| Containment measures | Containment levels | |||
|---|---|---|---|---|
| 2 | 3 | 4 | ||
| 1 | Viable micro-organisms should be contained in a system which physically separates the process from the environment (closed system). | Yes | Yes | Yes |
| 2 | Exhaust gases from the closed system should be treated so as to— | Minimise release | Prevent release | Prevent release |
| 3 | Sample collection, addition of materials to a closed system and transfer of viable micro-organisms to another closed system, should be performed so as to— | Minimise release | Prevent release | Prevent release |
| 4 | Bulk culture fluids should not be removed from the closed system unless the viable micro-organisms have been— | Inactivated by validated means | Inactivated by validated chemical or physical means | Inactivated by validated chemical or physical means |
| 5 | Seals should be designed so as to— | Minimise release | Prevent release | Prevent release |
| 6 | Closed systems should be located within a controlled area— | Optional | Optional | Yes, and purpose-built |
(a)biohazard signs should be posted; | Optional | Yes | Yes | |
(b)access should be restricted to nominated personnel only; | Optional | Yes | Yes, via air-lock | |
(c)personnel should wear protective clothing; | Yes, work clothing | Yes | Yes, a complete change | |
(d)decontamination and washing facilities should be provided for personnel; | Yes | Yes | Yes | |
(e)personnel should shower before leaving the controlled area; | No | Optional | Yes | |
(f)effluent from sinks and showers should be collected and inactivated before release; | No | Optional | Yes | |
(g)the controlled area should be adequately ventilated to minimise air contamination; | Optional | Optional | Yes | |
(h)the controlled area should be maintained at an air pressure negative to atmosphere; | No | Optional | Yes | |
(i)input and extract air to the controlled area should be HEPA filtered; | No | Optional | Yes | |
(j)the controlled area should be designed to contain spillage of the entire contents of closed system; | Optional | Yes | Yes | |
(k)the controlled area should be sealable to permit fumigation. | No | Optional | Yes | |
| 7 | Effluent treatment before final discharge. | Inactivated by validated means | Inactivated by validated chemical or physical means | Inactivated by validated physical means |