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How to determine the sampling location of laser particle counter?

Particle counter

In order to meet GMP specifications, clean rooms used for pharmaceutical production need to meet the corresponding class requirements. Therefore, these sterile production environments require strict monitoring to ensure the controllability of the production process. Environments that require key monitoring generally install a dust particle monitoring system, which includes: control interface, control equipment, particle counter, air pipe, vacuum system and software, etc.
Each key area is equipped with a continuous measuring laser dust particle counter. Each area is continuously monitored and sampled through the workstation computer excitation instructions. The monitored data is transmitted to the workstation computer. The computer receives the data and can display and issue a report. to the operator. The selection of locations and quantities for online dynamic monitoring of dust particles should be based on risk assessment studies and require coverage of all critical areas.
The laser dust particle counter determines the sampling point based on the following six principles:

  1. ISO14644-1 specifications: For one-way flow clean rooms, the sampling port should face the direction of the air flow; for non-one-way flow clean rooms, the sampling port should face upward, and the sampling speed at the sampling port should be as close as possible to the indoor air flow speed.
  2. GMP principle: The sampling head should be installed close to the working height and where the product is exposed;
  3. The sampling location will not affect the normal operation of the production equipment, nor will it affect the normal operation of personnel in the production process, and avoid affecting the logistics channels;
  4. The sampling position will not cause large counting errors due to particles or drops produced by the product itself, causing the measurement data to exceed the limit value, and will not cause damage to the particle sensor;
  5. The sampling position is selected above the horizontal plane of the key point, and the distance from the key point should not exceed 30cm. If there is splash or overflow of chemical liquid in a special position, causing the measurement data results under simulated production conditions to exceed the regional standards of the level, the distance in the vertical direction can be limited. Relax appropriately, but should not exceed 50cm;
  6. Try to avoid placing the sampling position directly above the passing container to avoid insufficient air above the container and turbulence.
    After all candidate points are determined, use a laser dust particle counter with a sampling flow of 100L per minute to sample the candidate points in each key area for 10 minutes under the conditions of simulating the production environment, and collect the dust at all points. Particle sampling data recording.
    Comparatively analyze the sampling results of multiple candidate points in the same area to identify high-risk monitoring points, thereby determining this point as a suitable dust particle monitoring point sampling head installation location.

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