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The Differences Between The Online Monitoring Of Suspended Particles And The Cleanliness Level Of Clean Room

The manufacture of sterile products tenth clearly referred to the pharmaceutical clean area "aerosols on-line monitoring", many people misunderstand the meaning of this concept, confuse the cleanliness level verification requirements and the area of the square root of the particle sampling point layout ".

Let's talk about the difference between the two ways:

Different monitoring methods

First of all, we must know that the new version of the source can be traced back to EM cGMP, then the provisions of the requirements we can also be traced back to the requirements of the eu.

Dynamic monitoring can be understood as online monitoring, real-time monitoring, that is, can be found in the event of a possible event of excessive particles, so this approach requires the particle sensor

The sampling point is arranged according to the key process sampling point;

The cleanliness level verification, the use of the sample in the clean area to be placed in a uniform sampling point sampling;

Two, particle sampling point selection method is different

"Dynamic monitoring" is a key process point which directly or indirectly affects the quality of the product according to the difference of different production processes

Install a particle sensor sampling point for uninterrupted sampling in the production process.

"Cleanliness level verification" is to "open the root area clean area" method to determine the number of sampling points, and then evenly arranged, were sampled to determine whether achieve cleanliness level design.

The on-line monitoring of suspended particles is designed according to the principle of particle impact and the theory of constant velocity sampling, and the sampling speed is basically the same as that in the clean room. When sampling, with dust air speed through the pore, was hit in the culture dish on the agar surface; these living microorganisms in the training process, occurrence process of water, the kinetic energy of high speed growth, leading to faster results.

The suspended particle online monitoring structure is novel and unique, which is divided into two parts, the upper part of the sampling port and the sampling seat and the air pump, the lower part of the controller and the battery. The sampling port and the shell are made of high quality aviation aluminum, and the surface is closed. This instrument is powerful, sampling volume, high collection efficiency, stable performance, convenient operation, reached the international advanced level of similar products, is the ideal detection concentration of planktonic bacteria collector departments and pharmaceutical factory, hospital, biological products, food processing, the public places.


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