Stability Chamber
Stability Chamber
PSI Test Chambers are developed through intensive R&D and are designed to meet international standards. Our services include Calibration, Validation, and compliance with IQ, OQ, and PQ protocols.
ICH Guidelines
PSI chambers are specifically designed to conduct stability and shelf-life testing of drugs and drug substances, adhering to ICH Guidelines.
Test 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
Optional Features:
1. Microprocessor Auto-Tune PID Controller with Data Logging System
Microprocessor Touch Screen HMI Colour Display with PLC for data logging.
Data Record with 21 CFR Part 11 Compliance and secured audit trail.
Multilevel Password Protection.
Programmable Print Interval (1 to 240 minutes).
Multi-chamber data acquisition on a single software platform.
Data Exported as PDF Reports.
System settings, Humidity Control, Temperature Control, System Reset, Graph View, and User View can be managed via software.
Features like Auto Logout, Account Blocking, and Reactivating are available.
Log data, event, and audit trail data recording.
Tabular and Graphical Reports, and Audit Trail Reports.
2. Standby Humidity & Cooling System
Completely ready-to-use systems.
Automatic switch-over in case of primary system failure to achieve test conditions.
Switch-over also occurs upon detection of HP/LP and internal faults.
Scheduled and manual change-overs with recording of all change-overs in the software.
3. Door Access Security System (Optional)
Can be installed for authorized access and monitoring of chamber door openings.
Can be interfaced with PC software for full control.
Connectivity Features:
Mobile Alert System for real-time updates.
Door Access System, Print Facility, and Data Transfer Facility with Ethernet and LAN Connectivity.
Documentations Provided:
IQ, OQ, PQ
Calibration Certificate
User Manual of Instrument
PSI Test Chambers offer highly reliable and accurate testing conditions, adhering to ICH guidelines, with a range of advanced features for effective monitoring and management of test conditions, ensuring seamless performance and data integrity.
| 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 low water level in the reservoir tank. 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 |
