How to Raise the Quality of HVAC Qualification The 3-day HVAC qualification testing of a small warehouse in our fast-paced project had just ended. The testing included recording the warehouse’s temperature (T) and relative humidity (RH) using 29 sensors: 26 portable T & RH loggers and 3 EMS (Environmental Monitoring System) sensors: two (2) temperature
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How to Set Alarm Delays for GMP Differential Pressure Alarms Among all the HVAC-related GMP requirements, one of the most critical is the pressure difference between rooms of different grades. According to Annex-1 (EU GMP), a minimum of 10 Pa pressure difference should be maintained between rooms of different grades. The regulations also require a
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How to do Temperature Mapping for Warehouse Qualification A material storage area or warehouse is often a second-tier priority in a biopharma project. Unlike process areas, the environmental requirements are much more relaxed–no air changes or room pressures or particle counts to worry about. Compared to process areas, the temperature and humidity can vary over
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