Biosafety cabinet high efficiency filter integrity test and analysis
- Clicks: 1850 Release time: 2015/2/8
Biosafety cabinet high efficiency filter integrity test and analysis
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The integrity of high-efficiency filtration is an important performance for the safe use of biosafety cabinets, and it is also a problem frequently encountered by operators and during testing. Through the test, analysis and evaluation of the integrity of the high-efficiency filtration of the biosafety cabinet, the research on the research of the biosafety cabinet detection/calibration method and the development of the biosafety cabinet performance evaluation method are provided to ensure the use of the biological safety cabinet. Safe and reliable.
[Key words] biosafety cabinet; high efficiency filtration; test analysis; aerosol; biohazard particles
[Chinese Library Classification Number] TH789; TB9 [Document Mark Code] B
[Article ID] 1674-1633 (2010) 05-0054-03
Background of the project: The National Medium- and Long-Term Plan for Science and Technology Development (2006-2020) and the “Eleventh Five-Year Plan for Science and Technology Development of the General Administration of Quality Supervision, Inspection and Quarantine†have clearly included biosafety in the field of the Outline and its priority themes. . To this end, the State Administration of Quality Inspection and Quarantine gave the Institute a scientific and technological plan for the "Biosafety Cabinet Detection / Calibration Method Research" (project number: 2008QK285); meanwhile, the Guangdong Provincial Bureau of Quality and Technical Supervision also issued a "Biosafety" to our hospital. The plan for the performance evaluation of the cabinet" is planned by the local standard (project number: [2008] 354-26). It is mainly to establish biosafety cabinet testing items and technical requirements, and to select a traceable test standard with appropriate accuracy and accuracy; to develop a standard method for biosafety cabinet performance evaluation.
Terminology Analysis: Biological safety cabinets (BSCs) are air purification safety devices that prevent the containment of hazardous or unknown biological aerosols during laboratory operations.
Evaluation: The application of this method will make the biosafety cabinet detection method and technical indicators uniform and unified, ensure the safety and effectiveness of the biosafety cabinet, and at the same time protect the environment. With good application prospects, it will have significant social benefits. The Biosafety Cabinet's High Efficiency Air Particle Filter, referred to as the High Efficiency Filter (HEPA), is a dry filter with an extended/pleated media filter membrane. Its main purpose is to filter dust and other particles in the air flowing into the working area of ​​the safety cabinet to ensure that the air in the safety cabinet reaches a certain degree of cleanliness; and to filter out dangerous particles such as aerosols generated during the test operation to protect the sample. To avoid cross-contamination between samples and to prevent damage to bio-hazardous particles to the test operator [1]. At the same time, it is also avoided that the dangerous particles such as aerosol generated by the sample during the test operation are directly discharged into the environment to achieve the purpose of protecting the environment. Biofilters High-efficiency filter membranes are a single-use filtration facility that requires periodic testing and must be replaced if there is a leak, otherwise it poses a biological hazard. Therefore, the effectiveness and integrity of efficient filtration of biosafety cabinets is an important performance indicator for measuring biosafety cabinets. In order to complete the task of the “Biosafety Cabinet Detection/Calibration Method Research†scientific and technological plan project and the Guangdong Provincial Quality and Technical Supervision Bureau “Biosafety Cabinet Performance Evaluation Method†local standard, the hospital also completed the task of obtaining the national standard of the National Quality Inspection and Quarantine Bureau. More test data. An aerosol generation method using three different dielectric materials (1.5% KI, 0.9% NaCl, 10% C6H12O·6H2O) was used for detection. Through the use of aerosols generated from these three different media materials, the integrity of the biosafety cabinet filtration is tested and analyzed based on the test data to provide a reliable data basis for the safe use of the biosafety cabinet.
1. Test instruments and methods
1.1 test equipment
(1) Aerosol generator is used to produce polydisperse, high-concentration aerosol. Aerosol can be produced from different materials (such as PSL, DOP, silicone oil, salt, sugar, etc.); aerosol particles have a diameter ranging from 0.01 to 2 μm.
(2) Aerosol photometer sensor type: 90° light scattering instrument, 670μm wavelength laser tube; aerosol concentration measurement range: 0.001~20mg/m3; zero point stability: 24h±0.001 mg/m3.
1.2 Test methods
Open the fan and lamp of the biosafety cabinet and remove the diffuser and protective cover of the filter. Place and open the aerosol generator, and introduce the aerosol into the safety cabinet according to the introduction position of the aerosol set by the manufacturer, so that the aerosol is generated and evenly distributed in the upstream airflow of the high efficiency filter. If the manufacturer does not have an aerosol introduction location, the aerosol should be introduced in such a way as to ensure adequate mixing in the cabinet airflow [2]. Open the aerosol photometer and sample the upstream gas stream containing the aerosol in the high efficiency filter. The aerosol concentration should be no less than 10 mg/m3.
Place the aerosol photometer detection port on the test surface no more than 25mm from the test surface, and move at a scan rate of less than 50mm/s, so that the probe sweeps across the entire downstream airflow side of the high-efficiency filter and each combination filter At the edge of the film, the sweeping route should overlap slightly. Carefully test around the perimeter of the filter, along the junction of the combined filter and frame, and around the seal between the filter and the device [3]. For safety cabinets that are exhausted through the pipeline, the exhaust filter cannot be scanned. The aerosol concentration in the downstream airflow of the filter is measured by drilling a hole with a diameter of about 10 mm on the pipeline of the downstream airflow. The detection port is inserted into the hole for detection [4].
2. Test results
Entrusted by an occupational disease prevention and control institute in our city, the integrity of the high-efficiency filtration of 12 biological safety cabinets (including 4 grades II and 8 grades III) in use in the hospital was tested.
At present, the integrity test for the efficient filtration of biosafety cabinets is mainly based on the YY0569-2005 "Biosafety Cabinet" pharmaceutical industry standard, combined with the EU's EN12469:2000 "Biotechnology-Performance Criteria for Microbiological Safety Cabinets" and other technical requirements [5,6] . The integrity of the high-efficiency filtration of these 12 biosafety cabinets was tested using aerosols produced from three different media materials. The results are shown in Table 1.
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