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Grenzwerte für die Reinigungsvalidierung in der Blutplasma-Fraktionierung

Thomas Pracht, Ivo Lakomy und Markus Weber

ZLB Bioplasma AG, Bern (Schweiz)

Acceptance Criteria for the Cleaning Validation in the Blood Plasma Fraction

The classical Carry Over Concept which defines acceptance criteria in cleaning validation is limited to conventional production residues. For products having a virus risk - like blood plasma products - this concept is not applicable. Therefore this paper describes a complementary approach based on the so-called Process Based Limit concept (PBL). PBL describes the equipment’s surface having product contact after cleaning. This PBL is determined experimentally by field studies prior to cleaning validation and is analogue to a description of the process capability for the cleaning process being validated.

Key Words Batch segregation · Reinigungsvalidierung, Grenzwert, Prionen, Process Capability, Viren · Process Based Limit-Konzept