| Untersuchungen zur Verwendungsdauer von Sedimentationsplatten bei der Überwachung steriler Fertigungsbereiche Jens Schenk und Ortrun Herms DRK-Plasmaverarbeitungsgesellschaft mbH, Springe Examination of the Exposition Time of Settle Plates for Monitoring Sterile Production Areas For aseptic filling processes of medicinal products (e.g. medicinal solutions for injection or infusion) there are well-defined clean area conditions. The requirements for these conditions are set forth in the Guide to Good Manufacturing Practice. The compliance of the environ-mental conditions with these requirements has to be demonstrated. One way of doing this is by microbiological monitoring using settle plates. GMP rules limit the use of these plates to four hours. If the production process exceeds this time period, intervention in the clean area is necessary for changing the settle plates. Key words Arzneimittelherstellung, sterile • GMP • Monitoring, mikrobiologisches • Reinraumbedingungen |
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pharmind 2005, Nr. 5, Seite 603
