1、Designation: E1705 11Standard 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 parentheses indica
2、tes 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 ofterms, descriptions of terms, and acronyms used in ASTMdocuments related to the field of biotechnology. Terms tha
3、t 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 identificationof biological systems
4、, aseptic sampling, preservation of bio-logical samples, membrane filters, molecular biology, biomassconversion, fuel manufacturing facilities, and fuel analysis.2. Referenced Documents2.1 ASTM Standards:2E869 Test Method for Performance Evaluation of FuelEthanol Manufacturing FacilitiesE870 Test Me
5、thods for Analysis of Wood FuelsE1117 Practice for Design of Fuel-Alcohol ManufacturingFacilitiesE1126 Terminology Relating to Biomass Fuels3E1285 Guide for Identification of Bacteriophage Lambda(l) or Its DNAE1286 Guide for Identification of Herpes Simplex Virus orIts DNAE1287 Practice for Aseptic
6、Sampling of Biological Materi-als3E1298 Guide for Determination of Purity, Impurities, andContaminants in Biological Drug ProductsE1342 Practice for Preservation by Freezing, Freeze-Drying, and Low Temperature Maintenance of Bacteria,Fungi, Protista,Viruses, Genetic Elements, andAnimal andPlant Tiss
7、ues3E1344 Guide for Evaluation of Fuel Ethanol ManufacturingFacilitiesE1357 Test Method for Determining the Rate of Bioleach-ing of Iron From Pyrite by Thiobacillus Ferrooxidans3E1493 Guide for Identification of Bacteriophage M13 or ItsDNAE1531 Practice for Detection of Mycoplasma Contamina-tion of
8、Cell Cultures by Growth on Agarose MediumE1532 Practice for Detection of Mycoplasma Contamina-tion of Cell Cultures by Use of Bisbenzamide DNA-Binding FluorochromeE1533 Practice for Indirect Detection of Mycoplasma inCell Culture by 48-6-Diamidino-2-2 Phenylindole (DAPI)StainingE1535 Test Method for
9、 Performance Evaluation of Anaero-bic Digestion Systems3E1536 Practice for Detection of Mycoplasma Contamina-tion of Bovine Serum by Large Volume MethodE1564 Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopre-served Biological MaterialsE1565 Guide for Inve
10、ntory Control and Handling of Bio-logical Material Maintained at Low TemperaturesE1566 Guide for Handling Hazardous Biological Materialsin Liquid NitrogenE1567 Guide for Biopharmaceutical FacilitiesArchitecturalDesign Considerations32.2 Federal Standards:Title 21, Code of Federal Regulations (CFR),
11、Parts 210 and21143. Terminology3.1 Definitions:accessiblepermitting close approach or contact that couldinclude requiring removal or opening of an access panel ordoor. E1117aerobicable to live, grow, or take place only where freeoxygen is present. E1126aerobic fermentationfermentation processes that
12、 requirethe presence of air. E11261This terminology is under the jurisdiction of ASTM Committee E48 onBiotechnology and is the direct responsibility of Subcommittee E48.91 on Termi-nology.Current edition approved May 1, 2011. Published June 2011. Originallyapproved in 1995. Last previous edition app
13、roved in 2005 as E170505 which waswithdrawn January 2011 and reinstated in May 2011. DOI: 10.1520/E1705-11.2For 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 stand
14、ards Document Summary page onthe ASTM website.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.4Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http:/dodssp.daps.dla.mil.1Copy
15、right ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.alcoholsseries of liquid products composed of a hydrocar-bon plus a hydroxyl group, such as ethanol (C2H5OH).E1344alpha-amylaseenzyme that acts specifically to accelerate thehydrolysis of st
16、arch to dextrins. E1344alpha complementationthe ability of a short amino-terminal fragment (alpha fragment) of b-galactosidase toform a functional complex with the carboxyl terminalfragment (omega fragment). E1493anaerobicliving or active in an airless environment.E1126anaerobic bacteriamicrobes who
17、se metabolisms require theabsence of free oxygen. E1126anaerobic digestera chemical reactor in which anaerobicbacteria are used to decompose biomass or organic wastes toproduce methane and carbon dioxide. E1126anaerobic digestiondegradation of organic matter by mi-crobes in the absence of air (oxyge
18、n) to produce methaneand carbon dioxide (biogas). E1126anaerobic fermentationfermentation processes conductedin the absence of air. The following anaerobic fermentationprocesses are significant in obtaining useful forms of energyfrom biomass: (1) alcoholic fermentation, fermentation pro-cesses where
19、by certain microorganisms convert glucose andother substrates with alcohol as an end product, (2) methanefermentation, generally termed anaerobic digestion (See alsoanaerobic digestion). E1126anhydrousa material that does not contain water eitherabsorbed on its surface or as water of crystallization
20、; awater-free product. E1126anhydrous ethanol100 % ethanol, neat ethanol, 199 + proofethanol. E1344anhydrous, without waterterm used in chemistry to denoteabsence of water. 199 + proof ethanol is considered anhy-drous ethanol. E1344aseptic samplingsampling process in which no extraneousmicroorganism
21、s or substances are introduced into the sampleor its original bulk material as a result of the samplingsystem and activity. E1287ashinorganic residue remaining after combustion, deter-mined by definite prescribed methods. E1126ash fusion temperaturemelting point of ash, usually ex-pressed in degrees
22、 Fahrenheit. Variations include oxidizingatmosphere or reducing atmosphere, initial softening, orfinal fluid temperature. Some specifications include twointermediate points between initial softening and final fluid.E1126azeotropeconstant boiling mixture, for ethanol-water, theazeotrope of 95.6 % eth
23、anol and 4.4 % water (both percent-ages by volume) boils at one atmosphere pressure. E1344azeotropic distillationthe use of an organic solvent to createa new constant boiling point mixture, a method used toproduce anhydrous ethanol from the ethanol water azeo-trope. E1344backsetthe liquid portion of
24、 the thin stillage that is recycledas part of the process liquid in mash preparation. E1344bacteriophagea 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 com-
25、pound. E1344batch fermentationbatch of nutrient mixture and microor-ganisms mixed in a vessel and allowed to ferment. E1344beerterm used to describe the product of ethanol fermenta-tion by microorganisms. E1344bioconversiona general term describing the use of biologi-cal systems to transform one com
26、pound into another. Ex-amples are digestion of organic wastes or sewage bymicroorganisms to produce methane. E1126biofuelbiomass-derived fuel. E1126biogasa composition of methane and carbon dioxide andminor constituents produced by the digestion of organicsubstrates in the absence of oxygen. E1535bi
27、omasstotal 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 energy, and (2) secondarybiomass, biomass resid
28、ues 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 forestry indus-tries (manure, sewage, etc.) fro
29、m which energy may beproduced. The above distinction noted between primary andsecondary biomass is based on economic factors; these aredefined differently in ecological science. E1126biomassany material, excluding fossil fuels, which is or wasa living organism that can be used as a fuel directly or
30、aftera conversion 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. E1286carbohydratesmolecules consisting of carbon, hydrogenand oxygen that include celluloses,
31、 starches and sugars.E1344centrifugemachine that separates a mixture of solids andliquids by centrifugal force. E1344contaminantsall adventitious substances or microorganismspresent in raw materials, bulk drugs, or final products.E1298continuous fermentationnonstop flow of nutrients into afermenting
32、 vessel, with the simultaneous outflow of prod-ucts, organisms, and by-products. E1344conversion efficiencythe ratio of the actual to theoreticalfuel ethanol yield per unit mass of the feedstock. E1344corn stoverthe stalks of the maize plant. E1126cryogenic temperaturesfor purposes of this practice,
33、 cryo-genic temperatures are temperatures at or below 70C.E1342cryogenic temperaturestemperatures below or equalto 100C. E1564, E1565, E1566cryoprotectanta chemical substance used to protect cellsduring freezing and rewarming. E1342E1705 112current good manufacturing practices (CGMP)currentregulatio
34、ns 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 completeone cycle. E869dead legany inactive, trapped or stagnant zone of a biologi-cal
35、 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, materialcomposition, temperature, bacterial contamination, and otherprocess v
36、ariables that would prevent any sample drawnthrough this system from representating the bulk fluidquality to be tested. E1287deleterious impuritiesimpurities that might be a health orsafety concern, particularly with respect to toxicity, carcino-genicity, or immunogenicity. Deleterious impurities mu
37、st becontrolled and their levels determined using suitable analyti-cal methods. E1298denaturanttoxins or noxious materials added to ethanol tomake it unfit for human consumption. E1344denatured ethanolethanol that is mixed with other chemi-cals or denaturants to make it unsuitable for human con-sump
38、tion. E1344denatured 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 the U.S.Treasury Department. E1126densified particulate biomass fuelsa fue
39、l 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 largest dimension is 7.62 cm (3 in.).E1126dextrinshigh molecular weight sugars, in
40、termediates ob-tained in the conversion of starch to fermentable sugar.E1344digestera bioreactor in which anaerobic bacteria are used todecompose biomass or organic wastes into methane andcarbon dioxide. E1126direct detection of mycoplasmadetection of mycoplasmaby cultivation in culture media. E1531
41、, E1532, E1533,E1536distillatethe overhead product of distillation such as ethanolliquid from the top of a beer still. E1344distillationthe act of vaporizing and condensing a liquid insequential steps to effect separation from a liquid mixture.E1344distillers grainsthe insoluble solids that have bee
42、n separatedfrom the stillage bottoms or beer. Moisture content mayrange from 60 to 85 %, depending upon the level ofdewatering during separation. E1344DNA fluorochrome stainstaining of DNA specifically bythe use of bisbenzamide fluorochrome stain5or other DNAfluorochromes of comparable quality and p
43、erformance, suchas DAPI (48,6-diamidine-2-phenyl-indole-2HCl)-Serva18860. E1532dry basis moisture contentof biomass fuels, the ratio of theweight of the water in a sample to the weight of the drymaterial. It is expressed as a percent. E1126durabilitythe quality of a component to perform as designedf
44、or its design life. E1117envelopea layer of cell membrane-derived lipoprotein thatsurrounds the protein coat (capsid) of some viruses. E1286enzymebiological catalyst that is protein in nature. E1344ethanolethyl alcohol, the chemical compound C2H5OH, atwo carbon alcohol. E1344ethanol (ethyl alcohol,
45、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. E1126eutectic temperaturethe temperature below which all liquidportions of an aqueous suspen
46、sion have entered the solidphase. E1342extreme weather conditionsenvironmental conditions thathave occurred only once during the past 30 years. E1117feedstockthe base raw material that is the source of carbo-hydrate, such as starch, for producing sugars that can befermented into alcohol and carbon d
47、ioxide. E1344fermentationdecomposition of organic compounds, by mi-croorganisms, to fuels and chemicals such as alcohols, acids,and energy-rich gases. E1126fermentationthe biochemical reaction process where micro-organisms in a nutrient medium convert a feedstock to aproduct. E1344fermentation fuela
48、 fuel produced by fermentation of bio-mass. E1126F factoran episome of E. coli. Encoded on it are thefunctions necessary to produce an F pilus. E1493fixed carboncarbon remaining after heating in a prescribedmanner to decompose thermally unstable components and todistill volatiles. E1126flash pointth
49、e temperature at which a combustible liquidignites. E1344F pilusa protrusion on E. coli that is necessary for mating.The F pilus also contains the receptor for phage M13.E1493freeze-dryingsublimation of water from a frozen aqueoussuspension. E1342freezinglowering the temperature of an aqueous suspensionto a point at or below the temperature of ice crystalformation. E1342fuel alcoholethyl, methyl, or higher alcohols with impurities5Available from Calbiochem, P.O. Box 12087, San Diego, CA 92112-4180.E1705
