STABILITY CHAMBER-WITH PLC, HMI & 21 CFR SOFTWARE-REFRIGERATED-GMP MODEL-(125X60X60 CM)-

Construction Details:

• CE Certified
• Designed as per ICH guidelines to meet, WHO and USFDA requirement
• Fulfills storage conditions of 25° C - 60% RH, 40° C - 75% RH, 30° C - 65% RH, 25° C - 40% RH, 30° C - 35% RH
• Chamber equipped with PLC & Touch screen HMI system
• Highly accurate Individual control Loop for precise control of temp and humidity
• Interior fabricated from Mirror Polished Stainless Steel (S.S.-316 Grade).
• Exterior body is also fabricated from Stainless Steel material, (S.S.-304 Grade)
• 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 Compliance
• 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, DQ, PQ Qualifications documents and Instruction manuals.

Following advance features are available:

• Equipped with 7" Touch screen HMI Controller and PLC System
• 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
• Monitor Low water level status
• Facilitates automatic water filling system
• Auto resume after power failure
• Provision for Standby refrigeration and Standby humidity system (shall be procured at extra cost)
• Provision for GSM MODULE (Mobiler alert configuration) system for parameter deviation (shall be procured at extra cost)
• Provision for In-Built Data logger (Uniformity module) system  (shall be procured at extra cost)
• Provision for 4 Temp + 4 RH Sensor for data logging purpose (shall be procured at extra cost)

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.

Humidity Generation:

Humidity created by steam injection method. The boiler tank is fitted in the back side of the chamber for better servicing. Electromagnetic switch is provided for controlling the wet heater from burning off, if water level is not adequate. Float valve is provided to automatically control & maintain water level in the boiler tank.

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 : 04 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.
• Low water level boiler cut off
• Electrical overload cut off
• Time delay for compressor switch ON
• Electrical circuit breaker

Note

For these range of Equipment, the installation and demonstration at site by our technician is a prerequisite for availing free servicing during the guarantee period of 12 months from the date of sale. On site demonstration is essential and mandatory to avail warranty claim. Warranty void in case on site demonstration not availed.