ASTM E1705-95

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Designation: E 1705 – 95
Standard Terminology
Relating to Biotechnology
This standard is issued under the fixed designation E 1705; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope Culture by Broth Enrichment and Agar Growth
E 1532 Practice for Indirect Detection of Mycoplasma in
1.1 This document is composed of terms, definitions of
Cell Culture by DNA Binding with Bisbenzamide Fluoro-
terms, descriptions of terms, and acronyms used in ASTM
chrome Stain
documents related to the field of biotechnology. Terms that are
E 1533 Practice for Indirect Detection of Mycoplasma in
adequately defined in a general dictionary are not defined in
Cell Culture by 48-6-Diamidino-2-2 Phenylindole (DAPI)
this terminology standard.
Staining
1.2 This standard includes terminology used in biotechnol-
E 1535 Test Method for Performance Evaluation of Anaero-
ogy areas, such as, but not limited to: biological drug products,
bic Digestion Systems
materials for biotechnology, characterization and identification
E 1536 Practice for Large Volume Testing of Serum for
of biological systems, aseptic sampling, preservation of bio-
Mycoplasma Contamination
logical samples, membrane filters, molecular biology, biomass
E 1564 Guide for Design and Maintenance of Low-
conversion, fuel manufacturing facilities, and fuel analysis.
Temperature Storage Facilities for Maintaining Cryopre-
2. Referenced Documents served Biological Materials
E 1565 Guide for Inventory Control and Handling of Bio-
2.1 ASTM Standards:
logical Material Maintained at Low Temperatures
E 869 Test Method for Performance Evaluation of Fuel
E 1566 Guide for Handling Hazardous Biological Materials
Ethanol Manufacturing Facilities
in Liquid Nitrogen
E 870 Test Method for Analysis of Wood Fuels
E 1567 Guide for Biopharmaceutical Facilities Architec-
E 1117 Practice for Design of Fuel-Alcohol Manufacturing
tural Design Considerations
Facilities
2.2 Federal Standards:
E 1126 Terminology Relating to Biomass Fuels
Title 21, Code of Federal Regulations (CFR), Parts 210 and
E 1285 Guide for Identification of Bacteriophage Lambda
(l) or Its DNA
E 1286 Guide for Identification of Herpes Simplex Virus or
3. Terminology
its DNA
3.1 Definitions:
E 1287 Practice for Aseptic Sampling of Biological Mate-
rials
accessible—permitting close approach or contact that could
E 1298 Guide for Determination of Purity, Impurities, and
include requiring removal or opening of an access panel or
Contaminants in Biological Drug Products
door. E 1117
E 1342 Practice for Preservation by Freezing, Freeze-
aerobic—able to live, grow, or take place only where free
Drying, and Low Temperature Maintenance of Bacteria,
oxygen is present. E 1126
Fungi, Protista, Viruses, Genetic Elements, and Animal and
aerobic fermentation—fermentation processes that require
Plant Tissues
the presence of air. E 1126
E 1344 Guide for Evaluation of Fuel Ethanol Manufactur-
alcohols—series of liquid products composed of a hydrocar-
ing Facilities
bon plus a hydroxyl group, such as ethanol (C H OH).
2 5
E 1357 Test Method for Determining the Rate of Bleaching
E 1344
of Iron From Pyrite by Thiobacillus Ferrooxidans
alpha-amylase—enzyme that acts specifically to accelerate the
E 1493 Guide for Identification of Bacteriophage M13 or Its
hydrolysis of starch to dextrins. E 1344
DNA
alpha complementation—the ability of a short amino-
E 1531 Practice for Direct Detection of Mycoplasma in Cell
terminal fragment (alpha fragment) of b-galactosidase to
form a functional complex with the carboxyl terminal
1 fragment (omega fragment). E 1493
This terminology is under the jurisdiction of ASTM Committee E-48 on
Biotechnology and is the direct responsibility of Subcommittee E48.91 on Termi-
nology.
Current edition approved April 15, 1995. Published June 1995. Available from the Superintendent of Documents, U.S. Government Printing
Annual Book of ASTM Standards, Vol 11.05. Office, Washington, DC 20402.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
E 1705
anaerobic—living or active in an airless environment. amples are digestion of organic wastes or sewage by
E 1126 microorganisms to produce methane. E 1126
anaerobic bacteria—microbes whose metabolisms require the biofuel—biomass-derived fuel. E 1126
absence of free oxygen. E 1126 biogas—a composition of methane and carbon dioxide and
anaerobic digester—a chemical reactor in which anaerobic minor constituents produced by the digestion of organic
bacteria are used to decompose biomass or organic wastes to substrates in the absence of oxygen. E 1535
produce methane and carbon dioxide. E 1126 biomass—total weight of living matter in a given volume.
anaerobic digestion—degradation of organic matter by mi- When considered as an energy source, biomass is further
crobes in the absence of air (oxygen) to produce methane subdivided into: (1) primary biomass, rapidly growing plant
and carbon dioxide (biogas). E 1126 material that may be used directly or after a conversion
anaerobic fermentation—fermentation processes conducted process for the production of energy, and (2) secondary
in the absence of air. The following anaerobic fermentation biomass, biomass residues remaining after the production of
processes are significant in obtaining useful forms of energy fiber, food, or other products of agriculture, or biomass
from biomass: (1) alcoholic fermentation, fermentation pro- by-products from animal husbandry or food preparation that
cesses whereby certain microorganisms convert glucose and are modified physically rather than chemically. Examples
other substrates with alcohol as an end product, (2) methane include waste materials from agriculture and forestry indus-
fermentation, generally termed anaerobic digestion (See also tries (manure, sewage, etc.) from which energy may be
anaerobic digestion). E 1126 produced. The above distinction noted between primary and
anhydrous—a material that does not contain water either secondary biomass is based on economic factors; these are
absorbed on its surface or as water of crystallization; a defined differently in ecological science. E 1126
water-free product. E 1126 biomass—any material, excluding fossil fuels, which is or was
anhydrous ethanol—100 % ethanol, neat ethanol, 199 + proof a living organism that can be used as a fuel directly or after
ethanol. E 1344 a conversion process. Peat is not a biomass. E 1126
anhydrous, without water—term used in chemistry to denote biomass fuel—fuel derived from biomass. E 1126
absence of water. 199 + proof ethanol is considered anhy- capsomere—a structural subunit of the outer protein shell
drous ethanol. E 1344 (capsid) of a virus consisting of protein monomers.
aseptic sampling—sampling process in which no extraneous E 1286
microorganisms or substances are introduced into the sample carbohydrates—molecules consisting of carbon, hydrogen
or its original bulk material as a result of the sampling and oxygen that include celluloses, starches and sugars.
system and activity. E 1287 E 1344
ash—inorganic residue remaining after combustion, deter- centrifuge—machine that separates a mixture of solids and
mined by definite prescribed methods. E 1126 liquids by centrifugal force. E 1344
ash fusion temperature—melting point of ash, usually ex- contaminants—all adventitious substances or microorganisms
pressed in degrees Fahrenheit. Variations include oxidizing present in raw materials, bulk drugs, or final products.
atmosphere or reducing atmosphere, initial softening, or E 1298
final fluid temperature. Some specifications include two continuous fermentation—nonstop flow of nutrients into a
intermediate points between initial softening and final fluid. fermenting vessel, with the simultaneous outflow of prod-
E 1126 ucts, organisms, and by-products. E 1344
azeotrope—constant boiling mixture, for ethanol-water, the conversion efficiency—the ratio of the actual to theoretical
azeotrope of 95.6 % ethanol and 4.4 % water (both percent- fuel ethanol yield per unit mass of the feedstock. E 1344
ages by volume) boils at one atmosphere pressure. E 1344 corn stover—the stalks of the maize plant. E 1126
azeotropic distillation—the use of an organic solvent to create cryogenic temperatures—for purposes of this practice, cryo-
a new constant boiling point mixture, a method used to genic temperatures are temperatures at or below − 70°C.
produce anhydrous ethanol from the ethanol water azeo- E 1342
trope. E 1344 cryogenic temperatures—temperatures below or equal
backset—the liquid portion of the thin stillage that is recycled to − 100°C. E 1564, E 1565, E 1566
as part of the process liquid in mash preparation. E 1344 cryoprotectant—a chemical substance used to protect cells
bacteriophage—a virus that infects bacteria. E 1285 during freezing and rewarming. E 1342
bagasse—residue remaining after extraction of a sugar- current good manufacturing practices (CGMP)—current
containing juice from plants like sugar cane. E 1126 regulations published by the United States Food and Drug
basic hydrolysis—the chemical addition of water to a com- Administration (FDA) regarding manufacturing, processing,
pound. E 1344 packaging and storing of drug and biological products.
batch fermentation—batch of nutrient mixture and microor- E 1287
ganisms mixed in a vessel and allowed to ferment. E 1344 cycle time—the time required by an alcohol plant to complete
beer—term used to describe the product of ethanol fermenta- one cycle. E 869
tion by microorganisms. E 1344 dead leg—any inactive, trapped or stagnant zone of a biologi-
bioconversion—a general term describing the use of biologi- cal fluid that is to be sampled aseptically where this liquid
cal systems to transform one compound into another. Ex- zone would not be representative of the bulk fluid that is to
E 1705
be sampled. This “dead leg” zone could deviate from the surrounds the protein coat (capsid) of some viruses.
bulk system in oxygen content, nutrients levels, material E 1286
composition, temperature, bacterial contamination, and other enzyme—biological catalyst that is protein in nature. E 1344
process variables that would prevent any sample drawn ethanol—ethyl alcohol, the chemical compound C H OH, a
2 5
through this system from representating the bulk fluid two carbon alcohol. E 1344
quality to be tested. E 1287 ethanol (ethyl alcohol, grain alcohol)—CH CH OH; can be
3 2
deleterious impurities—impurities that might be a health or produced chemically from ethylene or biologically from the
safety concern, particularly with respect to toxicity, carcino- fermentation of various sugars from carbohydrates found in
genicity, or immunogenicity. Deleterious impurities must be agricultural crops and cellulosic residues from crops or
controlled and their levels determined using suitable analyti- wood. E 1126
cal methods. E 1298 eutectic temperature—the temperature below which all liquid
denaturant—toxins or noxious materials added to ethanol to portions of an aqueous suspension have entered the solid
make it unfit for human consumption. E 1344 phase. E 1342
denatured ethanol—ethanol that is mixed with other chemi- extreme weather conditions—environmental conditions that
cals or denaturants to make it unsuitable for human con- have occurred only once during the past 30 years. E 1117
sumption. E 1344 feedstock—the base raw material that is the source of carbo-
denatured fuel ethanol—fuel ethanol to which chemicals hydrate, such as starch, for producing sugars that can be
(denaturants) have been added to make the ethanol unfit for fermented into alcohol and carbon dioxide. E 1344
human consumption in accordance with the regulations of fermentation—decomposition of organic compounds, by mi-
the Bureau of Alcohol, Tobacco, and Firearms of the U.S. croorganisms, to fuels and chemicals such as alcohols, acids,
Treasury Department. E 1126 and energy-rich gases. E 1126
densified particulate biomass fuels—a fuel made by me- fermentation—the biochemical reaction process where micro-
chanical compression of biomass to increase the bulk density organisms in a nutrient medium convert a feedstock to a
and to press the fuel into a specific shape, such as pellets and product. E 1344
briquettes. The fuel can have a maximum volume of 16.39 fermentation fuel—a fuel produced by fermentation of biom-
3 3
cm (1 in. ) such that the largest dimension is 7.62 cm (3 in.). ass. E 1126
E 1126 F factor—an episome of E. coli. Encoded on it are the
dextrins—high molecular weight sugars, intermediates ob- functions necessary to produce an F pilus. E 1493
tained in the conversion of starch to fermentable sugar. fixed carbon—carbon remaining after heating in a prescribed
E 1344 manner to decompose thermally unstable components and to
digester—a bioreactor in which anaerobic bacteria are used to distill volatiles. E 1126
decompose biomass or organic wastes into methane and flash point—the temperature at which a combustible liquid
carbon dioxide. E 1126 ignites. E 1344
direct detection of mycoplasma—detection of mycoplasma F pilus—a protrusion on E. coli that is necessary for mating.
by cultivation in culture media. E 1531, E 1532, E 1533, The F pilus also contains the receptor for phage M13.
E 1536 E 1493
distillate—the overhead product of distillation such as ethanol freeze-drying—sublimation of water from a frozen aqueous
liquid from the top of a beer still. E 1344 suspension. E 1342
distillation—the act of vaporizing and condensing a liquid in freezing—lowering the temperature of an aqueous suspension
sequential steps to effect separation from a liquid mixture. to a point at or below the temperature of ice crystal
E 1344 formation. E 1342
distillers grains—the insoluble solids that have been separated fuel alcohol—ethyl, methyl, or higher alcohols with impurities
from the stillage bottoms or beer. Moisture content may (including water but excluding denaturants) produced for
range from 60 to 85 %, depending upon the level of use as a fuel alone or as an addition to other fuels, such as
dewatering during separation. E 1344 gasoline. E 1126
DNA fluorochrome stain—staining of DNA specifically by fuel ethanol—ethanol with impurities (including water but
the use of bisbenzamide fluorochrome stain or other DNA excluding denaturants). E 1126
fluorochromes of comparable quality and performance, such fuel ethanol manufacturing facility—a manufacturing facil-
as DAPI
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