Welcome to Pharma Topics Forums
The largest online community for industrial pharmacists.
Forum Navigation
Manufacturing Area RH & Temperature excursion allowable time
#1 · July 21, 2025, 7:11 am
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)
#2 · August 9, 2025, 12:45 am
You can do risk assessment considering:
- Molecule stability data
- Product stability data
- Product stress study data
- Current control (IPC test, Finished product test etc.)
- Future action (On-going stability study, Product recall procedure etc.)
