Picking HVAC Guidance Needles in PIC/S Haystack FDA GMP regulations are legally binding for drugs marketed in the US. Similarly, EU GMP regulations are binding for the EU market. But what about the rest of the world? That’s where PIC/S (Pharmaceutical Inspection Co-operation Scheme) comes in. While not legally binding, it offers harmonized guidance that […]
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Confusion Worth Avoiding: Design Vs. Minimum Air Changes Painful conflicts and problems in HVAC design often arise due to misunderstanding of the design requirements. When designing HVAC systems for pharmaceutical cleanrooms, one parameter that often creates confusion is Air Changes Per Hour (ACPH). ACPH significantly affects duct sizing, filter selection, air handling units (AHUs), space
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ISO 14644-16: Are 50 Pages Worth $500,000 of Energy Savings? ISO standards are usually a dry read, full of generalities with a few specifics — and open to different interpretations. An encounter with a typical ISO standard can easily drain your energy. But ISO 14644-16 (Energy Efficiency in Cleanrooms and Separative Devices) seems to be
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