Validation of disinfection procedures in pharmaceutical companies -: Limited efficacy of some commercial disinfectants against germs from the operational environment

Validation of Disinfection Procedures in Pharmaceutical Companies / Limited efficacy of some commercial disinfectants against germs from the operational environment The validation of cleaning and disinfection procedures is an obligatory task for every pharmaceutical contractor. The ratio behind qualification of disinfections in use is to ensure that representative germs isolated from the companies environment (grounds, product contacting surfaces etc.) are sufficiently and definitely inactivated. In that context the qualification procedure helps to optimize the efficiency of saving financial resources. Assays of bactericidal, fungicidal, and sporicidal efficacy are performed advisable close to practice according to the published methods of the DGHM (Deutsche Gesellschaft ftir Hygiene und Mikrobiologie) or DIN EN norms, respectively. The use of company specific surfaces is recommended. The informations of producers of disinfectants in reference to the microbicidal activity are frequently not sufficient and to some extent misleading. In particular the sporicidal efficacy of the compounds is not ensured, even declared on the product.