Routine monitoring is recommended to be carried out in accordance with Table 13.2.

Table 13.2 Recommended Items for Routine Monitoring

Item Class 100 Class 10 000 Class 100 000 Class 300 000 Notes
Bacterial concentration Evaluation standard Not exceeding management requirements Not exceeding management requirements Not exceeding management requirements Not exceeding management requirements At necessary locations or representative points
Bacterial concentration Frequency of measurement Air Frequent monitoring or once per operation Once every 1～2 days Once/week times/month At necessary locations or representative points
Bacterial concentration Frequency of measurement Surface Once per shift per day, 3 samples Once a week, 3 samples Once every 2 weeks, 3 samples Once a month, 3 samples At necessary locations or representative points
Bacterial concentration Frequency of measurement 5 fingers of glove 1 person/day 1 person/1～2 days 1 person/week Measured according to the standard disinfection method
Pressure difference Evaluation standard Not lower than the permissible lower limit and preferably not higher than 30Pa (except for biosafety cleanrooms); if lower than the permissible lower limit, adjustment should be made Not lower than the permissible lower limit and preferably not higher than 30Pa (except for biosafety cleanrooms); if lower than the permissible lower limit, adjustment should be made Not lower than the permissible lower limit and preferably not higher than 30Pa (except for biosafety cleanrooms); if lower than the permissible lower limit, adjustment should be made Not lower than the permissible lower limit and preferably not higher than 30Pa (except for biosafety cleanrooms); if lower than the permissible lower limit, adjustment should be made Measured by the differential pressure gauge on the wall at the doorway
Pressure difference Frequency of measurement Once/day Once/day Once/week Once/week Measured by the differential pressure gauge on the wall at the doorway
Air volume Evaluation standard Not lower than management requirements Not lower than management requirements Not lower than management requirements Not lower than management requirements Measured on rest days or during major overhaul; for rooms below Class 100, convert the air outlet velocity into the air change rate; for Class 100 rooms, it is the cross-sectional velocity in the working zone
Air volume Frequency of measurement Once/half year Once/half year Once/year Once/year Measured on rest days or during major overhaul; for rooms below Class 100, convert the air outlet velocity into the air change rate; for Class 100 rooms, it is the cross-sectional velocity in the working zone
Cleanliness class Evaluation standard Not lower than management requirements Not lower than management requirements Not lower than management requirements Not lower than management requirements With instruments; without instruments, have a specialized institution measure it
Cleanliness class Frequency of measurement Frequent monitoring Frequent monitoring Frequent monitoring Frequent monitoring With instruments; without instruments, have a specialized institution measure it
Cleanliness class Frequency of measurement Once/year Once/year Once/year Once/year With instruments; without instruments, have a specialized institution measure it

Part Two

Engineering Examples