ASTM E1705-1995(2002) Standard Terminology Relating to Biotechnology 《生物技术标准术语》.pdf

1、Designation: E 1705 95 (Reapproved 2002)Standard TerminologyRelating to Biotechnology1This standard is issued under the fixed designation E 1705; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number i

2、n parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This document is composed of terms, definitions ofterms, descriptions of terms, and acronyms used in ASTMdocuments related to the field of bio

3、technology. Terms that areadequately defined in a general dictionary are not defined inthis terminology standard.1.2 This standard includes terminology used in biotechnol-ogy areas, such as, but not limited to: biological drug products,materials for biotechnology, characterization and identification

4、of biological systems, aseptic sampling, preservation of bio-logical samples, membrane filters, molecular biology, biomassconversion, fuel manufacturing facilities, and fuel analysis.2. Referenced Documents2.1 ASTM Standards:2E 869 Test Method for Performance Evaluation of FuelEthanol Manufacturing

5、FacilitiesE 870 Test Method for Analysis of Wood FuelsE 1117 Practice for Design of Fuel-Alcohol ManufacturingFacilitiesE 1126 Terminology Relating to Biomass FuelsE 1285 Guide for Identification of Bacteriophage Lambda(l) or Its DNAE 1286 Guide for Identification of Herpes Simplex Virus orits DNAE

6、1287 Practice for Aseptic Sampling of Biological Mate-rialsE 1298 Guide for Determination of Purity, Impurities, andContaminants in Biological Drug ProductsE 1342 Practice for Preservation by Freezing, Freeze-Drying, and Low Temperature Maintenance of Bacteria,Fungi, Protista,Viruses, Genetic Elemen

7、ts, andAnimal andPlant TissuesE 1344 Guide for Evaluation of Fuel Ethanol Manufactur-ing FacilitiesE 1357 Test Method for Determining the Rate of Bleachingof Iron From Pyrite by Thiobacillus FerrooxidansE 1493 Guide for Identification of Bacteriophage M13 or ItsDNAE 1531 Practice for Detection of My

8、coplasma of Cell Cul-tures by Growth on Agrose MediumE 1532 Practice for Detection of Mycoplasma Contamina-tion of Cell Cultures by Use of the Bisbenzamide DNA-Binding FluorochromeE 1533 Practice for Indirect Detection of Mycoplasma inCell Culture by 48-6-Diamidino-2-2 Phenylindole (DAPI)StainingE 1

9、535 Test Method for Performance Evaluation ofAnaero-bic Digestion SystemsE 1536 Practice for Detection of Mycoplasma Contamina-tion of Bovine Serum by Large Volume MethodE 1564 Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopre-served Biological MaterialsE

10、 1565 Guide for Inventory Control and Handling of Bio-logical Material Maintained at Low TemperaturesE 1566 Guide for Handling Hazardous Biological Materialsin Liquid NitrogenE 1567 Guide for Biopharmaceutical Facilities Architec-tural Design Considerations2.2 Federal Standards:Title 21, Code of Fed

11、eral Regulations (CFR), Parts 210 and21133. Terminology3.1 Definitions:accessiblepermitting close approach or contact that couldinclude requiring removal or opening of an access panel ordoor. E 1117aerobicable to live, grow, or take place only where freeoxygen is present. E 1126aerobic fermentationf

12、ermentation processes that requirethe presence of air. E 1126alcoholsseries of liquid products composed of a hydrocar-bon plus a hydroxyl group, such as ethanol (C2H5OH).E 13441This terminology is under the jurisdiction of ASTM Committee E48 onBiotechnology and is the direct responsibility of Subcom

13、mittee E48.91 on Termi-nology.Current edition approved April 15, 1995. Published June 1995.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Su

14、mmary page onthe ASTM website.3Available from the Superintendent of Documents, U.S. Government PrintingOffice, Washington, DC 20402.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.alpha-amylaseenzyme that acts specifically to acceler

15、ate thehydrolysis of starch to dextrins. E 1344alpha complementationthe ability of a short amino-terminal fragment (alpha fragment) of b-galactosidase toform a functional complex with the carboxyl terminalfragment (omega fragment). E 1493anaerobicliving or active in an airless environment.E 1126anae

16、robic bacteriamicrobes whose metabolisms require theabsence of free oxygen. E 1126anaerobic digestera chemical reactor in which anaerobicbacteria are used to decompose biomass or organic wastes toproduce methane and carbon dioxide. E 1126anaerobic digestiondegradation of organic matter by mi-crobes

17、in the absence of air (oxygen) to produce methaneand carbon dioxide (biogas). E 1126anaerobic fermentationfermentation processes conductedin the absence of air. The following anaerobic fermentationprocesses are significant in obtaining useful forms of energyfrom biomass: (1) alcoholic fermentation,

18、fermentation pro-cesses whereby certain microorganisms convert glucose andother substrates with alcohol as an end product, (2) methanefermentation, generally termed anaerobic digestion (See alsoanaerobic digestion). E 1126anhydrousa material that does not contain water eitherabsorbed on its surface

19、or as water of crystallization; awater-free product. E 1126anhydrous ethanol100 % ethanol, neat ethanol, 199 + proofethanol. E 1344anhydrous, without waterterm used in chemistry to denoteabsence of water. 199 + proof ethanol is considered anhy-drous ethanol. E 1344aseptic samplingsampling process in

20、 which no extraneousmicroorganisms or substances are introduced into the sampleor its original bulk material as a result of the samplingsystem and activity. E 1287ashinorganic residue remaining after combustion, deter-mined by definite prescribed methods. E 1126ash fusion temperaturemelting point of

21、 ash, usually ex-pressed in degrees Fahrenheit. Variations include oxidizingatmosphere or reducing atmosphere, initial softening, orfinal fluid temperature. Some specifications include twointermediate points between initial softening and final fluid.E 1126azeotropeconstant boiling mixture, for ethan

22、ol-water, theazeotrope of 95.6 % ethanol and 4.4 % water (both percent-ages by volume) boils at one atmosphere pressure. E 1344azeotropic distillationthe use of an organic solvent to createa new constant boiling point mixture, a method used toproduce anhydrous ethanol from the ethanol water azeo-tro

23、pe. E 1344backsetthe liquid portion of the thin stillage that is recycledas part of the process liquid in mash preparation. E 1344bacteriophagea virus that infects bacteria. E 1285bagasseresidue remaining after extraction of a sugar-containing juice from plants like sugar cane. E 1126basic hydrolysi

24、sthe chemical addition of water to a com-pound. E 1344batch fermentationbatch of nutrient mixture and microor-ganisms mixed in a vessel and allowed to ferment. E 1344beerterm used to describe the product of ethanol fermenta-tion by microorganisms. E 1344bioconversiona general term describing the use

25、 of biologi-cal systems to transform one compound into another. Ex-amples are digestion of organic wastes or sewage bymicroorganisms to produce methane. E 1126biofuelbiomass-derived fuel. E 1126biogasa composition of methane and carbon dioxide andminor constituents produced by the digestion of organ

26、icsubstrates in the absence of oxygen. E 1535biomasstotal weight of living matter in a given volume.When considered as an energy source, biomass is furthersubdivided into: (1) primary biomass, rapidly growing plantmaterial that may be used directly or after a conversionprocess for the production of

27、energy, and (2) secondarybiomass, biomass residues remaining after the production offiber, food, or other products of agriculture, or biomassby-products from animal husbandry or food preparation thatare modified physically rather than chemically. Examplesinclude waste materials from agriculture and

28、forestry indus-tries (manure, sewage, etc.) from which energy may beproduced. The above distinction noted between primary andsecondary biomass is based on economic factors; these aredefined differently in ecological science. E 1126biomassany material, excluding fossil fuels, which is or wasa living

29、organism that can be used as a fuel directly or aftera conversion process. Peat is not a biomass. E 1126biomass fuelfuel derived from biomass. E 1126capsomerea structural subunit of the outer protein shell(capsid) of a virus consisting of protein monomers.E 1286carbohydratesmolecules consisting of c

30、arbon, hydrogenand oxygen that include celluloses, starches and sugars.E 1344centrifugemachine that separates a mixture of solids andliquids by centrifugal force. E 1344contaminantsall adventitious substances or microorganismspresent in raw materials, bulk drugs, or final products.E 1298continuous f

31、ermentationnonstop flow of nutrients into afermenting vessel, with the simultaneous outflow of prod-ucts, organisms, and by-products. E 1344conversion efficiencythe ratio of the actual to theoreticalfuel ethanol yield per unit mass of the feedstock. E 1344corn stoverthe stalks of the maize plant. E

32、1126cryogenic temperaturesfor purposes of this practice, cryo-genic temperatures are temperatures at or below 70C.E 1342cryogenic temperaturestemperatures below or equalto 100C. E 1564, E 1565, E 1566cryoprotectanta chemical substance used to protect cellsduring freezing and rewarming. E 1342current

33、 good manufacturing practices (CGMP)currentregulations published by the United States Food and DrugAdministration (FDA) regarding manufacturing, processing,packaging and storing of drug and biological products.E 1705 95 (2002)2E 1287cycle timethe time required by an alcohol plant to completeone cycl

34、e. E 869dead legany inactive, trapped or stagnant zone of a biologi-cal fluid that is to be sampled aseptically where this liquidzone would not be representative of the bulk fluid that is tobe sampled. This “dead leg” zone could deviate from thebulk system in oxygen content, nutrients levels, materi

35、alcomposition, temperature, bacterial contamination, and otherprocess variables that would prevent any sample drawnthrough this system from representating the bulk fluidquality to be tested. E 1287deleterious impuritiesimpurities that might be a health orsafety concern, particularly with respect to

36、toxicity, carcino-genicity, or immunogenicity. Deleterious impurities must becontrolled and their levels determined using suitable analyti-cal methods. E 1298denaturanttoxins or noxious materials added to ethanol tomake it unfit for human consumption. E 1344denatured ethanolethanol that is mixed wit

37、h other chemi-cals or denaturants to make it unsuitable for human con-sumption. E 1344denatured fuel ethanolfuel ethanol to which chemicals(denaturants) have been added to make the ethanol unfit forhuman consumption in accordance with the regulations ofthe Bureau of Alcohol, Tobacco, and Firearms of

38、 the U.S.Treasury Department. E 1126densified particulate biomass fuelsa fuel made by me-chanical compression of biomass to increase the bulk densityand to press the fuel into a specific shape, such as pellets andbriquettes. The fuel can have a maximum volume of 16.39cm3(1 in.3) such that the larges

39、t dimension is 7.62 cm (3 in.).E 1126dextrinshigh molecular weight sugars, intermediates ob-tained in the conversion of starch to fermentable sugar.E 1344digestera bioreactor in which anaerobic bacteria are used todecompose biomass or organic wastes into methane andcarbon dioxide. E 1126direct detec

40、tion of mycoplasmadetection of mycoplasmaby cultivation in culture media. E 1531, E 1532, E 1533,E 1536distillatethe overhead product of distillation such as ethanolliquid from the top of a beer still. E 1344distillationthe act of vaporizing and condensing a liquid insequential steps to effect separ

41、ation from a liquid mixture.E 1344distillers grainsthe insoluble solids that have been separatedfrom the stillage bottoms or beer. Moisture content mayrange from 60 to 85 %, depending upon the level ofdewatering during separation. E 1344DNA fluorochrome stainstaining of DNA specifically bythe use of

42、 bisbenzamide fluorochrome stain4or other DNAfluorochromes of comparable quality and performance, suchas DAPI (48,6-diamidine-2-phenyl-indole-2HCl)-Serva18860. E 1532dry basis moisture contentof biomass fuels, the ratio of theweight of the water in a sample to the weight of the drymaterial. It is ex

43、pressed as a percent. E 1126durabilitythe quality of a component to perform as designedfor its design life. E 1117envelopea layer of cell membrane-derived lipoprotein thatsurrounds the protein coat (capsid) of some viruses.E 1286enzymebiological catalyst that is protein in nature. E 1344ethanolethyl

44、 alcohol, the chemical compound C2H5OH, atwo carbon alcohol. E 1344ethanol (ethyl alcohol, grain alcohol)CH3CH2OH; can beproduced chemically from ethylene or biologically from thefermentation of various sugars from carbohydrates found inagricultural crops and cellulosic residues from crops orwood. E

45、 1126eutectic temperaturethe temperature below which all liquidportions of an aqueous suspension have entered the solidphase. E 1342extreme weather conditionsenvironmental conditions thathave occurred only once during the past 30 years. E 1117feedstockthe base raw material that is the source of carb

46、o-hydrate, such as starch, for producing sugars that can befermented into alcohol and carbon dioxide. E 1344fermentationdecomposition of organic compounds, by mi-croorganisms, to fuels and chemicals such as alcohols, acids,and energy-rich gases. E 1126fermentationthe biochemical reaction process whe

47、re micro-organisms in a nutrient medium convert a feedstock to aproduct. E 1344fermentation fuela fuel produced by fermentation of biom-ass. E 1126F factoran episome of E. coli. Encoded on it are thefunctions necessary to produce an F pilus. E 1493fixed carboncarbon remaining after heating in a pres

48、cribedmanner to decompose thermally unstable components and todistill volatiles. E 1126flash pointthe temperature at which a combustible liquidignites. E 1344F pilusa protrusion on E. coli that is necessary for mating.The F pilus also contains the receptor for phage M13.E 1493freeze-dryingsublimatio

49、n of water from a frozen aqueoussuspension. E 1342freezinglowering the temperature of an aqueous suspensionto a point at or below the temperature of ice crystalformation. E 1342fuel alcoholethyl, methyl, or higher alcohols with impurities(including water but excluding denaturants) produced foruse as a fuel alone or as an addition to other fuels, such asgasoline. E 1126fuel ethanolethanol with impurities (including water butexcluding denaturants). E 1126fuel ethanol manufacturing facilitya manufacturing f