1

Viable micro-organisms should be contained in a system which physically separates the process from the environment (closed system).

2

Exhaust gases from the closed system should be treated so as to–

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–

4

Bulk culture fluids should not be removed from the closed system unless the viable micro-organisms have been–

5

Seals should be designed so as to–

6

Closed systems should be located within a controlled area–

a

biohazard signs should be posted;

b

access should be restricted to nominated personnel only;

c

personnel should wear protective clothing;

d

decontamination and washing facilities should be provided for personnel;

e

personnel should shower before leaving the controlled area;

f

effluent from sinks and showers should be collected and inactivated before release;

g

the controlled area should be adequately ventilated to minimise air contamination;

h

the controlled area should be maintained at an air pressure negative to atmosphere;

i

input and extract air to the controlled area should be HEPA filtered;

j

the controlled area should be designed to contain spillage of the entire contents of closed system;

k

the controlled area should be sealable to permit fumigation.

7

Effluent treatment before final discharge.