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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How to Avoid Project Choices That Bite Back Later In projects, as in life, sometimes we make critical choices that initially look smart but later turn out to be dumb. During the lifecycle of a biopharma project, especially during the initial design phase, many such choices have to be made that do not reveal their
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Why is a Well-Written HVAC Commissioning Protocol a Game Changer? Regarding HVAC C&Q (commissioning and qualification), everyone understands that the second part – Q (qualification) requires detailed qualification test protocols. Tremendous effort goes into writing, executing, and approving these test protocols (DQ, IQ, and OQ) that serve as the “proof of the quality” during regulatory
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