Clean room (area) environmental testing standard operating procedures (original link: http://)
1 Purpose: To establish a clean room (district) environmental control monitoring standard operating procedures.
2 Scope: Applicable to clean room (room) clean air control indicators monitoring standard operation.
3 Responsible: Quality Department, QA, QC personnel, workshop related personnel.
4 procedures:
4.1 Clean air dust particle monitoring:
4.1.1 Requirements for the number of clean air dust particles: The air cleanliness requirement of the water needle and freeze-dried powder workshop is 10000 grade and 100000 grade. The number of dust particles with 10000 grades of ≥0.5μm shall not exceed 350,000/m3; the number of dust particles of ≥5μm shall not be higher than the number of dust particles of ≥0.5μm for 2000/m3.100000 The number of grains shall not be higher than 3,500,000/m3; the number of dust particles of ≥5 μm shall not be higher than 20,000/m3.
4.1.2 Dust particle number detection method:
4.1.2.1 According to the dust particle counter, according to the size of the clean room, the minimum number of sampling points is as specified in the following table, and the number of sampling points per point is 3 times.
level Sampling points area | 10000 level | 100000 level |
2 | 2 | |
10m2 | 2 | 2 |
20m2 | 2 | 2 |
40m2 | 2 | 2 |
100m2 | 3 | 3 |
200m2 | 6 | 6 |
4.1.2.2 When the number of sampling points is 3, it can be arranged on the diagonal line of the 0.8m high plane (see the following figure). When the number of sampling points is 10, it can be arranged in two layers, 5 points per layer.
Arrangement of 5 measuring points
4.1.2.3 For turbulent clean rooms, the sampling port should be upward and the sampling speed should be as close as possible to the indoor air velocity. The minimum sample size for the 0.5 μm and 5 μm particles tested was 2.83 liters.
4.1.2.4 The frequency of dust particles is measured. The clean area is measured once a month for key operating points.
4.1.2.5 The standard operating procedures for dust particle analyzers are to be carried out in accordance with the Standard Operating Procedures for Dust Particle Detectors.
4.2 Detection of sedimentation number:
4.2.1 When the sedimentation bacteria are measured, the culture dish is placed at a place where the representative airflow disturbance is extremely small. The number of points placed in the culture dish is the same as the number of dust particles sampled, but the number of culture dishes per point should be not less than 2.
4.2.2 When the sedimentation bacteria were measured, the culture dish used was Ф90 mm and ordinary broth medium.
4.2.3 After placing the culture medium as required, open the plate cover, expose the surface of the medium for 30 minutes, cover the plate cover, and place it in a constant temperature incubator at 30-35 ° C for 48 hours before counting.
4.2.4 Frequency of measurement: measured twice a month.
4.4.3 Determination of temperature and humidity:
4.3.1 Determination method: Record the temperature and humidity in the clean area with a thermometer and a hygrometer.
4.3.2 Standard: The temperature of the 10000-class clean zone is 20-24 °C, and the relative humidity is 45-60%.
The 100000-class clean zone has a temperature of 18 to 26 ° C and a relative humidity of 45 to 65%.
4.3.3 Measurement location: clean studio, clean corridor and clean locker room.
4.3.4 Frequency of measurement: The production process is measured once a day in the morning and afternoon.
4.4 Air pressure monitoring:
4.4.1 Determination method: The air pressure difference between different clean areas and clean areas and non-clean areas is measured by a micro differential pressure gauge.
4.4.2 Standard: The air pressure difference between different cleanliness levels should be ≥5Pa; the air pressure difference between clean room and non-clean room should be ≥10Pa.
4.4.3 Determination of position:
1 clean area - locker room - non-clean area.
2 room with large dust production - clean corridor
4.4.4 Frequency of measurement: The production process is measured once a day.
4.5 Clean room temperature humidity and pressure difference records are carried out by the clean room operators in the production workshop. The number of dust particles and sedimentation bacteria are carried out by quality inspectors. Fill in the "Settlement Test Record", "Dust Particle Test Record", "Temperature and Humidity Record", "Pressure Record".
Data reference (portal):
Air shower: http://
High efficiency air filter: http://
Clean room: http://
High efficiency filter leak detection: http://
Operating room purification project: http://
Cleanliness level standard: http://
Cleanroom testing standards: http://
Clean factory design specifications: http://
Cleanroom management system: http://
Clean room ventilation frequency standard: http://
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