BELGIAN BIOSAFETY SERVER : Directive 98/81/EC
[Annex IV : Principles - Table I A - Table I B - Table I C - Table II]
[Contents] [Preamble] [Articles] [Annex I] [Annex II] [Annex III] [Annex V]

ANNEX IV

Table II

Containment and other protective measures for other activities

Specifications
Containment levels
1
2
3
4

General

1

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

Optional

Required

Required

Required

2

Control of exhaust gases from the closed system

Not required

Required, minimise dissemination

Required, prevent dissemination

Required, prevent dissemination

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

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

5

Seals should be designed so as to minimise or prevent release

No specific requirement

Minimise dissemination

Prevent dissemination

Prevent dissemination

6

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

Optional

Optional

Required

Required

7

The controlled area should be sealable to permit fumigation

Not required

Optional

Optional

Required

Equipment

8

Entry via airlock

Not required

Not required

Optional

Required

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)

10

Specific measures to adequately ventilate the controlled area in order to minimise air contamination

Optional

Optional

Optional

Required

11

The controlled area should be maintained at an air pressure negative to the immediate surroundings

Not required

Not required

Optional

Required

12

Extract and input air from the controlled area should be HEPA-filtered

Not required

Not required

Required
(extract air, optional for input air)

Required
(input and extract air)

System of work

13

Closed systems should be located within a controlled area

Not required

Optional

Required

Required

14

Access should be restricted to nominated personnel only

Not required

Required

Required

Required

15

Biohazard sign should be posted

Not required

Required

Required

Required

17

Personnel should shower before leaving the controlled area

Not required

Not required

Optional

Required

18

Personnel should wear protective clothing

Required (work clothing)

Required (work clothing)

Required

Complete change before exit and entry

Waste

22

Inactivation of GMMs in effluent from handwashing sinks and showers or similar effluents

Not required

Not required

Optional

Required

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


BELGIAN BIOSAFETY SERVER : Directive 98/81/EC
[Annex IV : Principles - Table I A - Table I B - Table I C - Table II]
[Contents] [Preamble] [Articles] [Annex I] [Annex II] [Annex III] [Annex V]