HUMIDITY
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 humidity testing has been adopted across Europe, Japan
and the United States.
Within humidity 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.
Humidity 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
humidity 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 Stability Chamber serves as an important quality
attribute for the product. |
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