Clean room dust particle detection standard operating procedures

Purpose: 

To describe the test method for suspended particles in clean rooms (areas) to standardize the Detection operation of employees.

Scope: 

Applicable to the detection of dust particles in clean areas

Responsibility: 

Completion acceptance.

Testing basis: 

"Good Manufacturing Practice for Pharmaceuticals" (revised in 2010): "Test Method for Suspended Particles in Clean Rooms (Areas) for Pharmaceutical industry" (GB/T16292-2010)

Content

a.When using a particle counter, the instrument manual should be strictly followed.

Determination standard:

b.Test method

• After the instrument is turned on and preheated to a stable state, the instrument can be calibrated according to the provisions of the manual.

• When the sampling tube mouth is placed at the sampling point for sampling, continuous reading can be started only after confirming that the count is stable.

• The sampling tube must be clean and leakage is strictly prohibited.

• The length of the sampling tube should be based on the allowable length of the instrument. Unless otherwise specified, the length shall not exceed 1.5m.

• The sampling port of the counter and the working position of the instrument should be at the same air pressure and temperature to avoid measurement errors.

• The instrument must be calibrated regularly according to the calibration cycle of the instrument to ensure the reliability of the test data.

c.Test rules

1.Test conditions

• Temperature and humidity: The temperature and Relative humidity of the clean room should be consistent with its production and process requirements. The temperature should be controlled at 18~26℃ and the relative humidity should be controlled between 45~65%.

• Pressure difference: The pressure difference between clean rooms (areas) with different air cleanliness should be ≥5Pa. Clean rooms (areas) with the same high air cleanliness level requirements are generally required to be relatively positive pressure to adjacent clean rooms (areas) with low air cleanliness levels.

2.Test status: There are static tests and dynamic tests.

• During the static test, the indoor air conditioning system is in normal operation, and the number of testers shall not exceed 2. The number of dust particles must meet the requirements.

• During the dynamic test, the production is in normal state. The particles generated do not affect the operation of the final product. It is allowed to exceed the standard. However, 10 minutes after the work is completed, the particle level must be restored to the maximum allowable number of dust particles in the clean area. The cleanliness under dynamic conditions should be monitored regularly.

• The state used during the test should be indicated in the test report.

3.Test time: For unidirectional flow, the test should start after the purification Air conditioning system has been operating normally for no less than 30 minutes.

4.Suspended particle counting.

Number of sampling points and their layout

• The number of sampling points and their layout should be set according to the production and key operation areas of the product.

• The sampling points should be evenly arranged to avoid too sparse sampling points in a certain local area. 

• The sampling points are generally evenly arranged on a plane at a height of 0.2m on the work surface.

Limitation of sampling points: 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 times shall not be less than 5 times. The number of sampling times for each sampling point can be more than 1, but the number of sampling times for different sampling points can be different.

<td colspan="4" height="41" width=" style="border-width: 1px; border-style: solid; border-color: gainsboro;">Note: The area in the table refers to the air   supply area for unidirectional clean rooms, and refers to the room area for   non-unidirectional clean rooms.

Minimum number of sampling points:

Notes on food sampling
Minimum sampling volume

• Sampling can only be carried out after confirming that the air supply and pressure difference of the clean room (area) meet the requirements.

• For unidirectional flow, the sampling pipe mouth of the counter should face the direction of the airflow. For non-unidirectional flow, the sampling port should be upward.

• When arranging sampling points, the return air outlet should be avoided.

• When sampling, the tester should be on the downwind side of the sampling port.

• The sampling data of suspended particle concentration should be statistically calculated according to the following steps.

5.Result evaluation: The judgment of the county suspended particle cleanliness level should be based on the following two conditions.

• The average particle concentration of each sampling point must be lower than or equal to the specified level limit, that is, Ai≤level limit.

• The 95% confidence limit of the mean of the average particle concentration of all sampling points must be lower than or equal to the specified level limit, that is, UCL≤level limit.

6.When the test results of three consecutive samples exceed the warning index, or the results of the unit sample are particularly high, measures should be taken.

7.Use a page-numbered record book to record the dust-free room suspended particle test experiment, including: test status, test time, standard, test results, result calculation, result evaluation, etc. All records must be signed by the experimenter and signed by the head of the quality management department.

8.The record book should be kept for three years after the last record.