Just like any production machine or manual handling system, the filter system can be validated at the same OEB level together with the devices with which it is connected to.
Here it is of great importance, that it is demonstrated wholistically that:
the production machine(s), as well as the self-cleaning HEPA filter system connected to each otherboth functions according to the User Requirements Specification (URS), and meet the required OEB level, without breaking it at any time. during manual handling processesthe equipment in the production area, as well as the self-cleaning HEPA filter system, are at the same OEB level required and can be validated. the air managementof the equipment in the production area, as well as the filter system is correctly dimensioned,
so that a contamination of the operator as well as cross-contamination is impossible.