Fermenters capable of cultivation of pathogenic micro-organisms, or viruses or of toxin production, without the propagation of aerosols, and having all the following characteristics:
Capacity equal to or greater than 100 litres.
* Sub-groups of fermenters include bioreactors, chemostats and continuous-flow systems.
Centrifugal Separators *
Centrifugal separators capable of the continuous separation of pathogenic microorganisms, without the propagation of aerosols, and having all the following characteristics:
Flow rate greater than 100 litres per hour;
Components of polished stainless steel or titanium;
Double or multiple sealing joints within the steam containment area; and
Capable of in-situ steam sterilization in a closed state.
* Centrifugal separators include decanters.
Cross-flow filtration equipment
Cross-flow filtration equipment capable of continuous separation of pathogenic microorganisms, viruses, toxins, and cell cultures without the propagation of aerosols, having all the following characteristics:
Capable of in situ sterilization.
Steam sterilizable freeze-drying equipment with a condensor capacity greater than 50 kg of ice in 24 hours and less than 1000 kg of ice in 24 hours.
Equipment that incorporates or is contained in P3 or P4 (BL3, BL4, L3, L4) containment housing, as follows:
Independently ventilated protective full or half suits; and
Class III biological safety cabinets or isolators with similar performance standards.
Aerosol inhalation chambers
Chambers designed for aerosol challenge testing with microorganisms, viruses, or toxins and having a capacity of 1 cubic metre or greater.
The experts propose that the following items be included in awareness-raising guidelines to industry: