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Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)

Regulations

Hazardous Biological Agents Regulations

Annexure 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.

 

 

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