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Improved production flows by automation of the particle measurement

Verbesserte Produktionsabläufe durch Automatisierung der Partikelmessung
Verbesserte Produktionsabläufe durch Automatisierung der Partikelmessung
By the revised annex I of the guidelines for � manufacture practice (GMP) � manufacturers of sterile drugs, active substances and medicine products must fulfill increased requirements to property since March 2009 to their pure space monitoring. By the use of kommunikativen particle sensors � paired with an individual and intuitive control surface of established building instrumentation � the regulation specialist offers eNeG an optimal solution to the Pharma/LifeScience range for a monitoring system for the continuous monitoring of airborne particles.�� Usual practice in the pure space monitoring were so far h�ndisch accomplished particle measurements, which are attached by personnel and temporal resources on the one hand at high employment and do not fulfill on the other hand a substantial GMP requirement any longer: the monitoring of pure areas is to take place as far as possible from the outside. Savings with the individual space release can be obtained and be avoided by automation of the continuous particle measurement by the reduction of additional transferring procedures by service personnel and their equipment unnecessary particle entry. The latter decreases the contamination risk and increases thereby product security e.g. with classical aseptischen filling-open standards and established of ensuring constantly GMP conformal ProzessleitebeneUm an optimal performance and a simple expandability from existing infrastructure to sets eNeG on particle sensors, which by a TCP/IP network with the Monitoringserver and as autonomous OPC servers are connected to function. Apart from individual, customized visualization a comprehensive reporting and alarm management are ensured. In addition belong: - Restaurants messages over freely definable indicators such as signal columns or graphics panel, - announcement of warning value and limit value injuries in the process pictures of the monitoring system, - procedural instructions for the further treatment alarm report and archiving of the results in one event history over a schedule in the Monitoringserver knows besides the period of use of the pure areas are pre-defined. At expiration of this time a report is generated automatically, which is used for the addition of the batch report. This report contains the log values of the appropriate particle counters, as well as the information about warning and limit value injuries with data concerning time and frequency of the individual deviations in tabular and graphic form. The writing a report completely fulfills the regulatorischen defaults after CFR21 Part11 regarding data integrity and data security. Beyond the particle monitoring, easily a holistic monitoring of all quality relevant, spatial air-technical parameters, as e.g. relative space dampness, is ambient temperature and - possible for pressure or air speed with the same system. Good resonance at customers and authority by the homogeneous total concept, the flexible binding at inventory plants and the execution on highest technical level in accordance with the new GMP requirements, could provide eNeG always successfully custom-made solutions for customers. A smooth decrease by the authorities can be guaranteed thereby.�� �

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eNeG Gesellschaft für wirtschaftlichen Energieeinsatz mbH
Försterweg 144-146
22525 Hamburg
Germany
Phone: 04054776732
Fax: 040545610
email: k.loos@eneg.de
Internet: http://www.eneg.de


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