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Reinigungsvalidierung im Wirkstoffbereich bei Mehrprodukteanlagen

Jörg Koppenhöfer

gempex GmbH, Mannheim

Korrespondenz: Jörg Koppenhöfer, gempex GmbH, Besselstr. 6, 68219 Mannheim, e-mail: public-relation@gempex.com

Cleaning Validation of multi-purpose equipment in API production

The regulatory requirements of authorities (FDA, local German authorities, ...) on manufacturing of APIs are increasing continuously during the last years. This has also consequences with view to cleaning of equipment used for API production. It is required within relevant guidelines to perform cleaning of equipment according to validated cleaning procedures especially than, when the manufacturing equipment is used to produce different products (multi-product equipment).
In Cleaning Validation documented evidence has to be provided that a defined cleaning procedure meets the requirements reproducibly. When the validation is successfully done routine sampling and the analytical monitoring can be reduced to a necessary minimum.
Objective of the following article is to present the methodical execution of a Cleaning Validation Project with regard to multi-product manufacturing equipment in the chemical industry and the special considerations that have to be made. Thereby a cost saving and efficient execution is in focus.

Key words Akzeptanzkriterien • Beurteilung der Validität • Bracketing (Apparategruppen, Produktgruppen) • Prüf- und Probenahmeplan • Reinigungsanweisung / Reinigungscheckliste • Risikoanalyse „Reinigung“