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Clean room change

Views: 0     Author: Site Editor     Publish Time: 2022-04-07      Origin: Site

Shandong Xinli

In various countriesCleanroomIn the standard, the number of experience ventilation in the same level is not the same.
In my country, \"Clean Plant Design Specifications\" (GB 50073-2013) clearly stipulates that the number of experience refund required for different levels of non-single-way streamlined cleaning air supply volume is calculated, see below:

Picture 12

2 The lower limit should be employed according to the arrangement of indoor personnel, process equipment, and material transmission or the like.

Note:

The number of ventilation is suitable for clean room with a layer higher than 4.0

There are fewer people in the room, the heat source hours, should be used to use the lower limit

Clean room with more than 100,000 level is not less than 12 times

In addition: Experimental animal environment and facilities international standards GB14925-2001

Ordinary environment 8 ~ 10 times / h barrier environment 10 ~ 20 times / h isolation environment 20 ~ 50 times / h

(2) Temperature and relative humidity of temperature and relative humidity clean room (region) should be adapted to the drug production process. When there is no special requirements, the temperature should be controlled 18 to 26 ° C, and the relative temperature should be controlled at 45% to 65%.
(3) pressure difference

(1) Clean chamber must maintain a certain positive pressure, and can be achieved by making the air supply amount greater than the exhaust amount, and should have a device indicating the differential pressure.

(2) The static pressure difference between the adjacent rooms of the air cleanliness should be greater than 2Pa, and the static pressure difference between the clean room (zone) and the outdoor atmosphere should be greater than 10 Pa, and there should be an apparatus for applying a differential pressure.

(3) Process generation process produces a large amount of dust, harmful substances, alkene explosive substances and producing penicillin strongly sensitive drugs, some steroidal drugs, any microorganisms that believe in pathogenic effects, their operation rooms The neighboring room or region should remain relative negative pressure.

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Four,Fresh air volumeThe amount of fresh air should be maintained in the clean room, and the value should take the large value in the sum of the row:

(1) Non-single-way flow rate of 10% ~ 30%, 2% to 4% of the total air supply volume of unidirectional streams;

(2) Compensation of the amount of fresh air required for indoor exhausting and maintaining the positive pressure value;

(3) Ensure that the amount of fresh air per hour is not less than 40 m3 per hour.

Fives,generallyClean area ventilation

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