Equipment capable of use in handling biological materials, as follows: a. Complete biological containment facilities at P3, P4 containment level; Technical Note: P3 or P4 (BL3, BL4, L3, L4) containment levels are as specified in the WHO Laboratory Biosafety manual (3rd edition Geneva 2004). b. Fermenters capable of cultivation of pathogenic ‘micro-organisms’, viruses or capable of toxin production, without the propagation of aerosols, and having a total capacity of 20 litres or more; Technical Note: Fermenters include 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; Technical Note: Centrifugal separators include decanters. d. Cross (tangential) flow filtration equipment and components as follows: 1. Cross (tangential) flow filtration equipment capable of separation of pathogenic ‘micro-organisms’, viruses, toxins or cell cultures, without the propagation of aerosols, having all of the following characteristics: a. A total filtration area equal to or greater than 1 m 2 ; and b. Having either 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 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 m 2 for each component and designed for use in cross (tangential) flow filtration equipment specified in 2B352.d.; Note: 2B352.d. does not control reverse osmosis equipment, as specified by the manufacturer. e. Steam 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 control suits designed to be worn with self-contained breathing apparatus. 2. Class III biological safety cabinets or isolators with similar performance standards; Note: In 2B352.f.2., isolators include flexible isolators, dry boxes, anaerobic chambers, glove boxes and laminar flow hoods (closed with vertical flow). g. Chambers designed for aerosol challenge testing with ‘micro-organisms’, viruses or ‘toxins’ and having a capacity of 1 m 3 or greater.