For work with group 1 biological agents including life attenuated vaccines, the principles of good occupational safety and hygiene should be observed.
Group 2, 3 and 4 biological agents
It may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.
Containment measures | Containment levels | ||||
|---|---|---|---|---|---|
| 2 | 3 | 4 | |||
1. Viable organisms should be handled in a system which physically separates the process from the environment | Yes | Yes | Yes | ||
2. Exhaust gases from the closed system should be treated so as to: | Minimize release | Prevent release | Prevent release | ||
3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to: | Minimize release | Prevent release | Prevent release | ||
4. Bulk culture fluids should not be removed from the closed system unless the viable 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: | Minimize 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 airlock | ||
(c) Personnel should wear protective clothing | Yes, work clothing | 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 minimize air contamination | Optional | Optional | Yes | ||
(h) The controlled area should be maintained at air pressure negative to atmosphere | No | Optional | Yes | ||
(i) Input air and extact 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 the closed system | No | Optional | Yes | ||
(k) The controlled area should be sealable to permit fumigation | No | Optional | Yes | ||
(l). Effluent treatment before final discharge | Inactivated by validated means | Inactivated by validated chemical or physical means | Inactivated by validated chemical or physical means | ||