Export Control Classification Numbers (ECCN): 2B352听

  • Complete containment facilities at P3 or P4 containment level[1]
  • Fermenters capable of cultivation of pathogenic microorganisms, viruses, or for toxin production, without the propagation of aerosols, having a capacity equal to or greater than 20 liters[2]
  • Centrifugal separators capable of continuous separation of pathogenic microorganisms, without the propagation of aerosols, and having all of the following characteristics:[3]
    • One or more sealing joints within the steam containment area
    • A flow rate greater than 100 liters per hour
    • Components of polished stainless steel or titanium, and
    • Capable of in-situ steam sterilization in a closed state[4]
  • Cross (tangential) flow filtration equipment and accessories, as follows:
    • Cross (tangential) flow filtration equipment capable of separation of pathogenic microorganisms, viruses, toxins or cell cultures having all of the following characteristics:[5]
      • A total filtration area equal to or greater than 1 square meter, and
      • Having any of the following characteristics
        • Capable of being sterilized or disinfected in-situ
        • Using disposable or single-use filtration components.
    • Cross (tangential) flow filtration components (e.g., modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0.2 square meters for each component and designed for use in cross (tangential) flow filtration equipment controlled by 2B352.d.1
  • Steam sterilizable freeze-drying (lyophilization) equipment with a condenser capacity of 10 kgs of ice or greater in 24 hours (10 liters of water or greater in 24 hours), but less than 1,000 kgs of ice in 24 hours (less than 1,000 liters of water in 24 hours).
  • Protective and containment equipment, as follows:[6]
    • Protective full or half suits, or hoods dependent upon a tethered external air supply and operating under positive pressure
    • Class III biological safety cabinets or isolators with similar performance standards, e.g., flexible isolators, dry boxes, anaerobic chambers, glove boxes or laminar flow hoods (closed vertical flow).
  • Spraying or fogging systems and components therefor, as follows [7]
    • Complete spraying or fogging systems, specifically designed or modified for fitting to aircraft, 鈥渓ighter than air vehicles,鈥� or 鈥淯AVs,鈥� capable of delivering, from a liquid suspension, an initial droplet 鈥淰MD鈥� of less than 50 microns at a flow rate of greater than 2 liters per minute
    • Spray booms or arrays of aerosol generating units, specially designed or modified for fitting to aircraft, 鈥渓ighter than air vehicles,鈥� or 鈥淯AVs,鈥� capable of delivering, from a liquid suspension, an initial droplet 鈥淰MD鈥� of less than 50 microns at a flow rate of greater than 2 liters per minute
    • Aerosol generating units specially designed for fitting to the systems specified in the above two paragraphs

[1] P3 or P4 (BL3, BL4, L3, L4) containment levels are as specified in the WHO Laboratory Biosafety Manual (3rd editions, Geneva, 2004)

[2] Fermenters include bioreactors, chemostats, and continuous-flow systems.

[3] Centrifugal separators include decanters

[4] In this ECCN, 鈥渟terilized鈥� denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g., steam) or chemical agents.听 鈥淒isinfected鈥� denotes the destruction of potential microbial infectivity in the equipment through the use of chemical agents with a germicidal effect.听 鈥淒isinfection鈥� and 鈥渟terilization鈥� are distinct from 鈥渟anitization鈥�, the latter referring to cleaning procedures designed to lower the microbial content of equipment without necessarily achieving elimination of all microbial infectivity or viability

[5] Does not control reverse osmosis equipment, as specified by the manufacturer

[6]听This entry does not control suits designed to be worn with self-contained breathing apparatus

[7]听1. 鈥淎erosol generating units鈥� are devices specially designed or modified for fitting to aircraft and include nozzles, rotary drum atomizers and similar devices.

2. This ECCN does not control spraying or fogging systems and components, as specified in 2B352.h, that are demonstrated not to be capable of delivering biological agents in the form of infectious aerosols

3. Droplet size for spray equipment or nozzles specially designed for use on aircraft or 鈥淯AVs鈥� should be measured using either of the following methods (pending the adoption of internationally accepted standards):

听听听听听听听听听听听听听听听 a. Doppler laser method

听听听听听听听听听听听听听听听 b. Forward laser diffraction method