[Regulation 16 C]
For work with group 1 biological agents, including life-attenuated vaccines, the principles of good occupational safety and hygiene should be observed.
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.
The measures contained in this Annexure shall be applied according to the nature of the activities, the assessment of risk and the nature of the HBA concerned.
| A. Containment Measures | B. Containment Levels | |||
|---|---|---|---|---|
| Level 2 | Level 3 | Level 4 | ||
| 1. | Viable organisms should be handled in a system, which physically separates the process from the environment. | Yes | Yes | Yes |
| 2. | Extracted air 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 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 organisms have been - | inactivated by validated means | inactivated by validated chemical or physical means prevent release | inactivated by validated chemical or physical means |
| 5. | Seals should be designed as to - | Minimise release | Optional | Prevent release |
| 6. | Closed systems should be located within a controlled area. | optional | Yes | 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 an airlock |
| c. | Personnel should weal 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 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 air 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 the closed system | No | Optional | Yes |
| k. | The controlled area should be sealable in order to permit fumigation | No | Optional | Yes |
| l. | Effluent before final discharge | Inactivated by validated means | Inactivated by validated chemical or physical means | Inactivated by validated chemical or physical means |
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