Production hygiene relates directly to the quality and safety of pharmaceutical products, and in line with the rising significance of hygiene in production processes, international hygiene standards are becoming ever more important. An example is the growing influence of the US Food and Drug Administration (FDA) in international pharmaceutical manufacturing. At the same time, the harmonisation of international testing regulations (e.g. European Norms, EN) opens up new options for disinfectant risk assessment.
Choosing an effective disinfectant regime appropriate to the hygiene requirements in a production plant can be a complex process. In this context, consideration of the antimicrobial efficacy of different biocides is an important basis on which to make such decisions. Not all disinfectant actives have the same spectrum of effect and when systematically using disinfectants, it is vital to take into account the effect of different disinfectants. Table 1 gives an overview of the spectrum of antimicrobial efficacy of different biocides on selected actives, with a distinction being made between bactericidal, fungicidal, sporicidal, mycobactericidal and virucidal efficacy.1
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