ASTM E1705-2013 Standard Terminology Relating to Biotechnology《生物技术相关标准术语》.pdf

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1、Designation: E1705 11E1705 13Standard TerminologyRelating to Biotechnology1This standard is issued under the fixed designation E1705; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parenthese

2、s indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This document is composed of terms, definitions of terms, descriptions of terms, and acronyms used in ASTM documentsrelated to the field of biotechnology.

3、Terms that are adequately defined in a general dictionary are not defined in this terminologystandard.1.2 This standard includes terminology used in biotechnology areas, such as, but not limited to: biological drug products,materials for biotechnology, characterization and identification of biologic

4、al systems, aseptic sampling, preservation of biologicalsamples, membrane filters, molecular biology, biomass conversion, fuel manufacturing facilities, and fuel analysis.2. Referenced Documents2.1 ASTM Standards:2E869 Test Method for Performance Evaluation of Fuel Ethanol Manufacturing FacilitiesE8

5、70 Test Methods for Analysis of Wood FuelsE1117 Practice for Design of Fuel-Alcohol Manufacturing FacilitiesE1126 Terminology Relating to Biomass Fuels (Withdrawn 2003)3E1285 Guide for Identification of Bacteriophage Lambda () or Its DNAE1286 Guide for Identification of Herpes Simplex Virus or Its D

6、NAE1287 Practice for Aseptic Sampling of Biological Materials (Withdrawn 2008)3E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug ProductsE1342 Practice for Preservation by Freezing, Freeze-Drying, and Low Temperature Maintenance of Bacteria, Fungi, Protista,Vir

7、uses, Genetic Elements, and Animal and Plant Tissues (Withdrawn 2011)3E1344 Guide for Evaluation of Fuel Ethanol Manufacturing FacilitiesE1357 Test Method for Determining the Rate of Bioleaching of Iron From Pyrite by Thiobacillus Ferrooxidans (Withdrawn2010)3E1493 Guide for Identification of Bacter

8、iophage M13 or Its DNAE1531 Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose MediumE1532 Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-BindingFluorochromeE1533 Practice for Indirect Detection of Mycoplasma in Ce

9、ll Culture by 4-6-Diamidino-2-2 Phenylindole (DAPI) StainingE1535 Test Method for Performance Evaluation of Anaerobic Digestion Systems (Withdrawn 2011)3E1536 Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume MethodE1564 Guide for Design and Maintenance of Low-Temper

10、ature Storage Facilities for Maintaining Cryopreserved BiologicalMaterialsE1565 Guide for Inventory Control and Handling of Biological Material Maintained at Low TemperaturesE1566 Guide for Handling Hazardous Biological Materials in Liquid NitrogenE1567 Guide for Biopharmaceutical Facilities Archite

11、ctural Design Considerations (Withdrawn 2010)31 This terminology is under the jurisdiction of ASTM Committee E48 on Bioenergy and Industrial Chemicals from Biomass and is the direct responsibility ofSubcommittee E48.91 on Terminology.Current edition approved May 1, 2011Nov. 1, 2013. Published June 2

12、011January 2014. Originally approved in 1995. Last previous edition approved in 20022011 asE170595(2002)E1705 which was withdrawn January 2011 and reinstated in May 2011. DOI: 10.1520/E1705-11.11. DOI: 10.1520/E1705-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactAS

13、TM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.This document is not an ASTM standard and is intended on

14、ly to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current vers

15、ionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.2 Federal Standards:Title 21, Code of Federal Regulations (CFR), Parts 210 and 21143. Terminology3.1 D

16、efinitions:accessiblepermitting close approach or contact that could include requiring removal or opening of an access panel or door.E1117aerobicable to live, grow, or take place only where free oxygen is present. E1126aerobic fermentationfermentation processes that require the presence of air. E112

17、6alcoholsseries of liquid products composed of a hydrocarbon plus a hydroxyl group, such as ethanol (C2 H5OH). E1344alpha-amylaseenzyme that acts specifically to accelerate the hydrolysis of starch to dextrins. E1344alpha complementationthe ability of a short amino-terminal fragment (alpha fragment)

18、 of -galactosidase to form a functionalcomplex with the carboxyl terminal fragment (omega fragment). E1493anaerobicliving or active in an airless environment. E1126anaerobic bacteriamicrobes whose metabolisms require the absence of free oxygen. E1126anaerobic digestera chemical reactor in which anae

19、robic bacteria are used to decompose biomass or organic wastes to producemethane and carbon dioxide. E1126anaerobic digestiondegradation of organic matter by microbes in the absence of air (oxygen) to produce methane and carbondioxide (biogas). E1126anaerobic fermentationfermentation processes condu

20、cted in the absence of air.The following anaerobic fermentation processesare significant in obtaining useful forms of energy from biomass: (1) alcoholic fermentation, fermentation processes wherebycertain microorganisms convert glucose and other substrates with alcohol as an end product, (2 ) methan

21、e fermentation,generally termed anaerobic digestion (See also anaerobic digestion). E1126anhydrousa material that does not contain water either absorbed on its surface or as water of crystallization; a water-freeproduct. E1126anhydrous ethanol100 % ethanol, neat ethanol, 199 + proof ethanol. E1344an

22、hydrous, without waterterm used in chemistry to denote absence of water. 199 + proof ethanol is considered anhydrousethanol. E1344aseptic samplingsampling process in which no extraneous microorganisms or substances are introduced into the sample or itsoriginal bulk material as a result of the sampli

23、ng system and activity. E1287ashinorganic residue remaining after combustion, determined by definite prescribed methods. E1126ash fusion temperaturemelting point of ash, usually expressed in degrees Fahrenheit. Variations include oxidizing atmosphereor reducing atmosphere, initial softening, or fina

24、l fluid temperature. Some specifications include two intermediate points betweeninitial softening and final fluid. E1126azeotropeconstant boiling mixture, for ethanol-water, the azeotrope of 95.6 % ethanol and 4.4 % water (both percentages byvolume) boils at one atmosphere pressure. E1344azeotropic

25、distillationthe use of an organic solvent to create a new constant boiling point mixture, a method used to produceanhydrous ethanol from the ethanol water azeotrope. E1344backsetthe liquid portion of the thin stillage that is recycled as part of the process liquid in mash preparation. E1344bacteriop

26、hagea virus that infects bacteria. E1285bagasseresidue remaining after extraction of a sugar-containing juice from plants like sugar cane. E1126basic hydrolysisthe chemical addition of water to a compound. E1344batch fermentationbatch of nutrient mixture and microorganisms mixed in a vessel and allo

27、wed to ferment. E1344beerterm used to describe the product of ethanol fermentation by microorganisms. E13444 Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http:/dodssp.daps.dla.mil.E1705 132bioconversiona general term

28、describing the use of biological systems to transform one compound into another. Examples aredigestion of organic wastes or sewage by microorganisms to produce methane. E1126biofuelbiomass-derived fuel. E1126biogasa composition of methane and carbon dioxide and minor constituents produced by the dig

29、estion of organic substrates inthe absence of oxygen. E1535biomasstotal weight of living matter in a given volume. When considered as an energy source, biomass is further subdividedinto: (1) primary biomass, rapidly growing plant material that may be used directly or after a conversion process for t

30、heproduction of energy, and (2) secondary biomass, biomass residues remaining after the production of fiber, food, or otherproducts of agriculture, or biomass by-products from animal husbandry or food preparation that are modified physically ratherthan chemically. Examples include waste materials fr

31、om agriculture and forestry industries (manure, sewage, etc.) from whichenergy may be produced. The above distinction noted between primary and secondary biomass is based on economic factors;these are defined differently in ecological science. E1126biomassany material, excluding fossil fuels, which

32、is or was a living organism that can be used as a fuel directly or after aconversion process. Peat is not a biomass. E1126biomass fuelfuel derived from biomass. E1126capsomerea structural subunit of the outer protein shell (capsid) of a virus consisting of protein monomers. E1286carbohydratesmolecul

33、es consisting of carbon, hydrogen and oxygen that include celluloses, starches and sugars. E1344centrifugemachine that separates a mixture of solids and liquids by centrifugal force. E1344contaminantsall adventitious substances or microorganisms present in raw materials, bulk drugs, or final product

34、s. E1298continuous fermentationnonstop flow of nutrients into a fermenting vessel, with the simultaneous outflow of products,organisms, and by-products. E1344conversion efficiencythe ratio of the actual to theoretical fuel ethanol yield per unit mass of the feedstock. E1344corn stoverthe stalks of t

35、he maize plant. E1126cryogenic temperaturesfor purposes of this practice, cryogenic temperatures are temperatures at or below 70C. E1342cryogenic temperaturestemperatures below or equal to 100C. E1564, E1565, E1566cryoprotectanta chemical substance used to protect cells during freezing and rewarming

36、. E1342current good manufacturing practices (CGMP)current regulations published by the United States Food and DrugAdministration (FDA) regarding manufacturing, processing, packaging and storing of drug and biological products. E1287cycle timethe time required by an alcohol plant to complete one cycl

37、e. E869dead legany inactive, trapped or stagnant zone of a biological fluid that is to be sampled aseptically where this liquid zone wouldnot be representative of the bulk fluid that is to be sampled. This “dead leg” zone could deviate from the bulk system in oxygencontent, nutrients levels, materia

38、l composition, temperature, bacterial contamination, and other process variables that wouldprevent any sample drawn through this system from representating the bulk fluid quality to be tested. E1287deleterious impuritiesimpurities that might be a health or safety concern, particularly with respect t

39、o toxicity, carcinogenicity,or immunogenicity. Deleterious impurities must be controlled and their levels determined using suitable analytical methods.E1298denaturanttoxins or noxious materials added to ethanol to make it unfit for human consumption. E1344denatured ethanolethanol that is mixed with

40、other chemicals or denaturants to make it unsuitable for human consumption.E1344denatured fuel ethanolfuel ethanol to which chemicals (denaturants) have been added to make the ethanol unfit for humanconsumption in accordance with the regulations of the Bureau of Alcohol, Tobacco, and Firearms of the

41、 U.S. TreasuryDepartment. E1126densified particulate biomass fuelsa fuel made by mechanical compression of biomass to increase the bulk density and to pressthe fuel into a specific shape, such as pellets and briquettes. The fuel can have a maximum volume of 16.39 cm3 (1 in.3) suchthat the largest di

42、mension is 7.62 cm (3 in.). E1126dextrinshigh molecular weight sugars, intermediates obtained in the conversion of starch to fermentable sugar. E1344E1705 133digestera bioreactor in which anaerobic bacteria are used to decompose biomass or organic wastes into methane and carbondioxide. E1126direct d

43、etection of mycoplasmadetection of mycoplasma by cultivation in culture media. E1531, E1532, E1533, E1536distillatethe overhead product of distillation such as ethanol liquid from the top of a beer still. E1344distillationthe act of vaporizing and condensing a liquid in sequential steps to effect se

44、paration from a liquid mixture. E1344distillers grainsthe insoluble solids that have been separated from the stillage bottoms or beer. Moisture content may range from60 to 85 %, depending upon the level of dewatering during separation. E1344DNA fluorochrome stainstaining of DNA specifically by the u

45、se of bisbenzamide fluorochrome stain5 or other DNAfluorochromes of comparable quality and performance, such as DAPI (4,6-diamidine-2-phenyl-indole-2HCl)-Serva 18860.E1532dry basis moisture contentof biomass fuels, the ratio of the weight of the water in a sample to the weight of the dry material.It

46、 is expressed as a percent. E1126durabilitythe quality of a component to perform as designed for its design life. E1117envelopea layer of cell membrane-derived lipoprotein that surrounds the protein coat (capsid) of some viruses. E1286enzymebiological catalyst that is protein in nature. E1344ethanol

47、ethyl alcohol, the chemical compound C2H5OH, a two carbon alcohol. E1344ethanol (ethyl alcohol, grain alcohol)CH3CH2OH; can be produced chemically from ethylene or biologically from thefermentation of various sugars from carbohydrates found in agricultural crops and cellulosic residues from crops or

48、 wood. E1126eutectic temperaturethe temperature below which all liquid portions of an aqueous suspension have entered the solid phase.E1342extreme weather conditionsenvironmental conditions that have occurred only once during the past 30 years. E1117feedstockthe base raw material that is the source

49、of carbohydrate, such as starch, for producing sugars that can be fermentedinto alcohol and carbon dioxide. E1344fermentationdecomposition of organic compounds, by microorganisms, to fuels and chemicals such as alcohols, acids, andenergy-rich gases. E1126fermentationthe biochemical reaction process where microorganisms in a nutrient medium convert a feedstock to a product.E1344fermentation fuela fuel produced by fermentation of biomass. E1126F factoran episome of E. coli. Encoded on it are the functi