Primary Pack
Packaging that protects the inoculated carrier from damage and contamination without preventing penetration of the sterilizing agent(s). (TR51)
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Working Seed Lot
A seed lot generated from the master seed stock by a single passage. (TR51)
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Vapor
The gaseous form of materials that are normally liquids or solids at room temperature and pressure. (TR51)
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Sporicidal Vapor Phase Decontamination
The destruction of inactivation of microbial spores using a vapor or gaseous agent. (TR51)
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Sporulation
The formation of a spore. (TR51)
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System D-value
D-value of a BI when measured in a specified gas generator/separative enclosure combination operating within a defined sporicidal vapor-phase decontamination cycle. (TR51)
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Survivor Curve
Graphical representation of the inactivation of a population of microorganisms with increasing exposure to a microbicidal agent under stated conditions. (TR01) (TR3) (TR51) (TR61)
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Separative Enclosure
Device using constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume. [Synonym: Separative Device] (TR51)
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Operating Parameters (Critical Parameters)
Values that are controlled and/or measured and are linked to safety and efficacy of a product or the process. Failure to meet a critical parameter should result in rejection of the load. (TR01) (TR3) (TR48) (TR51)
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Operating Parameters (Key Parameters)
Values that are controlled and/or measured and are used to assure the ongoing “state of control” and consistency of runs. Failure to meet a key process parameter should result in an investigation with a documented rationale for the disposition of the load. (TR01) (TR3) (TR51) (TR48) Values that are controlled and/or measured and are used to assure the ongoing “state of control” of steam in place cycles. Failure to meet a key process parameter should result in an investigation. (TR61)
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Pathogen
Any microorganism which by direct interaction with (i.e., infection of) another organism causes disease in the organism (by convention, a multi-cellular organism). (TR51)
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Micro-condensation
The formation of very fine layers of condensation often invisible to the naked eye. (TR51)
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Most Probable Number (MPN) Method
A statistical method of estimating the number of viable organisms suspended in a liquid. (TR51)
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Master Seed Stock
Reference culture of a microorganism derived from an authenticated source such as American Type Culture Collection (ATCC) and used to produce working seed lots. (TR51)
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Inoculated Carrier
A carrier upon which a defined number of test organisms have been deposited. (TR51)
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Genotypic
Relating to those characters that reside in the genetic complement of a specific strain of a specific organism. (TR51)
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D-value (D10 -Value)
The time in minutes required for a one-logarithm, or 90%, reduction of the population of microorganisms used as a biological indicator under specified lethal conditions. (TR51)
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Endospore
A type of spore formed intracellularly by some bacterial genera. (TR51)
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Disinfection
The destruction of pathogenic and other kinds of microorganisms by thermal or chemical means. (TR51) (TR70) Process of eliminating nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) on inanimate objects. (TR69) The chemical or physical inactivation of a bioburden on inanimate surfaces. Typically this requires a minimum three-log (3-log) reduction of vegetative microorganisms and two-log (2-log) reduction for bacterial spore be achieved in validation. (TR13)
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Defect
(1) A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR51) (2) The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR43)
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Decontamination
A process that is designed to remove soil (including microorganisms) and may consist of cleaning and/or disinfection. (TR51)
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Change Management
A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. (TR 51) (TR 54-5)
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Carrier
A solid support upon which the test organism used in biological monitoring is inoculated. (TR51)
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Changeover
The steps taken for switching multiproduct equipment from the manufacture of one product to the manufacture of a different product. (TR29) (TR49)
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Biological Indicator (BI)
An inoculated carrier contained within its primary pack ready for use and providing a defined resistance to the specified sterilization process. (TR51)
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Bioburden
The total number of microorganisms per unit of material prior to sterilization. (TR13) Total number of viable microorganisms on or in a health care product prior to sterilization. (TR22)(TR61)(TR62) A population of viable microorganisms in a fluid prior to sterilizing filtration. (TR26) A measure of the contaminating organisms found in or on a given amount of material before it undergoes a sterilization process. (TR45) (TR70) The number of detectable microorganisms (bacteria and fungi) with which an object is contaminated. It is measured in CFU (colony forming units). (TR47) The number of viable, contaminating microorganisms present on a product immediately prior to decontamination. (TR51) Viable microbial contaminants associated with personnel manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, and finished products. (TR 67) (TR 69)
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Ballotini
Small glass beads (spheres) obtainable in a range of sizes, used in the recovery of spores from paper carriers. (TR51)
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Anaerobe
An organism that has the ability to grow in the absence of oxygen. (TR51)
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