Climate chamber C/280

temperaturehumiditylaboratory

The Pharma cabinets from weisstechnik® were specifically developed to meet the requirements of a test laboratory in pharmaceutics. They are robustly constructed and available in four sizes: Pharma 280, Pharma 600, Pharma 1300 and Pharma 2000. Reliable measurements are ensured by: The work area of the cabinets easily complies with the requirements of ICH Q1A Guideline. The cabinets also allow tests to be conducted with other specifications in the power range of the systems. The temperature and air humidity are controlled by high-precision sensors in conjunction with a specially designed controller. Only tested pharmaceuticals get the required approval. All drugs are subject to particularly strict guidelines. To determine the shelf life, the stability of chemical, microbiological and physical properties of pharmaceutical substances must be proven in long-term tests under strictly defined climatic conditions. Regulatory authorities and the pharmaceutical industry have jointly developed the ICH* Guidelines for the harmonisation of stability tests, which ensure uniform storage and define the assessment of the batches. Here is an overview: During the entire test the deviation in temperature is stipulated at ±2 °C and the deviation in relative humidity is stipulated at ±5% RH. In the ICH Guideline Q1B the methods for performing photostability tests are established with an irradiation dose of 1.2 million lxh and an integrated UV part of 200 Wh/m².