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GB 50346-2011: Architectural and technical code for biosafety laboratories
Status: Valid GB 50346: Evolution and historical versions
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Architectural and technical code for biosafety laboratories
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Architectural and technical code for biosafety laboratories
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Basic data | Standard ID | GB 50346-2011 (GB50346-2011) | | Description (Translated English) | Architectural and technical code for biosafety laboratories | | Sector / Industry | National Standard | | Classification of Chinese Standard | P33 | | Classification of International Standard | 91.040.10 | | Word Count Estimation | 146,161 | | Date of Issue | 2011-12-05 | | Date of Implementation | 2012-05-01 | | Older Standard (superseded by this standard) | GB 50346-2004 | | Quoted Standard | GB 50007; GB 50068; GB 50223; GB 50447; GB 50591; GB/T 13554; GB 19489 | | Regulation (derived from) | Bulletin of the Ministry of Housing and Urban No. 1214 | | Issuing agency(ies) | Ministry of Housing and Urban-Rural Development of the People's Republic of China; General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China | | Summary | This Chinese standard applies to new construction, renovation and expansion of biosafety laboratory design, construction and acceptance. | GB 50346-2011: Architectural and technical code for biosafety laboratories---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
1 General
1.0.1 In order to make the design, construction and acceptance of biosafety laboratories meet the laboratory biosafety protection requirements, this specification is formulated.
1.0.2 This specification is applicable to the design, construction and acceptance of new, rebuilt and expanded biosafety laboratories.
1.0.3 The construction of biosafety laboratories should strictly follow the building technology principles of physical isolation, take biosafety as the core, ensure the safety of experimenters and the safety of the surrounding environment of the laboratory, and should meet the environmental requirements of experimental objects, so as to achieve Practical and economical. The equipment and materials used in the biosafety laboratory should have qualified certificates and inspection reports that meet the requirements and are within the validity period. For newly developed products and processes, there should be identification certificates or test proof materials.
1.0.4 The design, construction and acceptance of biosafety laboratories shall not only implement the provisions of this specification, but also comply with the relevant current national standards.
2 terms
2.0.1 Primary barrier primary barrier
The isolation between the operator and the operated object is also called the first level of isolation.
2.0.2 secondary barrier secondary barrier
The isolation of the biosafety laboratory and the external environment is also called secondary isolation.
2.0.3 biosafety laboratory
Microbiology laboratories and animal laboratories that meet biosafety requirements through protective barriers and management measures. Including the main laboratory and its auxiliary rooms.
2.0.4 Laboratory containment area
It refers to the area with relatively high biological risk, and the area that has requirements for the tightness of the enclosure structure and the direction of airflow.
2.0.5 Non-contamination zone of laboratory auxiliary work area
The laboratory auxiliary work area refers to the area with relatively small biological risk, and also refers to the area outside the protective area in the biosafety laboratory.
2.0.6 main laboratory main room
It is the room with the highest pollution risk in the biosafety laboratory, including the experimental operation room, animal breeding room, animal anatomy room, etc. The main laboratory is also called the core work room.
2.0.7 buffer room
A closed room set between laboratory areas with different contamination probabilities. When necessary, a mechanical ventilation system can be installed, the doors of which have an interlocking function and cannot be opened at the same time.
2.0.8 Individually ventilated cage (IVC)
An independently ventilated barrier device with feeding boxes as the unit, clean air is sent into each independent cage box to keep the feeding environment at a certain pressure and cleanliness, to avoid environmental pollution of animals (positive pressure) or animal pollution of the environment (negative pressure)), all experimental operations need to be carried out in biological safety cabinets and other equipment. The device is used for breeding clean, specific pathogen free or infected (negative pressure) animals.
2.0.9 animal isolated equipment
Refers to the general term for the isolation devices used to raise animals in animal biosafety laboratories. The animal breeding environment of the equipment is negative pressure and one-way airflow to prevent pathogens from leaking into the environment and effectively prevent animals from escaping. Commonly used animal isolation equipment includes isolators, laminar flow cabinets, etc.
2.0.10 airtight door
The airtight door is a kind of airtight door. The airtight door usually has an integrated door leaf and door frame, and the gap is sealed by means of a mechanical compression device or an inflatable sealing ring.
2.0.11 Waste water of biohazard
Hazardous wastewater contaminated with harmful biological agents.
2.0.12 cleanliness class 7
The number of dust particles greater than or equal to 0.5 μm in the air is greater than 35200 grains/m3 to less than or equal to 352000 grains/m3, the number of dust particles greater than or equal to 1 μm is greater than 8320 grains/m3 to less than or equal to 83200 grains/m3, and the number of dust particles greater than or equal to 5 μm Greater than 293 grains/m3 to less than or equal to 2930 grains/m3.
2.0.13 Cleanliness Class 8
The number of dust particles greater than or equal to 0.5 μm in the air is greater than 352,000 grains/m3 to less than or equal to 3,520,000 grains/m3, the number of dust particles greater than or equal to 1 μm is greater than 83,200 grains/m3 to less than or equal to 832,000 grains/m3, and the number of dust particles greater than or equal to 5 μm Greater than 2930 grains/m3 to less than or equal to 29300 grains/m3.
2.0.14 Static at-rest
The facilities in the laboratory have been built, the process equipment has been installed, the ventilation and air conditioning system and equipment are in normal operation, but there is no staff to operate and the experimental subject has not yet entered the state.
2.0.15 comprehensive performance judgment comprehensive performance judgment
Carry out comprehensive testing and evaluation of the engineering and technical indicators of the biosafety laboratory that has been completed and accepted.
3 Classification, classification and technical indicators of biosafety laboratories
3.1 Classification of biosafety laboratories
3.1.1 The biosafety laboratory can be composed of a protective area and an auxiliary working area.
4.3.3 The foundation design of the biosafety laboratory should comply with the relevant provisions of the current national standard "Code for Design of Building Foundations" GB 50007.The foundations of Level 3 biosafety laboratories should be designed according to Class A, and the foundations of Level 4 biosafety laboratories should be designed according to Class A.
4.3.4 The main structure of Level 3 and Level 4 biosafety laboratories should adopt concrete structure or masonry structure system.
4.3.5 When the suspended ceiling of Level 3 and Level 4 biosafety laboratories is used as a technical maintenance interlayer, the live load of the suspended ceiling should not be less than 0.75kN/m2, and a separate maintenance channel should be used for particularly important equipment in the suspended ceiling.
5 Air Conditioning, Ventilation and Purification
5.1 General provisions
5.1.1 The division of air-conditioning and purification systems in biosafety laboratories should be determined after technical and economic comparisons based on the degree of hazard of the operating objects and the layout of the plane, and effective measures should be taken to avoid pollution and cross-contamination. The division of the air-conditioning purification system should be conducive to laboratory disinfection and sterilization, the setting of automatic control systems and energy-saving operation.
5.1.2 The design of the air-conditioning purification system of the biosafety laboratory should consider the heat and humidity load of various equipment.
5.1.3 The design of air supply and exhaust systems in biosafety laboratories should take into account the conditions of use of biological safety cabinets and animal isolation equipment.
5.1.4 Biosafety laboratories can choose biological safety cabinets according to the principles in Table 5.1.4.
5.1.5 Type a and type b1 laboratories in the second-level biosafety laboratories can use air-conditioning systems with circulating air. The B2 laboratory in the second-level biosafety laboratory should adopt a fresh air system, and the exhaust air in the protection area should be determined according to the risk assessment whether it needs to be filtered by a high-efficiency air filter before being discharged.
5.1.6 All-new air systems should be used in Level 3 and Level 4 biosafety laboratories.
5.1.7 Corrosion-resistant airtight valves should be installed in front of the air supply and exhaust branch pipes and exhaust fans of the main laboratory of the third-level and fourth-level biosafety laboratories, and the tightness of the valves should be compatible with the tightness requirements of the pipelines where they are located.
5.1.8 Ordinary fan coil units or room air conditioners should not be installed in the protective areas of level 3 and level 4 biosafety laboratories.
5.1.9 The protected area of the third-level and fourth-level biosafety laboratories should be able to carry out in-situ disinfection and leak detection of the exhaust high-efficiency air filter. The protective area of level 4 biosafety laboratory should be able to carry out in-situ disinfection and leak detection of the supply air high-efficiency air filter.
5.1.10 The protection area of the biosafety laboratory should be close to the air-conditioning machine room.
5.1.11 The fans used in the air-conditioning purification system and high-efficiency exhaust system of the biosafety laboratory should choose the type with small changes in air volume when the wind pressure changes greatly.
5.2 Air supply system
5.2.1 The air purification system should be equipped with at least three levels of coarse, medium and high air filtration, and should meet the following requirements.
1 The first stage is the coarse-effect filter. The coarse-effect filter of the fresh air system can be installed in the air-conditioning box; for the air-conditioning system with return air, the coarse-effect filter should be installed at or close to the fresh air outlet.
2 The second stage is a medium-efficiency filter, which should be installed in the positive pressure section of the air handling unit.
3 The third stage is a high-efficiency filter, which should be installed at or near the end of the system and should not be installed in the air-conditioning box.
4 The fresh air system should install a protective medium-efficiency filter in front of the surface cooler.
5.2.2 The setting of the fresh air outlet of the air supply system shall meet the following requirements.
1 Effective rain-proof measures should be taken for fresh air outlets.
2.A protection net against rodents, insects, fluff, etc. should be installed at the fresh air outlet, and it should be easy to disassemble.
3 The fresh air outlet should be 2.5m higher than the outdoor ground, and should be far away from pollution sources.
5.2.3 The BSL-3 laboratory should be equipped with a spare blower.
5.2.4 ABSL-3 laboratories and level 4 biosafety laboratories should be equipped with spare air blowers.
5.3 Exhaust system
5.3.1 The setting of the exhaust system of Level 3 and Level 4 biosafety laboratories should meet the following requirements.
1 The exhaust air must be interlocked with the air supply, the exhaust air is turned on before the air supply, and then closed after the air supply.
2 The main laboratory must be equipped with indoor air exhaust outlets, and biological safety cabinets or other negative pressure isolation devices must not be used as room exhaust outlets.
3 The equipment that may leak pollutants in the laboratory of category b1 must be equipped with a local negative pressure exhaust device with a high-efficiency air filter, and the negative pressure exhaust device should have the function of in-situ leak detection.
4 The connection methods between biological safety cabinets of different levels and types and the exhaust system shall be selected according to Table 5.3.1.
5.The connection between the animal isolation equipment and the exhaust system should adopt a closed connection or set up a local exhaust hood.
6 The exhaust fan shall be equipped with a balanced base, and effective vibration and noise reduction measures shall be taken.
5.3.2 The exhaust air in the protected area of the third-level and fourth-level biosafety laboratories must be filtered by high-efficiency filters before being discharged.
5.3.3 The high-efficiency filter for the exhaust air of the third-level and fourth-level biosafety laboratories should be installed at the indoor exhaust outlet or close to the exhaust outlet. If there are special requirements for the protection area of the third-level biosafety laboratory, two high-efficiency filters can be installed. device. In addition to the first high-efficiency filter at the indoor air outlet in the protection area of the fourth-level biosafety laboratory, a second high-efficiency filter should be connected in series behind it. The position of the high-efficiency filter in the protection area and the structure of the air outlet should be easy to replace the filter safely and detect leaks.
5.3.4 The positive pressure section of the exhaust duct in the protected area of the third-level and fourth-level biosafety laboratories should not pass through the room, and the exhaust fan should be installed near the outdoor air outlet.
5.3.5 Reserve exhaust fans should be set up in the protective areas of Level 3 and Level 4 biosafety laboratories. The standby exhaust fans should be able to switch automatically, and an orderly pressure gradient and directional flow should be maintained during the switching process.
5.3.6 Three-level and four-level biosafety laboratories should have measures that can adjust the exhaust or supply air to maintain the stability of the indoor pressure and pressure gradient.
5.3.7 The outdoor air outlets in the protected areas of Level 3 and Level 4 biosafety laboratories should be set in the downwind direction of the prevailing wind, and the straight-line distance from the fresh air outlets should be greater than 12m, and should be more than 2m higher than the roof of the building where they are located. The horizontal distance between the outdoor air outlet in the protected area of the third-level biosafety laboratory and the surrounding buildings should not be less than 20m.
5.3.8 The exhaust air between the ABSL-4 animal corpse treatment equipment room and the sewage treatment equipment room in the protection zone should be filtered through high-efficiency filters.
5.4 Airflow organization
5.4.1 The direction of the airflow between each area of the third-level and fourth-level biosafety laboratories should ensure that it flows from the auxiliary working area to the protection area, and a positive pressure buffer room should be set between the auxiliary working area and the outdoor.
5.4.2 The location of various equipment in Level 3 and Level 4 biosafety laboratories should be conducive to the flow of air from the space with low risk of contamination to the space with high risk of contamination, minimizing indoor backflow and vortex.
5.4.3 The air flow organization of the biosafety laboratory should adopt the method of sending up and down, and the arrangement of air supply outlets and exhaust outlets should be conducive to the discharge of indoor possibly polluted air. The airflow organization of the biosafety laboratory for raising large animals can adopt the method of upward delivery and upper row.
5.4.4 There should be no air outlet near the operating surface of the biological safety cabinet or other places where aerosols are generated.
5.4.5 The exhaust outlet of the high-efficiency filter should be located in the area with the highest risk of indoor pollution, and there should be no obstacles.
5.4.6 When the air flow is sent up and down, the lower edge of the high-efficiency filter air outlet should not be lower than 0.1m from the ground, and should not be higher than 0.15m; the height of the upper edge should not exceed 0.6m above the ground. The exhaust air velocity at the exhaust outlet should not be greater than 1m/s.
5.5 Components and materials of the air conditioning purification system
5.5.1 The high-efficiency filters for air supply and exhaust shall not use wooden frames. The high-efficiency filters in the protective areas of the third-level and fourth-level biosafety laboratories should be resistant to the erosion of disinfection gases, and the high-efficiency filters in the showers and chemical showers in the protective areas should be moisture-proof. The efficiency of high-efficiency filters in Class III and Class IV biosafety laboratories should not be lower than Class B in the current national standard "High Efficiency Air Filters" GB/T 13554.
5.5.2 Ventilation pipes that need to be disinfected should be made of corrosion-resistant, aging-resistant, non-absorbent, easy-to-sterilize materials, and should be integrally welded.
5.5.3 A protection net and a rainproof cover shall be installed at the outdoor air outlet on the exhaust pipe outside the exhaust fan.
5.5.4 The selection of air-conditioning equipment shall meet the following requirements.
1 Spray-type air handling units should not be used. When a surface cooler is used, the air velocity passing through the section where the coil is located should not be greater than 2.0m/s.
2 Differential pressure gauges should be installed before and after the air filters at all levels, and the measuring connection should be unobstructed and tightly installed.
3 It is advisable to use a dry steam humidifier.
4 There should be a sufficient distance between the humidification equipment and the subsequent filter section.
5 When the static pressure value of 1000Pa is maintained in the air conditioning unit, the air leakage rate of the box should not exceed 2%.
6 The material of the muffler or muffler parts should be corrosion-resistant, non-dust-producing and not easy to attach dust.
7 Medium-efficiency and high-efficiency filters in the air supply and exhaust systems should not be reused.
6 Water supply and drainage and gas supply
6.1 General provisions
6.1.1 The main water supply and drainage pipes of the biosafety laboratory and the main pipes of the gas pipelines shall be laid in the technical interlayer. There should be few pipelines laid in the biosafety laboratory protection area, and pipelines that have nothing to do with this area should not pass through. The pipelines leading into the protective areas of the three and four biosafety laboratories should be exposed.
6.1.2 Reliable sealing devices should be installed where the water supply and drainage pipes pass through the enclosure structure of the biosafety laboratory protection zone, and the tightness of the sealing device should meet the tightness requirements of the area.
6.1.3 The water supply and drainage and gas piping systems entering and leaving the protected area of the biosafety laboratory should be leak-proof, pressure-resistant, temperature-resistant, and corrosion-resistant. There should be sufficient space in the laboratory for cleaning, maintenance and repair of exposed piping.
6.1.4 The high-pressure gas or flammable gas used in the biosafety laboratory shall have corresponding safety measures.
6.1.5 Chemical booster pump in chemical shower system
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