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Intralogistik in der pharmazeutischen Industrie. Effiziente Gestaltung der Logistik kleiner Mengen in einem regulierten Umfeld

Intralogistik in der pharmazeutischen Industrie. Effiziente Gestaltung der Logistik kleiner Mengen in einem regulierten Umfeld

          
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About the Book

Materialfluss und Logistik in der pharmazeutischen Produktion unterliegen den regulatorischen Vorgaben der „Good Manufacturing Practice“ (GMP). Eine sichere und effiziente Gestaltung der Prozesse ist somit nur mit einem gemeinsamen Verstandnis der Logistik und der branchenspezifischen GMP-Anforderungen moglich. Diese Untersuchung macht die wechselseitigen Einflusse sichtbar und messbar. Uber die Stufen der pharmazeutischen Herstellung werden standardisierte Logistikprozesse modelliert. Hieran werden wesentliche Aspekte der Pharmaproduktion aus logistischer Sicht detailliert, z. B. Musterzug, Schleusenprozesse, kontrollierte Umgebungsbedingungen, Chargenmanagement, Informations- und Dokumentationsprozesse . Die Strukturierung erlaubt es auch, GMP-Risiken zu erfassen und ihnen entgegen zu wirken, z. B. Kontamination, Abfallmanagement, Forder- und Lagertechnik, Proben- und Dokumentenlogistik. Empfehlungen werden abgeleitet und miteinander verglichen, um eine Optimierung der Logistik im GMP-Umfeld und ggfs. eine bessere Umsetzung der Anforderungen zu erreichen. Beispiele umfassen Aspekte der baulichen Gestaltung bis hin zur Anordnung von Bereichen zueinander sowie des Prozessdesigns. Erganzt wird dies durch quantitative Ansatze, um die Empfehlungen bzw. (ggf. zusatzliche) GMP-Aufwande bewerten und vergleichbar machen zu konnen. Insbesondere werden Effekte aus der Produktion in Kampagnen (mit erheblichen Rust- und Reinigungszeiten), durch strategische Beschaffung sowie Batchmanagement analysiert. Basierend auf der detaillierten theoretischen Modellierung fur die pharmazeutische Industrie konnen die Ergebnisse auf andere Industrien mit reguliertem Umfeld ubertragen werden. Material-flow and logistics within the pharmaceutical production are subject to the regulatory requirements of “Good Manufacturing Practice” (GMP). To do a safe and efficient process design it is fundamental to have a joint understanding of material-flow processes and industry-specific GMP-requirements. This research visualizes bidirectional impacts and makes them quantifiably. Standardized material-flow processes are modelled along the different steps of pharmaceutical manufacturing. The model is used to detail essential aspects of the production from a logistics perspective, e.g. sampling, air-lock processes, controlled environment conditions, batch management, information and documentation processes. The structure also allows capturing risks and work to mitigate them, e.g. contamination, waste management, conveying systems, storage technology, sample- and document-logistics. Recommendations are derived and evaluated to optimize the material-flow processes and logistics in a GMP-environment. In some cases it might be possible to even reach a higher level of GMP-compliance. Examples include aspects of facility construction, general area layout as well as flow and process design. Quantitative approaches are added to calculate the impact of recommdations provided and – if applicable – additional effort caused by GMP-requirements. Especially effects from a batch-driven manufacturing (with extensive setup and cleaning times), strategic sourcing and batch management in logistics are analyzed. Based on detailed theoretical foundation for the pharmaceutical industry the results can be transferred to other industries with strict regulatory requirements.


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Product Details
  • ISBN-13: 9783736972551
  • Binding: Hardcover
  • Language: German
  • ISBN-10: 3736972555
  • Height: 302.999 mm
  • Weight: 20 gr

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Intralogistik in der pharmazeutischen Industrie. Effiziente Gestaltung der Logistik kleiner Mengen in einem regulierten Umfeld
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