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PHOTOSTABILITY CHAMBERS

ICH GUIDELINES (ICH Q1B ).
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.

ILLUMINATION
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.

INTELLIGENT CONTROL SYSTEM
The controlling system having is PLC Base and PC communication on Ethernet and data acquisition system complying with 21 CFR Part 11.

SENSOR
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.

COOLING SYSTEM :
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.

ALARMS :
Audio and visual alarms are generated for temperature variation, utility failure.

SAFETY :
A Safety thermostat to switch off the tube lights if temperature overshoots. Door switch to switch off the UV light when door is opened.

STANDBY SENSOR :
When controlling sensor fails it automatically switch over to standby sensor.

The unit works on 230 Volts AC and 50Hz mains supply.

SELECTION GUIDE FOR PHOTOSTABILITY CHAMBER :

Temperature Range : 10 °C to 40°C	Accuracy : ± 0.5°C
Temperature Uniformity : ±1.0°C

Models		Capacity		Inner Chamber Dimension	External Dimension
Exterior M.S	Exterior S.S	Cuft.	Liters	H x W x D (mm)	H x W x D (mm)
NEC-103RSP	NEC-103RSPS S	3	90	450 x 470 x 450	1200 x 600 x 900

SELECTION GUIDE FOR PHOTOSTABILITY CHAMBER WITH HUMIDITY :

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

Models		Capacity		Inner Chamber Dimension	External Dimension
Exterior M.S	Exterior S.S	Cuft.	Liters	H x W x D (mm)	H x W x D (mm)
NEC-203RSP	NEC-203RSPS	3	90	450 x 470 x 450	1200 x 600 x 900

* N.B. Custom build chambers also available