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Monitoring in GMP conformal pure areas

Monitoring in GMP konformen Reinräumen
Monitoring in GMP konformen Reinräumen
With the production of drugs and medicine products special regulations are valid for the monitoring the purity of air determining size. Differential pressure and air flow must be regarded thereby as work sizes, on whose fundamental function the effectiveness of the pure job depends.� Temperature and humidity can affect the quality of the product and the conditions of work of the coworkers. This is valid equally for the manual activity in a safety work bench as for automatic production by means of rack machine. For the differential pressure measurement a large selection of different sensor types is available. Of the installation of a multi-functional sensor panel in the pure space wall up to the control cabinet assembling of all� Pressure sensors are realizable many variants. For the selection the selected alarm concept, the measuring method of the differences of pressure is crucial and� the Wartungsfreundlichkeit desired. Flow sensors (laminar flow) represent an important safety factor in pure space work benches, therefore monitorings the sensors of all considerable manufacturers can be integrated into the Elpro. In production areas mostly the monitoring of the climatic sizes temperature and humidity is given. The positioning of these sensors depends very strongly on the spatial conditions. The use of radio sensors can cost particularly when rigging existing areas the installation times clearly and - lower, while the integration of these sensors takes place flowing into the total concept. Additionally to the monitoring of the work sizes the employment of a particle counter offers important functions for a meaningful documentation and a fast alarm in the trouble. For the standard employment ISO-kinetic probes are available, in addition, customized solutions can be realized. Elpro uses centers in the monitoring system for the pure classes of area A and B the PCSSair of the Swabian company Klotz. The equipment has one inserted pump and two measuring channels, which are according to standard to 0,5� and 5� particle size adjusted. The particle counter is integrated completely in the Monitoringsystem and permitted thereby meaningful automation solutions, e.g.� to deactivate when switching the work bench off at the same time the particle alarm. In the Elpro monitorings become all measuring data already selfly-sufficient buffered. By the input of alarm borders can be alarmed and warned already locally.� Pure-spacefair system components are integrated into the pure space walls and signal by automatically changing colors of the announcement (green/yellow/red), on a monitor or with acoustic warning signals the coworkers in the production areas the current safety status. The Monitoringserver gets itself continuously all data over a Ethernet LAN network,� supervised and the critical measured variables and all this of the system documents produced messages. Over adjustable exits an external alarm or building guidance periphery is controllable. The dispatch of language messages over telephone and the connection of a SMS modem are just as possible, as the deliveries of the data to a Web server and visualization in the Intranet/Internet.Das Elpro Monitoringsystem are GMP, GLP, FDA 21 CFR part 11 conformal to serve simply and economically too qualify. It is very easy to extend. Beside pure-space and climaticspecific sizes are also to sensors for other measurements at the disposal. By radio or by means of Lan network the system can fulfill still many requirements outside of the pure area, e.g. in camps, refrigerators, Inkubatoren. With extensive documentation for the qualification, risk analyses, validations and installation delivered, all work will become of the manufacturer also as service offered elproLOG the monitoring often commodity.�

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