2B352 Equipment capable of use in handling biological materials, as follows:
N.B.: SEE ALSO 9A350 FOR SPRAYING AND FOGGING SYSTEMS.
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 by 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 thereof, 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 capacity of 20 litres or more;
2. Components designed for fermenters specified by 2B352.b.1., as follows:
a. Cultivation chambers designed to be sterilised or disinfected in situ;
b. Cultivation chamber holding devices; or
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).
Fermenters include bioreactors (including single-use (disposable) bioreactors), chemostats and continuous‑flow systems.
c. Centrifugal separators, capable of continuous separation without the propagation of aerosols, having all the following characteristics:
1. Flow rate exceeding 100 litres per hour;
2. Components of polished stainless steel or titanium;
3. One or more sealing joints within the steam containment area; and
4. Capable of in‑situ steam sterilisation in a closed state;
Centrifugal separators include decanters.
d. Cross (tangential) flow filtration equipment and related components, as follows:
1. Cross (tangential) flow filtration equipment capable of separation of micro-organisms, viruses, toxins or cell cultures having all the following characteristics:
a. A total filtration area equal to or greater than 1 square metre; 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;
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 the destruction of potential microbial infectivity in the equipment through the use of chemical agents with a germicidal effect. Disinfection and sterilisation are distinct from sanitisation, the latter referring to cleaning procedures designed to lower the microbial content of equipment without necessarily achieving elimination of all microbial infectivity or viability.
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 square metres for each component and designed for use in cross (tangential) flow filtration equipment specified in 2B352.d.;
Note: 2B352.d. does not apply to reverse osmosis equipment or hemodialysis equipment, as specified by the manufacturer.
e. Steam, gas or vapour sterilisable freeze-drying equipment with a condenser capacity exceeding 10 kg of ice 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 apply to 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:
- Fully enclosed workspace where the operator is separated from the work by a physical barrier;
- Able to operate at negative pressure;
- Means to safely manipulate items in the workspace;
- 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. does not include 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:
- Whole-body exposure chambers having a capacity of 1 cubic metre or greater;
- Nose-only exposure apparatus or closed animal restraint tubes designed for use with such apparatus, utilising directed aerosol flow and having capacity for exposure of 12 or more rodents, or 2 or more animals other than rodents;
h. 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.
i. Nucleic acid assemblers and synthesizers, 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.