Section 8-5. Containment measures in industrial undertakings

In connection with industrial processes where biological agents in infection risk groups 2, 3 and 4 are used, cf. Annex 2 to the Regulations concerning Action and Limit Values, the following measures shall be implemented:
  1. a.
    at least containment level 2 for activities associated with group 2 biological agents;
  2. b.
    at least containment level 3 for activities associated with group 3 biological agents;
  3. c.
    at least containment level 4 for activities associated with group 4 biological agents.
In connection with industrial use of biological agents in infection risk groups 2, 3 or 4, competent authorities may decide which measures must be implemented.
As regards activities covered by this section, where a final classification of a biological agents has not been possible, but where there are indications that the planned use can entail serious harm to the employees' health, the work shall be carried out in premises that at least correspond to containment level 3.
For industrial processes, the following containment measures shall be implemented:
Containment measureContainment level
234
1.Viable micro-organisms shall be contained in a system that physically separates the work operation from the surrounding environmentYesYesYes
2.Closed production systems shall be placed in a confined area (rooms, buildings)RecommendedYesYes, confined area built for the purpose
3.A biological hazard sign shall be postedYesYesYes
4.An anteroom shall be providedNoYes, alternatively an airlockYes, airlock
5.An observation window or similar arrangement shall be provided so that the occupants can be seenRecommendedYesYes
6.It must be possible to communicate from inside the areaYesYes, handsfree telephone/ calling system recommendedYes, handsfree telephone/ calling system
7.The confined area must have sufficient ventilation to reduce the air pollution to a minimumRecommendedRecommendedYes
8.The pressure in the confined area must be lower than the atmospheric pressureNoRecommended, with air pressure controlYes, with air pressure control
9.Input and extract air from the confined area shall be filtered with the aid of a HEPA filterNoYes, extract airYes, extract and input air
10.The confined area must have emergency powerNoRecommendedYes
11.Gases released from the closed system shall be handled in a manner wherebyspreading is reduced to a minimumspreading does not occurspreading does not occur
12.Sampling, adding substances to a closed system and transferring viable microorganisms to another closed system shall be performed in a manner wherebyspreading is reduced to a minimumspreading does not occurspreading does not occur
13.Culture fluids shall not be removed from the closed system unless the viable micro-organisms have beenrendered inert with the aid of recognised methodsrendered inert with the aid of recognised chemical or physical methodsrendered inert with the aid of recognised chemical or physical methods
14.Seals shall be designed in a manner wherebyspreading is reduced to a minimumspreading does not occurspreading does not occur
15.The confined area shall be designed to hold the entire content of the closed system in the event of spillage from that systemNoYesYes
16.Surfaces must be watertight and easy to cleanYes, on worktops and similarYes, on worktops and similar and floorsYes, on worktops and similar, floors and ceilings
17.Surfaces must be resistant to acids, alkalis, solvents and disinfectantsYes, on work- topsYes, on worktops and floorsYes, on worktops, walls, floors and ceilings
18.It must be possible to disinfect polluted equipment in the confined area (corresponding effect as autoclave)NoYesYes
19.The confined area must be sealable to enable fumigationNoYesYes
20.Disinfection procedures shall be specifiedYesYesYes
21.Wastewater shall be treated before final disposalrendered inert with the aid of recognised methodsrendered inert with the aid of recognised chemical or physical methodsrendered inert with the aid of recognised chemical or physical methods
22.Only designated personnel shall have accessRecommendedYesYes, via airlock
23.Personnel shall wear protective clothingYes, work clothesYes, protective clothingYes, complete change of clothing
24.Personnel shall have access to decontamination units and sanitary facilitiesYesYesYes
25.Personnel shall shower before leaving the zoneNoRecommendedYes
26.Wastewater from washbasins and showers shall be collected and treated to render it inert before it is dischargedNoRecommendedYes