Pharmaceutical GMP workshop, electronic dust-free workshop, food and drug packaging material workshop, sterile medical equipment workshop, hospital clean operating room,
Biosafety laboratory, health food GMP workshop, cosmetics/consumer workshop, animal laboratory, veterinary drug GMP workshop, drinking bucket
Third-party testing and debugging are generally required after the clean room and clean room of the water-filling workshop are built.
Detection range: clean room environmental rating, engineering acceptance testing, including food, health products, cosmetics, bottled water, milk
Production workshop, electronic product workshop, GMP workshop, hospital operating room, animal laboratory, biosafety laboratory, biosafety
Cabinets, ultra-clean workbench, clean room, aseptic workshop, etc.
Test items: wind speed, frequency of ventilation, temperature and humidity, pressure difference, suspended particles, floating bacteria, sedimentation bacteria, noise, illumination
Wait.
1. Wind speed and air volume
The cleanliness of clean rooms and clean areas is mainly by feeding a sufficient amount of clean air to replace and dilute the particles generated in the room.
Dyeing to achieve. To this end, measure the air supply volume, average wind speed, air supply uniformity, airflow direction of the clean room or clean facilities, and
Projects such as flow patterns are necessary.
One-way flow mainly relies on clean air to push and replace indoor and indoor polluted air to maintain indoor and indoor cleanliness.
degree. Therefore, the wind speed and uniformity of the air supply section are important parameters that affect the cleanliness. Higher, more uniform cross-section wind speed energy
It is a major concern to detect pollutants from indoor processes faster and more efficiently.
The non-unidirectional flow mainly relies on the clean air sent in to dilute and dilute the pollutants in the room and the area to maintain its cleanliness. because
Therefore, the greater the number of air changes, the reasonable airflow pattern, the more significant the dilution effect, and the corresponding improvement in cleanliness. So non-single phase flow cleansing
The air supply volume in the room and clean area and the corresponding number of air changes are the main airflow test items.
In order to obtain repeatable readings, the time average of the wind speeds at each measuring point is recorded.
Number of air changes: according to the total air volume of the clean room divided by the volume of the clean room
2, temperature and humidity
The temperature and humidity of a clean room or clean room are usually measured in two grades: general test and comprehensive test. *A good grade
For the cross-check acceptance test in the empty state, the second grade is suitable for static or dynamic comprehensive performance test. This type of test applies
In the case of strict temperature and humidity performance requirements.
This test is performed after the airflow uniformity detection and after the air conditioning system is adjusted. The air conditioning system is fully equipped for this test.
Operation, the situation has been stable. At least one humidity sensor is placed in each humidity control zone, and the sensor is fully stabilized
set time. The measurement should be suitable for the purpose of actual use. The measurement is started after the sensor is stable. The measurement time is not less than 5 minutes.
bell.
3, pressure difference
The purpose of this test is to verify the ability to maintain a specified differential pressure between the completed facility and the surrounding environment and between the various spaces within the facility.
This test applies to all three occupancy states. This test needs to be done on a regular basis.
The test of differential pressure should be carried out under the condition that all the doors are closed, from high pressure to low pressure, and from the plane to the outside.
The room starts and is tested outwards in turn; there are different levels of adjacent clean rooms (areas) with holes and holes, and the hole should be reasonable.
Airflow and so on.
Differential pressure detection requirements:
(1) The measurement of the static pressure difference is required to be performed when all the doors in the clean area are closed.
(2) The cleanliness should be carried out in order from cleanliness to high cleanliness, and the room that passes straight outside is detected.
(3) The measuring tube is located anywhere in the room without airflow, and the measuring tube surface is parallel to the airflow streamline.
(4) The measured recorded data should be accurate to 1.0 Pa.
Differential pressure detection steps:
(1) Close all doors first.
(2) The differential pressure between the clean rooms, the clean room corridors, the corridors and the outside world is measured by a differential pressure gauge.
(3) Record all data.
Differential pressure standard
The positive or negative pressure value of the clean room to be tested is determined according to the clean room design or process requirements.
(1) The static pressure difference between different levels of clean room or clean area and non-clean room (area) shall be not less than 5Pa.
(2) The static pressure difference between the clean room (zone) and the outdoor should not be less than 10Pa.
(3) For a one-way flow clean room with an air cleanliness level of 5 (100), the dust concentration of the indoor working surface at 0.6m inside the door shall not exceed the dust concentration limit of the corresponding level.
(4) If the requirements of the above standards are not met, the fresh air volume and exhaust air volume should be re-adjusted until they are qualified.
4, suspended particles
A. Indoor testers must wear clean clothes, no more than 2 people, should be located on the downwind side of the test point and away from the test point, and should remain static. When performing the change point operation, the action should be light, and the interference of the indoor cleanliness should be reduced.
B. The equipment should be used during the calibration period.
C. Before the test and after the test, the device is “clearedâ€.
D. In the unidirectional flow region, the selected sampling probe should be close to the isokinetic sampling, and the wind speed entering the sampling probe and being taken out
The wind speed deviation should not exceed 20%. If this is not possible, the sampling port is facing the main direction of the airflow. Non-unidirectional flow sampling
Point, the sampling port should be vertical.
E. The connection port from the sampling port to the particle counter sensor should be as short as possible.
The sampling point is generally about 0.8-1.2m from the ground. It should be evenly distributed and avoid the return air. For any small clean room or bureau
In the air purification area, the number of sampling points shall not be less than two, and the total number of samples may be obtained by opening the root twice according to the area.
5, floating bacteria
The number of sampling points of zui corresponds to the number of sampling points of suspended particles, and the position of the measuring point in the working area is about 0.8-1.2m from the ground, and the measuring point of the air supply port
Set off from the air supply surface about 30cm, the measuring points can be added at key equipment or key working activities, and each sampling point is generally sampled once.
After all sampling is completed, the culture dish should be placed in a constant temperature incubator for not less than 48 hours. Each batch of medium should have a pair.
According to the experiment, the medium was tested for contamination.
6, sedimentation bacteria
The measuring point of the working area is 0.8-1.2m away from the ground. Place the prepared culture dish at the sampling point, open the petri dish cover and make it violent.
After the specified time, cover the culture dish and place the culture dish in a constant temperature incubator for no less than 48 hours.
The medium should have a control experiment to check if the medium is contaminated.
7, noise
The measuring height is about 1.2 meters from the ground, and the clean room area is less than 15 square meters. It can only measure 1 point in the center of the room; the area is 15 square meters.
Above the meter, you should also measure the diagonal 4 points, 1 meter away from the side wall, and the measuring points are facing the corners.
8, illuminance
The plane of the measuring point is about 0.8 meters from the ground, and the points are arranged at a distance of 2 meters. The measuring point of the room within 30 square meters is 0.5 meters away from the side wall.
The 30 square meter room is 1 meter from the wall.
Testing standards:
(1) "Code for Design of Clean Plants" GB50073-2001
(2) "Technical Specifications for the Construction of Hospital Cleansing Department" GB 50333-2002
(3) "Biosafety Laboratory Building Technical Specifications" GB 50346-2004
(4) "Code for construction and acceptance of clean rooms" GB 50591-2010
(5) "Test method for suspended particles in clean room (area) of the pharmaceutical industry" GB/T 16292-2010
(6) "Test method for floating bacteria in clean room (area) of the pharmaceutical industry" GB/T 16293-2010
(7) "Testing methods for sedimentation bacteria in clean room (area) of the pharmaceutical industry" GB/T 16294-2010
It is mainly used for urban intersection,
highway crossing, toll channel, garden, residential quarter, parking
lot, garage, gas station and other places. It can also be used for
separation of road racing road and separation of human road. All kinds
of exhibition halls are isolated and used to maintain the order of the
exhibition hall. It can also be used in sports field, to isolate the
track, avoid other people to walk freely, and cause unnecessary injury.
The main materials are rubber, PVC, etc.
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