Requirements for personnel and facilities in biosafety level 3 laboratories
Requirements for personnel and facilities in biosafety level 3 laboratories
Requirements for the staff of the Biosafety Level 3 : The experimental staff should be professionally trained and supervised by experienced and qualified scientific workers in the work. Floor layout requirements: The laboratory should clearly distinguish the auxiliary working area and the protective area, and should be in the building...
Text label: Biosafety Level 3 , Personnel Facility Requirements
Biosafety Level 3 Requirements for Personnel and Facilities
Requirements for the staff of the Biosafety Level 3 : The experimental staff should be professionally trained and supervised by experienced and qualified scientific workers in the work. Floor layout requirements: The laboratory should clearly distinguish the auxiliary work area and the protection area, and it should be a self-contained area or independent building in the building, and there should be access control; in the core work room in the protection area, personnel should enter the core work through the buffer room. The laboratory auxiliary work area suitable for the effective use of safety isolation devices to handle routine amounts of airborne biological agents should at least include monitoring rooms, clean clothes changing rooms and shower rooms, and protective areas should at least include protective clothing changing rooms and buffer rooms. and core work room; laboratory auxiliary work area suitable for the operation of non-airborne biological agents generally considered should include at least monitoring room and clean clothes changing room, and the protection area should at least include buffer room and core work room; if a transfer window is installed, Its structural pressure and airtightness should meet the requirements of the area where it is located, and it should have the conditions to sterilize the items in the transfer window. If necessary, a transfer window with air supply and exhaust or self-purification function should be set up, and the exhaust air should be filtered by HEPA. Drain after filtration.
Requirements for the air conditioning system of the biosafety level 3 laboratory: an independent laboratory air supply and exhaust system should be installed, and it should be ensured that the low-risk area flows to the high-risk area during the operation of the laboratory, and the laboratory air can only pass through After being filtered by the HEPA filter, it is discharged through a special exhaust duct; the arrangement of the air supply and exhaust openings in the room of the laboratory protection area should conform to the principle of directional airflow, which is conducive to reducing the eddy current and airflow in the room, and the supply and exhaust air should not affect other The normal function of the equipment; the air exhausted from the laboratory protection area shall not be recycled; the supply air should be filtered by HEPA filter, and the primary and medium effect filters should be installed at the same time; the biological safety cabinet and its exhaust air should be installed according to the design requirements of the product Pipes, which can discharge the air discharged from the biological safety cabinet into the exhaust duct system of the laboratory; the external exhaust outlet of the laboratory should be set in the downwind direction of the dominant wind, and the straight-line distance from the air supply outlet should be greater than 12m, and should be at least higher than The top 2m of the building where the laboratory is located should be designed to prevent wind, rain, rodents and insects, but it should not affect the discharge of gas to the air; it should be possible to sterilize and check the exhaust HEPA filter in situ; When the high-efficiency filter unit is used outside the laboratory protection area, its structure should be firm and should be able to withstand the pressure of 2500pa. The overall sealing performance of the high-efficiency filter unit should be able to close all passages and maintain the temperature in the chamber at the upper limit of the design range. Under certain conditions, if the air pressure is maintained at 1000pa, the amount of air leaking in the chamber per minute should not exceed 0.1% of the net volume of the chamber; the air supply and exhaust pipes connecting the biological airtight valve and the laboratory protection area should be Firm, corrosion-resistant, anti-aging, stainless steel pipes should be used, and the tightness of the pipes should reach the condition that all passages are closed and the temperature in the pipes is kept within the design range. If the air pressure is maintained at 500pa, every minute in the pipes The amount of leaked air should not exceed 0.2% of the net volume in the pipeline; there should be a spare exhaust fan, the length of the positive pressure section of the exhaust duct behind the exhaust fan should be minimized, and the pipeline should not pass through other rooms; it should not be used in the laboratory Install split air conditioners in the protected area.
Enclosure requirements: The enclosure structure should meet the seismic and fire protection requirements for this type of building; the corners of the ceiling, floor and wall corners should be easy to clean and sterilize; all gaps and penetrations of the enclosure structure in the protection area should be The joints should be reliably sealed; the inner surface of the building envelope should be smooth, corrosion-resistant, waterproof, easy to clean and sterilize; the floor of the protection area should be leak-proof, complete, smooth, non-slip, corrosion-resistant, and dust-free; all windows It should be an airtight window, and the glass should be resistant to impact and breakage; all doors should be able to close automatically, and observation windows should be provided when necessary, and the opening direction of the doors should not hinder escape; the height of the laboratory and equipment room should meet the installation requirements of the equipment , there should be room for maintenance and cleaning. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and laboratories.
Requirements for the water supply and gas supply system of the biosafety level 3 pharma machinery: non-manual hand washing facilities should be set up near the exit of the experimental room in the laboratory protection zone. If the laboratory does not have water supply conditions, non-manual hand washing facilities should be set up Sterilization device; backflow prevention device should be set up between laboratory water supply and municipal water supply system; liquid and gas piping systems should be firm, rust-proof, pressure-resistant, temperature-resistant and corrosion-resistant, and there should be enough space for cleaning, maintenance and repair experiments For exposed pipes in the room, shut-off valves, backflow prevention devices or HEPA filters should be installed at key nodes; if there is a vacuum device, measures should be taken to prevent the interior of the vacuum device from being polluted, and the vacuum device should not be installed outside the experimental site ; If there is a gas supply tank, etc., it should be located outside the laboratory protection area where it is easy to replace and maintain, and the installation should be firm, and incompatible gases or liquids should not be put together.
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