Insights Practical HVAC-CQ insights Drawn from fifteen years of commissioning and qualifying HVAC for biopharma facilities. Regulations and standards What’s the actionable gist of EU GMP for HVAC? FDA’s GMP regulations through a special HVAC filter Stuck on a flight with nothing to read except ISO 14644 Picking HVAC guidance needles in the PIC/S haystack User requirements and design How to draw sensible system boundaries Is <65% RH a safe bet with untreated fresh air in Singapore? How to systematically review HVAC design How to avoid cost and delays: write user requirements at the very beginning How to avoid project choices that bite back later What is HVAC Design Qualification, and how to do it? Design vs. minimum air changes per hour (ACPH) Construction and commissioning From Mechanical Completion to PQ: the sequence Three classic pitfalls that delay commissioning How to systematically walk down a system How to do air balancing for a biopharma facility How to commission HVAC systems for a biopharma facility How to systematically troubleshoot commissioning problems Why a well-written commissioning protocol is a game changer Qualification What to test for HVAC Operational Qualification What are the key prerequisites to HVAC qualification? What can be leveraged from commissioning to OQ? Step by step, how to qualify HVAC systems How to do temperature mapping for warehouse qualification How to set alarm delays for GMP differential pressure alarms How to raise the quality of HVAC qualification Energy saving How to save energy by trimming excessive air changes ISO 14644-16: Are 50 pages worth $500,000 of savings? Project management The subtle art of not screwing projects The law of karma Biopharma projects: seven random lessons What happens when HVAC and AI meet over drinks Project schedule: a knife that divides or glue that unites?
