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Class 300,000 clean workshop standards and class 100,000 clean room decoration standards
by：PHARMA
2022-11-04
Many friends have requirements for the purification level when planning to build clean workshops, clean workshops, GMP workshops, clean operating rooms, and clean laboratories, but they often find it difficult to choose which purification level. Standards and differences of cleanliness levels, as well as the most suitable cleanliness level for your own project. Today, the editor of sz-pharma will introduce the 300,000-level clean workshop standards and the 100,000-level clean room decoration standards to readers. 1. 300,000-level clean pharmaceutical cleanroom standard Air cleanliness is the degree of the amount of suspended particles in the air in a clean environment. Generally, the lower the dust concentration in the air, the higher the air cleanliness, and the higher the dust concentration, the lower the air cleanliness. Classifying air cleanliness in clean rooms and related controlled environments according to the concentration of suspended particles in the air
The air cleanliness level is determined by the maximum allowable number of particles per cubic meter of air. Pharmaceutical workshops generally have 10,000, 100,000 and 300,000 grades, of which 100,000 grades (filling, inner packaging) and 300,000 grades are the most, and 100,000 grades are more stringent than 300,000 grades.
a lot of. Cleanliness: The maximum number of dust particles greater than or equal to 0.5μm per cubic meter should not exceed 10,500,000; the maximum number of dust particles greater than or equal to 5μm per cubic meter should not exceed 60,000; the number of planktonic bacteria per cubic meter should not exceed at most More than 1000. Differential pressure and temperature and humidity control: Differential pressure: The static pressure difference between clean rooms (areas) of different cleanliness levels is greater than or equal to 5PA; the static pressure difference between clean rooms (areas) and outdoors is greater than or equal to 10PA. Temperature and humidity: temperature - 18~28℃; humidity - 45~65%. Number of air changes: The number of air changes per hour cannot be less than 12 times. 2. Class 100,000 clean room standards 1. The number of air changes in the clean room of a class 100,000 clean room is not less than 15 times/h, and that of class 100,000 is ≥ 15 times/hour; the air purification time after complete ventilation should not exceed 40 minutes. 2. The ventilation frequency of the 10,000-class clean room is not less than 25 times/h, and the 10,000-class clean room is ≥ 25 times/hour; the air purification time after complete ventilation is not more than 30 minutes. 3. The number of air changes in the Class 1000 clean room is not less than 50 times/h, and the number of times of air changes in the Class 1000 clean room is ≥ 50 times/hour; the air purification time after complete ventilation is not more than 20 minutes. The 100,000-level dust-free is to rely on the clean airflow to continuously dilute the indoor air, and gradually discharge the indoor pollution to achieve the cleaning effect. 4. The maximum allowable number of dust in a 100,000-level clean room standard is defined from the number of dust particles per unit volume: the number of particles greater than or equal to 0.5 microns shall not exceed 3,500,000 per cubic meter; greater or equal to The number of particles of 5 microns shall not exceed 20,000 per cubic meter. 5. Define the standard of 100,000-level purification workshop from the maximum allowable number of microorganisms The maximum allowable number of microorganisms in a 100,000-level clean room is: the number of planktonic bacteria does not exceed 500 per cubic meter; the number of settled bacteria does not exceed 10 per petri dish. 6. From the perspective of pressure difference, define the standard of 100,000-level purification workshop. The pressure difference of 100,000-level dust-free workshop: the pressure difference in the purification workshop area of the same cleanliness level remains the same, and the pressure difference between adjacent purification workshops with different cleanliness levels should be ≥5Pa, and the gap between the 100,000-level purification pharmaceutical cleanroom and the non-purification pharmaceutical cleanroom should be ≥10Pa.
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The air cleanliness level is determined by the maximum allowable number of particles per cubic meter of air. Pharmaceutical workshops generally have 10,000, 100,000 and 300,000 grades, of which 100,000 grades (filling, inner packaging) and 300,000 grades are the most, and 100,000 grades are more stringent than 300,000 grades.
a lot of. Cleanliness: The maximum number of dust particles greater than or equal to 0.5μm per cubic meter should not exceed 10,500,000; the maximum number of dust particles greater than or equal to 5μm per cubic meter should not exceed 60,000; the number of planktonic bacteria per cubic meter should not exceed at most More than 1000. Differential pressure and temperature and humidity control: Differential pressure: The static pressure difference between clean rooms (areas) of different cleanliness levels is greater than or equal to 5PA; the static pressure difference between clean rooms (areas) and outdoors is greater than or equal to 10PA. Temperature and humidity: temperature - 18~28℃; humidity - 45~65%. Number of air changes: The number of air changes per hour cannot be less than 12 times. 2. Class 100,000 clean room standards 1. The number of air changes in the clean room of a class 100,000 clean room is not less than 15 times/h, and that of class 100,000 is ≥ 15 times/hour; the air purification time after complete ventilation should not exceed 40 minutes. 2. The ventilation frequency of the 10,000-class clean room is not less than 25 times/h, and the 10,000-class clean room is ≥ 25 times/hour; the air purification time after complete ventilation is not more than 30 minutes. 3. The number of air changes in the Class 1000 clean room is not less than 50 times/h, and the number of times of air changes in the Class 1000 clean room is ≥ 50 times/hour; the air purification time after complete ventilation is not more than 20 minutes. The 100,000-level dust-free is to rely on the clean airflow to continuously dilute the indoor air, and gradually discharge the indoor pollution to achieve the cleaning effect. 4. The maximum allowable number of dust in a 100,000-level clean room standard is defined from the number of dust particles per unit volume: the number of particles greater than or equal to 0.5 microns shall not exceed 3,500,000 per cubic meter; greater or equal to The number of particles of 5 microns shall not exceed 20,000 per cubic meter. 5. Define the standard of 100,000-level purification workshop from the maximum allowable number of microorganisms The maximum allowable number of microorganisms in a 100,000-level clean room is: the number of planktonic bacteria does not exceed 500 per cubic meter; the number of settled bacteria does not exceed 10 per petri dish. 6. From the perspective of pressure difference, define the standard of 100,000-level purification workshop. The pressure difference of 100,000-level dust-free workshop: the pressure difference in the purification workshop area of the same cleanliness level remains the same, and the pressure difference between adjacent purification workshops with different cleanliness levels should be ≥5Pa, and the gap between the 100,000-level purification pharmaceutical cleanroom and the non-purification pharmaceutical cleanroom should be ≥10Pa.
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