WIP/CIP und geschlossene Anlagensysteme
im pharmazeutischen Feststoffbereich Axel Schiffmann a, Bernhard Luy b, Markus Bättig b und Hans Leuenberger a Universität Basel, Pharmazentrum a, Basel (Schweiz), und Glatt GmbH b, Binzen 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. The abbreviations WIP/CIP used in this context are clearly defined. WIP (washing in place) means semi- or fully-automated cleaning with either undefined result of cleaning or with the result that the system is not yet clean according to GMP-requirements. CIP (cleaning in place), on the other hand, stands for the entire process of a fully-automated cleaning to a GMP-conform level, including all factors, which have influence on the cleaning result. This includes the proof that the acceptance criterion of the cleaning validation was achieved.
A comparison study between the manual and fully-automated cleaning shows that by systematic modification of the individual components in connection with a fully-automated cleaning program a higher cleaning grade can be achieved. Furthermore, a statement about the reproducibility of cleaning success can be met. Key words Anlagensysteme, Containment · Cleaning in place · Feste Arzneimittelformen · Good Manufacturing Practice · Washing in place |
