PHOTOSTABILITY CHAMBER FOR WEBSITE

Photo Stability Test Chamber - GMP Model

Model Number : EIE-116RGT450

None

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

  • CE Certified
  • Designed as per ICH guidelines to meet, WHO and USFDA requirement
  • Fulfills storage conditions of  25°C, 40°C, 30°C etc.
  • Chamber equipped with PLC & Touch screen HMI system
  • Highly accurate Individual control Loop for precise control of temperature
  • Interior fabricated from mirror polished stainless steel  (S.S. - 316)
  • Exterior body is fabricated from stainless steel  (S.S. - 304)
  • Full size polycarbonate sheet inner door to inspect samples without affecting the chamber temperature.
  • Properties of polycarbonate sheet door (Unbreakable, Un-scratchable, High temperature resistant, Robust, Air tight and Transparent)
  • Sponge - type silicon gasket for air-tight sealing to avoid leakage of chamber uniformity
  • Electrical wiring as per CE Compliances
  • Chamber illumination by LED light with door switch.
  • User friendly and tactfully designed chamber door and locking mechanism
  • Aesthetic outer appearance and high quality
  • Unit mounted on castor wheels for easy movement.
  • 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 Sensor for data logging purpose
  • Monitors Low water level status
  • Facilitates automatic water filling system
  • Auto resume after power failure

Salient Features for photo-stability operation

      • Designed specifically to meet ICH and FDA requirements for photostability testing.
      • Near UV and visible light testing is performed simultaneously.
      • Calibrating Photon detectors measure lamp intensity on the product shelf.
      • 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)
      • After a programmed exposure level is reached, the lamps automatically shut-off.
      • To enhance reliability, internal air temp and Rh conditions are controlled throughout the photo stability test.

      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.

       

      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 : 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

      • Over temperature thermostat & thermal fuses provided for Heating system.
      • Electrical overload cut off
      • Time delay for compressor switch ON
      • Electrical circuit breaker


      Technical specification
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      Chamber Size

      125 x 125 x 125 (W x D x H)

      Chamber volume

      450 Liters

      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 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 Fluorescent Lights

      04/05 Nos

      Fluorescent light watts

      20 Watts

      No of UV 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 resolution

      1-10 Lux

      UV Meter accuracy

      ±4%+2d

      IQ, OQ, PQ

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

      Mobility

      On castor wheel

      Power Consumption

      230 Volts, 50 HZ, Single Phase, AC Supply

      Power Supply

      230 Volts, 50 HZ, Single Phase, AC Supply


      Accessories
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      Spares
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