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.
- 1. Centrifugal separators having all of the following characteristics:
- 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.
- 1. Cross (tangential) flow filtration equipment capable of separation of microorganisms, viruses, toxins or cell cultures having all of the following characteristics:
- 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 Explained
This ECCN is controlled for the following reasons. Each reason maps to a column on the Commerce Country Chart, which determines whether a license is required for a given destination.
- ATAnti-Terrorism
- Basic anti-terrorism controls that apply to most items on the CCL. A license is required for exports to countries designated as state sponsors of terrorism.
Common Questions About 2B352
What does ECCN 2B352 cover?
ECCN 2B352 is an entry on the Commerce Control List (Materials Processing). The List of Items Controlled below describes the products, software, or technology captured by this classification. Compare your item against those parameters when self-classifying.
How do license requirements work for this ECCN?
License need depends on the control reasons shown for this code (for example NS, RS, MT, AT), the destination country, and how your transaction maps against the Commerce Country Chart, de minimis, and other EAR provisions. This page is a research aid only. Confirm against the current rule text and your specific facts before exporting.
Where is the official text for this ECCN?
The legal text appears in Supplement No. 1 to part 774 of the Export Administration Regulations (15 CFR Part 774). Use the official BIS link on this page to open the current supplement entry for this ECCN.
What if my product matches more than one ECCN?
When several ECCNs appear to fit, the controlling entry is usually the one that is most specific to your item's form, function, or technical limits. Cross-references in the List of Items Controlled and related ECCNs listed on this page are common starting points for narrowing the choice.
How often should I re-check this classification?
The Commerce Control List changes when BIS publishes new or amended rules. Revisit the official entry when regulations update, when the product's technical parameters change, or when the destination, end-user, or end-use of a transaction changes.
What do the control reason codes mean?
Each control reason (NS, RS, MT, AT, etc.) maps to a column on the Commerce Country Chart in Supplement No. 1 to part 738 of the EAR. When a control reason applies to your ECCN and the destination country has an X in that column, a license is generally required unless an exception applies. See the Control Reasons Explained section on this page for details on each code.