| Photostability
Chamber
Wadegati offers a wide range of stability testing chambers that satisfy ICH Q1B guidelines. A state of the art Photostability chambers are available. This chamber has the capability to provide fluorescent light intensities from 1,000 to 10,000 Lux hour. Samples stored at 10,000 Lux can satisfy the ICH guidelines for light exposure in as little as five days. The UV study is done simultaneously. Separate switches are provided for incandescent & UV light sources.
The current ICH guidelines specify that drug and drug products must be phototested to ensure that exposure to light does not cause photochemical degradation of the product or packaging. The product under test must receive a measured dose of both UV-A (200 watt-hours per square meter) and visible (1.2 million lux-hours) optical radiation exposure. This requires both radiometric and photometric measurements in terms of illuminance in lux and UV-(315 to 400 nm) irradiance in W/m2 multiplied by exposure time in hours.
Storage Conditions
- 250C Ambient Humidity.
- 300C Ambient Humidity.
- Photostability…. 1,000 to 10,000 Lux (ICH Option 2).
Sequential and simultaneous ageing test. In addition to the temperature ageing, the short period photo-ageing is separately carried out with extremely strong light having a defined lighting specifications or the simultaneous ageing with temperature lighting in accordance with ICH guidelines.
- Construction as per cGMP regulations.
- Consisting of refrigeration, air handling, humidification, dehumidification,
temperature/humidity controlling
- Microprocessor based 2 channel multifunctional PID Temperature / Humidity
( RH) controller for simultaneous control of temperature and % RH. OR
PLC based system for chamber control and auto changeover of standby system
with touch screen display.
- Printer interface & PC interface for data storage
- Standard networking via Ethernet.
Light sources option 2 :
- UVA intensities = 1.5 w/m2 (require about 133 hours)
- VIS intensities = 10,000 lux (require 120 hours)
Validation :
DQ/ FAT /IQ / OQ / PQ documentation with test and calibration certificate.
Safety Features :
- Special software incorporated in the controller to give ‘FAULT’ indication in case of
failure of any control system.
- Audio alarm to signal variation in set temperature.
- A safety thermostat is provided to switch off the illumination if temperature overshoots.
- Door switch to switch off the UV light when door is opened.
- Safety digital temperature controller for main controller : In the event of failure of Micro-
PID Controller the high accurate safety controller will take over temperature controlling.
- Over load Protector for compressor.
Temperature Range |
: 20°C to 60°C |
Accuracy |
: ± 0.2°C |
Temperature uniformity |
: ± 1 °C. |
Power supply |
: 1 Phase, 230V ±10% AC, 50 Hz |
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Photostability Chamber with Humidity
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Temperature Range |
: 20°C to 60°C |
Accuracy |
: ± 0.2°C |
Temperature uniformity |
: ± 1 °C. |
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Humidity Range |
: 40% to 90% |
Accuracy |
: + 2% RH |
Humidity Uniformity |
: + 3% RH |
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N.B. : Internal light sensors to continuously monitor the light and
UV-A output can be provided on request.
Internal & External dimension : |
