Cleanroom testing
1. Detection range:
Clean room environmental grade assessment, engineering acceptance testing, including food, health products, cosmetics, bottled water, milk production workshop, electronic product production workshop, GMP workshop, hospital operating room, animal laboratory, biosafety laboratory, biological safety cabinet, ultra-clean workbench, dust-free workshop, aseptic workshop, etc.
2. Testing standards:
1) Code for Design of Clean Workshop GB50073-2001
2) "Technical Code for the Construction of Clean Operating Departments in Hospitals" GB 50333-2002
3) Technical Code for the Construction of Biosafety Laboratories GB 50346-2004
4) Code for Construction and Acceptance of Cleanroom GB 50591-2010
5) "Test Methods for Suspended Particles in Cleanrooms (Areas) of Pharmaceutical Industry" GB T 16292-2010
6) "Test Methods for Planktonic Bacteria in Cleanrooms (Areas) of Pharmaceutical Industry" GB T 16293-2010
7) Test Methods for Sedimentation Bacteria in Cleanrooms (Areas) of Pharmaceutical Industry GB T 16294-2010
3. Test items: wind speed, air volume, number of air exchanges, temperature and humidity, pressure difference, suspended particles, plankton, sedimentation bacteria, noise, illumination, etc.
1) Wind speed and air volume: The wind speed and air volume must be carried out first, and the effects of the purification system must be obtained under the conditions of the designed air volume and wind speed.
2) Number of air exchanges: Divide the total air supply volume per hour by the space area of the room. The larger the number of air exchanges, the more reasonable the airflow pattern, the more significant the dilution effect, and the cleanliness is also improved accordingly.
3) Temperature and humidity: The temperature and humidity determination of clean rooms or clean facilities are usually divided into two grades: general test and comprehensive test. The first grade is suitable for the completion acceptance test in the empty state, and the second grade is suitable for static or dynamic comprehensive performance testing. This type of test is suitable for occasions with strict requirements for temperature and humidity performance.
4) Differential pressure: Verify the ability to maintain the specified differential pressure between the completed facility and the surrounding environment, as well as between the spaces within the facility. According to the clean room design or process requirements, it is decided to maintain the positive or negative pressure value of the tested clean room.
The static pressure difference between different levels of clean rooms or clean areas and non-clean rooms (areas) should not be less than 5Pa.
The static pressure difference between the clean room (area) and the outdoor should not be less than 10pa.
5) Suspended particles: the sampling point is generally 0 above the ground8-1.About 2m, it should be evenly and scientifically distributed, and the return air outlet should be avoided. For any small clean room or local air purification area, the number of sampling points shall not be less than 2, and the total number of samples can be calculated according to the area of 2 roots.
6) Plankton: It is expressed by the number of colonies of planktonic bacteria per unit of air. Live microbial particles suspended in the air are collected and propagated to a visible number of colonies under the growing conditions of the matter through a specialized medium.
7) Sedimentation bacteria: the number of sedimentation bacteria collected in the air in each plate petri dish within the specified time, expressed in dishes. Live microbial particles in the air, through a specialized medium, multiply to a visible number of colonies under the production conditions of the matter.
7) Noise. The measured height is about 1 from the ground2 meters, the clean room area is less than 15 square meters, only 1 point in the center of the room can be measured; If the area is more than 15 square meters, the diagonal 4 points should be measured again, 1 meter away from the side wall, and the measuring points should be oriented towards each corner.
7) Illuminance. The plane of the measuring point is 0About 8 meters, according to the 2 meters apart, the room measurement point within 30 square meters is 0 from the side wall5 meters, and the measuring point of rooms of more than 30 square meters is 1 meter from the wall.