Stability 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 stability
testing has been adopted across Europe, Japan and the United States.
Within stability 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.
Stability 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 stability and photo-stability testing of drugs
according
stability 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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