What’s HVAC Design Qualification (DQ) and How To Do It? No project starts with a strategy to ignore the quality of design, but in the powerplay of a typical biopharma project, it happens: Under the severe constraints of time and cost, the design gets rushed and its quality gets crushed. However, the quality of design […]
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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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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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