2B352

Containment facilities and related equipment as follows:

Complete containment facilities that meet the criteria for P3 or P4 (BL3, BL4, L3, L4) containment as specified in the WHO Laboratory Biosafety Manual (3^rd edition, Geneva, 2004);

Equipment designed for fixed installation in containment facilities specified in 2B352.a., as follows:

Double-door pass-through decontamination autoclaves;

Breathing air suit decontamination showers;

Mechanical-seal or inflatable-seal walkthrough doors;

Fermenters and components as follows:

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;

Components designed for fermenters specified in 2B352.b.1. as follows:

Cultivation chambers designed to be sterilised or disinfected in situ;

Cultivation chamber holding devices;

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);

Centrifugal separators, capable of continuous separation without the propagation of aerosols, having all of 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;

Cross (tangential) flow filtration equipment and components as follows:

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 m^2; 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;

Cross (tangential) flow filtration components (e.g. modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0,2 m^2 for each component and designed for use in cross (tangential) flow filtration equipment specified in 2B352.d.;

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;

Protective and containment equipment, as follows:

Protective full or half suits, or hoods dependent upon a tethered external air supply and operating under positive pressure;

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;

Aerosol inhalation equipment designed for aerosol challenge testing with "microorganisms", viruses or "toxins" as follows:

Whole-body exposure chambers having a capacity of 1 m^3 or more;

Nose-only exposure apparatus utilising directed aerosol flow and having capacity for exposure of any of the following:

12 or more rodents; or

2 or more animals other than rodents;

Closed animal restraint tubes designed for use with nose-only exposure apparatus utilising directed aerosol flow;

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;

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.