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The clean room needs to provide third-party testing, debugging, consulting and other professional technical services for pharmaceutical GMP workshops, electronic dust-free workshops, sterile medical equipment workshops, hospital clean operating rooms, and biological universal laboratories
.
The editor of PATEO will show you the basic items that need to be tested in the clean room
.
1.
Wind speed, air volume, and ventilation times The cleanliness of clean rooms and clean areas is mainly achieved by feeding a sufficient amount of clean air to displace and dilute the particulate pollutants generated in the room
.
The one-way flow mainly relies on the clean air to push and displace the polluted air in the room and area to maintain the cleanliness of the room and area
.
Non-unidirectional flow mainly relies on the incoming clean air to dilute and dilute the pollutants in the room and area to maintain its cleanliness
.
2.
Temperature and humidity The measurement of temperature and humidity in clean rooms or clean facilities is usually divided into two grades: general testing and comprehensive testing
.
The first level applies to the acceptance test at the end of the empty state
.
The second grade is suitable for static or dynamic comprehensive performance testing
.
This type of test is suitable for occasions with strict requirements on temperature and humidity performance
.
3.
Differential pressure detection requirements The measurement of static pressure difference requires that all doors in the clean area be closed
.
On the clean plane, it should be carried out in order of cleanliness from high to low, until the room directly connected to the outside is detected
.
The measuring tube orifice can be located anywhere in the room without the influence of airflow, and the surface of the measuring tube orifice is parallel to the airflow streamline
.
The measured and recorded data should be accurate to 1.
0Pa
.
4.
The sampling point of suspended particles is generally about 0.
8-1.
2m away from the ground, and the points should be distributed evenly and scientifically, 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 root of the area twice
.
The minimum number of sampling points corresponds to the number of suspended particle sampling points.
The position of the measurement point in the work area is about 0.
8-1.
2m above the ground, and the position of the air outlet is about 30cm away from the air supply surface.
Additional measurement points can be added to key equipment or key work activities.
The sampling point is generally sampled once
.
5.
The measuring point of the sedimentation bacteria working area is about 0.
8-1.
2m away from the ground.
Place the prepared petri dish at the sampling point, open the petri dish cover and expose it for the specified time, then cover the petri dish and put the culture The dishes should be cultured in a constant temperature incubator for no less than 48 hours.
Each batch of culture medium should have a control experiment to check whether the culture medium is contaminated
.
6.
The noise measurement height is about 1.
2 meters from the ground.
If the area of the clean room 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, 4 additional points on the opposite corners should be measured, each 1 meter away from the side walls.
, the measuring points are oriented towards each corner
.
7.
The plane of the illuminance measuring point is about 0.
8 meters away 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, and the measuring point of the room exceeding 30 square meters is 1 meter away from the wall
.
.
The editor of PATEO will show you the basic items that need to be tested in the clean room
.
1.
Wind speed, air volume, and ventilation times The cleanliness of clean rooms and clean areas is mainly achieved by feeding a sufficient amount of clean air to displace and dilute the particulate pollutants generated in the room
.
The one-way flow mainly relies on the clean air to push and displace the polluted air in the room and area to maintain the cleanliness of the room and area
.
Non-unidirectional flow mainly relies on the incoming clean air to dilute and dilute the pollutants in the room and area to maintain its cleanliness
.
2.
Temperature and humidity The measurement of temperature and humidity in clean rooms or clean facilities is usually divided into two grades: general testing and comprehensive testing
.
The first level applies to the acceptance test at the end of the empty state
.
The second grade is suitable for static or dynamic comprehensive performance testing
.
This type of test is suitable for occasions with strict requirements on temperature and humidity performance
.
3.
Differential pressure detection requirements The measurement of static pressure difference requires that all doors in the clean area be closed
.
On the clean plane, it should be carried out in order of cleanliness from high to low, until the room directly connected to the outside is detected
.
The measuring tube orifice can be located anywhere in the room without the influence of airflow, and the surface of the measuring tube orifice is parallel to the airflow streamline
.
The measured and recorded data should be accurate to 1.
0Pa
.
4.
The sampling point of suspended particles is generally about 0.
8-1.
2m away from the ground, and the points should be distributed evenly and scientifically, 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 root of the area twice
.
The minimum number of sampling points corresponds to the number of suspended particle sampling points.
The position of the measurement point in the work area is about 0.
8-1.
2m above the ground, and the position of the air outlet is about 30cm away from the air supply surface.
Additional measurement points can be added to key equipment or key work activities.
The sampling point is generally sampled once
.
5.
The measuring point of the sedimentation bacteria working area is about 0.
8-1.
2m away from the ground.
Place the prepared petri dish at the sampling point, open the petri dish cover and expose it for the specified time, then cover the petri dish and put the culture The dishes should be cultured in a constant temperature incubator for no less than 48 hours.
Each batch of culture medium should have a control experiment to check whether the culture medium is contaminated
.
6.
The noise measurement height is about 1.
2 meters from the ground.
If the area of the clean room 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, 4 additional points on the opposite corners should be measured, each 1 meter away from the side walls.
, the measuring points are oriented towards each corner
.
7.
The plane of the illuminance measuring point is about 0.
8 meters away 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, and the measuring point of the room exceeding 30 square meters is 1 meter away from the wall
.
