Document ID: chunk:federal_register_of_legislation:F2024L01024:front:0:p120
Version: federal_register_of_legislation:F2024L01024
Segment Type: other
Provision Reference: 
Character Range: 335741–338699

of chemical agents, without necessarily killing or removing all organisms.
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 by 2B352.d.;
Note: 2B352.d. does not apply to reverse osmosis equipment or hemodialysis equipment, as specified by the manufacturer.
2. B. 352. 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;
2. B. 352. 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. B. 352. f. 2. Biocontainment chambers, isolators, or biological safety cabinets having all of the following characteristics, for normal operation:
2. B. 352. f. 2. 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 of transportation of infected patients.
2. B. 352. 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 cubic metre or greater;
2. 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;
2. B. 352. 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 sterilised or disinfected in situ;
2. B. 352. i. Nucleic acid assemblers and synthesizers, which are partly or entirely automated, and designed to generate continuous nucleic acids greater