For the basic requirements of the ultra-high efficiency filter for the construction of the biosafety laboratory, the environmental parameters are as follows. Compared with the outside of the laboratory, the inside of the laboratory maintains a negative pressure. There are several different types of laboratory construction specifications for reference.
Level 1 Biosafety Protection Laboratory
Laboratory construction safety equipment and personal protection 1. Generally, there is no need to use special safety equipment such as biological safety cabinets. 2. The staff should wear work clothes and protective glasses during the experiment. 3. Workers should wear gloves when they have broken skin or rash on their hands.
Special requirements for laboratory design and construction
1. Each laboratory should have a hand-washing sink, which should be located near the exit.
2. The inner surface of the laboratory enclosure structure should be easy to clean. The ground should be non-slip and seamless, and no carpet should be laid.
3. The surface of the test bench should be impermeable, corrosion-resistant, and heat-resistant.
4. The furniture in the laboratory should be firm. For easy cleaning, a table (rack) of biological waste containers should be kept between various furniture and equipment.
5. If the laboratory has windows that can be opened, screen windows should be installed.
Secondary Biosafety Protection Laboratory
1. Safety equipment and personal protection
1.1 Operations that may produce pathogenic microbial aerosols or splashes should be carried out in a biological safety cabinet (Class II biological safety cabinet is appropriate) or other physical suppression equipment, and personal protective equipment should be used.
1.2 The handling of high-concentration or large-volume infectious materials must be carried out in a biological safety cabinet (Class II biological safety cabinet is appropriate) or other physical suppression equipment, and personal protective equipment should be used. The centrifugation of the above materials can be carried out in the laboratory if sealed centrifuge rotors or safety centrifuge cups are used, and they are only opened and closed in the biological safety cabinet and loaded with infectious materials.
1.3 When the operation of microorganisms cannot be carried out in the biological safety cabinet and external operations must be taken, in order to prevent the splashing or atomization of infectious materials, facial protection devices (goggles, masks, personal respiratory protection products or other protective equipment) must be used. Splash protection equipment).
1.4 Protective clothing such as work clothes or overalls should be worn in the laboratory. When leaving the laboratory, protective clothing must be taken off and left in the laboratory. It is not allowed to go out in a dress, let alone take it home. The used work clothes should be disinfected in the laboratory first, and then uniformly washed or discarded.
1.5 Wear gloves when your hands may come into contact with infectious materials, contaminated surfaces, or equipment. If spills or spills of infectious materials may occur, two pairs of gloves should be worn. Do not leave the laboratory wearing gloves. After the work is completely finished, the gloves can be removed. Disposable gloves must not be washed and reused.
2. Special requirements for laboratory design and construction
2.1 The biological safety protection secondary laboratory must meet the requirements of each paragraph in 6.1.2 of this standard.
2.2 Facilities for implementing various disinfection methods should be set up, such as autoclaves, chemical disinfection devices, etc. to treat waste.
2.3 Eyewash devices should be provided.
2.4 The laboratory door should be locked and can be closed automatically.
2.5 The exit of the laboratory should have a luminous indicator.
2.6 The laboratory should have no less than 3 to 4 ventilation times per hour.
3. Biosafety protection laboratory
1. Safety equipment and personal protection
1.1 Class II or above biological safety cabinets must be installed in the laboratory.
1.2 All operations involving infectious materials should be carried out in a biological safety cabinet. When such operations have to be carried out outside the biological safety cabinet, comprehensive protective measures of personal protection and the use of physical restraint equipment must be adopted.
1.3 Personal protective equipment must be used when conducting infectious tissue culture and operations that may produce infectious aerosols.
1.4 When the aerosol cannot be safely and effectively restricted within a certain range, respiratory protection devices should be used.
1.5 Before entering the laboratory work area, the staff should wear back-opening work clothes or other protective clothing in the special changing room (or buffer room). The work clothes must be taken off after work, and the work clothes are not allowed to leave the laboratory. Work clothes that can be reused must be disinfected and then washed.
1.6 Must wear gloves when working (two pairs are appropriate). Disposable gloves must be disinfected before being discarded.
1.7 The laboratory must be equipped with effective disinfectants, eye cleansers, or physiological saline, and be easy to access. Can be equipped with emergency medicines.
2. Special requirements for laboratory design and construction
2.1 Site selection
The biosafety protection laboratory can be set up in the same building with other houses, but it must be a separate area. This area is separated from public corridors or public places by isolation doors.
2.2 Layout of laboratory construction
a) The core area of the biosafety protection laboratory includes the experimental room and the buffer room connected to it.
b) The buffer room forms a channel into the experiment room. Two interlocking doors must be set. When one of the doors is opened, the other door is automatically closed. If an electric interlocking device is used, both doors must be openable when the power is off. The second dressing can be done in the buffer room.
c) When the ventilation system of the laboratory is not equipped with automatic control devices, the area of the buffer room should not be too large, and should not exceed one-eighth of the area of the experimental room.
d) The installation location of the level II or level III biological safety cabinet should be far away from the entrance of the laboratory, avoid the area where the staff frequently walks, and is conducive to the formation of airflow pattern from the "clean" area to the "contaminated" area.
2.3 Envelope structure
a) The inner surface of the enclosure structure of the laboratory (including the buffer room) must be smooth, corrosion-resistant, waterproof, and easy to disinfect and clean. All gaps must be reliably sealed.
b) All doors in the laboratory can be closed automatically.
c) Except for observation windows, no windows are allowed. The observation window must be a sealed structure, and the glass used is not broken glass.
d) The ground should be free of leakage, smooth but not slippery. Do not use floor tiles and terrazzo on the ground with gaps.
e) The corners between the ceiling, floor, and walls are all arc-shaped and reliably sealed, and insects and mice should be prevented from entering the foot of the wall during construction.
2.4 Ventilation and air conditioning
a) An independent ventilation and air conditioning system must be installed to control the airflow direction and pressure gradient in the laboratory. The system must ensure that when the laboratory is used, the indoor air must not be discharged from other parts or gaps in the laboratory to the outdoors, except for the exhaust through the exhaust duct through high-efficiency filtration; at the same time, ensure that the airflow in the laboratory flows from the "clean" area to the "polluted" area. "area. The layout of the air intake and exhaust vents should minimize the dead space in the experimental area.
b) The ventilation and air-conditioning system is a direct exhaust system, and a partial return air system is not allowed.
c) Environmental parameters: Compared with the outside of the laboratory, the inside of the laboratory maintains negative pressure. The relative pressure between the experiments is preferable -30Pa～-40Pa, and the relative pressure between the buffers is -15Pa～-20Pa. The temperature and humidity in the laboratory should be controlled within the comfortable range of the human body, or determined according to the process requirements. The air cleanliness in the laboratory should be level seven to eight defined in GB50073-2001 "Code for Design of Clean Workshops". The artificial lighting in the laboratory should be uniform, not dazzling, and the illumination should not be less than 500lx.
d) In order to ensure that the airflow in the laboratory flows from the "clean" area to the "contaminated" area, the layout of exhaust outlets evenly distributed on both sides should not be used in the laboratory. The ventilation design of the upper delivery and upper row should not be adopted. The internal high-efficiency filtered air discharged from the biological safety cabinet can be directly discharged to the atmosphere through the exhaust pipe of the system, or sent into the exhaust system of the building. The pressure balance between the biological safety cabinet and the exhaust system should be ensured.
e) The inlet air of the laboratory should be filtered through the four-stage filter of the ultra-high efficiency filter, the mid-efficiency filter, the primary efficiency filter.
f) The exhaust air of the laboratory must be directly discharged into the air at a speed of no less than 12m/s after being processed by high-efficiency filtration or other methods. The air outlet should be far away from the air inlet of the system. The treated exhaust air can also be discharged into the exhaust duct of the building, but it must not be sent back to any part of the building.
g) HEPA filters for air intake and exhaust must be installed in the air openings of the laboratory on the enclosure structure to avoid polluting the air duct. (www.rfilter.com)
h) In the laboratory's ventilation system, air-tight regulating valves should be installed at the inlet and exhaust main pipes, which can be completely closed for indoor chemical fumigation and disinfection if necessary. i) All components used in the ventilation system of the laboratory must be airtight. The HEPA filter used must not be a wooden frame.
j) The fan starts automatic interlocking device should be installed to ensure that the exhaust fan is turned on first and then the blower is turned on when the laboratory is started. When closing, turn off the blower first and then the exhaust fan.
k) Split air conditioners shall not be installed in the laboratory.
2.5 Laboratory construction safety devices and special equipment a) A Class II or Class III biological safety cabinet must be installed in the main laboratory. The installation position should meet the requirements in 188.8.131.52 d).
b) Continuous flow centrifuges or other equipment that may generate aerosols should be placed in physical suppression equipment, and the device should be able to discharge the aerosols that may be generated by a high-efficiency filter. The exhaust of all other exhaust devices (fume hoods, exhaust hoods, etc.) that must be installed in the laboratory must be filtered by a high-efficiency filter before it can be exhausted. The indoor layout should be conducive to the formation of airflow from the "clean" area to the "contaminated" area.
c) An autoclave or other disinfection device that does not produce steam must be installed in the laboratory.
d) There should be a transfer window between the experiment room and the outside. The two doors of the transfer window shall not be opened at the same time, and a physical disinfection device shall be installed in the transfer window. Infectious materials must be placed in a closed container before they can be delivered through the delivery window.
e) A pressure display alarm device must be installed at a prominent position at the entrance of the laboratory to display the negative pressure in the experimental room and the buffer room. When the negative pressure indicator deviates from the preset interval, it must be able to send an alarm to the person inside and outside the laboratory through sound, light and other means. The airflow resistance of the high-efficiency filter can be displayed on the device.
f) During the start-up of the laboratory, the power cannot be cut off. A dual power supply should be used. If it is difficult to achieve, a backup power supply or uninterruptible power supply that can be automatically switched in the event of a power failure should be installed to supply power to key equipment (biological safety cabinets, fume hoods, exhaust hoods, lighting, etc.).
g) A washbasin can be set up in the buffer room: the water supply door of the washbasin must be a pedal, elbow, or automatic switch. If the sink is located in the main laboratory, the sewer must be separated from the sewer pipe of the building and be clearly marked. The sewage must be disinfected. The sink is for handwashing only, and no infectious materials may be poured inside. The water supply pipe must be equipped with a backflow prevention device. No floor drain shall be installed in the laboratory.
a) The surface of the test bench should be impermeable, corrosion-resistant, and heat-resistant.
b) The furniture in the laboratory should be firm. For easy cleaning, a certain gap should be maintained between various furniture and equipment. There should be a stand (rack) dedicated to placing biological waste containers. The corners and protruding parts of furniture and equipment should be smooth, free of burrs, and preferably circular.
c) The required vacuum pump should be placed in the laboratory. The vacuum pipeline must be equipped with an online high-efficiency filter.
d) Cylinders such as compressed air should be placed outside the laboratory. The pipe passing through the enclosure structure and the enclosure structure must be sealed with non-shrinkable sealing materials. The gas pipeline must be equipped with an online high-efficiency filter and a backflow prevention device.
e) An eyewash device should be installed in the laboratory.
f) Laboratory exits should have luminous indication signs.
g) Communication systems must be set up inside and outside the laboratory.
h) The experimental records and other materials in the laboratory should be sent out of the laboratory by fax.
3. Level 4 Biosafety Protection Laboratory
The four-level biosafety protection laboratory is divided into a safety cabinet type laboratory and a positive pressure suit type laboratory. In a safety cabinet type laboratory, all microbiological operations are carried out in class III biological safety cabinet. In laboratories wearing positive pressure suits, staff must wear special positive pressure suit protective clothing.
1. Safety equipment and personal protection
1.1 All operations of infectious materials in the laboratory must be carried out in Class III biological safety cabinet. If the staff wears overall positive pressure overalls supplied by the life support system, the relevant operations can be carried out in a Class II biological safety cabinet.
1.2 All staff must wear a full set of laboratory clothing when entering the laboratory, including underwear, underwear, shirt or jumpsuit, shoes, and gloves. All these laboratory protective clothing must be taken off in the locker room before showering and leaving the laboratory.
2. Special requirements for the design and construction of safety cabinet type laboratories
2.1 Site selection. The laboratory should be built in a separate building or a separate area in the laboratory building.
2.2 Floor layout
a) The core area of the laboratory consists of a room (safety cabinet room) with a Class III biological safety cabinet and an access channel. The entrance passage has at least three parts, which are the outer dressing room, the air shower room, the shower room, and the inner dressing room in sequence. There is an automatic interlocking device between any adjacent doors to prevent two adjacent doors from being opened at the same time. For materials, articles, and equipment that cannot be carried in and out of the safety cabinet room from the locker room, an autoclave with a double-door structure should be installed on the wall of the biological safety cabinet room, and there should be an immersion disinfection tank, a fumigation room or a disinfection device. The ventilation transfer window for transfer or disinfection. An emergency exit channel with an airlock chamber must be provided.
b) A buffer zone can be set around the safety cabinet room, which is a circular corridor or buffer room, which is part of the core area. The requirements for the construction of the buffer zone are the same as the **Biosafety Protection Laboratory.
2.3 Envelope structure
a) The walls, floors, and ceilings of the safety cabinet room and the inner dressing room should form a sealed inner shell. The floor should be sealed as a whole, and the corners of the walls should be rounded. The inner surface of the room should be waterproof and corrosion-resistant. All gaps in the structure should be sealed. Minimize the gap between the safety cabinet room and the inner locker room door and seal it to facilitate disinfection. All the sewer pipes on the floor of the safety cabinet room directly lead to the liquid disinfection system, and the sewer mouth and other service lines are equipped with high-efficiency filters to prevent pests from entering.
b) The door to the laboratory can be closed automatically and can be locked. All equipment for transferring items inside and outside the laboratory must be a double-door structure, and there must be an automatic interlocking device between the two doors.
c) Any window must be broken and sealed.
d) Install a double-door autoclave in the wall hole of the laboratory for disinfecting the items delivered from the Class III biological safety cabinet and the biological safety cabinet. The outer door opens outside the laboratory. The gap must be well sealed.
2.4 Laboratory construction of ventilation and air conditioning
a) A well-designed and constructed direct exhaust ventilation system must be installed. The air intake and exhaust design of the system should ensure that the directional airflow flows from the smallest hazardous area to the largest potential hazardous area. The layout of the air intake and exhaust vents should minimize the dead space in the experimental area.
b) The phase must be monitored