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monitoring report
Report number:
Test area name:
Clean room area area height cleanliness level
Monitoring status static airflow mode non-unidirectional airflow monitoring according to YY0033-2000 "Quality Management Specifications for the Production of Sterile Medical Devices".
| Room name | Room No. | Temperature (°C) | Ventilation times (times/h) | Settling bacteria (pieces/Ⅲ) | Static pressure difference (Pa) and non-clean area | Relative humidity | Result judgment |
| Production workshop second shift | 1 | 18.3 | 79.3 | 2.5 | 7.5 | 53% | Comply with regulations |
| Disinfection buffer room | 2 | 18.6 | 102 | 0.5 | For the second update of the same level:3 | 53% | Comply with regulations |
| Cleaning room | 3 | 18.5 | 90 | 0.5 | For disinfection buffer rooms of the same level: 56% Comply with regulations | ||
| Sanitary ware room | 4 | 18.3 | 96 | 2.0 | For disinfection buffer rooms of the same level: 55% Comply with regulations | ||
| Operation room | 5 | 18.5 | 36 | 1.0 | For disinfection buffer rooms of the same level: 53% Comply with regulations | ||
| Inner packaging room | 6 | 18.4 | 32.5 | 3.0 | For disinfection buffer rooms of the same level:4 | 54% | Comply with regulations |
| Laboratory second shift | 7 | 18.8 | 96 | 3.0 | 8 | 52% | Comply with regulations |
| Clean corridor | 8 | 18.7 | 53 | 3.0 | For the second update of the same level:2 | 53% | Comply with regulations |
| Positive control room | 9 | 18.8 | 55 | 1.5 | For clean corridors of the same level:-4 | 52% | Comply with regulations |
| Microbial limit room | 10 | 18.7 | 41 | 1.5 | For clean corridors of the same level:2 | 54% | Comply with regulations |
| Aseptic room | 11 | 18.9 | 83 | 1.0 | For clean corridors of the same level:3 | 53% | Comply with regulations |
: Suspended particles meet the requirements (report attached)
Ventilation times meet the requirements
Settled bacteria meet the requirements
Temperature meets the requirements
Relative humidity meets the requirements
Static pressure difference meets the requirements
Suspended particle measurement report
| Test results | |||||||
| ≥5um | ≥0.5um | Determination | |||||
| Room name | Room Number | Purification level | average value | Upper confidence limit | average value | Upper confidence limit | |
| Production workshop second shift | 1 | 300000 | 34570 | 52036 | 3035071 | 4113679 | Comply with regulations |
| Disinfection buffer room | 2 | 300000 | 32774 | 58973 | 3534865 | 4010292 | Comply with regulations |
| Cleaning room | 3 | 300000 | 32185 | 40175 | 3807509 | 5307527 | Comply with regulations |
| Sanitary ware room | 4 | 300000 | 12515 | 28308 | 1557715 | 3846855 | Comply with regulations |
| Operation room | 5 | 300000 | 21172 | 53688 | 628769 | 664630 | Comply with regulations |
| Inner packaging room | 6 | 300000 | 11042 | 13830 | 608746 | 910310 | Comply with regulations |
| Laboratory second shift | 7 | 300000 | 18080 | 37370 | 6078210 | 7325345 | Comply with regulations |
| Clean corridor | 8 | 300000 | 21849 | 28910 | 7145171 | 7281553 | Comply with regulations |
| Positive control room | 9 | 300000 | 23292 | 39829 | 6587721 | 7968451 | Comply with regulations |
| Microbial limit room | 10 | 300000 | 14517 | 15818 | 543846 | 752507 | Comply with regulations |
| Aseptic room | 11 | 300000 | 12610 | 12140 | 312220 | 521325 | Comply with regulations |
| Standard regulations | 5um particles, the average value and upper confidence limit are both <60000. 0.5um particles, the average value and upper confidence limit are both <10500000. The above clean room suspended particle measurement results meet the GMP requirements for Class 300000 cleanliness level. | ||||||
