WIP/CIP und geschlossene Anlagensysteme im pharmazeutischen Feststoffbereich
Axel Schiffmann1, Dr. Bernhard Luy2, Prof. Dr. Hans Leuenberger1, Dr. Matthias Plitzko2
1 Universität Basel, Pharmazentrum, Basel (Schweiz)
Corresponding author: Dr. Matthias Plitzko, Glatt GmbH, Abteilung Neue Technologien, Werner Glatt Str. 1, 79589 Binzen (Germany)
WIP/CIP and Closed Equipment Systems in the Field of Pharmaceutical Solid Dosage Forms
In the pharmaceutical industry production equipments for the manufacture of solid dosage forms are cleaned manually, semi- or fully-automated. In order to implement a fully automated cleaning process which meets pharmaceutical (i. e. GMP-)requirements, many conventionally used components must be changed considerably with respect to construction and design. An important aspect is the so-called Total Containment: CIP-ability and Total Containment are interdependent and must be considered equally with the development. The realisation of the Total Containment is an absolute prerequisite for the implementation of this new type of equipment. By the example of a fluid bed system this article describes, how this can be achieved by modifications of conventional equipments and of peripheral devices.
Key words Anlagensysteme, Containment • Cleaning in place • Feste Arzneimittelformen • Good Manufacturing Practice •
pharmind 2009, Nr. 7, Seite 1252