| 1. | Viable micro-organisms shall be contained in a system that physically separates the work operation from the surrounding environment | Yes | Yes | Yes |
| 2. | Closed production systems shall be placed in a confined area (rooms, buildings) | Recommended | Yes | Yes, confined area built for the purpose |
| 3. | A biological hazard sign shall be posted | Yes | Yes | Yes |
| 4. | An anteroom shall be provided | No | Yes, alternatively an airlock | Yes, airlock |
| 5. | An observation window or similar arrangement shall be provided so that the occupants can be seen | Recommended | Yes | Yes |
| 6. | It must be possible to communicate from inside the area | Yes | Yes, handsfree telephone/ calling system recommended | Yes, handsfree telephone/ calling system |
| 7. | The confined area must have sufficient ventilation to reduce the air pollution to a minimum | Recommended | Recommended | Yes |
| 8. | The pressure in the confined area must be lower than the atmospheric pressure | No | Recommended, with air pressure control | Yes, with air pressure control |
| 9. | Input and extract air from the confined area shall be filtered with the aid of a HEPA filter | No | Yes, extract air | Yes, extract and input air |
| 10. | The confined area must have emergency power | No | Recommended | Yes |
| 11. | Gases released from the closed system shall be handled in a manner whereby | spreading is reduced to a minimum | spreading does not occur | spreading does not occur |
| 12. | Sampling, adding substances to a closed system and transferring viable microorganisms to another closed system shall be performed in a manner whereby | spreading is reduced to a minimum | spreading does not occur | spreading does not occur |
| 13. | Culture fluids shall not be removed from the closed system unless the viable micro-organisms have been | rendered inert with the aid of recognised methods | rendered inert with the aid of recognised chemical or physical methods | rendered inert with the aid of recognised chemical or physical methods |
| 14. | Seals shall be designed in a manner whereby | spreading is reduced to a minimum | spreading does not occur | spreading does not occur |
| 15. | The confined area shall be designed to hold the entire content of the closed system in the event of spillage from that system | No | Yes | Yes |
| 16. | Surfaces must be watertight and easy to clean | Yes, on worktops and similar | Yes, on worktops and similar and floors | Yes, on worktops and similar, floors and ceilings |
| 17. | Surfaces must be resistant to acids, alkalis, solvents and disinfectants | Yes, on work- tops | Yes, on worktops and floors | Yes, on worktops, walls, floors and ceilings |
| 18. | It must be possible to disinfect polluted equipment in the confined area (corresponding effect as autoclave) | No | Yes | Yes |
| 19. | The confined area must be sealable to enable fumigation | No | Yes | Yes |
| 20. | Disinfection procedures shall be specified | Yes | Yes | Yes |
| 21. | Wastewater shall be treated before final disposal | rendered inert with the aid of recognised methods | rendered inert with the aid of recognised chemical or physical methods | rendered inert with the aid of recognised chemical or physical methods |
| 22. | Only designated personnel shall have access | Recommended | Yes | Yes, via airlock |
| 23. | Personnel shall wear protective clothing | Yes, work clothes | Yes, protective clothing | Yes, complete change of clothing |
| 24. | Personnel shall have access to decontamination units and sanitary facilities | Yes | Yes | Yes |
| 25. | Personnel shall shower before leaving the zone | No | Recommended | Yes |
| 26. | Wastewater from washbasins and showers shall be collected and treated to render it inert before it is discharged | No | Recommended | Yes |
