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文章出处:Technology|阅读量:536|发表时间:2021-03-22
With the popularity of newly built PCR laboratories and nucleic acid detection technologies that meet the safety level in my country, many large-scale nucleic acid screening tasks have been carried out across the country. As far as Beijing is concerned, there are 175 institutions capable of nucleic acid testing. At present, the nucleic acid detection work of the new coronavirus has changed from an emergency nature to a normalized nature. In fact, it has brought new challenges to clinical laboratories across the country, and it has also forced the rapid and standardized development of biosafety laboratories. On TV, we often see the completion of the PCR gene amplification nucleic acid monitoring laboratory of a certain hospital. Provincial, municipal and local leaders have come to participate in the inspection and acceptance process, marking a new level of medical and epidemic prevention in a certain area. . That's right, what each province is actively building is the protagonist of this article-a nucleic acid testing laboratory that meets the requirements of the secondary biosafety laboratory (BSL-2). In this article, CEIDI Xidi takes the nucleic acid testing laboratory as an example to analyze the relevant knowledge of the design and construction of biosafety laboratories represented by it.
Biosafety laboratories are protective measures (hardware) that may cause harm or potential harm to people, the environment and society during the activities of various harmful or potentially harmful biological factors in microbiology and medical laboratories. ) And management measures (software) to achieve the purpose of safety protection for people, the environment and society. According to the degree of biological hazard of the objects handled by the laboratory, the biosafety laboratory is divided into four levels. The first level laboratory is generally suitable for microorganisms that have no pathogenic effect on healthy adults; the second level is suitable for people and the environment with medium potential Hazardous microorganisms; level three is suitable for pathogenic microorganisms or their toxins that cause serious or even fatal diseases to be transmitted to humans mainly through the respiratory route; level four is suitable for transmission through aerosol routes or transmission routes that are highly dangerous to the human body Unknown pathogenic microorganisms or their toxins for which there is no effective vaccine or treatment method.
The nucleic acid testing laboratory/station that we are newly familiar with is actually a negative pressure PCR laboratory (ie, secondary biosafety laboratory/BSL-2). Biosafety experiments have a considerable risk of disease, so they must strictly follow the national medical laboratory construction standards. The planning area in the PCR nucleic acid testing laboratory is conventionally divided into three areas: reagent storage and preparation area, specimen preparation area, and amplification area (amplification analysis area). Specimen preparation area and amplification area are negative pressure areas, equipped with automatic nucleic acid extraction instrument, automatic gene amplification instrument, biological safety cabinet, ultra-clean workbench, low-temperature refrigerator, high-speed refrigerated centrifuge, fresh air negative pressure system, internal A batch of state-of-the-art nucleic acid testing facilities and equipment such as platoon pressure cookers.
The reason why the negative pressure laboratory is negative pressure is the same concept as the isolation ward. It is to prevent harmful or potentially harmful biological factors from moving through the air and aerosols as the carrier to cause harm to the normal space. In order to prevent the spread of such pathogenic biological factors, negative pressure is set, that is, the principle of air pressure difference is used. The pressure in the laboratory is less than the outdoor air pressure, and the pathogenic biological factors inside cannot get out, and the outdoor air is not. It will be contaminated, and the staff in the laboratory need to take full-service protective and isolation measures to work.
As CEIDI Xidi, with 12 years of industry experience in the field of laboratory and clean room construction, we emphasize the main points of its design and construction. First of all, the design and construction of biosafety laboratories need to meet the requirements of relevant national rules and regulations, and meet the requirements of national mandatory standards.
The relevant standard specifications are:
1.GB 50346-2011 Technical Specification for Biosafety Laboratory Building
2.GB 19489-2008 General requirements for laboratory biosafety
3. "Regulations on Biosafety Management of Pathogenic Microorganism Laboratories"
Secondly, the design and construction of biosafety laboratories should follow three key dimensions, cleanliness and airtightness, and air pressure control. The key to cleanliness lies in the clean air-conditioning system, so the temperature, humidity, wind speed, noise and other parameters should be designed reasonably. The key to airtightness lies in the choice of building materials, so you must choose building materials with strong airtightness. In order to maintain the negative pressure in the relevant core working room, to improve the uniformity of the indoor air flow, and to reduce airflow dead angles and vortexes, the core working room has air pressure and other environmental parameters control requirements. In order to reduce the loss of indicators, the entrance and exit should be equipped with a buffer room. In combination with the above situation, the basic structure of the negative pressure BSL-2 laboratory should be composed of the core work room and the buffer room, and the buffer room should be located outside the core work room to maintain the integrity of the core work room, and a special purpose must be set up The dressing room is conducive to the separation of clean dirt and avoid cross-contamination. At the same time, it is necessary to set up a preparation room in the clean area, and set up a double transfer window with the core work room to form a reasonable logistics procedure. According to the basic concept of biosafety, all pollutants must be safely treated before leaving the core workshop, so there is no need to set up a dedicated corridor for pollutants.
In addition, the air conditioning, ventilation and purification of negative pressure laboratories are also particularly important links. As a mature EPC engineering integration service provider, CEIDI Xidi has very rich experience, and we will also separate it in subsequent articles. Talk about the air conditioning, ventilation and purification aspects of the negative pressure biosafety laboratory.