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- Evidence for correct cleaning: visual clean criterion, hygiene monitoring
- equipment specific cleaning procedures
- sealed/closed equipment design
- Dedusting unit
- Manufacturing area daily cleaning period
- Evidence for correct cleaning: hygiene monitoring
HVAC System (if necessary containments for segregation are available)
F* area for manufacturing area
- High air renewal rate (8 times/ h)
- Used filter (HEPA H-13)
- Turbulence displacement flow in the dispensing area
- AA-SOP-0682 ‘Umgang mit dem Alarm- und Monitoringsystem, Verhalten bei Stormeldung’ (dealing with the alarm and monitoring system, behaviour with error message)
- AA-SOP-0682 ‘Umgang mit dem Alarm- und Monitoringsystem, Verhalten bei Stormeldung-(dealing with the alarm and monitoring system, **behaviour with error message**)