| 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. |