Every time after the installation of laboratory instruments, it is necessary to have each qualified instrument inspected by relevant professional staff in accordance with relevant regulations. Similarly, biosafety cabinets require professional staff to perform biological and physical certification of their overall operational performance to check for compliance with national and international performance standards. The detection of biological safety cabinet mainly includes two aspects of physical detection and biological detection, among which:

The physical assessment of the protective effect of the safety cabinet should include:

1. The safety cabinet's overall, HEPA filter leaks,

2. The rate at which air moves downwards, the rate at which air is introduced,

3. The number of negative pressure / ventilation,

4. Stability of the airflow (smoke characteristics),

5. As well as alarm and self-control (interlock) systems.

6. Leakage

7. Illuminance

8. UV intensity

9. Noise

10. Vibration test.

Biological assessments include:

1. Individual protection effect

2. Environmental protection effect

3. Sample protection test

4. Cross contamination test.

4.1 On-site inspection of biosafety cabinets is required in one of the following cases

1) Laboratory construction, after the biosafety cabinet is moved to the designated location.

2) When the biosafety cabinet moves in position.

3) After the biosafety cabinet is inspected.

4) After replacing the filter in the biosafety cabinet.

5) Annual routine testing of biological safety cabinets.

4.2 Inspection of Class I biosafety cabinets

4.2.1 Sealing test

4.2.2 Detection of exhaust filter

1) HEPA filter leak detection, the safety cabinet is carried out in the correct way under normal conditions of use.

2) Polydisperse DOP or equivalent aerosol pass rate is no more than 0.01%.

4.3 Class II biosafety cabinet testing

4.3.1 Principle

Imported Class II safety cabinets must comply with the corresponding standards in the producing country, such as: US, Canadian standard NSF49, British standard BS5726, German standard DIN12950-10, French standard NF X44201, Australian standard AS2252.2.

Domestically produced Class II biosafety cabinet manufacturers must formulate corresponding corporate standards, and their performance indicators are not lower than the standards of similar foreign products. Every biological safety cabinet must be tested and issued a test report according to the company's standards at the factory. The biosafety test using microorganisms should not be omitted. Product performance data sheets should be provided for each product. The quality control test shall include:

4.3.2 Smoke test:

Use a smoking device to smoke and visually determine the activity of the smoke.

1) Above the center line of the working surface, 15cm above the upper edge of the working window, smoke from one end to the other, the activity of the smoke should be downward vertical flow line, no countercurrent, no dead angle and backflow, no smoke from the safety cabinet overflow.

2) Smoke is generated along the outer edge of the window at 0.04m from the working window. The smoke flows into the cabinet without overflow, and the working surface is free of smoke.

3) If it is a push-pull working window, smoke along the outer periphery of the working window, the smoke flows inward, no backflow, no overflow, no smoke on the working surface.

4.3.3 Airflow velocity measurement

4.3.3.1 Determination of vertical airflow velocity

1) Instrument: An anemometer (alno8500 type hot ball) with a reading accuracy of ±3%.

2) Method: 15m below the air supply port in the cabinet, evenly distributed. The spacing between the measuring points is not more than 12cm. The measuring points are arranged not less than 3 rows, and the row of the inner wall is 15cm away from the inner wall, and the number of rows is not less than 7 measuring points.

3 Judgment: The uniform wind speed measured in the vertical airflow uniform area is 0.38m/s±0.025m/s, and the difference between the single point wind speed and the measured uniform wind speed is not more than 20%.

4.3.3.2 Determination of wind speed in the front window

The wind speed of the inlet is measured by a calculation method or a measured method.

The measured or calculated difference between the wind speed of the incoming air and the manufacturer's given value is less than 0.025 m/s.

The A1 type is 0.38m/s±0.025m/s. The working surface is 0.3m wide, and the minimum air flow per second should be 0.002m3.

The A2 type is 0.5m/s±0.025m/s. The working surface should be 0.03m3 per 0.3m wide.

Types B1 and B2 are 0.5m/s±0.025m/s. For every 0.3m width of the working surface, the minimum air flow per second should be 0.03m3.

4.3.4 High efficiency filter leak test

4.3.4.1 Air supply vertical HEPA and filter chamber and frame leakage test

1) The sealed perimeter of the supplied HEPA, the filter chamber and the filter media are to be detected by laser particle counter scanning. No leakage point, the transmittance can not exceed 0.01% or the cleanliness reaches 100.

2) Tested by agar plate deposition method, the cleanliness level is 100.

4.3.4.2 Exhaust HEPA and filter chamber and frame leak test

4.3.4.2 Safety Leakage Test

Before the gas leak test, the biosafety cabinet is fully enclosed, that is, the air duct and the working window are closed (sealed with sealing tape). In the static (power off), the inside of the biosafety cabinet is pressurized to 500 Pa, and the pressure is maintained. A pressure drop of less than 10% for 30 minutes is acceptable. Or do not leak the soap bubble test.

4.3.4.3 Exhaust HEPE leak detection and transmittance test

1) Using a laser particle counter, the leak detection and transmission rate of the exhausted HEPE and its attached filter chamber and holder are detected. There is no leak point, and the transmittance of 0.3 ≧μm particles is <0.01%.

2) Bio-aerosol detection Inhalation spray of 1-8×10-8 concentration of Bacillus subtilis or Serratia marcescens, attacking upstream of HEPA under normal working conditions of safety cabinet, using Level 2 Anderson The bioaerosol sampler is routinely sampled with an upstream sampling concentration of >300 pfu/m3 and is negative for downstream sampling results or no more than 1 pfu/m3.

4.3.5 Biological tests for products, individuals, environmental protection and cross-contamination

The protective properties of the safety cabinet must be tested with bioaerosols, including the following.

4.3.5.1 Personal protection test

1) One method is to operate 30g above the center of the working surface and 10cm inside the observation window at the center of the working surface, and atomize 30ml of the suspension of the hay spore or the sticky Serratia with a sprayer. The spray direction is outward. The concentration of the suspension bacteria was 108/ml. 4 Anderson bio-aerosol samplers are arranged in the upper and lower left and right sides of a cylinder (the axis is 7.0cm away from the working surface, simulating one arm), and the sampling is carried out at a distance of 250cm. In minutes, no more than 10 bacteria (cfu) were collected by all samplers, and the test was repeated 3 times. A plate is received in the cabinet for more than 300 pfu. The median mass diameter of the bacterial aerosol particles should be between 0.5 mm and 3.0 mm.

2) Put another 4 AGI around the cylinder according to one method. The sampling inlet is 6.3cm away from the observation window in front of the safety cabinet. Two of the AGIs are 15 cm apart, on the horizontal cut surface above the cylinder, and the other two AGI-30 are 5 cm apart, 2.5 cm below the cylinder. Two other Level 2 Anderson air microbial samplers were placed on the 2 side, the inlet level was 15 cm, and the side walls were 20 cm apart. Two AGIs are placed 36cm above the horizontal working surface of the air inlet, and 5cm outside the safety cabinet edge. Each interval center is 15cm.).

All AGI samples were filtered through a 47mm, 0.22 filter and incubated on appropriate medium for 24-28h. If negative, continue to observe 44-48h.

For new and importantly improved safety cabinets, the above tests shall be carried out under the following conditions: the original inlet air flow rate is reduced to 0.05 ± 0.015 m / s, and the original downward air flow rate is added to and subtracted from 0.05 ± 0.015 m / s. , the air flow rate is measured directly by the instrument. Each safety cabinet should be tested for airflow.

Use a uniform speed for all measurements when making downward airflow adjustments.

Avoid using unsuitable instruments when determining the downward and incoming airflow rates. Repeat the above steps for new and modified designs in response to advance and downflow speeds reduced to 0.05 ± 0.015 m/sd.

Eligibility criteria:

Each test 6 AGI received no more than 10 pfu of bacteria, 2 crack samplers received no more than 5 pfu in 30 minutes. The test was repeated 3 times, the control should be positive, a plate more than 300 pfu.

4.3.5.2 Product protection test

Place all the working surfaces on the sedimentation plate. The sprayer was placed 102 mm from the outer edge of the bottom of the observation window, and the direction was toward the observation window. The bacterial concentration was (1-8) × 10-6. A cylinder was placed 50 mm below the sprayer to simulate an arm. The test was carried out for 5 minutes, and the number of colonies received in the sedimentation plate in the cabinet was not more than 5, and the test was repeated 3 times.

4.3.5.3 Cross contamination test

Place the sinking plate on all working faces in the cabinet. The sprayer was placed 76-127 mm above the work surface and sprayed to the other side with a side wall as the background. The bacterial concentration was (1-8) x 10-4. The test was carried out for 5 minutes, and the result was no more than 2 cfu in a plate exceeding 356 mm from the attack side. The 2 side attacks required 3 times.

4.3.5.4 Environmental protection test

At the same time as the above attack test, a 2-stage Anderson sampler was used for sampling for 30 minutes at the air outlet of the safety cabinet, and the test bacteria received should not exceed 2 cfu.

4.3.6. Stability test

Anti-reverse and twist test for Class II biosafety cabinets

4.3.6.1. Anti-subversion in accordance with the seventh part of UL 3101

4.3.6.2 When the 110kg force is applied laterally near the top edge (reverse side), the front and side tops are displaced forward by no more than 1.6mm.

4.3.6.3 Work surface resistance The pressure is evenly distributed in the area of ​​25×25 cm in the center of the working surface, and the working surface is not skewed.

4.3.6.4 Anti-skew 110kg is placed at the edge of the cabinet, and the rear bottom is raised no more than 1.6mm.

4.3.7 Manufacturers should provide information

Product quality control data should be included in the instructions for each biosafety cabinet.

1) Pressure drop / soap bubble / identification gas leak detection,

2) Personal protection, product protection testing data

3) Environmental protection testing data

4.4 Other tests

1) The temperature rise in the cabinet for 4 hours of temperature rise does not exceed 8.50C.

2) Uniform illumination of 650 Lux in the illuminance cabinet. Personal reading (eye) is no less than 430Lux.

3) When the noise level is in normal working condition, the noise above the working surface is 38cm, and the noise outside the operating port is 30cm (the maximum background noise is 57db) does not exceed 67db.

4) The vibration works under the normal setting parameters, and the amplitude of the amplitude of the vibration frequency of the working surface from 10 Hz to 10 kHz does not exceed 2 × 10 -4 in (5 × 10 -6 m) rms.

5) Leakage detection grounding resistance and electrode polarity test.

6) Leech leak test 4 liters of water for 1 hour without visible leakage.

7) Fan performance When the set wind speed is not regulated, the pressure is reduced by 50%, and the air volume of the new filter is reduced by no more than 10%.

Shanghai Sujing Industrial Co., Ltd. is located at No. 6, Lane 358, Wencheng Road, Songjiang New City, Shanghai. It is one of the leading manufacturers in the purification equipment industry in East China. It can provide professional air purification system engineering design, construction, testing and technical services for microelectronics, biomedicine, hospital operating room, fiber optic cable, food and beverage, precision instruments, semiconductor and new materials applications according to national GMP requirements.

The company's purification workbench series, air shower room series, fume hood series, biosafety cabinet series are widely used in medical and health, electronics, pharmaceutical, biological, food, agriculture, forestry, animal husbandry and veterinary, inspection and quarantine, aerospace, automobile manufacturing, Precision instruments, universities and research institutes enjoy a high reputation in the domestic and Southeast Asian markets.

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