PHOTOSTABILITY CHAMBER

PHOTOSTABILITY CHAMBER

Model Number : EIE-116RGT800

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PHOTOSTABILITY CHAMBER SIZE
  • 45 X 45 X 45 CM
  • 70 X 50 X 50 CM
  • 60 X 60 X 60 CM
  • 90 X 60 X 60 CM
  • 125 X 60 X 60 CM
  • 125 X 80 X 80 CM
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Construction Details

  1. CE Certified
  2. Designed as per ICH guidelines to meet, WHO and USFDA requirement
  3. Fulfills storage conditions of  25°C, 40°C, 30°C ETC.
  4. Also fulfills storage conditions of 30°C & 65% RH, 25°C & 40% RH, 40°C & 75% RH, 25°C & 60% RH etc (RH Provision at extra cost)
  5. Chamber equipped with PLC & Touch screen HMI system
  6. Highly accurate Individual control Loop for precise control of temp and humidity
  7. Interior fabricated from mirror polished stainless steel  (S.S. - 316)
  8. Exterior body is fabricated from stainless steel  (S.S. - 304)
  9. Full size polycarbonate sheet inner door to inspect samples without affecting the chamber temperature.
  10. Properties of polycarbonate sheet door (Unbreakable, Un-scratchable, High temperature resistant, Robust, Air tight and Transparent)
  11. Sponge - type silicon gasket for air-tight sealing to avoid leakage of chamber uniformity
  12. Electrical wiring as per CE Compliances
  13. Chamber illumination by LED light with door switch.
  14. User friendly and tactfully designed chamber door and locking mechanism
  15. Aesthetic outer appearance and high quality
  16. Unit mounted on castor wheels for easy movement.
  17. Supplied complete with IQ/OQ/PQ Documents, Calibration certificates and Instruction manual.


Following advance features are available

  1. Equipped with 7" Touch screen HMI Controller and PLC System
  2. Equipped with GSM MODULE (Mobiler alert configuration) system for parameter deviation
  3. Equipped with Magnetic Door Lock Mechanism 
  4. Password protected door access system
  5. Supplied complete with 21-CFR (PART-11) Compliance PC Software
  6. Audit trail generation in PC Software
  7. Equipped with In-Built Data logger (Uniformity module) system 
  8. Also equipped with 4 Temp Sensors for data logging purpose
  9. Monitors Low water level status
  10. Facilitates automatic water filling system
  11. Auto resume after power failure
  12. Ready to use STANDBY REFRIGERATION SYSTEM in case main system fails (Optional)
  13. Auto Switch-Over facility from Mains to Standby system and vice versa (Optional)
  14. Calendar options for choosing the days on which Either Mains or Standby system will remain active (Optional)


Salient Features for photo-stability operation


  1. Designed specifically to meet ICH and FDA requirements for photostability testing.
  2. Near UV and Visible light testing using Fluorescent D65 Tubelight is performed simultaneously.
  3. Calibrating Photon detectors measure lamp intensity on the product shelf.
  4. Lamp intensity (W/m2 or Lux) and exposure level (W-hr/m2 or Lux/hr) are conveniently displayed at eye level by a calibrated digital light (LUX) meter. The LUX Meter will be having measuring range from 400 Lux, 4000 Lux, 40 KLux, 400 KLux with an accuracy of ±5% rgd ±10d (10,000 lux)
  5. After a programmed exposure level is reached, the lamps automatically shut-off.
  6. To enhance reliability, internal air temp is controlled throughout the photo stability test.


Technical Specification

•Chamber Size: 80 x 80 x 125 (W x D x H)
•Chamber volume: 800 iters
•Inner chamber: Stainless steel S.S. - 316 Mirror Polished
•Exterior body: Stainless steel S.S. - 304 Matt finished
•Insulation: Puff insulation
•Insulation thickness: 75mm
•No. of trays: 05 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)


•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
•Mobility: On castor wheels
•Power Consumption: 3000 Watts (3 KW)
•Power Supply: 230 Volts, 50 HZ, Single Phase, AC Supply


Salient Features of 21-CFR Compliance Software

  1. Multi Chamber data - Acquisition Software
  2. Generates graphical analysis of DATA as per - 21 CFR Compliance guidelines
  3. File encryption Facility
  4. Secure login facility
  5. Password protected. System access is controlled by the system supervisor
  6. Limit system access
  7. Limit module access
  8. Password expiration
  9. Bilateral user ID and password identification
  10. Access failure lock out
  11. System access logs
  12. System audit trail report.
  13. System Input / Output  logs
  14. Mean kinetic temperature calculation
  15. Maintains log of user activities like users logged in, login/logout time, and changes made by the user in software settings Audit Trail Reports.
  16. Ensure Gap-free Records
  17. Schedule Reports via Email
  18. Meet Tough Standards
  19. View Environments in Real-Time
  20. Flexible Alarm Management
  21. Consistent Alarm Acknowledgements
  22. Highly Secure & Temper proof
  23. 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.


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

  1. Removable Stainless steel rod trays
  2. Strong enough to withstand heavy load of test specimens
  3. Such trays will also facilitate better air circulation.
  4. The distance between trays will be 15-20 centimeters.
  5. Number of tray supplied : 05 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


  1. Over temperature thermostat & thermal fuses provided for Heating system.
  2. Low water level boiler cut off
  3. Electrical overload cut off
  4. Time delay for compressor switch ON
  5. Electrical circuit breaker


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