Document ID: chunk:federal_register_of_legislation:F2024L01024:front:0:p119
Version: federal_register_of_legislation:F2024L01024
Segment Type: other
Provision Reference: 
Character Range: 332857–336025

of less than 0.3 mg/m3; or
b. Designed for the detection of cholinesterase‑inhibiting activity.
2. B. 352. 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.1., 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).
Technical Notes:
1. Fermenters include bioreactors (including single‑use (disposable) bioreactors), chemostats and continuous‑flow systems.
2. Cultivation chamber holding devices include single‑use cultivation chambers with rigid walls.
2. B. 352. 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. B. 352. c. 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;
Technical Note:
Centrifugal separators include decanters.
2. B. 352. 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.
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.
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