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Stability Chamber
Stability Chamber Details
PSI Test Chambers are developed as a result of intensive R & D, and confirming international standards, our offering services are Calibration, validation and comply IQ, OQ, and PQ protocols.*
ICH GUIDELINES*
PSI chambers are specialized designed to carry out stability & shelf list test on drug & drugs substance according ICH Guidelines.
For conditions as per ICH guidelines 25°C - 60% RH/40°C - 75% RH/ 30°C - 65% RH/25°C - 40% RH/ 40°C - 25% RH/ 30°C - 35% RH.
TECHNICAL SPECIFICATIONS | |
Temperature Range | 10°C to 60°C Accuracy / Uniformity : ±0.2°C / ±1.0°C |
Humidity Range | 40% to 95% Rh. Accuracy / Uniformity ±2%RH / ±3%RH |
Temperature / Humidity Display | Digital LED 3 ½ Digit, Resolution :0.1°C / 1% RH |
Control | Microprocessor based PID Control with auto tune CE Marked |
Temperature Sensor | PT -100 |
RH Sensor | Direct Electronics Capacitance type |
Heating | U’ Shaped Nichrome wire Air heater in SS Sheathing |
Cooling | CFC Free Emerson make compressor utilizing R 134A ecofriendly refrigerant |
Steam Injection | Boiler with reservoir made of thick stainless steel, with heater, water inlet control, low water level safeguard and insulation |
Air circulation | Bharat Vidhut make Flange motor with impeller / Blower |
Construction | Double Walled, gap between walls filled with PUF Insulation |
Shelves | Heavy S.S 304 Rod Adjustable Trays |
GMP model | Inner Chamber Stainless steel mirror polished 0.8 mm Outer chamber and exterior of Mett finish 1.0 mm stainless steel. |
Double Door | Inner full viewing door and outer door insulated with lock and key arrangement Control panel with electrical switch gear and refrigeration system (CFC Free) mounted on top for easy service accessibility. Unit mounted on castor wheels |
Safety Features | · Float switch to cutoff the mains supply in case of · Safety Thermostat in evaporation tray to cut off heater supply in case of low water level. · Inbuilt safety control system to cut off the supply in case of overshoot and undershoot of Temperature giving audio visual alarm. · Additional safety thermostat to cut off the supply in case of overshoot of temperature. · 2 min. compressors ‘ON’ delay timer to safe guard the compressor |
Model No. | Inner dimension (W x D x H) MM | Capacity (Liters) | No. of Trays |
PSI-SC100L | 450 x 450 x 500 | 100 | 2 |
PSI-SC175L | 500 x 500 x 700 | 175 | 2 |
PSI-SC200L | 600 x 600 x 600 | 220 | 3 |
PSI-SC285L | 600 x 600 x 750 | 285 | 3 |
PSI-SC340L | 600 x 600 x 900 | 340 | 3 |
PSI-SC450L | 600 x 600 x 1200 | 450 | 4 |
PSI-SC600L | 700 x 700 x 1200 | 600 | 4 |
PSI-SC800L | 700 x 750 x 1500 | 800 | 4 |
PSI-SC1000L | 800 x 800 x 1500 | 1000 | 5 |
OPTIONAL - 1
- MICROPROCESSOR AUTO TUNE PID CONTROLLER WITH DATA LOGIN SYSTEM WITH SOFTWARE.
- MICROPROCESSOR TOUCH SCREEN HMI COLOUR DISPLAY WITH PLC FOR DATA LOGGING
DATA RECORD:
- 21 CFR Part 11 Compliance Secured audit trail
- Multilevel Passwords
- Print Interval Programmable Between 1 to 240 minutes
- Multi Chamber data acquisition on Single Software.
- Data Generated on PDF Report
- Provision to do system setting, Humidity Control, Temp. Control, System reset, Graph View, User View, off line Print.
- Auto logout, account Blocking and reactivating facility.
- Log data, event and audit trail data recording
- Tabular and graphical report, audit trail report
STANDBY HUMIDITY & COOLING SYSTEM:
- Completely ready-to-use systems.
- Automatic switch-over upon failure of primary systems to achieve conditions.
- Switch-over also upon detection of HP/LP & Internal fault.
- Scheduled & manual change-overs.
- Recording of all change-overs in the software.
OPTIONAL - 2
DOOR ACCESS SECURITY SYSTEM
- Door access security system can be installed to authorize or to monitor the opening of the chamber. It can be interfaced with the pc with software.
CONNECTIVITY
- Provision for Mobile Alerts System, Door Access System, Print Facility, Data Transfer Facility with Ethernet & LAN Connectivity.
Documentations Provided
- IQ OQ PQ
- Calibration Certificate
- User Manual of Instrument
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