10 steps to close the gap in the containment
Step 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.

In order not to break containment, it is utmost important, that production machines and filter units are at the OEB level and are linked together in accordance with engineered air management.

Only then is a complete validation of the production process possible. Thus, it can be proven that an impermissible contamination of the operators as well as a cross-contamination is excluded.

  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.