The standard ventilation times of the 10,000-class clean workshop and the standard ventilation times of the 100,000-class clean workshop

The interior decoration specifications of the clean pharmaceutical cleanroom should be set according to the number of floating dust objects per cubic ≥ 0.5 μm. For example, more than ten levels means that the total number of 0.5μm dust objects in each cube is 10. The pharmaceutical industry plants usually have 10,000, 100,000 and 300,000 grades, among which 100,000 grades (canned, packaging) and 300,000 grades are the most, and the 10,000 grades are much more stringent than the 100,000 grade cleanliness. . In the clean room standards of various countries, the number of air changes in non-unidirectional flow clean rooms of the same level is not the same. It specifies the number of empirical air changes required for the calculation of clean air supply in non-unidirectional flow clean rooms of different levels. In my country, non-one-way 10,000-level 100,000-level purification workshops are more common, so how to estimate the standard ventilation times of 10,000-level clean workshops and 100,000-level clean workshops? The clean room is not less than 50 times/h; the 10000 class clean room is not less than 25 times/h; the 100000 class clean room is not less than 15 times/h. 1000-level ventilation times ≥ 25 times/hour (usually 27-28); 100,000-level ventilation times ≥ 15 times/hour (usually 17-18), but it is not allowed to blindly follow the trend to design the exhaust volume according to the ventilation times , It is necessary to take into account the waste heat recovery and residual humidity of the house and processing technology. Pay attention to the key points of the ventilation frequency: the thousand-level ventilation frequency is ≥25 times/hour (usually 25-30); the 100,000-level ventilation frequency is ≥15 times/hour (usually 15-25). The clean pharmaceutical cleanroom is generally estimated according to the number of air changes: a class 1000 clean room is not less than 50 times/h; a class 10000 clean room is not less than 25 times/h; a class 100,000 clean room is not less than 15 times/h. 1000-level ventilation times ≥ 25 times/hour (usually 27-28); 100,000-level ventilation times ≥ 15 times/hour (usually 17-18), but it is not allowed to blindly follow the trend to design the exhaust volume according to the ventilation times , It is necessary to take into account the waste heat recovery and residual humidity of the house and processing technology. Pay attention to the key points of the ventilation frequency: the thousand-level ventilation frequency is ≥25 times/hour (usually 25-30); the 100,000-level ventilation frequency is ≥15 times/hour (usually 15-25). 1. Fresh air volume The clean room should maintain a certain amount of fresh air, and its value should take the upper limit of the following air volume: 1. 10%-30% of the total air volume of the non-unidirectional flow clean room, and the total air volume of the one-way flow clean room 2%—4% of the air volume 2. Compensate the indoor exhaust air and maintain the fresh air volume required to maintain the positive pressure value 3. Ensure that the fresh air volume per person per hour in the room is not less than 40m3 2. Pressure difference 1. The clean room must maintain a certain Positive pressure can be achieved by the way that the air supply volume is greater than the exhaust air volume, and there should be a device indicating the pressure difference. 2. The net pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5Pa, the static pressure difference between the clean room and the outdoor atmosphere should be greater than 10Pa, and there should be a device to indicate the pressure difference. 3.
In the production process that produces a large amount of dust, harmful substances, flammable and explosive substances, and the production of penicillin-type strong allergenic drugs and other pathogenic microorganisms, the operating room and the adjacent room or area should maintain a relatively negative pressure. Under normal circumstances, the estimated number of air changes in the 10,000-level purification pharmaceutical cleanroom is: 10,000-level air changes ≥ 25 times/hour (generally 25-30); 100,000-level air changes ≥ 15 times/hour (generally 15- 25) Of course, this number of air changes also has certain applicable conditions: 1. The number of air changes is suitable for dust-free workshops with a floor height of less than 4 meters. 2. The number of people in the room is small, and the lower limit of heat source hours should be used. The number of air changes in the clean room should not be less than 12 times. Moreover, the air volume should not be designed blindly according to the number of air changes, and the residual heat and residual humidity of the room and process should be considered. Otherwise, the air volume may be able to meet the temperature and humidity requirements at the beginning, and the effect will not be so good after the system runs for a period of time.
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