Analysis, Treatment And Prevention Of Clean Room Debugging Problems (1)

- May 15, 2019-

Most of the problems encountered in commissioning are the problems of designing construction materials in the front, and the problems encountered by the small series from the analysis of the project examples, analysis and treatment methods, to prevent in advance, less detours.


The main technical parameters of the late acceptance of the medical clean room are: air volume, air change, high efficiency filter leakage, pressure difference, cleanliness, microbial quantity, airflow pattern, etc. The following are some technical issues to analyze the design and construction of the clean room of the pharmaceutical industry:



1, tuyere air volume (number of air changes)


The number of air changes is a prerequisite for the qualification of a medical clean factory. If the number of air changes is unqualified, it will directly affect the cleanliness effect and affect the owner's use. Common problems when checking the number of air changes are:


1.1 The system has insufficient total air volume




1) A pharmaceutical factory should design no variable air volume valve. The residual pressure of the air conditioning unit is 800Pa, and the measured air supply volume is 16000m 3/h. Later, due to the design change, some air supply pipes have increased the variable air volume valve (the working pressure is 150). ~700Pa), in this case, the measured air supply volume is only about 11000 m 3 / h.


2) In a purification plant in Suzhou, due to limited space, one air supply system has three Z-shaped elbows, and the Z-type elbow closest to the wind outlet has a measured pressure loss of more than 200 Pa.


1.2 High-efficiency tuyere air volume test problem


For the direct measurement of the high-efficiency filter air volume after installing the cyclone diffusion plate, we use the auxiliary means of adding a cross in the air volume cover to guide the swirling airflow passing through the diffuser plate to the four diffusion areas separated by the cross and Diffusion, and finally form a flow pattern of approximately unidirectional flow, so that the air volume can be directly measured by the air volume cover. It has been proved by practice that the direct measurement of the air volume by the cross-assisted diversion method is smaller than the data directly tested by the air volume cover, and the small amplitude is about 15-20%, but it is closer to the actual air volume.


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