Can any on suggest how can we proceed for area requalifiction in case of sterile aseptic area where any new LAF is installed or any modification done. how can we qualify area in static condition as equipments are in place and personnel movement is there to operate particle counter and to do microbiological monitoring.
Thanks in advance
This basically a Change control mode:
- Take the previous drawings of room and electrical connections.
- Raise a change control and get approved the changes.
- Consider the impact of change in Space, People, Air quality, Suitability of space, Hazards etc.
- After proper risk impact evaluation- approve the change.
- Bring the proper laf into area and install as per protocol.
6.Operate the machine and requality the whole area for air changes and environmental monitoring.
7.Carry monitoring in with conditions like :people during operation and People with out operating.
- Compare the earlier validated data for that particular room for limits.
- Carry out environmental monitoring for adjescent room or corridor or Air locks.
All the air changes, Environmental monitoring and particulate monitoring must be considered both in static and Dynamic conditions.
Approve the qualification document.
thank for guidance but my question is how can we evaluate the area in static condition if equipments are in place and presonnel movement is there for non viable particle counter operation and plate exposure this condition we call it as dynamic as per guideline ( ISO 14644 )
Static condition is only equipments with out any movements.
Just do it before enter and people start their work.
In dynamic condition both people and equipments are at work.