With the expansion of domestic influence of FDA and EU GMP and the launch of new GMP nationwide, the dynamic monitoring of the clean area environment in pharmaceutical companies, especially suspended particles, has become a threshold that those companies must cross.
The clean area environment online monitoring system realize the dynamic monitoring of suspended particles by installing multiple remote particle sensors at each key sampling point in the workshop, monitoring and recording air in the monitored area through the sensors in real time, transferring monitoring results to the control computer and by processing those results with a monitoring software that is specially for pharmaceutical industry and in accordance to 21CFR PART11.
System Function
(1) Remote control: Operations like remote real-time monitoring and alarm setting, data storage, report editing and printout can be carried out through the computer in the control room;
(2) Sound-light alarm: Multiple alarms including sampling flow rate alarm, communication failure alarm, numerical excess alarm and hardware fault alarm can guarantee the long-term stable operation of the system;
(3) The online dust particle monitoring system is configured with an external vacuum system which is capable of isokinetic sampling at the flow rate of 28.3L/min;
(4) Two-channel simultaneous particle counting, simultaneous monitoring of suspended particles with a particle size of 0.5 and 5.0 microns;
(5) It can monitor the operating flow rate of each particle sensor device and display the operating status;
(6) The particle counter working in a sterile environment can perform continuous monitoring for as long as 24 hours and is set with built-in flow monitor.
Characteristics
(1) The online dust particle monitoring system can monitor particles (0.5/5.0 microns) synchronically through multiple channels in accordance with monitoring requirements in pharmaceutical industry;
(2) Its flow rate is mainly 28.3L/min;
(3) The sensor is placed in a stainless steel (316L) housing, corrosion-resistant
(4) It can be anti-VHP (vaporized hydrogen peroxide) model which is suitable for fumigation disinfection environments in cleanrooms;
(5) It is equipped with an isokinetic sampling head which will not interfere in airflow;
(6) It can cache 250 groups of data for the sake of responding to sudden network failure;
(7) The form of its report conforms to the related standards of FS-209E, ISO14644-1 and EU GMP.
(8) Its calibration is carried out as per stipulations of NIST (National Institute of Standards and Technology);
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