- Overview
- Customer Benefits
- Performance Characteristics
- Technical Data
- Accessories
- Download PDF
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Photostability Chambers
The REMI Photostability Chambers are designed for Photostability Tests as per ICH guidelines Q1B. These conditions require white fluorescent light exposure of not less than 1.2 million LUX hours and integrated near Ultra Violet energy of not less than 200 watt hours/square meter. These chambers are manufactured as per GMP norms.
Advantages
- Maintains precise long term conditions
- Complete solution for simulation of desired Fluorescent, UV Illumination, Temperature & humidity in the chamber
- Calibrated digital light meter for measuring the light intensity
Features | Customer benefits | Characteristics |
Positive Air flow technology |
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Constant circulation of air throughout the chamber achieves homogeneous Temperature & Humidity conditions. |
Illumination system |
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Fluorescent & UV tubes fitted in a proper way. |
Humidifier system |
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Humidity sensor |
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Cooling system |
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Safety Features |
Auto switch off of UV tubes once the door is opened. |
Float switch cuts off supply to heater in case of low water level in humidifier tank. |
Stand-by Cooling system & Humidity system |
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Controller with LCD |
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Software |
As per 21 CFR Part 11 requirements. |
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Qualification |
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IQ, OQ, PQ, DQ documents. |
Accessories and Services |
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- Multiple sizes available to suite customer requirement.
- Photostability conditions with Fluorescent Tubes exposure to 1.2 million lux hours & UV to 200 watt hours/square meter.
- Tubes fitted in a proper way for uniform exposure of light intensity over complete area of tray.
- Auto switch off of UV tubes once the door is opened.
- Microprocessor controlled refrigeration system & heaters provide temperature accuracy and reproducible results.
- Temperature range 10 °C to 60 °C, Accuracy ± 1⁰C.
- Humidity range 40 % to 95 % RH,Accuracy ± 2% RH.
- User friendly LCD screen
- Easy-to-read large display.
- Integrated memory for data storage.
- Variety of options for the graphic display of process parameters & utilities.
- Real time clock for proper data management.
- Electronically controlled humidification system with capacitance type humidity sensors.
- Suitable for stability studies according to ICH guidelines.
- Double door with Inner full door of plexi glass to view samples.
- Temperature, Humidity and utility failures visual and audible alarms.
- Remi “DATASOFT” data monitoring software as per FDA guideline of 21 CFR Part 11.
- Stainless steel trays.
- IQ OQ PQ DQ documentation.
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PSC-6 Plus |
PSC-10 Plus |
PSC-12 Plus |
PSC-16 Plus |
PSC-19 Plus |
PSC-28 Plus |
PSC-35 Plus |
Internal Volume (Liters.) |
200 |
280 |
370 |
450 |
540 |
800 |
1000 |
Number of Shelves |
1 |
2 |
2 |
3 |
3 |
4 |
4 |
Internal Dimensions W x D x H (mm) |
660 x 655 x 450 |
660 x 655 x 650 |
660 x 655 x 850 |
660 x 655 x 1050 |
660 x 655 x 1250 |
800 x 800 x 1250 |
800 x 800 x 1580 |
External Dimensions W x D x H (mm) |
800 x 1095 x 1020 |
800 x 1095 x 1220 |
800 x 1095 x 1420 |
800 x 1095 x 1620 |
800 x 1095 x 1820 |
960 x 1370 x 1950 |
950 x 1370 x 2270 |
Temperature Range & Accuracy |
10°C to 60°C, ± 1°C |
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Humidity Range (Rh) & Accuracy |
40% to 95%, ± 3% |
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Temperature & Humidity control |
Microprocessor with Capacitance type sensor |
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Display |
4" LCD Screen, Large size Display for ease of reading |
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Power Failure Alarm |
Audio Visual Alarm |
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Door Open Alarm |
Audio Alarm in case door open for over one minute |
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Humidity/Temperature Variation Alarm |
Set Humidity ± 3% Rh, Set Temperature ± 2°C, Audio Visual Alarm |
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Illumination |
UV & Flourescent Tubes for exposure of 1.2million lux hours and UV energy of 200 watt hours / M2 |
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Internal Body Material |
Stainless Steel - 316 grade |
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External Body Material |
Stainless Steel - 304 grade |
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Insulation |
70 mm minimum for Body & 80 mm for Door, CFC free polyurethane foam |
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Noise Level |
Less Than 65 db(A) |
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Recommended Voltage Stabilizer |
VS-04 |
VS-07 |
VS-07 |
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Electrical |
220-240 volts, 50Hz, Single Phase |
- Digital light meter (Luxmeter with UV indication)
- PLC Based Control System with 7” colour HMI Touch Screen
- Software as per 21 CFR Part 11
- Data logger with 8 Capacitance type Sensors (4 Temperature + 4 Humidity )
- Standby Refrigeration System
- Standby Humidity System
- Magnetic Door Access Security System
- GSM Mobile Alert for six Numbers
- Validation [ mapping ] consist of one cycle for temperature and humidity at any one set point for 24 hours on empty and loaded condition of Chambers