ANNEXURE B
| 1. | EQUIPMENT CAPABLE OF USE IN HANDLING BIOLOGICAL MATERIALS, AS FOLLOWS: |
| (a) | Complete biological containment facilities at Biosafety Level 3 or 4 containment level (BSL3/4). |
Technical Note:
Biosafety Level 3 or 4 containment levels are as specified in Government Notice No. R. 178 of 02 March 2012 promulgated in terms of the National Health Act, 2003 (Act No. 61 of 2003)
| (b) | Major components that can be used to build a functional Biosafety Level 3 or 4 facility as follows: |
| (i) | Safe-change filter-housings [Bag-in-Bag-out (BIBO)] with in-situ filter test system and filtration efficiency greater than 99,99% at Most Penetrating Particle Size (MPPS) (Leakage less than 0.01%); |
| (ii) | Effluent Decontamination Systems (EDS) (thermal or chemical process). |
| (c) | Fermenters, roller/cassette type incubators capable of cultivating biological agents as follows: |
| (i) | Fermenters controlling the release of aerosols and are capable of sterilisation/decontamination in-situ; |
| (ii) | Incubators that are fitted with disposable/sterilisable sealed culture flasks/bottles/cassettes that have aerosol control devices fitted. |
| (d) | Autoclaves with internal effluent/condensate decontamination and/or sterilisation systems. The autoclaves must be the double door type (as per BSL3/4 laboratory use) or attachable to Biosafety Cabinet Class III isolators. |
Technical Note:
In this control, 'sterilisation' denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g. steam) or chemical agents. 'Decontamination' denotes the destruction of potential microbial infectivity in the equipment through the use of chemical agents with a germicidal effect.
| (e) | Freeze-drying equipment with condensate collection systems to safely collect potentially contaminated condensate or with disinfection systems (such as EDS) including vacuum line HEPA (High Efficiency Particulate Arrestor/Air) filtration. |
| (f) | Spray Drying equipment that comply with all of the following: |
| (i) | capacity to control/contain aerosols; |
| (ii) | all internal areas that are in contact with the biological agent are sterilisable I decontaminatable I disposable; |
| (iii) | used in conjunction with a containment system (BSL3/4 or Class Ill Cabinet). |
| (g) | Milling equipment with all of the following: |
| (i) | capacity to grind biological material to a powder; |
| (ii) | capacity to control aerosols; and |
| (iii) | sterilise/decontaminate internal areas/components. |
| (h) | Biological safety cabinets or isolators, which allow manual operations to be performed within, whilst providing an environment equivalent to Class Ill biological protection. |
The Biological safety cabinets or isolators shall comply with all of the following:
| (i) | exhaust air ducted to the outside atmosphere or treated (HEPA filtered and activated carbon adsorption) to safely recirculate within the working environment; |
| (ii) | airflow velocity through the glove ports of at least 0.75m/s, when all gloves are detached; |
| (iii) | smooth, rigid, flat and chemically resistant work floor; |
| (iv) | fitted with pressure and/or airflow quantity controls, and/or |
| ▪ | Interlocking door pass-through chamber, and/or |
| ▪ | Disinfectant dunk tank, and/or |
| ▪ | Fitted gaseous decontamination system (for example, formaldehyde gas generator). |
Technical Note:
Isolators include flexible isolators, drying boxes, anaerobic chambers and glove boxes that can protect the operator from biological agents and toxins (direct contact and/or aerosols exposures) with condensate collection systems to safely collect potentially contaminated condensate or with disinfection systems (such as EDS) including vacuum line HEPA filtration.
| (i) | Chambers designed for aerosol challenge testing with micro-organisms, viruses or toxins and equipped with any of the following: |
| (i) | capacity of 1 m3 or greater; |
| (ii) | operating under negative pressure and having controllable airflows; |
| (iii) | equipped with HEPA filtration on the chambers exhaust; |
| (iv) | fitted with a nebuliser capable for aerosolising controlled biological agents; |
| (v) | having at least one aerosol sample collector, capable of being controlled from outside of the chamber or live animal attachment/introduction capabilities. |
