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Jason@cleanroomequips.com
After the construction of clean rooms and clean
workshops such as food and drug packaging material workshops, sterile medical
equipment workshops, hospital clean operating rooms, biosafety laboratories,
health food GMP workshops, cosmetics/disinfectant product workshops, animal
laboratories, and veterinary drug GMP workshops, they generally require
third-party testing and debugging.
Testing scope: Clean room environment grade assessment, project acceptance testing, including medicines, health products, cosmetics, medical devices, and microbiological laboratories.
Testing items: Wind speed and volume, ventilation times, temperature and humidity, pressure difference, suspended particles, floating bacteria, settling bacteria, noise, illumination, etc.
Wind speed, air volume, ventilation times
The cleanliness of clean rooms and clean areas is mainly achieved by supplying a sufficient amount of Clean air to replace and dilute the particulate pollutants generated in the room. For this reason, it is necessary to measure the air supply volume, average wind speed, air supply uniformity, air flow direction and flow pattern of clean rooms or clean facilities.
Unidirectional flow mainly relies on Clean air flow to push and replace the polluted air in the room and area to maintain the cleanliness of the room and area. Therefore, its air supply cross-sectional wind speed and uniformity are important parameters affecting cleanliness. Higher and more uniform cross-sectional wind speeds can remove pollutants generated by indoor process faster and more effectively, so they are the main test items of concern.
Non-unidirectional flow mainly relies on the clean air supplied to dilute and dilute the pollutants in the room and area to maintain its cleanliness. Therefore, the more ventilation times and the more reasonable the airflow pattern, the more significant the dilution effect, and the corresponding improvement in cleanliness. Therefore, the air supply volume and corresponding ventilation times of non-single-phase flow clean rooms and clean areas are the main airflow test items of concern. In order to obtain repeatable readings, record the time average of the wind speed at each measuring point.
Ventilation frequency: calculated by dividing the
total air volume of the clean room by the volume of the clean room.
Temperature and humidity
The temperature and humidity measurement of clean
rooms or clean facilities is usually divided into two levels: general test and
comprehensive test. The first level is suitable for the delivery acceptance test
in an empty state, and the second level is suitable for static or dynamic
comprehensive performance test. This type of test is suitable for occasions with
strict requirements on temperature and humidity performance.
This test is carried out after the air flow
uniformity test and the air conditioning system adjustment. When conducting this
test, the air conditioning system is fully operational and all conditions are
stable. At least one humidity sensor is set in each humidity control area, and
the sensor is given sufficient stabilization time. The measurement should be
suitable for the actual purpose of use. The measurement should be started after
the sensor is stable, and the measurement time should not be less than 5
minutes.
Pressure difference
The purpose of this test is to verify the ability to maintain a specified pressure difference between the completed facility and the surrounding environment, and between the spaces within the facility. This test is applicable to all three occupancy states. This test needs to be conducted regularly. The pressure difference test should be conducted with all doors closed, from high pressure to low pressure, starting from the inner room farthest from the outside world in the plan layout, and then tested outward in sequence; there are clean rooms (areas) of different levels connected by holes, and there should be reasonable airflow directions at the openings, etc.
The purpose of this test is to verify the ability to maintain a specified pressure difference between the completed facility and the surrounding environment, and between the spaces within the facility. This test is applicable to all three occupancy states. This test needs to be conducted regularly. The pressure difference test should be conducted with all doors closed, from high pressure to low pressure, starting from the inner room farthest from the outside world in the plan layout, and then tested outward in sequence; there are clean rooms (areas) of different levels connected by holes, and there should be reasonable airflow directions at the openings, etc.
Pressure difference test requirements:
The static pressure difference measurement requires that all doors in the clean area are closed.
On the clean plane, the cleanliness should be tested in descending order until the room directly connected to the outside.
The measuring pipe mouth can be set anywhere in the rate without airflow influence, and the measuring pipe mouth surface is parallel to the airflow streamline
The measured and recorded data should be accurate to 1.0Pa.
Pressure difference detection steps:
Close all doors first.
Use a micro differential pressure gauge to measure the pressure difference between clean rooms, clean room corridors, and corridors and the outside world.
Record all data.
Pressure difference standard requirements:
Determine the positive or negative pressure value of the clean room to be tested according to the Clean room design or process requirements.
The static pressure difference between clean rooms of different levels 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 outside should not be less than 10Pa.
For unidirectional cleanrooms with air cleanliness levels stricter than level 5 (level 100), when the door is opened, the dust concentration on the indoor working surface at 0.6m inside the door should not exceed the dust concentration limit of the corresponding level.
If the above standards are not met, the fresh air volume and exhaust air volume should be readjusted until they are qualified.
Suspended particles
Indoor test personnel 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 still. When changing points, the movement should be gentle, and the interference of personnel on the cleanliness of the room should be reduced.
The equipment should be used within the calibration period.
The equipment should be "zeroed" before and after the test.
In the unidirectional flow area, the selected sampling probe should be close to isokinetic sampling, and the wind speed entering the sampling probe should not deviate from the wind speed of the sampled air by more than 20%. If this cannot be done, the sampling port should face the main direction of the airflow. For sampling points with non-unidirectional flow, the sampling port should be vertically upward.
The connecting pipe from the sampling port to the particle counter sensor should be as short as possible. The sampling points are generally about 0.8-1.2m from the ground. The points 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 sampling points can be obtained by taking the second root of the area.
Floating bacteria
The minimum number of sampling points corresponds to
the number of sampling points for floating particles in the county. The
measuring point in the working area is about 0.8-1.2m from the ground, and the
measuring point at the air outlet is about 30cm away from the air supply
surface. Additional measuring points can be added at key equipment or key work
activity ranges. Each sampling point is generally sampled once. After all
sampling is completed, the culture dish is placed in a constant temperature
incubator for incubation for no less than 48 hours. Each batch of culture medium
should have a control experiment to check whether the culture medium is
contaminated.
sedimentation bacteria
The measuring point in the work area is about 0.8-1.2m above the ground. Place the prepared culture dish at the sampling point, open the cover of the culture dish, expose it for the specified time, then cover the culture dish and place it in a constant temperature incubator for incubation for no less than 48 hours. Each batch of culture medium should have a control experiment to check whether the culture medium is contaminated.
Noise
The measurement height is about 1.2 meters from the ground. For clean rooms with an area of less than 15 square meters, only one point in the center of the room can be measured; for clean rooms with an area of more than 15 square meters, four diagonal points should be measured, each 1 meter away from the side wall, and the measurement points should face each corner.
Illumination
The measurement point plane is about 0.8 meters from the ground, and the points are arranged at a spacing of 2 meters. The measurement point of a room within 30 square meters is 0.5 meters away from the side wall, and the measurement point of a room over 30 square meters is 1 meter away from the wall.
