10 steps to close the gap in the containment
Step 7: Protection of the operator during HEPA filter change
OEB 1 – 6

Here, too, the system must be designed in such a way that only trained personnel can carry out the procedure and thus ensure that the containment cannot be broken by incorrect treatment.

Additional components must be provided to the filter system, to make a safe, ergonomic and contamination-free filter change according to OEB 1 – 6 possible.

  • The lifting table
    makes a safe and ergonomic, simple HEPA filter change process possible
  • Bag sealing tools
    make a safe closing of the plastic bag possible, so that it cannot leak anytime.
  • Glove in plastic bag
    allows that neither the sealed HEPA filter cassette nor the dirtied filter unit inside can emit dust into the room and contaminate the operator.
  • Disposal of sealed HEPA filter cassette in a plastic bag additionally in a fibre drum
    for OEB 5 / 6 levels H10/G HEPA filter cassette types can be sealed additionally as second security in fibre drums. 
Thus the HEPA cassette can be transported in a safe way to the place of disposal or incineration.

The OEB level to be achieved can be proven accordingly during validation.

  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.