Cleanroom Temperature & Humidity: Are Your Limits Scientifically… — Pharmatalks — TG.ME

🌡️ Cleanroom Temperature & Humidity: Are Your Limits Scientifically Justified? Temperature and relative humidity are important cleanroom parameters—but EU GMP Annex 1 does not define fixed Grade A–D temperature/RH limits like the example ranges shown in this graphic. Instead, environmental conditions should be controlled within ranges appropriate to the product, process, equipment, and personnel requirements. (Public Health) 🔹 Why control temperature? • Supports process consistency • Helps maintain product stability • Improves operator comfort • Can influence equipment and HVAC performance 💧 Why control relative humidity? • Helps control condensation risk • Supports material and product requirements • Can reduce electrostatic issues • Contributes to stable cleanroom operation ⚠️ Important: Values such as 20–22°C or 45–60% RH may be useful facility design or operating targets, but they should not be presented as universal EU GMP Annex 1 Grade A–D limits.