stability chamber qualification procedure
IQ/OQ/PQ for stability chambers Following steps are performed by Meditech Technologies private India Limited to perform stability chamber qualification. Basic Overall Approach Meditech performs the basics of all qualifications. IQ/OQ and PQ are therefore performed prior to use. To begin the testing, Meditech establishes the operation conditions such as temperature and relative humidity and prepare IQ/OQ/PQ protocols based on the pre established user requirements specifications. The acceptance criteria for the above tests and mappings are clear on the protocols. Installation Qualification The first step is to check the correct positioning of the chamber and then check if the chamber and all components are correctly installed, and also the presence of documentation. Documentation usually includes user’s manual, certificates and SOPs. Utilities can be verified at this phase: electrical feeding, water (pressure, pumps, filters and connections) and exhaust. If the chamb
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