Medicines and Related Substances Act, 1965
R 385
Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)RegulationsHazardous Biological Agents RegulationsAnnexure F : Containment for Industrial Processes |
[Regulation 16 C]
Group 1 biological agents
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 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.
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A. Containment Measures |
B. Containment Levels |
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Level 2 |
Level 3 |
Level 4 |
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1. |
Viable organisms should be handled in a system, which physically separates the process from the environment. |
Yes |
Yes |
Yes |
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2. |
Extracted air from the closed system should be treated so as to - |
Minimise release |
Prevent release |
Prevent release |
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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 |
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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 |
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5. |
Seals should be designed as to - |
Minimise release |
Optional |
Prevent release |
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6. |
Closed systems should be located within a controlled area. |
Optional |
Yes |
Yes, and purpose-built |
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a. |
Biohazard signs should be posted. |
Optional |
Yes |
Yes |
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b. |
Access should be restricted-to nominated personnel only. |
Optional |
Yes |
Yes, via an airlock |
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c. |
Personnel should weal protective clothing. |
Yes, work clothing |
Yes |
A complete change |
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d. |
Decontamination and washing facilities should be provided for personnel. |
Yes |
Yes |
Yes |
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e. |
Personnel should shower before leaving the controlled area. |
No |
Optional |
Yes |
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f. |
Effluent from sinks and showers should be collected and inactivated before release. |
No |
Optional |
Yes |
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g. |
The controlled area should be adequately ventilated to minimise air contamination. |
optional |
Optional |
Yes |
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h. |
The controlled area should be maintained at an air pressure negative to atmosphere. |
No |
Optional |
Yes |
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i. |
Input air and extract air to the controlled area should be HEPA filtered. |
No |
Optional |
Yes |
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j. |
The controlled area should be designed to contain spillage of the entire contents of the closed system. |
No |
Optional |
Yes |
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k. |
The controlled area should be sealable in order to permit fumigation |
No |
Optional |
Yes |
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l. |
Effluent before final discharge |
Inactivated by validated means |
Inactivated by validated chemical or physical means |
Inactivated by validated chemical or physical means |
