Methoden zur Desinfektionsmittelvalidierung
GMP / GLP / GCP
Abstract
Disinfectant validation methods
The use of disinfectants as agents to control microbiological contamination of an environment is well established and governed by regulatory bodies in both Europe and the United States. Data demonstrating the efficacy claim of a disinfectant, whether it is bactericidal, fungicidal, sporicidal or viricidal, is a clear requirement of Biocidal Product Regulation (BPR) or Environmental Protection Agency (EPA) for a disinfectant manufacturer to achieve registration. In Europe, European Norm (EN) standards provide reference to required test methods to be used by disinfectant manufacturers to support claims of microbiocidal activity. This article provides an overview of the EN standards available for disinfectant efficacy testing and whilst providing an oversight to specific test phases performed for registration, will also provide guidance on how these standards may be utilized for end user validation. The article will review factors to consider when establishing parameters and conditions that may be modified from the standard for the purpose of validation.
This article presents the Ecolabs guideline for validation of disinfectants. It is the responsibility of each user to review this guideline and make their own evaluation to select the best method based on their specific needs, industry sector and business model.
 | David Collins ist Diplom-Biologe mit über 10 Jahren Erfahrung in pharmazeutischer und kosmetischer Mikrobiologie. Seit 2019 arbeitet er als Global Corporate Account Technical Project Manager bei Ecolab. Er betreut Kunden bei reinigungs- und desinfektionsbezogenen Themen wie z. B. bei Harmonisierungsprojekten von mehreren Standorten, Desinfektionsmittelwirksamkeitsprüfungen und bei der Erstellung von internen Richtlinien. |
Zusammenfassung
Der Einsatz von Desinfektionsmitteln, um mikrobiologische Kontaminationen eines Bereiches unter Kontrolle zu bringen, wird durch Aufsichtsbehörden in Europa und in den USA
