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Elements to Consider When Qualifying Control Environmental Chambers Used for CGMP Applications | IVT

As part of the installation, operational, and performance qualification (IQ, OQ, PQ) protocol of the control of environmental chambers, the thermo-mapping elements for testing are indicated as follows: Installation meeting the design specification  Empty chamber thermo-mapping test Open-door study (for informational purposes only) Power failure (for informational purposes only) Full loaded chamber thermo-profile mapping. This is a technical article on how to perform a specific validation function. This article aims to give guidance to the industry on utilizing one methodology for thermo-mapping...

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