PHOTOSTABILITY CHAMBER-WITH PLC, HMI TOUCH SCREEN & 21-CFR SOFTWARE-REFRIGERATED-GMP MODEL-60 X 60 X 60 CM

PHOTOSTABILITY CHAMBER-WITH PLC, HMI TOUCH SCREEN & 21-CFR SOFTWARE-REFRIGERATED-GMP MODEL-60 X 60 X 60 CM

Model No: EIE-116RGT216

The Photo stability chamber is designed to perform near UV and visual light testing with fluorescent lamps per ICH Q1B Guidelines. The unit controls light and temperature conditions through an easy-to-use color touch-screen interface. Equipped with GSM Module, magnetic door lock mechanism with password protected door access, in built Data Logger with 4 temp. sensors, Low water level monitor, automatic water filling system and 21 CFR complaint software.

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 temperature
  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 Sensor for data logging purpose
  9. Monitors Low water level status
  10. Facilitates automatic water filling system
  11. Auto resume after power failure


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.


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 : 03 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. Electrical overload cut off
  3. Time delay for compressor switch ON
  4. Electrical circuit breaker


Chamber Size

60 x 60 x 60 (W x D x H)

Chamber volume

216 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

03 Numbers

Controlling System

Highly advanced Touch screen HMI & PLC Control system

Display

Digital LCD Display (7" Screen Size)

Temperature Range

10° C to 60° 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

Blower

For uniform temp & humidity distribution

UV Tube Light Watts

20 Watts

No of UV Lights

04/05 Nos

Fluorescent light watts

20 Watts

No of Fluorescent Lights

04/05 Nos

LUX Meter

Shall be procured at extra cost (Optional)

Digital Lux Meter Range

400 Lux, 4000 Lux, 40 KLux, 400 KLux

40 FC, 400 FC, 4000 FC, 40 KFC

LUX Meter accuracy

±5% rgd ±10d (<10,000 lux)

±10% rgd ±10d (>10,000 lux)

UV Meter

Shall be procured at extra cost (Optional)

UV Meter measuring range

1999-19990 Lux

UV Meter accuracy

±4%+2d

UV Meter resolution

1-10 Lux

IQ, OQ, PQ

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

Mobility

On castor wheels

Power Consumption

3000 Watts (3 KW)

Power Supply

230 Volts, 50 HZ, Single Phase, AC Supply

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