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Trends bei der Entwicklung von Isolatoren für die pharmazeutische Industrie

Volker Sigwarth und Thomas Huber

Skan AG, Allschwil (Schweiz)

Trends in the Development of Isolator Technology for the Pharmaceutical Industry

Some clear trends can be observed in the pharmaceutical industry. First: more and more drug substances are biotech-based and therefore highly sensitive against environmental influences. They require aseptic production processes. Second: drug substances in development and in production become more and more potent, so that operator and environmental safety issues have gained high priority. Additionally there is an increasing pressure on the cost effectiveness and flexibility of pharmaceutical production processes. Due to these facts current production processes and production equipment used are deeply challenged in Operational Excellence initiatives.
This article focuses on development and possibilities in isolator technology as increasing key equipment in modern aseptic processes. Progresses in technology are required to face the characteristics of the new drug substances on one hand and the request for effective and flexible production processes on the other. Besides these technical items a thorough understanding of pharmaceutical processing is needed. Finally close cooperation during the whole project phase and getting involved responsibility are key factors for a successful implementation as advanced technology for pharmaceutical production and quality control.

Key words H₂O₂-Dekontamination, schnelle • Isolatortechnologie • Materialtransfer, schneller • Operational Excellence • Prozesssicherheit