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1.4.2 Evaluation of Efficacy

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The antimicrobial activity of a biocide or a biocidal process can be investigated using a variety of methods that can range from simple laboratory tests to evaluation under actual use conditions. These tests not only are important in the investigation of biocides and the development of products and processes but are also the basis for the regulatory clearance, labeling, and use of antiseptics, disinfectants, and sterilization processes. The various tests and requirements can vary considerably, and there are currently no standardized requirements that apply to all situations. Most countries specify particular test methods to verify antimicrobial activity, but these also vary for the particular application (e.g., medical, dental, agricultural, water disinfection, or industrial), type of biocide or process, and use of the formulation or process (e.g., preservation, antisepsis, disinfection, or sterilization).


FIGURE 1.17 General microbial resistance to biocides and biocidal processes. This classification can vary depending on the biocide or biocidal process under consideration.

TABLE 1.17 Examples of surrogate microorganisms used to test and verify antimicrobial activities of biocides, products, and processes

Efficacy claim Surrogate Example(s) of use
Sporicidal Bacillus atrophaeus, Bacillus cereus, Clostridium sporogenes General disinfectant and sterilant testing; sterility assurance testing for sterilization processes
Fungicidal Trichophyton mentagrophytes, Aspergillus niger, Candida albicans General disinfectant testing
Bactericidal Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella enterica serovar Choleraesuis, Enterococcus hirae, Escherichia coli, Serratia marcescens General antiseptic and disinfectant testing
Virucidal Poliovirus, adenovirus, herpesvirus, bacteriophages (e.g., Lactococcus phage F7/2) General antiseptic and disinfectant testing
Mycobactericidal Mycobacterium bovis, Mycobacterium terrae, Mycobacterium smegmatis General disinfectant testing
Oocysticidal Cryptosporidium parvum General disinfectant testing
Antisepsis, Disinfection, and Sterilization

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