Stability tests of drugs, e.g. as per ICH can be performed in the Bio Line Pharma systems. The compact Bio Line Pharma chambers offer large storage areas approx. 10 m² or 20 m ² – without taking up a great deal of space.
Storage space: 9,6 m² or 19,2 m²
Shelves: 15 or 30 pieces
Temperature range for climatic tests: +5 °C to +45 °C
Humidity range: 40 % to 95 % RH
The documentation of temperature and humidity 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)