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Quote from iqbalsikder on July 21, 2025, 7:11 amHow can I set the excursion allowable time if RH/temperature/both goes out of limit within the production area? To set a fixed time or allowable limit, might have to conduct a risk assessment. But how to do that?
Our production area limit: RH (20-40)% and Tem: (15-25) degrees Celsius; Intended Product: Inhaler (MDI & DPI)
How can I set the excursion allowable time if RH/temperature/both goes out of limit within the production area? To set a fixed time or allowable limit, might have to conduct a risk assessment. But how to do that?
Our production area limit: RH (20-40)% and Tem: (15-25) degrees Celsius; Intended Product: Inhaler (MDI & DPI)