Detailed Product Description

Photostability chamber  satisfies  both FDA and ICH guidelines.

Salient Features :

• 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 and UV light sources.
• Door switch for switch off the UV light when door is opened.
• Regular & GMP model.
• Temperature range : 5°C to 50°C, ± 0.5°C.
• Humidity range :  40% to 95% ± 2% RH.
• Illumination : 1.2 million Lux hours.
• UV light :  UV-A, 200 watts hours/m²
• Capacity : 200 / 400 / 800 / 1000 Litres

Storage Conditions :

5°C Refrigerated Condition.
25°C Ambient Humidity.
25°C / 60% R.H. Primary ICH Long Term Condition.
30°C Ambient Humidity.
30°C / 60% R.H. Intermediate ICH Condition.
40°C / 75% R.H. Accelerated ICH Condition.

Photostability... 1,000 to 10,000 Lux  (ICH Option 2).

Sequential and simultaneous ageing test. In addition to the temperature and humidity 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, humidity and lighting in accordance with ICH guidelines.

The stability tests in accordance to the ICH guidelines CPMP/ICH/279/95 under constant temperature and humidity conditions and at the same time under the effect of light.