Environmental testing of pharmaceutical products is addressed by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the final guidance on environmental testing has been adopted across Europe, Japan and the United States.
Within environmental test chambers, parameters such as temperature, humidity, differential pressure, lighting, gas levels and other environmental conditions must be controlled, monitored and documented. To reduce the risk of failed studies, a monitoring system designed for both functionality and compliance is required.
Environmental Test Chambers and Incubators with heating, cooling, lighting and humidity control are specifically designed for applications in which exact and reproducible simulation of various environmental conditions are important such as stability testing of components, packaging materials, food or chemicals, germination studies, plant cell or tissue cultures, insect cultures and humidity and photo-stability testing of drugs according
Environmental testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or product under recommended storage conditions. Hence, Pharmaceutical Environmental Chamber serves as an important quality attribute for the product
