(1) The technical foundation is weak
The manufacturer's production technology and technical conditions are uneven. From the product registration certificate, most of the production enterprises were originally engaged in the production of purification equipment. They saw a broad market prospect and switched to ESCO 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 taking into account the 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 manufacturers are carefully prepared in type inspection. Subsequently, in order to bid down, market competition and other factors, reduce production costs and arbitrarily change key parts of products (such as fans and filters), resulting in loss or reduction of safety barrier performance; The technology invests 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 the use of institutions and laboratories, most manufacturers do not have an effective inspection and installation engineer's actual inspection operation capability for after-sales installation and maintenance engineers. Generally low, the ability is uneven, there is no necessary professional equipment for installation and maintenance inspection, installation and commissioning inspection is not in place, the equipment after installation is tangible and can not guarantee normal operation.
Second, the use of unit problems
(1) The degree of emphasis on the use of the department is the main body of the biosafety cabinet. Due to the lack of safety protection system and lack of regulatory awareness, the biosafety cabinet without the medical device registration certificate will be used, not to mention the product technical indicators. The control of the above does not guarantee the safety of the laboratory. Second. The monitoring of ESCO biosafety cabinet installation location, use status, maintenance and cycle inspection 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 for the environment and other personnel. An effective means of health and safety 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 strength is not in place for the relevant operators and maintenance personnel. The operator is unfamiliar with the correct operation and maintenance of the biosafety cabinet, which will lead to a significant reduction in the normal service life of the biosafety cabinet, burying safety hazards and providing a safety barrier. Dedicated equipment is actually not secure.
Third, third-party testing agency issues
Due to the special features of the ESCO biosafety cabinet and the specific requirements of its use, it is necessary to have a third-party testing agency with the qualification to conduct 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
one. 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 ESCO biosafety cabinet equipment management department, increase investment, make each operator clear operational skills and their responsibilities; improve safety risk awareness, perform their duties with due diligence, strictly follow the installation, problems maintenance, 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 ESCO biosafety cabinet, 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. And the use of terminal management to improve their 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 the design process, ensure product quality, enhance product competitiveness, Promote technological innovation and 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 biological safety cabinet, the relevant testing personnel must be specially trained 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.
The manufacturer's production technology and technical conditions are uneven. From the product registration certificate, most of the production enterprises were originally engaged in the production of purification equipment. They saw a broad market prospect and switched to ESCO 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 taking into account the 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 manufacturers are carefully prepared in type inspection. Subsequently, in order to bid down, market competition and other factors, reduce production costs and arbitrarily change key parts of products (such as fans and filters), resulting in loss or reduction of safety barrier performance; The technology invests 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 the use of institutions and laboratories, most manufacturers do not have an effective inspection and installation engineer's actual inspection operation capability for after-sales installation and maintenance engineers. Generally low, the ability is uneven, there is no necessary professional equipment for installation and maintenance inspection, installation and commissioning inspection is not in place, the equipment after installation is tangible and can not guarantee normal operation.
Second, the use of unit problems
(1) The degree of emphasis on the use of the department is the main body of the biosafety cabinet. Due to the lack of safety protection system and lack of regulatory awareness, the biosafety cabinet without the medical device registration certificate will be used, not to mention the product technical indicators. The control of the above does not guarantee the safety of the laboratory. Second. The monitoring of ESCO biosafety cabinet installation location, use status, maintenance and cycle inspection 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 for the environment and other personnel. An effective means of health and safety 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 strength is not in place for the relevant operators and maintenance personnel. The operator is unfamiliar with the correct operation and maintenance of the biosafety cabinet, which will lead to a significant reduction in the normal service life of the biosafety cabinet, burying safety hazards and providing a safety barrier. Dedicated equipment is actually not secure.
Third, third-party testing agency issues
Due to the special features of the ESCO biosafety cabinet and the specific requirements of its use, it is necessary to have a third-party testing agency with the qualification to conduct 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
one. 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 ESCO biosafety cabinet equipment management department, increase investment, make each operator clear operational skills and their responsibilities; improve safety risk awareness, perform their duties with due diligence, strictly follow the installation, problems maintenance, 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 ESCO biosafety cabinet, 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. And the use of terminal management to improve their 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 the design process, ensure product quality, enhance product competitiveness, Promote technological innovation and 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 biological safety cabinet, the relevant testing personnel must be specially trained 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.
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