Operation procedure for environmental test in biological clean area

Objective: this system has made specific regulations on the monitoring department, monitoring frequency, testing method, record filing and result processing of the clean room (area) air purification system of our company 2 Scope this system is applicable to the monitoring behavior of suspended particles and settling bacteria in the clean room (area) of the existing air purification system in the whole company The monitoring of the air purification system in the clean room (area) shall be carried out by the quality and technology department 4 Regulated content 4.1 Monitoring frequency 4.1.1 Test of suspended particles once a quarter 4.1.2 the test of settling bacteria shall be conducted once a quarter 5 For the test method of suspended particles, please refer to the operation procedure for testing suspended particles in clean room (area) (qa-o-002) for the test method of settling bacteria, please refer to the operation procedure for testing settling bacteria in clean room (area) (qa-o-003) 6 The results of the treatment and test shall be reported to the relevant production workshop and the quality and technology department in a timely manner 7 In case of any abnormality in the number of suspended particles and microorganisms, 7.1 In case of any abnormality in the number of suspended particles and microorganisms, the production area shall be thoroughly cleaned and cleaned After the completion of sanitation, the purification system shall be started and the self-cleaning time shall be reached before re detection 7.2 check the air conditioning system, such as leak detection test on the filter, detection and adjustment of room positive pressure and air change frequency If leakage is found, the filter shall be repaired or replaced, and the room positive pressure and air change frequency shall be increased appropriately until the test data meet the requirements, etc 7.3 review the air tightness of the plant and the management of pollution sources in production 7.4 retraining of personnel hygiene, changing procedures, etc 7.5 the following table shows the deviation items and measures to be taken For deviation items, measures shall be taken to adjust the cooling capacity and dehumidification force Air volume and air speed increase or decrease the air inlet valve; replace the filter Adjust the distribution of air volume and increase the air volume by static pressure difference; repair the air conditioning pipeline, measure the air speed; replace the terminal filter; check the air tightness of the production area Clean the dust thoroughly; increase the self-cleaning time; check the leakage or replacement of the filter; check the air tightness of the production area Thoroughly clean and disinfect the microorganism; check or replace the filter; check the air tightness of the production area; strengthen the education of personnel hygiene requirements and retraining of changing procedures