- List
- EU dual-use list – Annex I to Regulation (EU) 2021/821, updated annually
- Originating regime
- Nhóm Úc (AG)
a. Containment facilities and related equipment as follows:
1. Complete containment facilities that meet the criteria for P3 or P4 (BL3, BL4, L3, L4) containment as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004);
2. Equipment designed for fixed installation in containment facilities specified in 2B352.a., as follows:
a. Double-door pass-through decontamination autoclaves;
b. Breathing air suit decontamination showers;
c. Mechanical-seal or inflatable-seal walkthrough doors;
b. Fermenters and components as follows:
1. Fermenters capable of cultivation of "microorganisms" or of live cells for the production of viruses or toxins, without the propagation of aerosols, having a total internal volume of 20 litres or more;
2. Components designed for fermenters specified in 2B352.b.1. as follows:
a. Cultivation chambers designed to be sterilised or disinfected in situ;
b. Cultivation chamber holding devices;
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);
Technical Notes:
1. For the purposes of 2B352.b. fermenters include bioreactors, single-use (disposable) bioreactors, chemostats and continuous-flow systems.
2. For the purposes of 2B352.b. cultivation chamber holding devices include single-use cultivation chambers with rigid walls.
c. Centrifugal separators capable of continuous separation, without the propagation of aerosols, having a flow rate greater than 100 litres per hour, as follows:
1. Centrifugal separators having all of the following characteristics:
a. One or more sealing joints within the steam containment area;
b. Components of polished stainless steel or titanium;
c. Capable of in-situ steam sterilisation 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.
Technical Note:
Centrifugal separators and single-use centrifugal separators include decanters.
d. Cross (tangential) flow filtration equipment and components as follows:
1. Cross (tangential) flow filtration equipment capable of separation of "microorganisms", viruses, toxins or cell cultures having all of the following characteristics:
a. A total filtration area equal to or greater than 1 m2; and
b. Having any of the following characteristics:
1. Capable of being ‘sterilised’ or ‘disinfected’ in-situ; or
2. Using disposable or single-use filtration components;
Technical Note:
In 2B352.d.1.b. ‘sterilised’ denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g. steam) or chemical agents. ‘Disinfected’ denotes a process to reduce the number of microorganisms but not usually of bacterial spores, through the use of chemical agents, without necessarily killing or removing all organisms.
Note:
2B352.d. does not control reverse osmosis and hemodialysis equipment, as specified by the manufacturer.
2. Cross (tangential) flow filtration components (e.g. modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0,2 m2 for each component and designed for use in cross (tangential) flow filtration equipment specified in 2B352.d.;
e. Steam, gas or vapour sterilisable freeze-drying equipment with a condenser capacity of 10 kg of ice or more in 24 hours and less than 1 000 kg of ice in 24 hours;
f. 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;
Note
:
2B352.f.1. does not control suits designed to be worn with self-contained breathing apparatus.
2. Biocontainment chambers, isolators, or biological safety cabinets having all of the following characteristics, for normal operation:
a. Fully enclosed workspace where the operator is separated from the work by a physical barrier;
b. Able to operate at negative pressure;
c. Means to safely manipulate items in the workspace;
d. Supply and exhaust air to and from the workspace is HEPA filtered;
Note 1:
2B352.f.2. includes Class III biosafety cabinets, as described in the latest edition of the WHO Laboratory Biosafety Manual or constructed in accordance with national standards, regulations or guidance.
Note 2:
2B352.f.2. includes any isolator meeting all of the above mentioned characteristics, regardless of its intended use and its designation, except for medical isolators specially designed for barrier nursing or transportation of infected patients.
g. 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 m3 or more;
2. Nose-only exposure apparatus utilising directed aerosol flow and having capacity for exposure of any of the following:
a. 12 or more rodents; or
b. 2 or more animals other than rodents;
3. Closed animal restraint tubes designed for use with nose-only exposure apparatus utilising directed aerosol flow;
h. Spray drying equipment capable of drying toxins or pathogenic "microorganisms" having all of the following:
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 μm with existing fittings or by minimal modification of the spray-dryer with atomisation nozzles enabling generation of the required particle size; and
3. Capable of being sterilised or disinfected in situ;
i. Nucleic acid assemblers and synthesisers, which are partly or entirely automated, and designed to generate continuous nucleic acids greater than 1,5 kilobases in length with error rates less than 5 % in a single run.
j. Peptide synthesizers that are partly or entirely automated and capable of generating peptides at a 'system synthesis scale' of 1 mmol or greater.
Technical Note:
'System synthesis scale' denotes the maximum amount of peptide (mmol) that can be produced by the instrument using the largest compatible reaction vessels (L). For multiple peptides produced in parallel, this is the sum of the largest compatible reaction vessels (L).
N.B. For chemical reaction vessels or reactors, see 2B350.a.
1. Complete containment facilities that meet the criteria for P3 or P4 (BL3, BL4, L3, L4) containment as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004);
2. Equipment designed for fixed installation in containment facilities specified in 2B352.a., as follows:
a. Double-door pass-through decontamination autoclaves;
b. Breathing air suit decontamination showers;
c. Mechanical-seal or inflatable-seal walkthrough doors;
b. Fermenters and components as follows:
1. Fermenters capable of cultivation of "microorganisms" or of live cells for the production of viruses or toxins, without the propagation of aerosols, having a total internal volume of 20 litres or more;
2. Components designed for fermenters specified in 2B352.b.1. as follows:
a. Cultivation chambers designed to be sterilised or disinfected in situ;
b. Cultivation chamber holding devices;
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);
Technical Notes:
1. For the purposes of 2B352.b. fermenters include bioreactors, single-use (disposable) bioreactors, chemostats and continuous-flow systems.
2. For the purposes of 2B352.b. cultivation chamber holding devices include single-use cultivation chambers with rigid walls.
c. Centrifugal separators capable of continuous separation, without the propagation of aerosols, having a flow rate greater than 100 litres per hour, as follows:
1. Centrifugal separators having all of the following characteristics:
a. One or more sealing joints within the steam containment area;
b. Components of polished stainless steel or titanium;
c. Capable of in-situ steam sterilisation 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.
Technical Note:
Centrifugal separators and single-use centrifugal separators include decanters.
d. Cross (tangential) flow filtration equipment and components as follows:
1. Cross (tangential) flow filtration equipment capable of separation of "microorganisms", viruses, toxins or cell cultures having all of the following characteristics:
a. A total filtration area equal to or greater than 1 m2; and
b. Having any of the following characteristics:
1. Capable of being ‘sterilised’ or ‘disinfected’ in-situ; or
2. Using disposable or single-use filtration components;
Technical Note:
In 2B352.d.1.b. ‘sterilised’ denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g. steam) or chemical agents. ‘Disinfected’ denotes a process to reduce the number of microorganisms but not usually of bacterial spores, through the use of chemical agents, without necessarily killing or removing all organisms.
Note:
2B352.d. does not control reverse osmosis and hemodialysis equipment, as specified by the manufacturer.
2. Cross (tangential) flow filtration components (e.g. modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0,2 m2 for each component and designed for use in cross (tangential) flow filtration equipment specified in 2B352.d.;
e. Steam, gas or vapour sterilisable freeze-drying equipment with a condenser capacity of 10 kg of ice or more in 24 hours and less than 1 000 kg of ice in 24 hours;
f. 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;
Note
:
2B352.f.1. does not control suits designed to be worn with self-contained breathing apparatus.
2. Biocontainment chambers, isolators, or biological safety cabinets having all of the following characteristics, for normal operation:
a. Fully enclosed workspace where the operator is separated from the work by a physical barrier;
b. Able to operate at negative pressure;
c. Means to safely manipulate items in the workspace;
d. Supply and exhaust air to and from the workspace is HEPA filtered;
Note 1:
2B352.f.2. includes Class III biosafety cabinets, as described in the latest edition of the WHO Laboratory Biosafety Manual or constructed in accordance with national standards, regulations or guidance.
Note 2:
2B352.f.2. includes any isolator meeting all of the above mentioned characteristics, regardless of its intended use and its designation, except for medical isolators specially designed for barrier nursing or transportation of infected patients.
g. 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 m3 or more;
2. Nose-only exposure apparatus utilising directed aerosol flow and having capacity for exposure of any of the following:
a. 12 or more rodents; or
b. 2 or more animals other than rodents;
3. Closed animal restraint tubes designed for use with nose-only exposure apparatus utilising directed aerosol flow;
h. Spray drying equipment capable of drying toxins or pathogenic "microorganisms" having all of the following:
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 μm with existing fittings or by minimal modification of the spray-dryer with atomisation nozzles enabling generation of the required particle size; and
3. Capable of being sterilised or disinfected in situ;
i. Nucleic acid assemblers and synthesisers, which are partly or entirely automated, and designed to generate continuous nucleic acids greater than 1,5 kilobases in length with error rates less than 5 % in a single run.
j. Peptide synthesizers that are partly or entirely automated and capable of generating peptides at a 'system synthesis scale' of 1 mmol or greater.
Technical Note:
'System synthesis scale' denotes the maximum amount of peptide (mmol) that can be produced by the instrument using the largest compatible reaction vessels (L). For multiple peptides produced in parallel, this is the sum of the largest compatible reaction vessels (L).
N.B. For chemical reaction vessels or reactors, see 2B350.a.