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The basis of the validation is to prove the anaerobic conditions are maintained by circulating the anaerobic gases such as CO2, H2 and N2 in addition to thermal mapping to identify risk to product that may be exposed to temperature that is unsuitable for its state and composition.
The IOQ (Installation Operational and Qualification) for Incubator Validation is to ensure that the Incubator has been installed in accordance with manufacturer’s specifications and operates correctly and is fit for use in accordance with cGLP, Health and Safety requirements and user requirements.
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