC Software
  • Equipped with In-Built Data logger (Uniformity module) system 
  • Also equipped with 4 Temp + 4 RH Sensor for data logging purpose
  • Monitor Low water level status
  • Facilitates automatic water filling system
  • Auto resume after power failure
  • Ready to use STANDBY REFRIGERATION SYSTEM  in case main system fails
  • Ready to use STANDBY HUMIDITY SYSTEM in case main system fails
  • Auto Switch-Over facility from Mains to Standby system and vice versa
  • Calendar options for choosing the days on which Either Mains or Standby system will remain active
Salient Features of 21-CFR Compliance Software:
  • Multi Chamber data - Acquisition Software
  • Generates graphical analysis of DATA as per - 21 CFR Compliance guidelines
  • File encryption Facility
  • Secure login facility
  • Password protected. System access is controlled by the system supervisor
  • Limit system access
  • Limit module access
  • Password expiration
  • Bilateral user ID and password identification
  • Access failure lock out
  • System access logs
  • System audit trail report.
  • System Input / Output  logs
  • Mean kinetic temperature calculation
  • Maintains log of user activities like users logged in, login/logout time, and changes made by the user in software settings Audit Trail Reports.
  • Ensure Gap-free Records
  • Schedule Reports via Email
  • Meet Tough Standards
  • View Environments in Real-Time
  • Flexible Alarm Management
  • Consistent Alarm Acknowledgements
  • Highly Secure & Temper proof
  • Protection From Data Loss 
Air Circulation:
Temperature is maintained by a quiet running blower circulation throughout the chamber.  Forced air circulated vertically down and re-circulated throughout the chamber for uniform temperature and humidity distribution.

Humidity Generation:
Humidity created by steam injection method. The boiler tank is fitted in the back side of the chamber for better servicing. Electromagnetic switch is provided for controlling the wet heater from burning off, if water level is not adequate. Float valve is provided to automatically control & maintain water level in the boiler tank.

Heating & Cooling System:
Long lasting SS tubular heaters used as heating element. The stainless steel fins provided to ensure better heat transfer. Hermetically sealed compressor CFC free compressor (134 A gas) coupled with evaporation coil and condenser. All refrigeration components like expansion valve, driers, oil separators, pressure gauges and vibration eliminators provided. Reputed company make refrigeration system such as Emerson/Kirloskar Make

Door & Gasket:
Robust type hinges fitted on the right hand side of the chamber with front opening single door.  Leak proof double lined silicon gasket will be provided. The inner surface of the door will be provided with pre-polished stainless steel and will be mounted such that conduction is avoided.

Trays for samples:
  • Removable Stainless steel rod trays
  • Strong enough to withstand heavy load of test specimens
  • Such trays will also facilitate better air circulation.
  • The distance between trays will be 15-20 centimeters.
  • Number of tray supplied : 8 Numbers
Electrical controls:
Relays, Contactors, SSR, MCB, Mains Switch, Fan control switch, compressor ON/OFF switch with indicator, Dry heater switch with indicator for safe and ease of operation.

Electrical Circuitry Wires:
CE Certified : Inner circuitry wires with individual number tags for ease of servicing and maintenance

Safety Provisions:
  • Over temperature thermostat & thermal fuses provided for Heating system.
  • Low water level boiler cut off
  • Electrical overload cut off
  • Time delay for compressor switch ON
  • Electrical circuit breaker
Viewing window:
Multi pane window, toughened clear glasses sealed with silicone and separated by spacers to form a completely vacuumed window.

Wiper:
Viewing window facilitates with wiper to clear the condensed water droplets on the glass.

Technical specification
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Chamber Size

2 x 1 x 2 (W x D x H) Meter

Chamber volume

4000 liters

Inner chamber

Stainless steel S.S. - 316 Mirror Polished with cam lock

Exterior body

Stainless steel S.S. - 304 Matt finished

Insulation

Puff insulation

Insulation thickness

75mm

No. of trays

8 Numbers

Controlling System

Highly advanced Touch screen HMI & PLC Control system

Display

Digital LCD Display (7" Screen Size)

Temperature Range

10° C to 70° C

Temperature Accuracy

± 0.5° C

Temperature sensor

Pt - 100 sensor

No. of Temperature Sensors

05 Nos (01 Main + 04 For data logging purpose)

Humidity Range

40% RH to 90% RH

Humidity Accuracy

± 3% RH

Rh sensor

Capacitance type RH Sensor

No. of Rh Sensors

05 Nos (01 Main + 04 For data logging purpose)

Validation port hole

150 mm diameter, port hole provided with removable sealed cap.

Observation door

Polycarbonate sheet door to inspect test samples without disturbing chamber operation

Illumination

LED Light

Time & Date

User adjustable Date & Time settings

PC Software

21-CFR (Part-11) compliance software as per USFDA Guidelines

Communication

RS - 232/RS - 485 communication port

Magnetic door lock

Password protected entry levels for Operator, Supervisor etc

IQ, OQ, PQ

IQ, OQ, DQ, Documents as per USFDA Guidelines, Validation Report and Instruction Manual.

Blower

For uniform temp & humidity distribution

Power Consumption

3000 Watts (3 KW)

Power Supply

230 Volts, 50 HZ, Single Phase, AC Supply


Accessories
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Spares
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