10 steps to close the gap in the containment
Step 10: Validation of the filter system.
The self-cleaning HEPA filter system becomes a fully adequate production machine.

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 other
    both functions according to the User Requirements Specification (URS), and meet the required OEB level, without breaking it at any time.
  • during manual handling processes
    the 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 management
    of 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.

  1. Grading of standardized self-cleaning HEPA filter units according to OEB requirements OEB 1-6.
  2. Selection of equivalent self-cleaning HEPA filter systems, which comply with the respective production machine(s), so that both can be validated at the same OEB level.
  3. Avoidance of cross-contamination.
    Engineering of air management solutions, so that no cross-contamination of products can occur.
  4. Developing filtration islands
    for 1-5 production machines only.
  5. Protection of the environment.
    Guaranteed filter efficiency H14 EN 1822 at any time.
  6. Protection of the operator during dust recovery
    OEB 1-6
  7. Protection of the operator during HEPA filter change
    OEB 1-6
  8. Fully automated control technology
    to avoid false handling of the system by the operator at any time.
  9. Explosion prevention
    to avoid any kind of explosion within the filter system and thus protect the operator and the environment, as well as prevent cross-contamination.
  10. Validation of the filter system. The self-cleaning HEPA filter system becomes a fully adequate production machine.