Analysis of the main problems and solutions in the practical application of biological safety cabinet
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. * Information comes from Hangzhou Shenan Testing Technology Co., Ltd.
First, the manufacturer's problem
(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 biosafety cabinet production. Therefore, when the product is finalized, although the manufacturer's enterprise standard is based on YY 0569-2005 "Biosafety Cabinet", the manufacturer does not have many testing conditions such as microbial protection, and it is generally difficult to pass the inspection once. It is often in the repeated state of rectification to re-examination, and the detection is regarded as a verification design. Moreover, since the biosafety cabinet standard is based on the NSF/ANSI 49-2002 and EN 12469:2000 standards, domestic manufacturers have very limited knowledge of the standard, so there are often defects in product design that do not pass through microorganisms. Protection and other related tests are difficult to find. In the registration inspection, it was also found that the first registered biosafety cabinet product products had the most prominent and most problematic; even if the manufacturer who obtained the registration certificate used the new model to design and produce the new model biosafety cabinet product, it will face some technical problems. Reconstruction, 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 biosafety cabinet safety barrier.
(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, due to the consideration of sales service costs and Chinese policies and regulations, The mandatory installation and periodic inspection factors, the imported biosafety cabinets have not carried out 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 YY 0569-2005 "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 department has a low degree of attention
Medical institutions are the main body of biosafety cabinets. Due to the lack of safety protection system and lack of regulatory awareness, biosafety cabinets without medical device registration certificates will be used, not to mention the control of product technical indicators. Security. 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 donâ€™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. The operator is 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 special equipment for safety barriers. Not safe.
Third, third-party testing agency issues
Due to the structural function of the biosafety cabinet and the special requirements of the use requirements, it is necessary to have a third-party testing agency with the qualification to conduct the test. 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 support and third-party technical support, it 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 plan
(1) Enhance the awareness of biosafety risks of the units using biosafety cabinets and improve the capabilities 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. Play the role of a third-party testing agency
We will improve policies and regulations as soon as possible, and ensure the smooth implementation of installation, use and maintenance, and cycle inspection in accordance with the requirements of YY0569-2005 "Biosafety Cabinet" standards; third-party testing organizations should also continuously improve their publicity, enhance their technical capabilities, quality, and expand their influence. To establish a brand; third-party testing organizations consider establishing a technology platform from contact to implementation to ensure the safe and effective use of biological safety cabinets, and also provide effective technical supervision for fair competition in the biosafety cabinet market.
four. Conclusions and recommendations
The administrative department can rely on the technical conditions of the third-party testing organization to implement on-site installation inspection of the biosafety cabinet, maintenance inspection during use, and annual cycle inspection to further effectively develop the biosafety cabinet manufacturer and the use organization. Supervision and management, which can improve the use and maintenance capacity of the biosafety cabinet of the institution, which can save equipment costs, improve the safety of the biosafety cabinet, reduce the occurrence of adverse events, and strengthen the production source and use terminal of the biosafety cabinet. Management, improve awareness of preventive maintenance or maintenance, ensure the safety of operators and other personnel; encourage manufacturers to establish an effective quality management system, stabilize design processes, ensure product quality, enhance product competitiveness, and promote technological innovation, 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.
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