Definition of P2 Laboratory

P2 laboratory is a biosafety protection level two laboratory. The World Health Organization (WHO) classifies infectious microorganisms into four categories based on their pathogenicity and the degree of risk of transmission; According to equipment and technical conditions, biological laboratories are also divided into four levels (generally referred to as P1, P2, P3, P4 laboratories), with level 1 being the lowest and level 4 being the highest. Among various laboratories nowadays, P2 laboratory is the most widely used biosafety level laboratory.

Design Basis for 2P2 Laboratory Construction

 1. Design Specification for Cleanrooms in the Pharmaceutical Industry (1997)

 2. Design Specification for Cleanroom (1984)

 3. Design Code for Heating, Ventilation and Air Conditioning (GBJ19-87)

 4.<Disinfection Management Measures>(Ministry of Health, 1992)

 5. The laboratory floor plan and other relevant technical information and requirements provided by Party A;

 3P2 Laboratory Requirements

 The P2 laboratory is mainly used for primary health services, diagnosis, and research. The national standard specifies corresponding requirements, and the hazard level of its experimental subjects is Level II (moderate individual hazard, limited group hazard), suitable for microorganisms with moderate potential harm to humans and the environment. The specific definition is "a pathogen that can cause illness in humans or animals, but generally does not cause serious harm to health workers, populations, livestock, or the environment. The representative pathogen is influenza virus. Laboratory infections do not cause serious diseases, have effective treatment and prevention measures, and have limited transmission risks. Based on this, the upcoming national standard "Technical Specification for Building Biosafety Laboratories" specifies the following technical indicators (static) for BLS-2 laboratory:

 1. Cleanliness: Class 10000 to Class 100000

 2. Pressure difference between rooms adjacent to the outdoor direction: No requirement

 3. Temperature ℃: 18-27

 4. Relative humidity%: 30~70

 5. Noise dB (A):&le; sixty

 6. Minimum illuminance lx: 300

 Note: The appeal criteria are the minimum requirements for establishing a P2 laboratory. Builders may increase the corresponding criteria as needed, such as cleanliness, pressure difference, etc.

 System components of 4P2 laboratory

1. Laboratory structure decoration:

The ceiling and enclosure partitions of the laboratory are made of polystyrene sandwich color steel plate with a thickness of 50mm, and the steel plate is Baosteel 0.5mm. (The advantages of color steel plate are light weight, high mechanical strength, good waterproof and insulation performance); The corners of the wall, as well as the angles between the wall and the ground, and between the wall and the ceiling, are all made of aluminum alloy with circular arc yin-yang transition and sealing. All supporting aluminum alloy profiles are made of electrophoretic profiles to prevent oxidation of the aluminum material during long-term laboratory disinfection. The laboratory floor is seamlessly connected with imported plastic PVC flooring, which has the characteristics of acid and alkali corrosion resistance, wear resistance, and slip resistance.

 2. Cleanliness and pressure gradient between each experimental room:

The laboratory is mainly divided into contaminated areas and experimental operation rooms according to conventional division.

The cleanliness level of the operating room is 10000, the air exchange rate is not less than 40 times/hour, and the room pressure difference is -40Pa (for the atmosphere)

The cleanliness level of the disinfection and sterilization room is 100000, the air exchange rate is not less than 40 times/hour, and the room pressure difference is -40Pa (for the atmosphere);

The cleanliness level of the secondary buffer room is 100000, the air exchange rate is not less than 30 times/hour, and the room pressure difference is -30Pa (for the atmosphere);

The cleanliness level of the semi polluted area is 100000, the air exchange rate is not less than 30 times/hour, and the room pressure difference is -20Pa (for the atmosphere);

The cleanliness level of the clean corridor is 100000, the air exchange rate is not less than 30 times/hour, and the room pressure difference is+10Pa (for the atmosphere);

The cleanliness level of the preparation room is 100000, the air exchange rate is not less than 30 times/hour, and the room pressure difference is+10Pa (for the atmosphere);

The cleanliness level of the buffer room is 100000, the air exchange rate is not less than 30 times/hour, and the room pressure difference is+10Pa (for the atmosphere);

The internal shower room has no cleanliness requirements and is equipped with independent exhaust, with a ventilation rate of no less than 10 times per hour;

Set up an independent monitoring room and air conditioning room next to the laboratory.

 3. Laboratory airflow organization method:

 From a safety perspective, this system is designed as a brand new wind directional DC system. The biosafety laboratory adopts a brand new wind top delivery single-sided downward discharge form, with the airflow direction flowing from the clean area to the contaminated area (from the buffer changing area&rarr;); Shower room&rarr; Change clothes and rarr; Clean corridor&rarr; Preparation Room&rarr; Semi polluted area&rarr; One buffer&rarr; Wear protective clothing&rarr; Secondary buffering&rarr; Operating Room&rarr; Biosafety cabinet).

 The air outside the laboratory is processed by air conditioning and filtered through a medium efficiency fan filter box. It is then filtered through a high-efficiency filter in the room through a pipeline and sent into the room. After passing through an exhaust duct equipped with a high-efficiency filter, it is efficiently filtered again by a high-efficiency filter exhaust box through an exhaust duct. After being physically sterilized with ozone, it is discharged outside.

 4. Air conditioning system:

 The biosafety laboratory adopts constant temperature and humidity air conditioning units to provide cold and hot loads in winter and summer; Increase the start-up electric heater during winter peak hours to meet the winter heat load.

 5. Laboratory ventilation system:

 The experimental operation room, secondary buffering area, semi polluted area, primary buffering and preparation room, clean changing area, and clean corridor are equipped with one set of air supply unit and one set of exhaust unit. The air supply and exhaust volume ratio is used to maintain negative pressure in the room and prevent harmful pollutants from leaking out. The exhaust fan unit adopts dual fans, one for use and one for backup. In the event of a malfunction of the exhaust fan during operation, the backup fan can be interlocked to ensure the continuous and normal operation of the laboratory without hindering normal experimental work.

 6. Room pressure display and alarm system:

 The laboratory is equipped with pressure display and overpressure/undervoltage alarm systems. When the indoor pressure exceeds or falls below the set pressure warning value, the alarm will sound and light to alert the experimental staff.

 7. Electronic Chain System:

 All buffer rooms in the laboratory are equipped with electronic interlocking doors. When any door in the buffer room is opened, the other door interlocked with it cannot be opened (using a power-off electronic lock) to prevent the laboratory from losing pressure when both doors are opened at the same time. Install imported door closers on all doors that can automatically close.

 8. Automatic air volume control system:

 Install an imported mechanical action (fault free) constant air volume control valve on the main air supply pipe of the main experimental room in the laboratory. The high-efficiency exhaust outlet in the room is equipped with a variable air volume control valve. As the resistance of the high-efficiency filter changes, the signal is fed back to the pressure controller by the indoor pressure sensor. The pressure controller controls the opening of the air valve actuator to adjust the air volume and maintain a constant pressure in the laboratory.

 9. Anti backflow system:

 The new exhaust system in the biosafety protection laboratory is equipped with an electric sealed valve (chain supply and exhaust control) fan to prevent air backflow during shutdown and to be able to seal and disinfect.

 10. Entry and exit of laboratory items:

 The items, instruments, etc. required for experimental operations must enter through the stainless steel transfer window (with ultraviolet sterilization lamp) connected to the semi contaminated area and preparation room; After on-site high-pressure disinfection in the laboratory operation room, laboratory waste is subjected to secondary high-pressure sterilization in the disinfection and sterilization room before being transported out through a stainless steel transfer window (with ultraviolet sterilization lamp) connected to the waste buffer room for further processing.

 11. Laboratory gas pipeline connection:

 Install experimental tracheal fittings and valves in the biosafety protection laboratory; To avoid placing gas cylinders for instrument use directly into the laboratory operation area.

 12. Data transmission system:

 Install network cables, telephone and fax lines in the biosafety protection laboratory so that experimental data can be transmitted outdoors.

 13. Monitoring system:

 The biosafety protection laboratory is equipped with a closed-circuit television monitoring and recording system. The monitoring system consists of one host and multiple zoom cameras, which control the laboratory operation room, semi polluted area, preparation room, etc. The host is installed in the central control room; It is convenient to observe the operation process of each experimental room and avoid visitors entering the laboratory.

 14. Communication system:

 The intercom system consists of two sets of telephones located in the central control room and various experimental rooms.

 15. Access control system:

 Install a set of high recognition password locks at the entrance of the door during preparation. The information of experimental personnel can be entered into the database, and the data can be adjusted as needed to ensure laboratory safety.

 16. Form and configuration of power distribution system:

 1) The system is a TN-S220V/380V distribution system, powered by dedicated feeders. The distribution room is equipped with one main distribution box, one dedicated interlocking start and stop distribution box for air supply and exhaust, one control for air supply and exhaust fans and interlocking backup fans, one lighting control box, and one control for laboratory lighting, sockets, and biosafety cabinets. All laboratory lighting uses airtight purification lamps, ceiling mounted, and at least one set of purification lamps with emergency power supply in each room. Install illuminated indicator lights at each exit of the laboratory. Install ultraviolet sterilization lamps in the laboratory.

 2) The biosafety cabinet in the biosafety laboratory is equipped with a (1-hour) UPS uninterruptible power supply to prevent emergency response and evacuation time in case of sudden power outages.

 3) The position and height of each indoor electrical point can be adjusted according to user requirements during construction. All other electrical circuits are laid in flame-retardant PVC pipes on the color steel plate ceiling and in the sandwich layer. 

5P2 Laboratory Management System

 Only authorized personnel are allowed to enter the P2 laboratory work area.

 Children under the age of 16 are prohibited from entering the P2 laboratory work area.

 3. Experimental personnel should receive corresponding immunization with preventive biological products.

 4. It is prohibited to bring unrelated animals into the experimental area.

 5. Visitors, visitors, and trainees from external units must obtain approval from the central supervisory department and are not allowed to enter the P2 laboratory work area without approval.

 6. Foreign personnel entering the P2 laboratory must be accompanied by personnel from the laboratory and must strictly comply with relevant regulations before entering. At the same time, they must fill out the "Registration Form for Foreign Personnel Entering and Exiting Special Areas of the Laboratory".

 7. Restrict the entry of immunocompromised individuals into the laboratory.

 8. Restrict the entry of individuals receiving immunosuppressants into the laboratory.

 Smoking, eating, makeup, etc. are strictly prohibited in the laboratory.

 Enter the program

 2.1 Enter the P2 laboratory, reach out and turn on the air conditioning and biosafety cabinet buttons in the buffer room to purify the laboratory and biosafety cabinet for more than 10 minutes. Only then can one enter the laboratory to conduct experiments.

 2.2 Place the materials and items required for the experiment into a biosafety cabinet.

 2.3. Enter the buffer zone of P2 laboratory, close the outer door, wear a P2 laboratory specific cover (tight mouth, back strap) outside the work clothes, wear a disposable mask, hat, and two layers of gloves, and change into P2 laboratory specific shoes. Turn on the lighting button when needed.

 2.4. When entering the laboratory workspace, first turn on the lighting button, open the front glass door, and adjust it to the required height. Place all the necessary items for the experiment into the experimental platform at once, in an orderly manner and with a relative distinction between cleaning materials and pollutants, and purify the biosafety cabinet for about 10 minutes.

 2.5 Observe whether the negative pressure gauge in the experimental area indicates a value within the required working range. If it cannot meet the requirements, adjust the negative pressure. Observe the thermometer and hygrometer, and fill in the usage record of the thermometer and hygrometer.

 2.6 After placing the arm of the experimenter in the biosafety cabinet for about 1 minute, the experimental operation can be carried out according to the sterile requirements.

 2.7 After completing the entire experimental operation, classify and process the used items. Disinfect the entire workbench and let the exhaust run for at least 10 minutes.

 2.8. Put down the front glass door and turn on the UV lamp of the biosafety cabinet for poisoning.

 2.9. Remove the second layer of gloves and disinfect the designated container before leaving the experimental operation area.

 2.10. Fill in the instrument usage record.

 3. Post experiment items and pollutant treatment

 3.1 After carefully wrapping non recyclable contaminated items, they should be sterilized in a high-pressure sterilizer according to the prescribed requirements. Then, the medical waste will be handed over to the center for unified disposal.

 3.2. Carefully wrap the recyclable contaminated items and perform high-pressure sterilization according to the prescribed requirements in a high-pressure sterilizer. Then transfer to the washing room for washing.

 3.3 Place disposable experimental supplies into containers for high-pressure sterilization, and then dispose of them uniformly as medical waste at the center.

 3.4 For items that cannot be sterilized by high pressure, appropriate disinfectants should be selected for soaking and disinfection. Recyclable items, sent to the washing room; Non recyclable items shall be handled in accordance with the relevant regulations of the center's "three wastes" disposal.

 4. Out of laboratory procedures

 4.1 Open the laboratory door and close it as soon as you come out. Remove the laboratory specific cover and hang it in a buffer zone for UV disinfection later. Remove disposable hats, masks, and gloves, place them in the garbage bin to be disinfected, press the door lock button, open the outer door, replace slippers, turn on the UV button, and turn off the exhaust button, then close the outer door. Note: If the lighting is turned on when entering, it should be turned off at this time.

 4.2. If pollutants have been passed through the transfer window during the experiment, ultraviolet disinfection should be carried out after the experiment.

 4.3 After disinfection is completed (at least 30 minutes), turn off the biosafety cabinet and UV button.

 5. Precautions

 5.1. The laboratory environment should be kept clean.

 5.2. The internal space of the workbench needs to be cleaned with disinfectant. If the disinfectant is corrosive, the countertop should be cleaned with tap water to avoid corrosion.

 5.3. The experimental equipment inside the control panel should avoid blocking the perforated grids in front and behind, and avoid getting things caught up in them. All operations should be carried out on the working surface within about 10 centimeters from the front grille.

 5.4 During operation, slow movements should be made to reduce unnecessary hands and arms reaching into and out of the air barrier to avoid affecting airflow.

 5.5. When operating the workbench, efforts should be made to minimize the opening and closing of doors and the movement of personnel in the laboratory to avoid affecting indoor airflow.

 5.6 Generally, alcohol lamps or similar open flames should not be used in biosafety cabinets, as they can disrupt airflow patterns, damage HEPA filters, and pose a fire hazard (unless otherwise specified).

 5.7 Do not continue operating when the alarm light or bell rings.

 5.8. In the event of an accident during the operation of the workbench, it must be thoroughly disinfected along with the workbench before being removed. If any spilled sewage or liquid is concentrated in the drainage tank, emergency measures must be taken to discharge the sewage. Simultaneously fill in the 'Laboratory Potential Hazardous Material Spill or Shallow Record'.

 5.9 After the experiment is completed, remove the test items from the biosafety cabinet and do not use the biosafety cabinet as a storage box.