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Manufacturing Area RH & Temperature excursion allowable time

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)