ECCN 2B352
CBATEquipment Capable of Use in Handling Biological Materials, as Follows .
Items Covered
- a.Containment facilities and related equipment, as follows:
- 1. Complete containment facilities at P3 or P4 containment level.
- 2. Equipment designed for fixed installation in containment facilities specified in paragraph a.1 of this ECCN, as follows:
- 2.a. Double-door pass-through decontamination autoclaves;
- 2.b. Breathing air suit decontamination showers;
- 2.c. Mechanical-seal or inflatable-seal walkthrough doors.
- b.Fermenters and components as follows:
- 1. Fermenters capable of cultivation of micro-organisms or of live cells for the production of viruses or toxins, without the propagation of aerosols, having a total internal volume of 20 liters or greater.
- 2. Components designed for such fermenters, as follows:
- 2.a. Cultivation chambers designed to be sterilized or disinfected in situ;
- 2.b. Cultivation chamber holding devices; or
- 2.c. Process control units capable of simultaneously monitoring and controlling two or more fermentation system parameters (e.g., temperature, pH, nutrients, agitation, dissolved oxygen, air flow, foam control).
- c.Centrifugal separators capable of continuous separation, without the propagation of aerosols, having a flow rate greater than 100 liters per hour, as follows:
- 1. Centrifugal separators having all of the following characteristics:
- 1.a. One or more sealing joints within the steam containment area;
- 1.b. Components of polished stainless steel or titanium; and
- 1.c. Capable of in-situ steam sterilization in a closed state.
- 2. Single-use centrifugal separators, in which all components that come in direct contact with the substances being processed are disposable or single-use.
- d.Cross (tangential) flow filtration equipment and "accessories", as follows:
- 1. Cross (tangential) flow filtration equipment capable of separation of microorganisms, viruses, toxins or cell cultures having all of the following characteristics:
- 1.a. A total filtration area equal to or greater than 1 square meter (1 m2); and
- 1.b. Having any of the following characteristics:
- 1.b.1. Capable of being sterilized or disinfected in-situ; or
- 1.b.2. Using disposable or single-use filtration "parts" or "components".
- 2. Cross (tangential) flow filtration "parts" or "components" (e.g., modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0.2 square meters (0.2 m2) for each "part" or "component" and designed for use in cross (tangential) flow filtration equipment controlled by 2B352.d.1.
- e.Steam, gas or vapor sterilizable freeze-drying equipment with a condenser capacity of 10 kg of ice or greater in 24 hours (10 liters of water or greater in 24 hours) and less than 1000 kg of ice in 24 hours (less than 1,000 liters of water in 24 hours).
- f.Spray-drying equipment capable of drying toxins or pathogenic microorganisms having all of the following characteristics:
- 1. A water evaporation capacity of ≥0.4 kg/h and ≤400 kg/h;
- 2. The ability to generate a typical mean product particle size of ≤10 micrometers with existing fittings or by minimal modification of the spray-dryer with atomization nozzles enabling generation of the required particle size; and
- 3. Capable of being sterilized or disinfected in situ.
- g.Protective and containment equipment, as follows:
- 1. Protective full or half suits, or hoods dependent upon a tethered external air supply and operating under positive pressure.
- 2. Biocontainment chambers, isolators, or biological safety cabinets having all of the following characteristics, for normal operation:
- 2.a. Fully enclosed workspace where the operator is separated from the work by a physical barrier;
- 2.b. Able to operate at negative pressure;
- 2.c. Means to safely manipulate items in the workspace; and
- 2.d. Supply and exhaust air to and from the workspace is high-efficiency particulate air (HEPA) filtered.
- h.Aerosol inhalation equipment designed for aerosol challenge testing with microorganisms, viruses or toxins, as follows:
- 1. Whole-body exposure chambers having a capacity of 1 cubic meter or greater;
- 2. Nose-only exposure apparatus utilizing directed aerosol flow and having a capacity for the exposure of 12 or more rodents, or two or more animals other than rodents, and closed animal restraint tubes designed for use with such apparatus.
- i.Spraying or fogging systems and "parts" and "components" therefor, as follows:
- 1. Complete spraying or fogging systems, specially designed or modified for fitting to aircraft, "lighter than air vehicles," or "UAVs," capable of delivering, from a liquid suspension, an initial droplet "VMD" of less than 50 microns at a flow rate of greater than 2 liters per minute;
- 2. Spray booms or arrays of aerosol generating units, specially designed or modified for fitting to aircraft, "lighter than air vehicles," or "UAVs," capable of delivering, from a liquid suspension, an initial droplet "VMD" of less than 50 microns at a flow rate of greater than 2 liters per minute;
- 3. Aerosol generating units specially designed for fitting to the systems as specified in paragraphs i.1 and i.2 of this ECCN.
- a.Doppler laser method,
- b.Forward laser diffraction method.
- j.Nucleic acid assemblers and synthesizers that are both:
- j.1 Partly or entirely automated; and
- 2. Designed to generate continuous nucleic acids greater than 1.5 kilobases in length with error rates less than 5% in a single run.
- k.Peptide synthesizers that are both:
- k.1 Partly or entirely automated; and
- k.2 Capable of generating peptides at a 'system synthesis scale' of 1 mmol or greater.
Control Reasons
CBChemical & Biological Weapons
Items controlled for chemical and biological weapons proliferation concerns.
Column 1: YesColumn 2: No
ATAnti-Terrorism
Items controlled for anti-terrorism reasons. Most items on the CCL have AT controls.
Column 1: YesColumn 2: No
Disclaimer
This information is for reference only. For official classifications, consult BIS or a qualified export control professional.