GMP Twin Chamber With HMI, PLC & 21-CFR Software

Applications:

Refrigerator Cum Freezer are designed for bio sample storage applications in pharmaceutical, microbiology, biotechnology, chemical industries & research labs.

Salient Features:

1. Standalone instrument comprises of (Upper & Lower chambers) Twin chambers i.e. Refrigerator Cum Freezer
2. Both Chambers are equipped with separate PLC controller & Touch screen HMI display
3. Upper chamber works as a deep freezer While the lower chamber works as laboratory refrigerator.
4. Interior of both the chambers are fabricated from Mirror Polished Stainless Steel (S.S.-304 Grade) material.
5. Exterior body of the instrument is also fabricated from Stainless Steel material (S.S.-304 Grade)
6. Both upper & lower chambers are filled with 65-75 mm PUF insulation on all sides to avoid thermal leakage
7. Both upper & lower chamber are Fitted with special heavy duty Stainless steel lock and door hinges with spring-roller mechanism
8. Both chambers are fitted with Sponge - type silicon gasket for air-tight sealing to avoid leakage of chamber uniformity
9. Both Chamber illumination is provided by LED light with door switch
10. Both chambers are equipped with Adjustable Shelves to place the Test Samples/Glass wares of varying dimensions
11. Laboratory Refrigerator (lower chamber) is fitted with forced air circulation blower such to achieve uniform temperature distribution throughout the working chamber
12. In case of refrigerator, Electric Motor for blower is located at the back side of unit, which is protected with safety cover to avoid accident
13. Refrigerator is fitted with Full size polycarbonate sheet inner door to inspect the samples without affecting the chamber temperature.
14. Properties of polycarbonate sheet door (Unbreakable, Un-scratchable, High temperature resistant, Robust, Air tight and Transparent)
15. Entire Unit is mounted on castor wheels for easy movement.
16. Internal circuit wiring as per international norms
17. Aesthetic external appearance
18. Complete with pilot indicating lamps, 2 meter cord wire and power plug.
19. Operation on 220/230 Volt, 50 Hz, Single phase, AC Supply
20. Supplied complete with IQ OQ DQ documents.
    

Following advance features are available:

1. Equipped with Touch screen HMI Controller and PLC System
2. Equipped with Magnetic Door Lock Mechanism in both the chambers
3. Password protected door access system
4. Supplied complete with 21-CFR (PART-11) Compliance PC Software
5. Audit trail generation in PC Software
6. Auto resume after power failure
7. Provision for GSM MODULE (Mobile alert configuration) system for parameter deviation (shall be procured at extra cost)
8. Provision for In-Built Data logger (Uniformity module) system  (shall be procured at extra cost)
   

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 in refrigerator:

Temperature is maintained by a quiet running blower for better air circulation throughout the chamber. Forced air circulated vertically down and re-circulated throughout the chamber for uniform temperature distribution.

Trays for samples:

1. Trays of the refrigerator and deep freezer will be manufactured from strong Stainless steel sheet - strong enough to with-stand heavy load of test specimens, which should be equally distributed among trays.
2. Such trays will also facilitate better air circulation.
3. The distance between trays will be 15-20 centimeters.
   

Safety Features:

Electrical overload safety (Fuse 10 Amperes)

Pre installation mandatory requirement : (Guarantee void in case of non compliance):

1. An operator shall maintain Room temperature around machine preferably at 25 °C with air conditioning system or shall arrange for a well ventilated room with exhaust fan. However, surrounding temperature should not exceed 30 °C .
2. Stabilized Input Voltage of 230 Volt, 50 Hz, 20 Amps, AC Supply must be available for error less performance of the instrument. Use of Servo Controlled Stabilizer is recommended.