"High-level laboratories are intricately designed at the beginning of construction, typically dedicated to biological safety experiments, with many devices integrated into the building, making relocation rare."
"During occasional relocations, all contaminants in the original laboratory are treated, equipment is disinfected to eliminate infection risks; the main concern is with samples or strains that pose infection risks,
According to the degree of danger associated with the use or storage of hazardous sources in laboratories, laboratory safety risk levels are divided into four levels. Interviewees provide insights.
Pengpai Technology: Who proposed this classification? We often see that some universities and institutions have their own laboratory standards. Does this indicate differences in laboratories across different organizations? Are there differences in the standards for these classifications domestically and internationally?
Li Qingchao: The iconic equipment in biosafety laboratories is the biosafety cabinet, with its earliest prototype seen in the US Army biological warfare laboratory in 1943. Discussions about biosafety laboratories also began due to the needs of biological warfare. With the participation of universities, hospitals, and corporate representatives, the American Biological Safety Association was established in 1984, drafting relevant regulations. In China, the "Regulations on Biosafety Management of Pathogenic Microorganisms in Laboratories" were issued and implemented on November 5, 2004.
In addition to national regulations, there is international consensus on biosafety levels and related regulations. While laboratory standards issued by universities or institutions may have detailed differences, they should all comply with national laws and regulations as well as academic consensus. China's "General Requirements for Laboratory Biosafety" (GB 19489-2008), issued in 2008, provides detailed provisions.
Pengpai Technology: Is the safety level of a laboratory related to the complexity of experiments conducted, the number of personnel, and the level of equipment? Does a higher safety level in a laboratory mean it is larger and more "advanced"?
Li Qingchao: The higher the biosafety level, the more dangerous the pathogens being studied, requiring stricter protective measures and more sophisticated safety equipment. However, the biosafety level of a laboratory is not necessarily related to the complexity of experiments or the number of personnel. Laboratories with higher biosafety levels have high training and operating costs, making it impractical for a large number of personnel to be involved. It is advisable to have only two people working in the same laboratory (watching out for each other).
Generally, laboratories with higher biosafety levels are more "advanced" in biosafety and are more expensive to build. Biosafety Level 4 laboratories are only found in a few countries. In 2003, the Chinese Academy of Sciences approved the construction of the first BSL-4 laboratory in mainland China at the Wuhan Institute of Virology. After a decade of effort, the National Biosafety Laboratory at the Wuhan Institute of Virology, completed in 2014, cost 300 million RMB (44 million USD).
The higher the biosafety level, the stricter the protective measures.
Pengpai Technology: What types of experimental subjects are typically handled in laboratories of different biosafety levels? What are the differences in laboratory design, equipment, and regulatory measures?
Li Qingchao: BSL-1 laboratories can handle microorganisms that do not typically pose a threat to human or animal health. Operations must adhere to microbiological techniques, without the need for special isolation measures, and can be used for basic teaching and research.
BSL-2 laboratories are suitable for microorganisms that can cause human or animal diseases but do not pose a serious threat, have limited transmission risks, and have controllable diseases with effective treatment and prevention measures. In addition to adhering to microbiological techniques, personnel must wear personal protective equipment, have biosafety cabinets, and display biohazard signs. These laboratories can be used for primary healthcare services, diagnostics, or research.
BSL-2 laboratory. Interviewees provide photos.
BSL-3 laboratories are suitable for pathogens that can cause serious diseases in humans or animals with a high risk of transmission, but typically have vaccines for prevention. At Biosafety Level 3, additional protective measures include specialized protective clothing, controlled laboratory airflow (preventing air from escaping), personnel training, and access control systems.
BSL-3 Laboratory. Interviewees provide images.
BSL-4 laboratories are used for pathogens that cause extremely serious diseases in humans or animals, are transmitted through aerosols, or have unknown transmission routes, for which there are currently no effective vaccines or treatments, as well as pathogens that have not been discovered or have been declared eradicated in China. Increase the airlock at the level of biosafety level 3, entrance and exit showers, special handling of contaminated items, and wear positive pressure protective clothing.
The Paper: What are the special requirements for personnel protection in high-level laboratories (such as BSL-3 and BSL-4)?
Li Qingchao: First, strict biosafety training is required before entering BSL-3 or BSL-4 laboratories.
BSL-3 operators wear personal protective equipment such as hoods, goggles, masks, gloves (multiple layers), shoe covers, and lab coats (multiple layers). No mucous membranes are directly exposed to the laboratory space, and all skin does not directly contact laboratory equipment, samples, or supplies, effectively preventing droplet contamination of the face.
BSL-4 operators are isolated from the entire body and laboratory space by wearing positive pressure protective suits (completely sealed protective suits that deliver fresh air through pipelines and maintain higher air pressure inside the protective suits than in the laboratory, ensuring that if there is a leak, air can only leak from the protective suit to the laboratory), effectively preventing the spread of aerosols.
The Paper: How are accidental spills and infection accidents generally handled in laboratories? What are the common causes of negligence or defects in these incidents? Are there any famous examples?
Li Qingchao: Biosafety laboratories need to strictly follow regulations for operations. Accidental exposure or infection is a very serious incident. The main reason for problems is not strictly adhering to biosafety operation norms.
There have been many accidents caused by laboratory safety issues in history, such as the 1967 Marburg virus laboratory infection incident in Germany, where 37 laboratory personnel were infected with a virus from monkeys used in the institute's research. In 2019, an accident occurred at the Lanzhou Veterinary Research Institute laboratory in China, leading to 65 staff members being infected with brucellosis, followed by over 10,000 residents being infected. It was reported that this outbreak was caused by inadequately disinfected emissions from a nearby biopharmaceutical factory.
In the event of a biosafety accident, on-site personnel must remain calm, take scientifically reasonable rescue measures; all personnel should not act blindly, actively assist each other while ensuring their own safety. Measures include: immediately closing the laboratory; effectively disinfecting contaminated areas; properly isolating, treating, and placing infected individuals; cooperating with supervisory authorities to carry out emergency response measures (such as disinfection, isolation, investigation, etc.).
Biosafety regulations should cover the entire experimental research process, from biosafety laboratory training and access systems to the handling of biosafety waste after experiments, contaminated gloves, lab coats, etc. Responsibility for safety lies not only with oneself but also with colleagues and the safety of the laboratory's location, to prevent personal infections and environmental leaks.
Biosafety management should be legal and compliant, with "no room for error."
The Paper Technology: How are laboratory levels generally assessed? Which organization is responsible for the assessment?
Li Qingchao: The state has clear regulations on the establishment and responsibilities of pathogenic microorganism laboratories, especially the establishment of level 3 and level 4 laboratories. The "Regulations on Biosafety Management of Pathogenic Microorganism Laboratories" stipulates that institutions certified by the State Council can accredit level 3 and level 4 laboratories. Laboratories that pass accreditation are issued corresponding biosafety laboratory certificates. The validity period of the certificate is 5 years.
In addition, the regulations also stipulate that level 1 and level 2 laboratories are not allowed to conduct experiments with highly pathogenic microorganisms. Level 3 and level 4 laboratories that conduct experiments with highly pathogenic microorganisms must be accredited by the state and have qualified personnel and building conditions.
Laboratory safety requires the establishing unit to be responsible for filing and management. The Chinese "Biosafety Law" stipulates that the legal representative of the pathogenic microorganism laboratory establishment unit and the laboratory director are responsible for the laboratory's biosafety, establishing and improving security systems, taking security measures, and ensuring the safety of the laboratory and its pathogenic microorganisms.
The Paper Technology: Does a laboratory with a higher safety level mean it can "downwardly compatible" to conduct less dangerous experiments? Can lower-level laboratories be "upgraded" by adding equipment and modifications?
Li Qingchao: In principle, laboratories with higher safety levels can be "downwardly compatible," but no one does this because it would be a significant waste. Lower-level laboratories can be upgraded by adding equipment and modifications, but they must comply with legal requirements.
The Paper Technology: How do domestic universities and institutions generally manage and allocate laboratories? How do research teams typically apply to use laboratories of different levels? Is safety training required?
Li Qingchao: Generally, when introducing talent or establishing a laboratory, specific experimental and office space is allocated to the talent or laboratory. In addition, some units may have shared spaces such as cold storage rooms and bacterial rooms. For large equipment or public facilities, they are generally open for use by teachers and students in schools or research institutes.
For high-level biosafety laboratories, there may be dedicated experimental spaces for a specific laboratory or shared experimental spaces by appointment. This mainly depends on the needs of the research team: if specialized research on pathogenic microorganisms requires a significant need for biosafety laboratory use and conditions permit, they may have their own biosafety laboratory space (often a room in a biosafety laboratory set up in the same building or floor), or if the need is not significant, they can reserve the use of the laboratory on a public biosafety platform. Regardless of the situation, entry into the laboratory requires training and approval from the safety supervisor. When using someone else's laboratory, in addition to bio-safety training and approval, permission from the lab manager is also needed to access another person's bio-safety laboratory.
Pengpai Technology: What steps are required when high-level laboratories need to be relocated for various reasons?
Li Qingchao: High-level laboratories are meticulously designed at the beginning of construction, typically dedicated to bio-safety labs with many integrated devices within the building, hence relocation is rare.
More commonly, samples are brought in for experiments in well-equipped bio-safety labs, following the guidelines of the "Regulations on Bio-safety Management of Pathogenic Microorganisms" during transport.
During occasional relocations, all contaminants in the original lab are treated, equipment is disinfected to eliminate infection risks. The focus is on high-risk samples or strains, ensuring no leaks or deactivation, often by transporting refrigerators or liquid nitrogen tanks.
Pengpai Technology: In your observation, what are the issues in managing domestic bio labs, and where can improvements be made?
Li Qingchao: For bio-safety labs in universities or research institutes, rapid personnel turnover due to graduations, resignations, and new members joining can lead to varying mentorship quality, affecting training standards. Continuous standardized training and assessment are necessary to avoid unauthorized experiments by junior students or interns.
Pengpai Technology: With the advancement of biotechnology, what potential changes could occur in the classification and management of lab safety levels?
Li Qingchao: As research progresses on known pathogens, experiments previously exclusive to high-level bio-safety labs can gradually shift to lower-level labs using alternative methods like pseudo-viral particles, defective viruses, non-reversible weak strains, or one-time infection models. Some dangerous pathogens may be conquered, reducing the need for research in high-level bio-safety labs.
However, unexpected new virus outbreaks may still require research on new pathogens in high-level bio-safety labs. While scientific research demands innovation, lab safety classification and management prioritize "no accidents, no room for error," emphasizing stability and safety above all.
