Since the dust recovery process takes place at very short intervals, the emptying of the dust containers must be designed according to the required OEB level.
The emptying of the dust container must be carried out at the same safety level as the product is handled in the production area, otherwise containment is broken during the dust recovery.
During the validation process, it must be proven in detail that:
The operator is exposed only to the maximum permitted OEB level during dust recovery, andThe production room is not dirtied during the dust recovery process, because the emitted dust into the room cannot be taken away by air management, so that the room must be cleaned additionally. In case of a product change there is furthermore the danger of cross-contamination.
The method of dust recovery has to be designed according to the required OEB level. The filter system is designed, so that only trained personnel can carry out the dust recovery process, and no breaking of containment can occur.
The OEB level to be achieved can be proven accordingly during validation.
