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Praxisnahe Validierung von Desinfektionsmitteln im pharmazeutischen Umfeld

Das neue USP-Kapitel <1072> „Disinfectants and Antiseptics“

Anastasija Matin1, Sabrina Biemüller¹, Erwin Post², Frank Kloep² und Andreas Schlösser¹

¹ Labor L+S AG, Bad Bocklet
² Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein

Korrespondenz: Dipl.-Biol. Anastasija Matin, Labor L+S AG, Mangelsfeld 4, 97708 Bad Bocklet (Germany), Fax +49 (0)9708-910 036, e-mail: Anastasija.Matin@Labor-LS.de

Field-orientated Validation of Disinfectants in the Pharmaceutical Area

Due to the EC-GMP Guideline pharmaceutical companies have to demonstrate the efficacy of the used disinfectants on company specific surfaces against internal isolates. In the past there were no obligatory guidelines for test procedure and evaluation of results. The validation was therefore performed in line to DGHM (Deutsche Gesellschaft für Hygiene und Mikrobiologie) or EN guidelines. The new USP chapter <1072> describes the determination of the disinfectant efficacy for usage in the pharmaceutical environment. The scope of a disinfection validation is described and the parameters for a practical surface disinfection are specified, according to the situation on-site. Within an accomplished validation at a Boehringer Ingelheim site according to the DGHM guidelines an inadequate efficacy of the disinfectants was demonstrated. Performing the validation according to USP criteria the requirements were met with high satisfaction.

Key words Betriebsisolate • Desinfektionsmittel • Firmenspezifische Oberflächen • USP <1072> • Validierung