Clean room (area) environmental testing standard operating procedures

1. Purpose

To establish standard operating procedures for monitoring clean room (area) environmental control.

2. Scope

Applicable to standard operations for monitoring Clean air control indicators in clean areas (rooms).

3. Responsible persons

Quality department, QA, QC personnel, and relevant personnel in the workshop.

4. Procedures

4.1 Monitoring of clean air particle count.

a. Requirements for clean air particle count: The air cleanliness requirements for water injection and freeze-dried powder injection workshops are 10000 and 100000. The requirements for the number of particles at the 10000 level are that the number of particles of 20.5um shall not exceed 350000/m3; the number of particles of 25um shall not exceed 2000/m3. The requirements for the number of particles at the 100000 level are that the number of particles of 20.5um shall not exceed 3500000/m3: the number of particles of =5um shall not exceed 20000/m3.

The dust particle counter is used for measurement. According to the size of the clean room, the minimum number of sampling points is specified in the following table, and the number of sampling times at each point is 3 times.

b. Dust particle number detection method:

• Use a dust particle counter to measure. According to the size of the clean room, the minimum number of sampling points is as specified in the table below, and the number of sampling times per point is 3 times.

• When the number of sampling points is 3, it can be arranged on the diagonal line of the plane 0.8m above the ground (see the figure below) for sampling. When the number of sampling points is 10, it can be arranged in two layers, with 5 points on each layer.Arrangement of 5 measurement points.

• For turbulent clean rooms, the sampling port should be upward, and the sampling speed should be as close to the indoor air flow speed as possible. The minimum sampling volume for 0.5um and 5um particle tests is 2.83F respectively.

• Frequency of dust particle number measurement: the key operating points in the clean area are measured once a month.

• The standard operating procedures for dust particle detectors shall be carried out in accordance with the "Standard Operating Procedures for the Use of Dust Particle Detectors".

4.2 Detection of sedimentation bacteria.

• When measuring sedimentation bacteria, the culture dishes are placed at representative locations with minimal air flow disturbance. The number of points where the culture dishes are placed is the same as the number of points where the dust particles are sampled, but the number of culture dishes at each point should not be less than 2.

• When measuring sedimentation bacteria, the culture dishes used are 90mm and ordinary broth culture medium.

• After placing the culture medium according to the specified requirements, open the plate cover, expose the surface of the culture medium for 30 minutes, cover the plate cover, and place it in a constant temperature incubator at 30~35℃ for 48 hours before counting.

• Measurement frequency: twice a month.

Temperature and humidity measurement.

4.3 Measurement method:

Use a thermometer and a hygrometer to record the temperature and humidity of the clean area.

• Standard: The temperature of the 10000 clean area is 20~24℃, the Relative humidity is 45~60%6, the temperature of the 100000 clean area is 18~26℃, the relative humidity is 45~65%.

• Measurement location: clean studio, clean corridor and clean dressing room.

• Measurement frequency: production process, once in the morning and afternoon every day.

4.4 Air pressure monitoring

a. Measurement method: use a micro differential pressure gauge to measure the air pressure difference between different clean areas and between clean areas and non-clean areas.

b. Standard: The air pressure difference between different clean levels should be >5Pa; the air pressure difference between clean rooms and non-clean rooms should be >10Pa.

c. Measurement location:

• Clean area-dressing room-non-clean area.

• Room with large dust production-clean corridor.

d. Measurement frequency: production process, once a day.

e. The temperature, humidity and pressure difference records of clean rooms are carried out by the operators in each clean room of the production workshop. The number of dust particles and sedimentation bacteria are carried out by the quality inspection personnel. Write down the "Sedimentation Bacteria test record", "Dust Particle Test Record", "Temperature and Humidity Record" and "Pressure Difference Record".