Notice of the General Office of the National Health Commission on Printing and Distributing Biosafety Guidelines for New Coronavirus Laboratories (Second Edition)
Science and Technology Education Department
Provinces, autonomous regions, municipalities directly under the Central Government and cities with separate plans, Xinjiang Production and Construction Corps Health Committee, Chinese Center for Disease Control and Prevention, Chinese Academy of Medical Sciences:
In order to guide the prevention and control of pneumonia caused by new coronavirus infections, experts organized by our committee revised the “Biosafety Guidelines for New Coronavirus Laboratories” (Second Edition), please follow them. All localities encounter relevant situations and problems during the implementation process, please feedback to our committee in time.
General Office of the National Health Commission
New Coronavirus Laboratory Biosafety Guidelines
According to the current biological characteristics, epidemiological characteristics, pathogenicity, clinical manifestations and other information of the new coronavirus, the pathogen is temporarily managed according to the second category of pathogenic microorganisms in the classification of pathogenic microorganisms.
1. Biosafety requirements for experimental activities
(1) Virus culture: refers to the operations of virus isolation, culture, titration, neutralization test, live virus and protein purification, virus freeze-drying, and recombinant virus producing live virus. The above operations should be carried out in a biosafety level 3 laboratory. To extract nucleic acid using virus culture, the addition of lysing agent or inactivator must be carried out under the same level of laboratory and protective conditions as virus culture. After adding the lysing agent or inactivating agent, it can be compared with the protection of uncultivated infectious materials. Operation. Before carrying out related activities, the laboratory shall report to the National Health and Health Commission for approval and obtain the qualifications to carry out the corresponding activities.
(2) Animal infection experiments: refer to experimental operations such as infecting animals with live virus, sampling infected animals, handling and testing of infectious samples, special inspection of infected animals, and treatment of excreta of infected animals, and should be conducted in a Level 3 laboratory of biological safety. Before carrying out related activities, the laboratory shall report to the National Health and Health Commission for approval and obtain the qualifications to carry out the corresponding activities.
(3) Operation of uncultivated infectious material: refers to virus antigen detection, serological testing, nucleic acid extraction, biochemical analysis, and clinical sample destruction before uncultivated infectious material is inactivated by a reliable method The live operation should be carried out in the biosafety second-level laboratory, and the personal protection of the biosafety third-level laboratory should be adopted.
(4) Operation of inactivating materials: nucleic acid testing, antigen testing, serological testing, biochemical analysis and other operations of infectious materials or live viruses after inactivation by reliable methods should be carried out in the biosafety secondary laboratory. Other operations, such as molecular cloning, which do not contain pathogenic live viruses, can be carried out in a biosafety laboratory.
Second, pathogen and sample transportation and management
(1) Domestic transportation: The transportation packaging classification of new coronavirus strains or other potentially infectious biological materials belongs to category A, and the corresponding UN number is UN2814. The packaging conforms to the ICAO document Doc9284 “Technical Rules for the Safe Transport of Dangerous Goods by Air” PI602 classification and packaging requirements; environmental samples belong to category B, the corresponding UN number is UN3373, and the packaging conforms to the PI650 classification and packaging requirements of the ICAO document Doc9284 “Technical Rules for the Safe Transport of Dangerous Goods by Air”; for transportation by other means of transportation, the above standards can be referred to package.
The transportation of new coronavirus strains or other potentially infectious materials shall be handled in accordance with the “Qualified Transportation Certificate” in accordance with the “Administrative Provisions on the Transport of Species or Samples of Highly Pathogenic Microorganisms (Poisons) Infecting Humans” (Order No. 45 of the Ministry of Health) .
(2) International transportation: If new coronavirus strains or samples are transported internationally, they should be packaged in a standardized manner, go through relevant procedures in accordance with the Regulations on the Administration of Health and Quarantine of Special Items for Entry and Exit, and meet relevant national and international requirements.
(3) Management of strains and samples: New coronavirus strains and related samples should be managed by dedicated personnel, accurately record the source, type, quantity and serial number registration of the strains and samples, take effective measures to ensure the safety of the strains and samples, and strictly prevent Misuse, malicious use, stolen, robbed, lost, leaked, etc. occurred.
3. Waste management
(1) Laboratories carrying out experimental activities related to new coronaviruses shall formulate waste disposal procedure documents and sewage and sewage treatment operation procedures.
(2) All hazardous wastes must be labeled in a complete and compliant manner in accordance with uniformly standardized containers and labeling methods.
(3) Properly trained personnel should use appropriate personal protective equipment and equipment to handle hazardous waste.
(4) Waste disposal measures: Waste disposal is the key link to control laboratory biosafety. To deal with infectious wastes safely and safely, we must fully grasp the classification of biosafety wastes and strictly implement the corresponding treatment procedures.
1. Treatment of waste liquid: The waste liquid generated in the laboratory can be divided into ordinary sewage and infectious waste liquid.
(1) General sewage is generated from equipment such as a sink, etc. Such sewage should be collected separately and discharged into a laboratory water treatment system.
(2) Infectious waste liquid is the wastewater generated during the experimental operation, which is treated by chemical disinfection or physical disinfection, and the disinfection effect is verified to ensure complete inactivation.
(3) The staff should dispose of the waste in a timely manner and must not take the waste out of the experimental area.
2. Treatment of solid waste:
(1) Separate collection of solid waste, the collection container of solid waste should have the characteristics of not easy to be broken, leakproof, moisture and heat resistant, and sealable. Infectious garbage in the laboratory is not allowed to be stored in piles, and should be sterilized by pressure steam in time. Before disposal, the waste should be stored in a safe place designated in the laboratory.
(2) Small solid wastes such as tissue specimens, consumables, personal protective equipment, etc. need to be sterilized by pressure steam, and then moved out of the laboratory along the waste channel.
(3) Large-volume solid wastes such as HEPA filters should be disinfected in situ by professionals and put into safe containers for disinfection and sterilization. Items that cannot be sterilized by pressure steam, such as electronic equipment, can be fumigated with ethylene oxide.
(4) After being sterilized and sterilized, the solid waste removed from the laboratory shall be handed over to the solid waste disposal unit for disposal.
(5) If the sharps (including needles, knives, metal, glass, etc.) are used in the experimental process, they should be directly discarded in the sharps box. After autoclaving, they should be treated uniformly.
(5) Establish waste disposal records: regularly conduct leak detection and replacement of laboratory exhaust HEPA filters, regularly monitor the treated sewage, and use biological indicators to monitor the effect of pressure steam sterilization.
Fourth, laboratory biosafety operation errors or unexpected handling
(1) New coronavirus strains or other potentially infectious materials contaminate the operating table of the biosafety cabinet to cause limited pollution: use disinfectant with an effective chlorine content of 0.55%. The disinfectant needs to be used and prepared within 24 hours. The content of available chlorine in the following content refers to this concentration.
(2) Vibration of culture vessels containing virus or overturning causes laboratory pollution: Keep the laboratory space closed to avoid the spread of pollutants, and use a towel with 0.55% effective chlorine disinfectant to cover the contaminated area. When necessary (when a large amount of spilling), peracetic acid can be used to heat the fumigation laboratory, the dose is 2g / m3, fumigation overnight; or 20g / L peracetic acid disinfectant is sprayed with an aerosol sprayer, the dosage is 8ml / m3, and the effect is 1 ~ 2 Hours; if necessary or fumigation with potassium permanganate-formaldehyde: potassium permanganate 8g / m3, put in a heat-resistant and corrosion-resistant container (pottery jar or glass container), then add formaldehyde (40%) 10ml / m3, fumigation 4 More than hours. The indoor humidity during fumigation is 60% -80%.
(3) Clean up the pollutants strictly in accordance with the requirements of live virus biological safety operation, adopt pressure steam sterilization treatment, and conduct laboratory ventilation, etc., to prevent secondary hazards.