The photostability test chamber VP 500-L has an ideal light, temperature and humidity distribution and is thus able to simulate reproducible light and climatic conditions. The lighting equipment complies with the ICH Guideline Q1B Option 2 and enables photostability tests to be performed in less than 100 hours. All specimens are positioned at the same distance from the light source and are evenly irradiated by a special light/UV filter system. This system can be equipped with appropriate light and UV sensors for recording irradiation values, e.g. the total number of lux hours as well as the total irradiation.
Test space volumes: 460 l
Temperature range: from +10 to +50 °C
Humidity range: from 20 to 90 % RH
Illumination: max. 25000 lx
UV energy: max. 3,7 W/m²
The documentation of temperature and humidity and optional illumination is obtainable via an interface and our optional software S!MPATI* Pharma (in accordance with FDA 21 CFR, Part 11) and also possible via an independent measurement system.
Qualification documentation according to FDA requirements is available.
Leaflet Stability Testing GMP & FDA (pdf)