Biosafety Laboratory Classification Standards

Biosafety laboratory means

Laboratory structure, safety procedures, and equipment are vital for protecting staff from pathogenic microorganisms and toxins. Microorganisms are classified into four biosafety levels, from level one (non-pathogenic) to level four (highly dangerous, with unknown transmission).

P1 laboratory

1. The laboratory has the same level of equipment as the general microbiology laboratory,

2. If non-genetic recombination experiments are carried out in this level of laboratory at the same time, the experimental area must be clearly divided and the operation must be carried out carefully.

3. When conducting experiments, always close the doors and windows of the laboratory.

4. The laboratory bench must be sterilized at the end of each day's experiment. If contamination occurs during the experiment, it must be sterilized immediately.

5. All biological material waste generated must be sterilized as soon as possible and then discarded in accordance with the hospital's [Infectious Waste Management| related regulations. Contaminated instruments must be sterilized before cleaning, use or disposal.

6. Do not use your mouth to perform pipetting operations.

7. Eating, smoking and storing food are prohibited in the laboratory.

8. Wash your hands after operating recombinants or before leaving the laboratory.

9. In all operations, try to avoid the generation of aerosols.

10. When moving contaminated items out of the laboratory, they must be placed in a sturdy and leak-proof container and sealed in the laboratory before they can be transported out.

11. Prevent non-experimental organisms in the laboratory, such as insects and rodents, etc.

12. If other methods are available, avoid using needles

13. The use of experimental clothing must follow the instructions of the project leader.

14. Other matters set by the project leader must be followed.

P2 laboratory

1. Meet the construction requirements of BSL-2 laboratory.

2. The door of the laboratory is locked and can be closed automatically. The door of the laboratory should have a visible window.

3. There is enough storage space to place items for easy use.

4. There is also storage space for long-term use in the laboratory work area.

5. There should be conditions for storing personal clothing in the laboratory work area.

6. High-pressure steam sterilizers are equipped in all laboratory buildings, and they are inspected and verified regularly to ensure compliance with requirements.

7. Biosafety cabinets are equipped in the laboratory.

8. Eyewash facilities are set up, and emergency spray devices should be provided when necessary.

9. Consider mechanical ventilation, such as using windows for natural ventilation, and insect-proof screens.

10. There is a reliable power supply and emergency lighting. When necessary, important equipment such as incubators, biosafety cabinets, refrigerators, etc. should be equipped with power supplies.

11. The laboratory exit has a clearly identifiable sign in the dark.

P3 laboratory

The full name is "biosafety protection level 3 laboratory". P is the abbreviation of the English word protect. The entire laboratory is completely sealed, and the room is in a negative pressure state, so that the gas inside the laboratory will not escape to the outside and cause pollution.

Level 3 Biosafety Protection Laboratory

1. Safety Equipment and Personal Protection

A biosafety cabinet must be installed for handling infectious materials. Personal protective equipment is required, especially during aerosol-generating procedures. Staff should change into dedicated work clothes and use disinfectants, eye washes, and emergency medicines as needed.

2. Site selection

The third-level biosafety protection laboratory can be set up in the same building as other purpose houses, but it must be a separate area. This area is separated from the public corridor or public area by an isolation door.

3. Plan layout

a) The core area of the third-level biosafety protection laboratory includes the laboratory and the buffer room connected to it.

b) The buffer room forms the passage to the laboratory. Two interlocking doors must be set up. When one door 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. Secondary changing of clothes can be carried out in the buffer room.

c) When the laboratory Ventilation system is not equipped with an automatic control device, the area of the buffer room should not be too large and should not exceed one-eighth of the area of the laboratory.

d) The installation location of the Class II or Class III biosafety cabinet should be far away from the entrance of the laboratory, away from the area where the staff frequently walks, and it is conducive to the formation of an airflow pattern from the "clean" area to the "contaminated" area.

4. Enclosure structure

a) The inner surface of the enclosure structure of the laboratory (including the buffer room) must be smooth, corrosion-resistant and waterproof to facilitate disinfection and cleaning. All gaps must be reliably sealed.

b) All doors in the laboratory can be closed automatically.

c) No windows except observation windows shall be installed. The observation window must be a sealed structure, and the glass used must be unbreakable glass.

d) The floor should be leak-free, smooth but not slippery. Floor tiles and terrazzo with gaps shall not be used.

e) The intersection angles between the ceiling, floor, and wall are all arc-shaped and reliably sealed. During construction, insects and mice should be prevented from drilling into the foot of the wall.

5. Ventilation and air conditioning

a) An independent ventilation and air conditioning system must be installed to control the direction of laboratory air flow and pressure gradient. The system must ensure that when the laboratory is in use, the indoor air shall not be discharged from other parts or gaps of the laboratory to the outside except through the exhaust duct after high-efficiency filtration; at the same time, it must ensure that the air flow in the laboratory flows from the "clean" area to the "contaminated" area. The layout of the air inlet and exhaust outlet 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 shall not be used.

c) Environmental parameters: The inside of the laboratory maintains a negative pressure relative to the outside of the laboratory. The relative pressure of the laboratory room should be -30Pa~-40Pa, and the relative pressure of the buffer room should be -15Pa~-20Pa. The temperature and humidity in the laboratory should be controlled within the human comfort range, or according to the process requirements. The air cleanliness in the laboratory should be level 7 to 8 as defined in G8 50073-2001 "Cleanroom Design Specifications". The artificial lighting in the laboratory should be uniform, non-glaring, and the illumination should not be less than 500lx.

d) To ensure that the airflow in the laboratory flows from the "clean" area to the "contaminated" area, the laboratory should not use a double-sided evenly distributed exhaust vent layout. The ventilation design of top delivery and top exhaust should not be used. The air exhausted from the biological safety cabinet after internal high-efficiency filtration can be directly discharged to the atmosphere through the exhaust duct of the system, or it can be sent to the exhaust system of the building. The pressure balance between the biological safety cabinet and the exhaust system should be ensured.

e) The air intake of the laboratory should be filtered through primary, medium and high efficiency levels.

f) The exhaust air of the laboratory must be filtered through high efficiency or treated by other methods, and then discharged directly into the air at a speed of not less than 12m/s. The exhaust port should be far away from the air intake 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) The air intake and exhaust high efficiency filters must be installed in the air outlets of the laboratory on the enclosure structure to avoid contaminating the air duct.

h) In the ventilation system of the laboratory, airtight regulating valves should be installed at the air intake and exhaust main pipes, which can be completely closed when necessary for indoor chemical fumigation.

i) All components used in the ventilation system of the laboratory must be airtight. The high efficiency filters used must not be wooden frames.

j) The fan start-up automatic interlock device should be installed to ensure that the exhaust fan is turned on first and then the supply fan when the laboratory is started. When shutting down, the supply fan is turned off first and then the exhaust fan.

k) Split air conditioners shall not be installed in the laboratory.

6. Safety devices and special equipment

a) Class II or Class III biosafety cabinets must be installed in the main laboratory. 

b) Continuous flow centrifuges or other equipment that may generate aerosols should be placed in physical suppression equipment, which should be able to filter and discharge the aerosols that may be generated through high-efficiency filters. The exhaust of all other exhaust devices (fume hoods, exhaust hoods, etc.) that must be installed in the laboratory must be filtered by high-efficiency filters before being discharged. Its indoor layout should be conducive to the formation of airflow patterns from the "clean" area to the "contaminated" area.

c) The laboratory must be equipped with a high-pressure sterilization pot or other disinfection device that does not generate steam.

d) A transfer window should be set between the laboratory and the outside. The double 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 transferred through the transfer line.

e) A pressure display alarm device must be installed in a prominent position at the entrance of the laboratory to display the negative pressure between the laboratory and the buffer. When the negative pressure indication deviates from the preset interval, it must be able to send an alarm to personnel inside and outside the laboratory through sound, light and other means. The display of the air flow resistance of the supply and exhaust high-efficiency filters can be added to the device.

f) The power cannot be cut off during the startup of the laboratory. A dual-circuit power supply should be used. If it is difficult to achieve, a backup power supply or uninterruptible power supply that can be automatically switched during a power outage should be installed to power key equipment (biosafety cabinets, fume hoods, exhaust hoods, and lighting, etc.)

g) A wash basin can be set up in the buffer room: the water supply gate of the wash basin must be a foot-operated, elbow-operated or automatic switch. If the wash basin is located in the main laboratory, the sewer must be separated from the building's sewer line and clearly marked. The sewer must be disinfected. The wash basin is only for hand washing, and no infectious materials may be poured into it. The water supply pipe must be equipped with a backflow prevention device, and a floor drain shall not be installed in the laboratory.

7. Others

a) The surface of the laboratory table 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 table (rack) for placing biological waste containers. The corners and protruding parts of furniture and equipment should be smooth and burr-free, preferably in an arc shape.

c) The required vacuum pump should be placed in the laboratory, and the vacuum pipeline must be installed with an online high-efficiency filter.

d) Compressed air cylinders should be placed outside the laboratory. The pipeline passing through the enclosure structure must be sealed with non-shrinking sealing materials. The gas pipeline must be installed with an online high-efficiency filter and a backflow prevention device.

e) An eyewash device should be installed in the laboratory.

f) There should be a luminous indicator sign at the laboratory exit.

g) A communication system must be set up inside and outside the laboratory.

h) Experimental records and other materials in the laboratory should be sent to the outside of the laboratory via a fax machine.

P4 laboratory

P4 laboratories conduct experiments on highly pathogenic microorganisms, requiring strict measures to prevent contamination and environmental release. They operate under four biosafety levels, with P4 being the highest, ensuring protection against infectious pathogens like Ebola and anthrax.

1. Exploring the P4 laboratory

The P4 laboratory is the highest biosafety level globally, currently unavailable in mainland China. It handles highly dangerous pathogens, utilizing advanced safety systems and strict protocols. Access is restricted to authorized personnel, with multiple interlocked doors and specialized air filtration to prevent contamination, ensuring maximum safety in lab operations.

2. The most advanced P4 laboratory in France

Lyon, France's second-largest economic city, hosts the advanced Jean Merieux P4 Laboratory, operational since 1999. It focuses on high-risk viruses, utilizing a complex biosafety design. Biosafety regulations, like WHO's guidelines and China's P3 standards, ensure the safety of biological research and laboratory practices.

The P4 laboratory is a "double-edged sword". Its application may benefit mankind, but if it is not handled properly, it may also bring various "harms" to mankind. In recent years, the international community generally believes that the potential threat of biological weapons has greatly increased.

Negligence and accidents in the management of P4 laboratories can not only lead to infection of laboratory workers, but also cause Environmental pollution and large-scale infection of the population. Accidental infection accidents in laboratories at home and abroad are not uncommon.