How to Avoid Extra Cost, Delays and Confusion by One Simple Step: Writing User Requirements at the Very Beginning A few years back, as the owner’s HVAC Lead in a biopharma project, I had an urgent task on my hand: Create User Requirements Specifications (URS) for the Primary Air Handling Units (PAHUs). Unfortunately, this particular […]
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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Step by Step, How to Qualify HVAC systems? At which point an HVAC qualification team can proudly say, “HVAC qualification is done”? Is it after successfully completing Operational Qualification (OQ) or Environmental Monitoring Performance Qualification (EMPQ)? In my view, the right answer is EMPQ. Until EMPQ concludes, the game is not over! But then, what’s
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