A global disinfectant standard for cleanrooms: Presenting a harmonised approach

Abstract

Disinfectant efficacy testing is an essential part of a facility contamination control strategy. Pharmaceutical and healthcare products facilities must know that the products they are using can achieve effective levels of microbial kill across a range of surface types. The problem faced by microbiologists and production managers is that the various national and international standards use different methodologies. In addition, these standards and methods have not been written specifically for cleanrooms and the microbial test panels and logarithmic reduction expectations are not considered suitable. In order to develop an international standard suitable for all pharmaceutical facility cleanrooms, Ecolab has developed the Validex™ method, which is independently assessed in this paper. This method involves using 2 cm diameter disks, to target a 3 log reduction for vegetative bacteria in 5 minutes; and a 2 log reduction for fungi and bacterial spores in 10 minutes. The key criteria and rationale for selection, along with the methodology, are presented in this paper.