Clean area environment test operation procedure

Clean area environment test operation procedure

 

1. Purpose

This system has made specific provisions for the monitoring department, monitoring frequency, test method, record filing and result processing of the air purification system of our company's clean room (area).

 

2. area

This system is applicable to the monitoring of suspended particles and sedimentation bacteria in the clean room (area) of the existing air purification system throughout the company.

Clean area

3 Responsibilities

The monitoring of the clean room (area) air purification system is performed by the Quality Technology Department.

 

4 Provisions

4.1 Monitoring frequency

4.1.1 The suspended particle test is conducted every quarter.

4.1.2 The test of sedimentation bacteria shall be conducted every quarter.

 

5 Test method

For details of suspended particle test, please refer to "Clean Room (Area) Suspended Particle Test Operating Regulations" (QA-O-002)

For the test method of settling bacteria, please refer to the "Clean Room (Area) Settling Bacteria Test Procedure" (QA-O-003).

 

6 Results processing

The results of the test shall be promptly issued with suspended particle test reports, sedimentation bacteria test reports and micro-reports of production equipment, and shall be notified to the relevant production workshop and the quality and technology department.

 

7 Handling when the number of suspended particles and micrometers are abnormal

7.1 When the number of suspended particles and the number of micrometers are abnormal, the production area shall be thoroughly cleaned and sanitary. After the sanitation is completed, the purification system shall be activated, and the inspection shall be performed again after the self-cleaning time is reached.

7.2 Check the air-conditioning system, such as leak detection test on the filter, detection and adjustment of room positive pressure, air exchange frequency, leaking filters must be repaired or replaced, and the room positive pressure and air exchange should be increased appropriately The number of times until the test data meets the requirements.

7.3 Audit the air tightness of the plant and the management of pollution sources during production.

7.4 Retraining personnel hygiene, changing procedures, etc.

7.5 The following table shows the deviation items and the measures that should be considered.

Deviation item

Take measures

Temperature and humidity

Adjust the cooling capacity;

Adjust the dehumidification power.

Air volume and wind speed

Increase or decrease the air inlet valve;

Replace the high efficiency filter.

 

Static pressure difference

Adjust the air volume distribution and increase the air volume;

Check and repair air-conditioning pipes and measure wind speed;

Replace the terminal filter;

Check the air tightness of the production area.

 

Dust particles

Thorough hygiene;

Increase self-cleaning time;

Leak detection or replacement of the high efficiency filter;

Check the air tightness of the production area.

 

micro-

Thoroughly clean and disinfect;

Leak detection or replacement of the high efficiency filter;

Check the air tightness of the production area;

Strengthen personnel hygiene requirements education and retraining of changing procedures.