Problems and solutions of biosafety cabinet in practical use

Guide reading: if the biosafety cabinet has not been installed, periodically and maintained, it is difficult to ensure the parameters to operate in normal state, which can not play a role of safety barrier, and it is impossible to talk about the protection of operators, laboratory environment and the safety of experimental materials Biosafety cabinets have been widely used in all levels of medical institutions, disease control centers, medical and health care, food hygiene and medical research institutions, in which hospitals and disease control centers account for a large proportion Through investigation, it can be found that there are three main problems in the practical application of biosafety cabinet, one is the manufacturer's problem, the other is the user's problem, and the third is the third-party testing agency's problem I Problems of manufacturers (manufacturers) of biosafety cabinets (1) weak technical foundation and uneven participation of manufacturer's production process and technical conditions From the product registration certificate, it can be seen that most of the production enterprises were originally engaged in purification equipment production and saw a broad market prospect, but transferred to biosafety cabinet production So in the process of product finalization, although the manufacturer's enterprise standard is based on yy0569-2005 "biosafety cabinet", the manufacturer does not have many testing conditions such as microbial protection Generally, the products submitted for inspection and registration are difficult to pass the inspection at one time, often in the repeated state of rectification to re inspection, and the inspection is regarded as a verification design Moreover, as the biosafety cabinet standard is formulated by reference to NSF / ansi49-2002 and en12469:2000 standards, domestic manufacturers have very limited awareness of the standard, so there are often defects in product design, which are difficult to be found without microbial protection and other related tests It is also found in the registration inspection that the registered biosafety cabinet products have prominent problems Many; even if the manufacturer who has obtained the registration certificate designs and produces the new type of biosafety cabinet products with the new process, it will face some technical problems, which need to be rectified The design concept of various safety performance can not be effectively reflected in the overall performance operation of the product, which of course also affects the role of the biosafety cabinet safety barrier (2) lack of self-regulation and awareness of technical services As domestic manufacturers are in the fierce stage of product market competition, installation inspection, maintenance inspection and periodic inspection are ignored If the biosafety cabinet has not passed the professional installation, cycle and maintenance inspection, it is difficult to ensure the parameters to operate in normal state, which is unable to play a role of safety barrier, and it is impossible to protect the safety of operators, laboratory environment and experimental materials
The domestic manufacturers of biosafety cabinets carefully prepare for the type inspection, and then, in order to bid, market competition and other factors, reduce the production cost, change the key parts of the products (such as fans and filters) at will, resulting in the loss or reduction of the safety barrier performance of the products; because the periodic inspection requires a large amount of manpower and material resources, the manufacturers are not very active, the vast majority of domestic manufacturers The enterprise does not have the ability of on-site inspection and can not meet the needs of customers These factors have seriously affected the use quality of biosafety cabinets in China The manufacturers of imported biosafety cabinets started earlier and have rich experience in testing and maintenance of biosafety cabinets However, because the main system of imported biosafety cabinets is the agent system, due to the consideration of cost and the fact that China's policies and regulations do not force the installation and periodic inspection, the imported biosafety cabinets do not meet the requirements of the safety regulations of their home countries for domestic customers Users conduct installation inspection and daily maintenance inspection of * * What's more, they will sell their obsolete products and products that do not meet the requirements of yy0569-2005 "biosafety cabinet" in China The lack of effective supervision in the later stage, coupled with the lack of attention of foreign manufacturers themselves to follow-up services, has serious security risks When most manufacturers sell biosafety cabinets, they promise to install and debug the biosafety cabinets after they are installed in place, and check that all parameters of the biosafety cabinets are normal; they also promise to have a one-year warranty period However, in fact, due to the lack of corresponding follow-up supervision and the lack of technical monitoring and maintenance means by using institutions and laboratories, most manufacturers do not provide effective training for after-sales installation and maintenance engineers The actual inspection and operation ability of installation and maintenance engineers is generally low, with uneven ability, and they do not have the necessary professional equipment for installation and maintenance inspection , the installation and commissioning inspection is not in place, and the equipment after installation is invisible and cannot guarantee normal operation 2 Problems of users (1) poor attention of users Medical institutions are the main users of biosafety cabinets Due to the lack of safety protection system and awareness of laws and regulations, they even use biosafety cabinets without medical device registration certificate, not to mention the control of product technical indicators, which can not guarantee the safety of laboratories Secondly The monitoring of the installation position, use status, maintenance and periodic inspection of the biosafety cabinet is an important link for the safe use of the relevant operators of the use agency and laboratory and for the safety of the test operation, as well as an effective means to ensure the health and safety of the environment and other personnel However, due to the user department's own understanding of the safety cabinet is still in the primary stage, and the importance and necessity of installation, commissioning, maintenance and periodic inspection are not fully understood, which mainly shows in the lack of communication with the manufacturer before the on-site installation, mismatches and early defects in the placement environment, placement position and relevant configuration of the biosafety cabinet, resulting in the use of the biosafety cabinet Reduction of service life and unsafe operation Do not know the technical indicators of product installation inspection, maintenance inspection and periodic inspection, do not have the ability to confirm themselves, and do not have the sense of entrusting a third party with a qualified inspection agency to test (2) insufficient training: the training of relevant operators and maintenance personnel is not in place, and the operators are not familiar with the correct operation and maintenance of the biosafety cabinet, which will greatly reduce the normal service life of the biosafety cabinet, bury potential safety hazards, and the special equipment providing the safety barrier is not safe Third party testing agency problem: due to the particularity of the structure, function and use requirements of the biosafety cabinet, the third party testing agency with authorized qualification is required for testing But so far, there are very few qualified third-party testing institutions Due to the need for necessary biological protection and the cooperation of manufacturers, for the sake of safety of inspectors, there is a shortage of institutions and personnel capable of carrying out on-site inspection services On the one hand, through policy guarantee and the third party, to assist medical institutions and laboratories in dynamic monitoring and maintenance of the biosafety cabinets to be put into use and in use, to improve the safety of the use of the biosafety cabinets and reduce the occurrence of adverse events On the other hand, through the monitoring and evaluation of the installation, maintenance and cycle of the biosafety cabinet, the manufacturer is indirectly urged to increase the input of personnel and technical services in product design verification and later test maintenance, establish an effective quality management system, guarantee the quality of after-sale products, improve product competitiveness, and promote the reasonable, effective and healthy development of the industry II Technical proposal (1) enhance the biosafety risk awareness of the users of biosafety cabinets and improve the ability of operators Strengthen the management of biosafety cabinet equipment management department, increase investment, make each operator clear of operation skills and their own responsibilities through training; improve safety risk awareness, fulfill their responsibilities wholeheartedly, and strictly follow the technical standards for installation, maintenance of problems and annual periodic inspection, so as to achieve correct and effective communication with manufacturers (2) strengthen the service ability and awareness of manufacturers for biosafety cabinets The ex factory inspection shall be strictly carried out, and the ex factory safety cabinet shall be tested and qualified; before installation, it is necessary to actively communicate with users and install the biosafety cabinet scientifically and reasonably; it is necessary to actively improve the ability of the installation and maintenance engineer and equip with necessary special instruments to ensure the installation quality of the biosafety cabinet III give full play to the role of the third-party testing organization, improve the policies and regulations as soon as possible, according to yy0569-2005 The requirements of the biosafety cabinet standard are to ensure the smooth implementation of installation, use and maintenance and periodic inspection; the third-party testing agency should also continue to improve publicity, enhance its technical ability and quality, expand its influence, and establish a brand; the third-party testing agency should consider establishing a technical platform from contact to cooperate with the implementation of inspection to ensure the safe and effective use of the biosafety cabinet, It can also provide effective technical supervision for the fair competition of the biosafety cabinet market Conclusions and recommendations The administrative department can rely on the technical conditions of the third-party testing agency to carry out the on-site installation inspection, maintenance inspection in the use process and the annual periodic inspection of the biosafety cabinet, and further carry out effective dynamic supervision and management on the manufacturers and users of the biosafety cabinet, so as to improve the use and maintenance capacity of the biosafety cabinet of the users In order to save the equipment cost, it can also improve the safety of the biosafety cabinet and reduce the occurrence of adverse events; strengthen the management of the production source and the use terminal of the biosafety cabinet, improve the awareness of its preventive maintenance or maintenance, and ensure the safety of the operators and other personnel; promote the manufacturers to establish an effective quality management system, stabilize the design process, and ensure the product quality, Enhance product competitiveness, promote technology * *, and promote the healthy development of the industry The establishment of biosafety cabinet technical testing standards provides technical basis for the effective control of biosafety cabinets in the domestic scope, the safety effect is guaranteed, and the potential safety risks of the use agencies are reduced, and the social benefits are huge Due to the particularity of the structure, function and use requirements of the biosafety cabinet, the relevant testing personnel shall be specially trained and adopt special equipment Professional personnel of the qualified organization must carry out on-site installation inspection, maintenance inspection and periodic inspection of the in-service biosafety cabinet according to yy0569-2005 biosafety cabinet standard, so as to ensure its safe and effective use.