Refrigerated Photostability Chamber - Gmp

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 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 and Rh conditions are 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 : 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. Electrical overload cut off
3. Time delay for compressor switch ON
4. Electrical circuit breaker