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Components of the new GMP online monitoring system for sterile pharmaceutical companies

 Last Update: 2022-09-21
 Source: Internet
 Author: User

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With the expansion of the influence of the FDA and EU GMP in China and the launch of a new version of GMP in China, the dynamic monitoring of the clean area environment of pharmaceutical companies, especially the dynamic monitoring of suspended particles, has become a threshold
that pharmaceutical companies must cross.

The clean area environmental online monitoring system is to install a number of remote particle sensors in each key sampling point in the workshop, sample and record the air in the monitoring area in real time through the sensor, and transmit the monitoring results to the control computer, and use professional pharmaceutical monitoring software for processing, which can realize the dynamic monitoring
of suspended particles.

The following is an example
of MetOne's online particle monitoring system.

The hardware of the whole system mainly includes the following parts, and the system structure diagram is shown in the following figure: Laser Particle Sensor (MetOne 6015) Portable High Flow Particle Counter (MetOne 3445) Online Biological Sampling System (BPI) Temperature and Humidity Sensor Pressure Differential Sensor Anemometer Vacuum System (including Dual Pump Redundancy) Alarm System

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