What’s the “Actionable Gist” of EU GMP for HVAC? At the heart of all that we usually care about while designing, commissioning, or qualifying HVAC systems for a sterile manufacturing facility are three letters: GMP (Good Manufacturing Practice). From air changes to room pressures to room classification to filtration, all key HVAC requirements ultimately originate […]
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How to Avoid Extra Cost, Delays, and Confusion: Write 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 URS never saw the
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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