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PHOTOSTABILITY
CHAMBERS
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ICH GUIDELINES
(ICH Q1B).
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For confirmatory
studies, samples should be exposed to light providing an overall
illumination of not less than 1.2 million Lux hours and an
integrated near ultraviolet energy of not less than 200 watt
hours/square meter to allow direct comparisons to be made
between the drug substance and drug product.
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| CONSTRUCTION : |
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Double walled interior made of stainless steel. Exterior of mild
finished in powder coating paint (optional stainless steel). Glass-wool/PUF
insulation between both the wall is provided. Full-length inner
glass door and outside metal door with magnetic gasket and lock.
Forced air circulation for uniform temperature. One stainless
steel, perforated tray is provided. The tray can be placed at
various heights to accommodate the change in sample height. The
purpose of doing so is to vary the exposure intensity to reduce
the test duration. PU wheels for easy movability. In case of model
Photostability Chamber With Humidity. Humidity is by steam injection
and Humidity is directly displayed in % RH measured by capacitance
type Electronic Humidity Sensor.
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| ILLUMINATION |
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Chamber is illuminated using 4nos of flourescent tube light to
produce visible light (measure in lux). A one no. Near UV light
of wavelength 365nm (measured in watt/sq. Meter) are fitted on
topside of the chamber.
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| INTELLIGENT CONTROL SYSTEM : |
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The controlling system having is PLC Base and PC communication
on Ethernet and data acquisition system complying with
21 CFR Part 11.
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| SENESOR : |
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Temperature and Humidity transmitter 4-20mA used for measurement.
Temperature in degree Celsius and Humidity in %RH with 0.1°C and
0.1%RH resolution.
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| COOLING SYSTEM : |
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Hermetically sealed compressor couple with evaporation coil and
fan cooled condenser, assembled in easy serviceable tray at bottom
provides cooling below ambient temperature. Cooling in the chamber
in necessary as the light source also generates excessive heat,
which results in burning of samples without cooling.
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| ALARMS
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Audio and visual alarms are generated for temperature variation,
utility failure.
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| SAFETY
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A Safety thermostat to switch off the tube lights if temperature
overshoots. Door switch to switch off the UV light when door is
opened.
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| STANDBY
SENSOR : |
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When controlling sensor fails it automaticallyswitch over to standby
sensor.
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The unit works on 230 Volts AC and 50Hz mains supply. |
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| SELECTION GUIDE
FOR PHOTOSTABILITY CHAMBER : |
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| Temperature Range : 10°C to 40°C |
Accuracy : ± 0.5°C |
| Temperature Uniformity : ±1°C |
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Models
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Capacity
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Inner Chamber
Dimension
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External
Dimension
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Exterior M.S.
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Exterior S.S.
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Cuft.
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Liters
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H x W x D (mm)
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H x W x D (mm)
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NEC-103RSP
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NEC-103RSPS
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3
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90
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450 x 470 x 450
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1200 x 600 x 900
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| SELECTION GUIDE
FOR PHOTOSTABILITY CHAMBER WITH
HUMIDITY : |
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| Temperature Range : 10°C to 40°C |
Accuracy : ± 0.2°C |
| Humidity Range : 40% RH to 80% RH |
Accuracy : ±2% RH |
| Temperature Uniformity : ±1°C |
Humidity Uniformity : ± 3% RH |
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Models
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Capacity
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Inner Chamber
Dimension
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External
Dimension
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Exterior M.S.
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Exterior S.S.
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Cuft.
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Liters
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H x W x D (mm)
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H x W x D (mm)
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NEC-203RSP
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NEC-203RSPS
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3
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90
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450 x 470 x 450
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1200 x 600 x 900
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* N.B. CUSTOM BUILD CHMABERS ALSO AVAILABLE. |
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| OPTIONALS
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