7.0 Analysis of biological safety cabinets in actual use problems and solutions Guide: Biosafety cabinets without professional installation, cycle and maintenance inspection, it is difficult to ensure that all parameters operate under normal conditions, it is not a safety barrier There is no way to protect the safety of the operator, the laboratory environment and the experimental materials.
Biosafety cabinets have been widely used in medical institutions, disease control centers, health care, food hygiene and medical research institutions at all levels in the province, of which hospitals and CDCs account for a large proportion. Through research, it can be found that there are three main problems in the practical application of the biosafety cabinet. One is the manufacturer's problem, the other is the use of the unit, and the third is the third-party inspection agency.
First, the problem of biosafety cabinet manufacturers (manufacturers) (1) weak technical base manufacturers of production technology and technical conditions are uneven, from the product registration certificate can be seen, most of the production enterprises were originally engaged in the production of purification equipment, saw The market prospect is broad, and the switch to biosafety cabinet production. Therefore, when the product is finalized, 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. It is generally difficult to pass the inspection once the product is submitted for inspection. Often it is in the repeated state of rectification to re-examination, using detection as a verification design. Moreover, since the biosafety cabinet standards are based on the NSF/ANSI49-2002 and EN12469:2000 standards, domestic manufacturers have very limited knowledge of standards, so there are often defects in product design that do not pass microbial protection. Related tests are hard to find. In the registration inspection, it was also found that the first-time registered biosafety cabinet product product problem was outstanding, and even if the manufacturer who obtained the registration certificate used the new process design and production of the new model biosafety cabinet product, it would face some technical problems. Need to rectify, the design concept of various safety performance can not be effectively reflected in the overall performance operation of the product, of course, also affects the role of the safety barrier of the biosafety cabinet.
(2) Lack of self-regulatory constraints and technical service awareness As domestic manufacturers are in the fierce stage of competition in the product market, they are not taken care of in terms of installation inspection, maintenance inspection and cycle inspection. If the biosafety cabinet is not professionally installed, cycled and maintained, it is difficult to ensure that the parameters are operated under normal conditions. It is not a safety barrier. It is impossible to protect the operator, laboratory environment and experimental materials. Security.
Domestic biosafety cabinet manufacturers are carefully prepared in type inspection. Subsequently, for the purpose of bidding, market competition and other factors, the production cost is lowered, and the key components of the product (such as fans and filters) are randomly changed, resulting in loss or reduction of safety barrier performance; The cycle inspection requires a lot of manpower and material resources, and the enthusiasm of the manufacturers is not high. Most domestic enterprises do not have the ability to conduct on-site inspections and cannot meet the needs of customers. These factors have seriously affected the quality of the use of biosafety cabinets in China.
The imported biosafety cabinet manufacturer started earlier and has rich experience in testing and maintenance of biosafety cabinets. However, since the imported biosafety cabinets mainly implement the agency system, they are not mandatory for cost considerations and Chinese policies and regulations. Due to installation and periodic inspection factors, the imported biosafety cabinets did not perform comprehensive installation inspections and routine maintenance inspections for domestic customers in accordance with the safety regulations of their countries. What's more, the products of the eliminated models and the products that do not meet the requirements of YY0569-2005 "Biosafety Cabinet" are sold in China. The lack of effective supervision in the later period, coupled with the lack of attention of foreign manufacturers on follow-up services, has serious security risks.
Most manufacturers, when selling biosafety cabinets, promise to install and debug and check the biosafety cabinet parameters after the biosafety cabinet is in place. It also promises a one-year warranty. However, in fact, due to the lack of corresponding follow-up supervision and the lack of technical monitoring and maintenance methods by institutions and laboratories, most manufacturers do not provide effective training for after-sales installation and maintenance engineers, and the actual inspection operations of installation and maintenance engineers. The capacity is generally low, the capacity is uneven, and there is no necessary professional equipment for installation and maintenance inspection. The installation and commissioning inspection is not in place, and the equipment after installation is tangible and cannot guarantee normal operation.
Second, the use of unit problems (1) the use of departments to pay attention to the poor degree of medical institutions is the main body of the use of biological safety cabinets, due to the lack of safety protection system and lack of regulatory awareness, and even the use of biological safety cabinets without medical device registration certificate, not to mention It is said that the control of product technical indicators cannot guarantee the safety of the laboratory. Second. The monitoring of the installation position, use status, maintenance and periodic inspection of the biosafety cabinet is an important part of the safe use of the operating agencies and laboratory operators and the safety of the test operation. It is also the health of the environment and other personnel. An effective means of security assurance. However, due to the fact that the use of the safety department is still in its infancy, the importance and necessity of installation, commissioning, maintenance and cycle inspection are not enough. This is mainly due to the lack of communication with the manufacturer before the site installation. Mismatches and prior defects in the placement, placement, and related configuration of the biosafety cabinet result in reduced life and unsafe operation of the biosafety cabinet. I don’t understand the technical indicators of product installation inspection, maintenance inspection and cycle inspection, and I have no confirmation ability, and I have not entrusted the third party to have the qualification of testing by qualified inspection agencies.
(2) Insufficient training The training of relevant operators and maintenance personnel is not in place. Operators are unfamiliar with the correct operation and maintenance of the biological safety cabinet, which will lead to a significant reduction in the normal service life of the biosafety cabinet, burying safety hazards and providing safety. The special equipment for the barrier is actually not safe.
Third, the third-party testing agency problems Due to the structural functions of the biosafety cabinet and the special requirements of the use of the requirements, it is necessary to have a third-party testing agency with authorized qualifications for testing. But so far, there are very few qualified third-party testing agencies. Due to the need for the necessary bio-protection and the cooperation of the manufacturer, the institutions and personnel capable of implementing on-site inspection services are even scarce for the safety of inspectors.
Ideas and solutions to solve the problems faced by biosafety cabinets in use. On the one hand, through policy guarantees and third parties, we will assist medical institutions and laboratories to carry out dynamic monitoring and maintenance of biosafety cabinets that are about to be put into use and in use, improve the safety of 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 post-testing and maintenance, and establish an effective quality management system to ensure The quality of after-sales products enhances the competitiveness of products and promotes the rational, effective and healthy development of the industry.
Second, the technical program (1) to enhance the biosafety risk awareness of the use of biological safety cabinets, improve the ability of operators.
Strengthen the management of biosafety cabinet equipment management department, increase investment, and make each operator clear operational skills and responsibilities through training; improve safety risk awareness, perform duties with due diligence, strictly follow installation, problem maintenance, and annual cycle inspection Technical standards are implemented to communicate correctly and effectively with manufacturers.
(2) Strengthen the service capabilities and awareness of manufacturers for biological safety cabinets.
To be strictly factory inspection, the factory safety cabinet should be tested by the platform and the platform should be qualified; the user should actively communicate with the user before installation, and scientifically and rationally install the biological safety cabinet; the ability of the installation and maintenance engineer should be actively upgraded, and the necessary special equipment should be equipped to ensure biosafety. The quality of the installation of the cabinet.
three. Give play to the role of third-party testing institutions to improve policies and regulations as soon as possible, and ensure the smooth implementation of installation, maintenance, and cycle inspection in accordance with the requirements of YY0569-2005 "Biosafety Cabinet" standards; third-party testing organizations should also continuously enhance their publicity and enhance themselves. Technical ability, quality, expand influence, establish a brand; third-party testing organizations consider establishing a technology platform from contact to cooperate with the implementation of inspection to ensure the safe and effective use of biological safety cabinets, and also provide effective competition for fair competition in the biosafety cabinet market. Technical supervision.
four. Conclusions and recommendations The administrative department can rely on the technical conditions of third-party testing agencies to implement on-site installation inspection of biosafety cabinets, maintenance inspections during use, and annual cycle inspections to further develop biosafety cabinet manufacturers and users. Effective dynamic supervision and management, which can improve the use and maintenance capabilities of the biosafety cabinets of the organization, which can save equipment costs, improve the safety of biosafety cabinets, reduce the occurrence of adverse events, and strengthen the production source of biosafety cabinets. Use terminal management to improve awareness of preventive maintenance or maintenance, to ensure the safety of operators and other personnel; to promote manufacturers to establish an effective quality management system, stabilize design processes, ensure product quality, enhance product competitiveness, and promote Technological innovation to promote the healthy development of the industry.
The establishment of biosafety cabinet technology testing norms provides a technical basis for the effective control of biosafety cabinets nationwide, the safety effect is guaranteed, and the potential safety hazards existing in the use institutions are reduced, and the social benefits are enormous. Due to the structural function and special requirements of the biosafety cabinet, the relevant testing personnel must undergo special training and use special equipment. Professionals of qualified institutions must conduct on-site installation inspection, maintenance inspection and periodic inspection according to the YY0569-2005 "Biosafety Cabinet" standard to ensure the safety and effectiveness of their use.
Second-level biosafety cabinet manufacturer installation guidance, professional training for operators!
Biosafety cabinets have been widely used in medical institutions, disease control centers, health care, food hygiene and medical research institutions at all levels in the province, of which hospitals and CDCs account for a large proportion. Through research, it can be found that there are three main problems in the practical application of the biosafety cabinet. One is the manufacturer's problem, the other is the use of the unit, and the third is the third-party inspection agency.
First, the problem of biosafety cabinet manufacturers (manufacturers) (1) weak technical base manufacturers of production technology and technical conditions are uneven, from the product registration certificate can be seen, most of the production enterprises were originally engaged in the production of purification equipment, saw The market prospect is broad, and the switch to biosafety cabinet production. Therefore, when the product is finalized, 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. It is generally difficult to pass the inspection once the product is submitted for inspection. Often it is in the repeated state of rectification to re-examination, using detection as a verification design. Moreover, since the biosafety cabinet standards are based on the NSF/ANSI49-2002 and EN12469:2000 standards, domestic manufacturers have very limited knowledge of standards, so there are often defects in product design that do not pass microbial protection. Related tests are hard to find. In the registration inspection, it was also found that the first-time registered biosafety cabinet product product problem was outstanding, and even if the manufacturer who obtained the registration certificate used the new process design and production of the new model biosafety cabinet product, it would face some technical problems. Need to rectify, the design concept of various safety performance can not be effectively reflected in the overall performance operation of the product, of course, also affects the role of the safety barrier of the biosafety cabinet.
(2) Lack of self-regulatory constraints and technical service awareness As domestic manufacturers are in the fierce stage of competition in the product market, they are not taken care of in terms of installation inspection, maintenance inspection and cycle inspection. If the biosafety cabinet is not professionally installed, cycled and maintained, it is difficult to ensure that the parameters are operated under normal conditions. It is not a safety barrier. It is impossible to protect the operator, laboratory environment and experimental materials. Security.
Domestic biosafety cabinet manufacturers are carefully prepared in type inspection. Subsequently, for the purpose of bidding, market competition and other factors, the production cost is lowered, and the key components of the product (such as fans and filters) are randomly changed, resulting in loss or reduction of safety barrier performance; The cycle inspection requires a lot of manpower and material resources, and the enthusiasm of the manufacturers is not high. Most domestic enterprises do not have the ability to conduct on-site inspections and cannot meet the needs of customers. These factors have seriously affected the quality of the use of biosafety cabinets in China.
The imported biosafety cabinet manufacturer started earlier and has rich experience in testing and maintenance of biosafety cabinets. However, since the imported biosafety cabinets mainly implement the agency system, they are not mandatory for cost considerations and Chinese policies and regulations. Due to installation and periodic inspection factors, the imported biosafety cabinets did not perform comprehensive installation inspections and routine maintenance inspections for domestic customers in accordance with the safety regulations of their countries. What's more, the products of the eliminated models and the products that do not meet the requirements of YY0569-2005 "Biosafety Cabinet" are sold in China. The lack of effective supervision in the later period, coupled with the lack of attention of foreign manufacturers on follow-up services, has serious security risks.
Most manufacturers, when selling biosafety cabinets, promise to install and debug and check the biosafety cabinet parameters after the biosafety cabinet is in place. It also promises a one-year warranty. However, in fact, due to the lack of corresponding follow-up supervision and the lack of technical monitoring and maintenance methods by institutions and laboratories, most manufacturers do not provide effective training for after-sales installation and maintenance engineers, and the actual inspection operations of installation and maintenance engineers. The capacity is generally low, the capacity is uneven, and there is no necessary professional equipment for installation and maintenance inspection. The installation and commissioning inspection is not in place, and the equipment after installation is tangible and cannot guarantee normal operation.
Second, the use of unit problems (1) the use of departments to pay attention to the poor degree of medical institutions is the main body of the use of biological safety cabinets, due to the lack of safety protection system and lack of regulatory awareness, and even the use of biological safety cabinets without medical device registration certificate, not to mention It is said that the control of product technical indicators cannot guarantee the safety of the laboratory. Second. The monitoring of the installation position, use status, maintenance and periodic inspection of the biosafety cabinet is an important part of the safe use of the operating agencies and laboratory operators and the safety of the test operation. It is also the health of the environment and other personnel. An effective means of security assurance. However, due to the fact that the use of the safety department is still in its infancy, the importance and necessity of installation, commissioning, maintenance and cycle inspection are not enough. This is mainly due to the lack of communication with the manufacturer before the site installation. Mismatches and prior defects in the placement, placement, and related configuration of the biosafety cabinet result in reduced life and unsafe operation of the biosafety cabinet. I don’t understand the technical indicators of product installation inspection, maintenance inspection and cycle inspection, and I have no confirmation ability, and I have not entrusted the third party to have the qualification of testing by qualified inspection agencies.
(2) Insufficient training The training of relevant operators and maintenance personnel is not in place. Operators are unfamiliar with the correct operation and maintenance of the biological safety cabinet, which will lead to a significant reduction in the normal service life of the biosafety cabinet, burying safety hazards and providing safety. The special equipment for the barrier is actually not safe.
Third, the third-party testing agency problems Due to the structural functions of the biosafety cabinet and the special requirements of the use of the requirements, it is necessary to have a third-party testing agency with authorized qualifications for testing. But so far, there are very few qualified third-party testing agencies. Due to the need for the necessary bio-protection and the cooperation of the manufacturer, the institutions and personnel capable of implementing on-site inspection services are even scarce for the safety of inspectors.
Ideas and solutions to solve the problems faced by biosafety cabinets in use. On the one hand, through policy guarantees and third parties, we will assist medical institutions and laboratories to carry out dynamic monitoring and maintenance of biosafety cabinets that are about to be put into use and in use, improve the safety of 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 post-testing and maintenance, and establish an effective quality management system to ensure The quality of after-sales products enhances the competitiveness of products and promotes the rational, effective and healthy development of the industry.
Second, the technical program (1) to enhance the biosafety risk awareness of the use of biological safety cabinets, improve the ability of operators.
Strengthen the management of biosafety cabinet equipment management department, increase investment, and make each operator clear operational skills and responsibilities through training; improve safety risk awareness, perform duties with due diligence, strictly follow installation, problem maintenance, and annual cycle inspection Technical standards are implemented to communicate correctly and effectively with manufacturers.
(2) Strengthen the service capabilities and awareness of manufacturers for biological safety cabinets.
To be strictly factory inspection, the factory safety cabinet should be tested by the platform and the platform should be qualified; the user should actively communicate with the user before installation, and scientifically and rationally install the biological safety cabinet; the ability of the installation and maintenance engineer should be actively upgraded, and the necessary special equipment should be equipped to ensure biosafety. The quality of the installation of the cabinet.
three. Give play to the role of third-party testing institutions to improve policies and regulations as soon as possible, and ensure the smooth implementation of installation, maintenance, and cycle inspection in accordance with the requirements of YY0569-2005 "Biosafety Cabinet" standards; third-party testing organizations should also continuously enhance their publicity and enhance themselves. Technical ability, quality, expand influence, establish a brand; third-party testing organizations consider establishing a technology platform from contact to cooperate with the implementation of inspection to ensure the safe and effective use of biological safety cabinets, and also provide effective competition for fair competition in the biosafety cabinet market. Technical supervision.
four. Conclusions and recommendations The administrative department can rely on the technical conditions of third-party testing agencies to implement on-site installation inspection of biosafety cabinets, maintenance inspections during use, and annual cycle inspections to further develop biosafety cabinet manufacturers and users. Effective dynamic supervision and management, which can improve the use and maintenance capabilities of the biosafety cabinets of the organization, which can save equipment costs, improve the safety of biosafety cabinets, reduce the occurrence of adverse events, and strengthen the production source of biosafety cabinets. Use terminal management to improve awareness of preventive maintenance or maintenance, to ensure the safety of operators and other personnel; to promote manufacturers to establish an effective quality management system, stabilize design processes, ensure product quality, enhance product competitiveness, and promote Technological innovation to promote the healthy development of the industry.
The establishment of biosafety cabinet technology testing norms provides a technical basis for the effective control of biosafety cabinets nationwide, the safety effect is guaranteed, and the potential safety hazards existing in the use institutions are reduced, and the social benefits are enormous. Due to the structural function and special requirements of the biosafety cabinet, the relevant testing personnel must undergo special training and use special equipment. Professionals of qualified institutions must conduct on-site installation inspection, maintenance inspection and periodic inspection according to the YY0569-2005 "Biosafety Cabinet" standard to ensure the safety and effectiveness of their use.
Second-level biosafety cabinet manufacturer installation guidance, professional training for operators!
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