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 |
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