10 steps to close the gap in the containment
Step 6: Protection of the operator during dust recovery
OEB 1 – 6

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, and
  • The 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.

OEB 1 – 3

OEB 4 – Inside the glove box

OEB 4 & 5 – Inside glove box / isolator and endless liner

OEB 6 – with isolator, RTP port and WIP / CIP device

  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.