| 2 | 3 | 4 |
| Viable microorganisms will be handled in a system that physically separates the process from the environment. | Yes | Yes | Yes |
| The exhaust gases from the closed system must be treated in order to: | Minimising release | Preventing release | Preventing release |
| The taking of samples, the addition of materials to a closed system and the transfer of organisms to another closed system will be carried out in a way that allows: | Minimising release | Preventing release | Preventing release |
| Fluids from large cultures must not be removed from the closed system unless the viable micro-organisms have been: | Inactivated by proven effective means | Inactivated by physical or chemical means of proven efficacy | Inactivated by physical or chemical means of proven efficacy |
| The seals will be designed so as to | minimising release | preventing release | preventing release |
| The closed systems will be located in a controlled area: | Optional | Sí | Sí |
| Signs of biological danger will be placed on the site | Optional | Sí | Sí |
| Access will only be allowed to designated personnel | Optional | Sí | Yes, by airlock |
| Personnel must wear protective clothing | Yes, working clothes | Yes | Completely changed |
| Staff must be provided with decontamination and renting facilities | Yes | Yes | Yes |
| The personnel will have to be in a safe area before leaving the controlled area | No | Optional | Yes |
| Effluent from sinks and showers shall be collected and inactivated before release | No | Optional | Yes |
| The controlled area must be adequately ventilated to minimise atmospheric pollution | Optional | Optional | Yes |
| In the controlled area a negative air pressure will be maintained regarding the atmosphere | No | Optional | Yes |
| The air entering and leaving the controlled area shall be treated with HEPA filters | No | Optional | Yes |
| The controlled area shall be designed to prevent leakage of the closed system content | No | Optional | Yes |
| The controlled area may be sealed for fumigation | No | Optional | Yes |
| Effluent treatment before final discharge | Inactivated by proven effective means | Inactivated by proven physical or chemical means | Inactivated by proven physical or chemical means |