Biological indicator definition

Biological indicator means a representative microorganism used to evaluate treatment efficacy.
Biological indicator means a representative microor- ganism used to evaluate treatment efficacy.
Biological indicator means a commercially prepared device with a known population of highly resistant bacterial spores to test the method of sterilization being monitored. The indicator is used to demonstrate that conditions necessary to achieve sterilization were met during the cycle being monitored. Biological indicators are regulated by the FDA.

Examples of Biological indicator in a sentence

  • Biological indicator monitoring test results shall be recorded in a log that shall be kept on site for three years after the date of the results.

  • Biological indicator test results shall be maintained on the premises for a minimum of three (3) years and must be available for inspection at all times.

  • Biological indicator species may be useful in evaluating the existing degree of stress at both sites.

  • Biological indicator for autoclave shall be Geobacillusstearothermophilus spores using vials or spore Strips; with at least 1X106 spores.

  • Biological indicator monitoring test results shall be recorded in a log that shall be kept on site for two years after the date of the results.

  • Table 2: Indicator Organism Monitoring Parameters MeasurementInstrument or Analysis Biological indicator compliance monitoring sampling of ballast water effluent must be conducted 2 times during the first year the system is installed or used for vessels with devices for whichhigh quality data are available.

  • Biological indicator for autoclave shall be Bacillus stearothermophilus spores using vials or spore Strips; with at least 1X104 spores per millilitre.

  • Sterilization Validation – Ethylene Oxide should include:• Protocol;• Summaries regarding commissioning of the sterilization equipment;• Validation of bioburden testing method & test report;• Bioburden determination and test reports;• Biological indicator data;• All cycle data and test reports (fractional, half, full);• Validation of product sterility testing method & test report;• Product sterility testing & test report;• Sterilant residual analysis reports.

  • Biological indicator for autoclave shall be Bacillus stearothermophilus spore using vials or spore strips, with at least 1 x 104 spores per milliliter.

  • Biological indicator products are disposable and are used on a routine basis for quality control, thus product sales are less sensitive to general economic conditions.


More Definitions of Biological indicator

Biological indicator means a standardized viable population of migroorganisms known to be resistant to the mode of sterilization being monitored.
Biological indicator means a species, community or biological process used to provide qualitative and/or

Related to Biological indicator

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • Therapeutic school means a residential group living facility:

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Opioid antagonist means a drug that binds to opioid

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Biosimilar means a biological product that is highly similar to a specific reference biological