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1.2 DEFINITIONS

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In considering biocidal applications, definitions can vary widely. The following terms and their definitions, where possible, are consistent with international consensus documents.

 Aerobe (adj., aerobic): An organism that grows in the presence of oxygen. Can be obligate (requiring oxygen), facultative (able to grow in the presence or absence of oxygen), or microaerophilic (requiring a lower concentration of oxygen than is present in air).

 Anaerobe (adj., anaerobic): An organism that grows in the absence of oxygen. Can be obligate (requiring the absence of oxygen) or facultative (able to grow in the presence or absence of oxygen).

 Antibiotic: A substance (or drug) that kills or inhibits the growth of bacteria. This definition has also been applied to substances that affect other microorganisms, in particular, fungi. Originally, antibiotics were discovered as substances that were produced by one type of microorganism (in particular, fungi) which selectively inhibited the growth of other microorganisms (in particular, bacteria). Many antibiotics are now synthetically produced.

 Anti-infective: A substance (or drug) capable of killing microorganisms or inhibiting their growth, in particular, pathogenic microorganisms. This term is used to encompass drugs that specifically act on certain microbial types, including antibacterials (antibiotics), antifungals, antivirals, and antiprotozoal agents. For the purpose of discussion, the term anti-infectives will be used to described drugs that are used to treat specific infections within animals, plants, and humans. This is in contrast to biocides or biocidal processes, which are considered to be broad-spectrum antimicrobials that are used on inanimate surfaces or the skin and mucous membranes. The differentiation between anti-infectives and biocides is considered further in section 7.1.

 Antimicrobial: A process or product that is effective at killing microorganisms. This can vary, depending on the process or product and the target microorganism (e.g., antibacterial or antifungal). Antimicrobial agents include physical and chemical methods.

 Antisepsis (noun and adj., antiseptic): Destruction or inhibition of microorganisms in or on living tissue, e.g., on the skin. An antiseptic is a biocidal product used on the skin.

 Aseptic (noun, asepsis): Free of, or using methods to keep free of, microorganisms.

 Aseptic processing: The act of handling materials in a controlled environment in which the air supply, materials, equipment, and personnel are regulated to control microbial and particulate contamination within acceptable levels.

 Bioburden: The microbial load, or numbers and types of microorganisms, with which an item (surface or product) is contaminated.

 Biocide: A chemical or physical agent, usually with a broad spectrum of activity, that inactivates microorganisms. Chemical biocides include hydrogen peroxide and phenols, while physical biocides include heat and radiation. Biocides are generally broad spectrum, in contrast to anti-infectives, which have a narrower range of antimicrobial activity (see section 7.1).

 Biofilm: A community of microorganisms (either single or multiple species) developed on or associated with a surface.

 -Cidal: Suffix indicating lethal activity against a group of microorganisms (e.g., sporicidal means having activity to kill bacterial spores, and bactericidal means having the ability to kill bacteria). Compare to -static.

 Cleaning: Removal of contamination (often referred to as “soil”) from a surface to the extent necessary for further processing or for the intended use.

 Decontamination: Physical and/or chemical means to render a surface or item safe for handling, use, or disposal. Decontamination can refer to either chemical and biological removal or inactivation, with emphasis on biological decontamination. Decontamination is generally a combination of cleaning and disinfection or sterilization.

 Deinfestation: Removal or destruction of macroorganisms (e.g., insects).

 Disinfection (noun, disinfectant): The antimicrobial reduction of the number of viable microorganisms, or bioburden, on or in a product or surface to a level previously specified as appropriate for its intended further handling or use. In general, disinfection is used to describe a product (a disinfectant) or process that is effective against most pathogens, with the exception of bacterial spores, which are considered the organisms most resistant to disinfection and sterilization. Disinfectants are often subdivided into high level, intermediate, and low level (depending on the product claims and registrations). High-level disinfectants are considered effective against most microbial pathogens, with the exception of large numbers of bacterial spores. These products are usually sporicidal over longer exposure times. Intermediate-level disinfectants are effective against mycobacteria, vegetative bacteria, most viruses, and fungi, but not necessarily bacterial or some fungal spores. Low-level disinfectants are generally effective against most bacteria, some (in particular, enveloped) viruses, and some fungi, but not mycobacteria and bacterial spores.

 Depyrogenation: The inactivation or removal of pyrogens.

 Detergent: A surface-active agent (surfactant) that can emulsify oils and hold dirt in suspension; generally related to cleaning, where “detergents” can refer to cleaning mixtures that contain surfactants.

 D value: The time required to achieve inactivation of 90% (or 1 log unit) of a population of a given test microorganism under stated conditions.

 Endotoxin: Any of a class of toxins (or pyrogens) present in a microorganism but released only on cell disintegration. Specifically, a major component (lipopolysaccharide [LPS]) of the outer membrane in gram-negative bacteria.

 Exotoxin: Any of a class of toxins produced by and secreted from a microorganism.

 Formulation: Combination of ingredients, including active (biocide) and inert ingredients, into a biocidal product for its intended use (e.g., cosmetics, antiseptics, and disinfectants).

 Fumigation: Delivery of an antimicrobial process (gas or liquid) indirectly to the internal surfaces of an enclosed area. An example is fogging, which is the indirect application of a biocidal liquid to a given area.

 Germ: A general term referring to a microorganism.

 Germicidal (noun, germicide): Able to kill microorganisms. In some countries, this specifically refers to bactericidal activity only.

 Germination: The initiation of growth in a dormant spore.

 Hydrophilic (polar): Able to attract and absorb water (“water loving”). Similar to lipophobic (“lipid hating”; avoiding lipid).

 Hydrophobic (nonpolar): Having the properties of repelling and not absorbing water (“water hating”). Similar to lipophilic (“lipid loving”; having an affinity for lipid).

 Parasite: An organism able to live on and cause damage to another organism.

 Pathogen: A disease-causing organism.

 Pasteurization: The antimicrobial reduction, usually by heat, of microorganisms that can be harmful or cause product spoilage.

 Preservation: The prevention of the multiplication of microorganisms in products.

 Pyrogen: A substance that can cause a rise in body temperature; for example, some exotoxins and endotoxins.

 Resistance: The inability of an anti-infective or biocide to be effective against a target microorganism. See Tolerance.

 Sanitization: The removal or inactivation of microorganisms that pose a threat to public health.

 Secondary metabolites: Various products produced by microorganisms at the end of exponential growth or during stationary phase.

 Sporulation: The process of spore development in microorganisms.

 -Static: Suffix indicating the ability to inhibit the growth of a group of microorganisms (e.g., bacteriostatic means having activity to inhibit the growth of vegetative bacteria, and fungistatic means having activity to inhibit the growth of fungi). Compare to -cidal.

 Sterile (noun, sterility): Free from viable organisms.

 Sterilization:A defined process used to render a surface or product free from viable organisms, including bacterial spores.

 Sterilizing agent: A physical or chemical agent (or combination of agents) that has sufficient microbicidal activity to achieve sterility under defined conditions.

 Tolerance: A decreased effect of an anti-infective or biocide against a target microorganism, requiring an increased concentration or other modifications for it to be effective. Compare to Resistance.

 Validation: A documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield a product complying with predetermined specifications.

 Viable: Alive and able to reproduce.

Antisepsis, Disinfection, and Sterilization

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