ANNEX IV
Table II
Containment and other protective measures for other activities
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General
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1 |
Viable micro-organisms should be contained in a system which separates the process from the environment (closed system) |
Optional |
Required |
Required |
Required |
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2 |
Control of exhaust gases from the closed system |
Not required |
Required, minimise dissemination |
Required, prevent dissemination |
Required, prevent dissemination |
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3 |
Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system |
Optional |
Required, minimise dissemination |
Required, prevent dissemination |
Required, prevent dissemination |
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4 |
Inactivation of bulk culture fluids before removal from the closed system |
Optional |
Required, by validated means |
Required, by validated means |
Required, by validated means |
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5 |
Seals should be designed so as to minimise or prevent release |
No specific requirement |
Minimise dissemination |
Prevent dissemination |
Prevent dissemination |
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6 |
The controlled area should be designed to contain spillage of the entire contents of the closed system |
Optional |
Optional |
Required |
Required |
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7 |
The controlled area should be sealable to permit fumigation |
Not required |
Optional |
Optional |
Required |
Equipment
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8 |
Entry via airlock
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Not required |
Not required |
Optional |
Required |
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9 |
Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean |
Required (bench if any) |
Required (bench if any) |
Required (bench if any, floor) |
Required (bench, floor, ceiling, walls) |
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10 |
Specific measures to adequately ventilate the controlled area in order to minimise air contamination |
Optional |
Optional |
Optional |
Required |
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11 |
The controlled area should be maintained at an air pressure negative to the immediate surroundings |
Not required |
Not required |
Optional |
Required |
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12 |
Extract and input air from the controlled area should be HEPA-filtered |
Not required |
Not required |
Required |
Required |
System of work
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13 |
Closed systems should be located within a controlled area |
Not required |
Optional |
Required |
Required |
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14 |
Access should be restricted to nominated personnel only |
Not required |
Required |
Required |
Required |
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15 |
Biohazard sign should be posted |
Not required |
Required |
Required |
Required |
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17 |
Personnel should shower before leaving the controlled area |
Not required |
Not required |
Optional |
Required |
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18 |
Personnel should wear protective clothing |
Required (work clothing) |
Required (work clothing) |
Required |
Complete change before exit and entry |
Waste
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22 |
Inactivation of GMMs in effluent from handwashing sinks and showers or similar effluents |
Not required |
Not required |
Optional |
Required |
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23 |
Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge |
Optional |
Required, by validated means |
Required, by validated means |
Required, by validated means |