
A
| B |
C |
D |
E |
F |
G |
H |
I |
K |
L |
M |
N |
O |
P |
Q |
R |
S |
T |
U |
V |
W |
X |
Y |
Z
Acclimatization
The biological process whereby an organism adapts to a new
environment. One example is the process of developing microorganisms
that degrade toxic wastes in the environment.
Accommodation Schedule
Defines all areas that can influence unit operations required for
manufacturing, and relationships and flows between them.
Account Policy
Specifies how passwords must be defined and employed for all user
accounts on a system. It specifically addresses the issues of
password aging, password uniqueness, and locking a user account
because of invalid logon attempts. CFR 21 Part 11 mandates technical
controls in these areas specifically.
Acid
A compound of an electronegative element or radical with hydrogen;
it form salts by replacing all or part of the hydrogen with an
electropositive element or radical. Or, a hydrogen-containing
substance that when dissolved in water dissociates to produce one or
more hydrogen ions (H+).
Acid Feed
Injection of an acid into a liquid stream to make it less alkaline
(pH adjustment).
Action Point
A value set to identify when a parameter has drifted outside the
operating range (Acceptance Criteria). A documented response is
usually required.
Activated Carbon
Material used to adsorb organic impurities from water. Derived from
wood, lignite, pulp-mill char, blood, etc. The source material is
initially charred at high temperature to convert it to carbon. The
carbon is then "activated" by oxidation from exposure to
high temperature steam. It comes in granular or powdered form.
Active Immunity
The formation of an antibody that can be stimulated by infection or
vaccination.
Active Ingredient
Any component that is intended to furnish pharmacological activity
or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease, or to affect the structure or
any function of the body of man or other animals. The term includes
those components that may undergo chemical change in the manufacture
of the drug product and are present in the drug product in a
modified form intended to furnish the specified activity or effect.
Active Pharmaceutical Ingredient
Active Site
The region of a protein molecule that binds the specific substrate
and chemically modifies it into the new product (in an enzyme) or
interacts with it (in a receptor).
Active Transport
Energy-requiring transport of a solution across a membrane in the
direction of increasing concentration.
Actual Yield
The quantity that is actually produced at any appropriate phase of
manufacture, processing, or packaging of a particular drug product.
Adenine (A)
A purine base, 6-aminopurine, occurring in RNA (ribonucleic acid)
and DNA (deoxyribonucleic acid) and as a component of adenosine
triphosphate.
ADR
see: Adverse Drug Reaction
Adsorption
Adhesion of the molecules of a gas, liquid or dissolved substance
to a surface because of chemical or electrical attraction -
typically accomplished with granular activated carbon to remove
dissolved organics and chlorine. The attachment of charged particles
to the chemically active groups on the surface and in the pores of
an ion exchanger.
Adventitious Agents
Acquired, sporadic, accidental contaminants.
Adverse Agents
Undesired effects or toxicity due to exposure (often but not
limited to a drug or medical device).
Adverse Drug Reaction (ADR)
An undesirable effect that may be caused by a study drug.
Advisory Alarm
An alarm indicating a drift of a monitored parameter toward an
out-of-spec condition. It is advisory in that no GMP violation has
occurred, and is used to advise corrective action before an action
alarm can happen.
Aerobe
An organism that can live and grow only in the presence of oxygen.
1. Facultative aerobe: one which normally thrives in the absence of
oxygen, but which may acquire the faculty of living in the presence
of oxygen.
2. Obligate aerobe: one that cannot live without air.
Aerobia
The plural of aerobe.
Aerobic
Living in air.
Aerobic Bacteria
Bacteria capable of growing in the presence of Oxygen.
Aerobion
see: Aerobe
Aerosol
A product that is dispensed by a propellant from a metal can up to
a maximum size of 33.8 fluid ounces (1000 mL) or a glass or plastic
bottle up to a size of 4 fluid ounces (118.3 mL), other than a
rim-vented container.
Aerosol
A gaseous suspension of fine (100µm or smaller in size) solid
or liquid particles.
Aerosol Photometer
Light-scattering mass concentration indicating instrument with a
threshold sensitivity of at least 10 to the negative third power
microgram per liter for 0.3µm diameter DOP (Dioctyl Phthalate)
concentrations over a range of 10 to the fifth power times the
threshold sensitivity. Photometers may include hand-held remote
meter probes that can scan for airborne contaminants in HEPA
filters, in penetrations around frames, seals and plenums, and in
hoods and work stations.
AES
see: Auger Electron Spectroscopy
Agar
A complex mixture of polysaccharides obtained from marine red
algae, used as an emulsion stabilizer in foods, as a sizing in
fabrics, as a gelling agent and as a solid substrate or media for
the laboratory culture of microorganisms. Agar melts at 100ºC
and when cooled below 44ºC forms a stiff and transparent gel.
Microorganisms are seeded and grown on the surface of the gel.
Agarose
A highly purified form of agar.
Agarose Gel Electrophoresis
A method used to separate, identify, and purify molecules of
different molecular weight and/or structure. It is specifically
applied to the separation of protein or DNA fragments where it is
rapid, simple, and accurate, and the separated molecules can be
visualized directly by staining with dyes. The electrophoretic
migration rate of molecules through agarose gel is dependent on the
following parameters:
1. Molecular size: molecules pass through the gel at rates that are
inversely proportional to the log of their molecular weight.
2. Agarose concentration: a molecule of a given size migrates at
different rates through gels containing different concentrations of
agarose.
3. Molecular conformation: a molecule of the same molecular weight
but of a different conformation will migrate at different rates.
Generally, closed circular or globular forms will migrate faster
than linear forms.
4. Electric current: at low voltages the rate of migration is
proportional to the voltage, but as the voltage is increased the
rate of migration of high molecular weight fragments is increased
differentially.
Agene
Nitrogen Trichloride (NCl3).
Agglomerate
Suspended solids clustered together to form larger clumps or masses
that are easier to remove by filtration or settling.
Agglutination
The sticking together of insoluble antigens such as bacteria,
viruses or erythrocytes by a particular antibody. Agglutination
assays are used to type human blood before a transfusion.
AHF (Antihemophilic Factor)
In the clotting of blood it is also known as Factor VIII.
Airborne Particulate Cleanliness Classes
Statistically allowable number of particles equal to, or larger
than 0.5µm in size per cubic foot of air. According to ISO
14644-1, a classification number, N, shall designate airborne
particulate cleanliness.
Air Change Rate
The number of times the total air volume of a defined space is
replaced in a given unit of time. This is computed by dividing the
total volume of the subject space (in cubic feet) into the total
volume of air exhausted from (or supplied to) the space per unit of
time.
Air Cleaners
Filtration systems that may be freestanding or installed in a
ceiling or wall to remove contaminants such as bacteria, viruses,
and dust from the air. Air cleaners may incorporate HEPA filters.
Airflow Visualization
Using chemical smoke or fog to visualize flow patterns in a
cleanroom or clean space.
Air-Lift Bioreactor
A reactor in which the source of agitation is air sparged upwards
through a draft tube - most widely used for cell culture
applications and monoclonal antibody production.
Airlock
A room or space designed to act as a means of segregating areas of
different air classification or quality. It may contain a method to
remove particulate contamination from clean room garments as
personnel pass through, and usually includes HEPA filtered air
supply and interlocking doors. Airlocks pressure will "float"
between those of the spaces being protected. With all doors closed,
the airlock pressure will be somewhere between that of the highest
adjoining room and that of the lowest adjoining room as air flows
through it from room to room. "Ventilated airlocks" are in
neutral ducted air balance (supply CFM = return CFM).
Air Velocity Meters/Monitors
Meters to measure and indicate the force and speed of airflow.
Meters may use a variety of probes for measuring near HEPA filters
and at right angles. Monitors check and record air velocity.
Alarms
Audible or visual signals used to warn of unacceptable conditions
at monitored sites. They may be buzzers, horns, speakers, bells, or
warning lights. They can be Advisory, Alert, or Action alarms. The
first two are for operation and maintenance information, to alert of
abnormal situations that do not compromise product SISPQ. The Action
alarm is for GMP records, indicating that product SISPQ may have
been compromised, but Alert alarms are also usually recorded.
Albumin
Commonly, the white of egg is a simple protein widely distributed
throughout the tissues and fluid of plants and animals. Soluble in
pure water it is also precipitable from a solution by mineral acids,
and coagulable by heat in acid or neutral solution.
Albuminoid
Resembling albumin, a simple protein present in horny and
cartilaginous tissues, insoluble in neutral solvents. Keratin,
elastin, and collagen are albuminoids.
Alert Point
Used in determining when a parameter is drifting toward extremes of
the operating range.
Aliquot
Of, pertaining to, or designating an exact divisor or factor of a
quantity, specially of an integer. To divide out a sample to
multiple containers for multiple analytical tests.
Alkalinity
An expression of the total amount of basic anions (hydroxyl groups)
present in a solution. In water analysis, it also represents the
presence of carbonate, bicarbonate, and occasionally borate,
silicate, and phosphate salts that react to produce hydroxyl groups.
Bicarbonate and carbonate ions are expected to be in most waters.
Hydroxide may occur in water that has been softened by the lime soda
process or has been in contact with fresh concrete. Alkalinity
furnishes a guide in choosing appropriate treatment of either raw
water or plant effluents.
Allantoic Fluid
The clear white portion of an egg. In influenza vaccine
manufacturing, the virus is propagated in the embryonic chick and
sloughed into the allantoic fluid that is harvested to produce the
vaccine.
Allele
Alternative form of a genetic locus; a single allele for each locus
is inherited separately from each parent (e.g., at a locus for eye
color the allele might result in blue or brown eyes)
Allergenic Extract
An extract in a solvent of a substance that causes an allergic
reaction. They are relative crude drugs by contemporary standards
and are manufactured by specialty companies and in some cases, by a
practicing allergist. Also, allergenic extracts are generally
difficult to filter since they most frequently are extracts of
natural substances such as foods, house dust, animal hair, etc.
Alum
Aluminum sulfate, commonly added during municipal water treatment
to cause insoluble colloids to coalesce into larger particles that
can be removed by settling.
Alzheimer's Disease
A disease that causes memory loss, personality changes, dementia
and, ultimately, death. Not all cases are inherited, but genes have
been found for familial forms of Alzheimer's disease.
Ambient
The normal environment conditions such as temperature, relative
humidity, or room pressure of a particular area under consideration.
Ames Test
A simple bacterial test for carcinogens.
Amine
A substance that may be derived from ammonia by the replacement of
one or more of the hydrogen atoms by hydrocarbon radicals.
Amino Acids
Any of a group of twenty hydrocarbon molecules (containing the
radical group NH2) linked together in various combinations to form
proteins in living things. Synthesized by living cells or obtained
as essential components of the diet of human and animals, these
twenty amino acids are divided into four (4) groups on the basis of
their side-chain properties:
1. Neutral, hydrophobic side chains,
2. Neutral, hydrophilic side chains,
3. Acid, hydrophilic side chains,
4. Basic, hydrophilic side chains.
In addition to the twenty common amino acids there are less common
derivatives (e.g. hydroxyproline, found in collagen) formed by the
modification of a common amino acid.
Ampholyte
Amphoteric electrolyte. Electrolyte that can either give up or take
on a hydrogen ion and can thus behave as either an acid or a base.
Amphoteric
Having two opposite characteristics.
Ampicillin
An antibiotic widely used in clinical treatment and rDNA research.
It is a derivative of penicillin, which kills bacteria by
interfering with the synthesis of the cell wall.
Amplification
An increase in the number of copies of a specific DNA fragment; can
be In Vivo or In Vitro.
Amplification
The production of additional copies of a chromosomal sequence,
found as either intrachromosomal or extrachromosomal DNA.
Ampoule or Ampule
A small glass vial sealed after filling and one of the earliest
devices developed for safe storage of sterile injectable unit.
Amyotrophic Lateral Sclerosis
An inherited, fatal degenerative nerve disorder, also known as Lou
Gehrig's disease.
Anabolism
The intracellular process involved in the synthesis of more complex
compounds than those involved in catabolism (for example, glucose to
glycogen) and requires energy.
Anaerobe
A microorganism that thrives best, or only, when deprived of
oxygen.
1. Facultative anaerobe: one able to grow in the presence or
absence of free oxygen.
2. Obligate or obligatory anaerobe: one that will grow only in the
absence of free oxygen.
Anaerobic
Relating to an anaerobe.
Anaerobic Bacteria
Bacteria capable of growing in the absence of Oxygen.
Analog
Pertaining to data that consists of continuously variable physical
qualities.
Analytical Data Interchange (ANDI)
A generic file format. It was common practice before CFR 21 Part 11
to save information from analytical instruments in this file format.
The disadvantage now is that the approach does not allow replaying
of data on a different system to yield the same result.
Analytical Method
Small scale process used to characterize and/or separate a mixture,
a compound, or an unknown material into its constituent parts or
elements.
Ancillary Material
Material used in preparing drugs that does not become a component
of the drug (e.g. steam, air, N2, DI water).
ANDI
Anemometer
A device that measures air speed.
Angstrom (?)
A unit of length equal to one hundred-millionth of a centimeter
(one ten-thousandth of a micron) used especially to specify
radiation wavelengths.
Anion
A negatively charged particle or ion.
Anion Exchange Resin
An ion exchange material that removes anions from solution by
exchanging them with hydroxyl ions.
Anneal
The process by which the complementary base pairs in DNA strands
combine.
Annealing
A treatment process for steel in which the metal is heated and held
at a suitable temperature and then cooled at a suitable rate for the
purpose of reducing hardness, improving machinability, facilitating
cold working, producing a desired microstructure, or obtaining
desired mechanical, physical, or other properties.
Antibiotic
An organic substance of microbial origin (usually mold or
actinomycete bacteria) that is either toxic or growth inhibiting for
other organisms. Also with the advent of synthetic methods of
production, a substance produced by a microorganism or a similar
substance (produced wholly or partly by chemical synthesis) which,
in low concentrations, inhibits the growth of other microorganisms.
Penicillin, tetracycline, and erythromycin are examples of
antibiotics.
Antibody
A modified protein molecule present in the blood serum or plasma
(and other body fluids), whose activity is associated chiefly with
gamma globulin. Produced by the immune system in response to
exposure to a foreign substance, it is the body's protective
mechanism against infection and disease. An antibody is
characterized by a structure complementary to the foreign substance,
the antigen that provokes its formation, and is thus capable of
binding specifically to the foreign substance to neutralize it.
Antigen
Any of various foreign substances such as bacteria, viruses,
endotoxins, exotoxins, foreign proteins, pollen, and vaccines, whose
entry into an organism induces an immune response (antibody
production, lymphokine production, or both) directed specifically
against that molecule. Response may be demonstrated as an increased
reaction, such as hypersensitivity (usually protein or a complex of
protein and polysaccharide, or occasionally a polysaccharide of high
molecular weight), a circulating antibody that reacts with the
antigen, or some degree of immunity to infectious disease if the
antigen was a microorganism or its products.
Anti-interferon
An antibody to an interferon. Used for the purification of
interferons.
Antiseptic
Acting against sepsis. An antiseptic agent is one that has been
formulated for use on living tissue such as mucous membranes or skin
to prevent or inhibit growth or action of organisms. Antiseptics
should not be used to decontaminate inanimate objects.
Antiserum
The blood serum obtained from an animal after has been immunized
with a particular antigen. It contains antibodies specific for that
antigen as well as antibodies specific for any other antigens with
which the animal has previously been immunized.
Antistatic
Reducing static electric charges by retaining enough moisture to
provide electrical conduction.
Antistatic Cleaners
Liquid cleaners that enhance surface conductivity of cleanroom
tabletops, workstations, and other surfaces.
Antitoxin
An antibody that is capable of neutralizing the specific toxin that
stimulated its production in the body. Antitoxins are produced in
animals for medical purposes by injection of a toxin or toxoid, with
the resulting serum being used to counteract the toxin in other
individuals.
API (Active Pharmaceutical Ingredient)
Also called Drug Substance. Any substance or mixture of substances
intended to be used in the manufacture of a drug (medicinal) product
and that when used in the production of a drug becomes an active
ingredient of the drug product. Such substances are intended to
furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease or
to affect the structure and function of the body.
API Starting Material
A material used in the production of an API which is itself or is
incorporated as a significant structural fragment into the structure
of the API. A starting material may be an article of commerce, a
material purchased from one or more suppliers under contract or
commercial agreement, or it may be produced in-house. Starting
materials are normally of defined chemical properties and structure.
Apoenzyme
The protein moiety of an enzyme - determines the specifity of the
enzyme reaction.
Application Software
Any executable program developed or modified specially for customer
applications.
Appropriated login or Impersonation
Someone using the authorization code, usually user ID and password
of another person to secure access to network resources for which he
or she does not have privileges or authorization. Can be intentional
or not. CFR 21 Part 11 mandates technical controls that prevent
this.
Aquifer
An underground layer of permeable rock, sand, or gravel that
contains water for wells or springs.
Arithmetic Average Roughness (Ra)
The arithmetic average height of roughness component irregularities
from the mean line measured within the sample length (L). This
measurement conforms to ANSI/ASME B46.1 "Surface Texture -
Surface Roughness, Waviness and Lay". Ra (formerly known as AA
or Arithmetic Average in the U.S., and CLA Centerline Average in the
U.K.) is usually expressed in microinches (µin), and performed
by moving a stylus or profilometer in a straight line along the
surface. A consistent and measurable surface finish can be specified
for a desired roughness i.e., 9-11 microinch.
"As-Built" Cleanroom
ISO 14644-1 defines the "as built" occupancy state as "condition
where the installation is complete with all services connected and
functioning but with no production equipment, materials, or
personnel present".
Ascomycetes
A family of fungi marked by long spore-containing cells. Form
sexual spores called ascospores, which are contained within a sac (a
capsule structure). Ergot, truffles, some molds of the genera
Neurospora and Aspergillus, and yeasts belong to this category.
Asepsis
A condition in which living pathogenic (causing or capable of
causing disease) organisms are absent.
Aseptic
Marked by or relating to asepsis.
Aseptic Processing
Processing conditions designed to achieve a sterile product.
Aseptic Processing Area
Area in which sterile product is formulated, filled into
containers, and sealed.
Aseptic Transfer (in Isolators)
The key issue in all contained aseptic environments. Aseptic
transfer is essential for change parts, components, and even product
to enter and exit an isolator system without sterility challenges.
There are an increasing number of ways to make an aseptic transfer.
The following is a brief list of some of the key techniques:
1. Alpha Beta Systems Double Door Systems: also called RTPs (Rapid
Transfer Ports) and HCT (High Containment Transfer). When mated, the
two ports act as one door, protecting the internal and external
environments.
2. Alpha Beta Dry Heat Sterilized: similar to Alpha Beta port with
the additional safeguard of a heat sterilized seal.
3. UV and Pulsed Light: light sterilization/sanitization.
Sterilizing the system by making use of a wide spectrum of light
within the transfer chamber.
4. One Shot Systems: basically, two halves coming together. Similar
to an Alpha Beta port but simpler, cheaper, and capable of only a
single connection.
5. Heat Welded Bag Systems: passed in or passed out using a
continuous polyethylene liner which is heat sealed and cut to
maintain the integrity of the internal and external environments.
6. Steam Sterilized: the liquid component or powder path is clean
steam sterilized after connection and prior to transfer.
7. Autoclave/Depyrogenation/Dryheat: pass through for batch. Use of
conventional autoclave to sterilize a canister provided with an
Alpha Beta port and filters to allow the passage of steam and safe
aspiration on cooling. Depyrogenation/Dryheat uses dry heat to
sterilize and at sufficient temperature depyrogenate components,
typically glassware, in a batch oven
8. Depyrogenation Tunnel: standard volume glassware entry.
Depyrogenation/Dry heat uses dry heat to sterilize and at sufficient
temperature to depyrogenate components, typically glassware, in a
tunnel allowing continuous input.
ASME Bioprocessing Equipment (BPE- 1997)
An American National Standard that covers, either directly or by
reference, requirements for materials, design, fabrication,
examination, inspection, testing, certification (for pressure
systems), and pressure relief (for pressure systems) of vessels and
piping for bioprocessing systems, including sterility and
cleanability (Part SD), dimensions and tolerances (Part DT), surface
finish requirements (Part SF), material joining (Part MJ), and
equipment seals (Part SG) for the bioprocessing systems in which the
pressure vessels and associated piping are involved. This
Bioprocessing Equipment (BPE) Standard does not address all aspects
of these activities, and those aspects that are not specifically
addressed should not be considered prohibited.
Requirements of this Standard apply to:
1. All parts that contact the product, raw materials, and/or
product intermediates during manufacturing, process development, or
scale-up.
2. All equipment or systems that are critical part of product
manufacture, such as Water For Injection (WFI), clean steam,
ultrafiltration, intermediate product storage, and centrifuges.
ASME/ANSI B31 Code for Pressure Piping
A number of individually published Sections, each an American
National Standard. Rules for each Section reflect the kinds of
piping installations considered during its development, as follows:
1. B31.1 Power Piping: piping typically found in electric power
generating stations, in industrial and institutional plants,
geothermal heating systems, and central and district heating and
cooling systems.
2. B31.3 Process Piping: piping typically found in petroleum
refineries, chemical, pharmaceutical, textile, paper, semiconductor,
and cryogenic plants, and related processing plants and terminals.
Certain piping within a facility may be subject to other codes and
standards, including but not limited to: (a) ANSI Z223.1 National
Fuel Gas Code: piping for fuel gas from the point of delivery to the
connection of each fuel utilization device. (b) NFPA Fire Protection
Standards: fire protection systems using water, carbon dioxide,
halon, foam, dry chemical, and wet chemicals. (c) NFPA 99 Health
Care Facilities: medical and laboratory gas systems. (d) Building
and plumbing codes, as applicable, for potable hot and cold water,
and for sewer and drain systems.
3. B31.4 Pipeline Transportation Systems for Liquid Hydrocarbons
and Other Liquids: piping transporting products that are
predominately liquids between plants and terminals and within
terminals, pumping, regulating, and metering stations.
4. B31.5 Refrigeration Piping: piping for refrigerants and
secondary coolants.
5. B31.8 Gas Transportation and Distribution Piping Systems: piping
transporting products that are predominately gas between sources and
terminals, including compressor, regulating, and metering stations;
gas gathering pipelines.
6. B31.9 Building Services Piping: piping typically found in
industrial, institutional, commercial, and public buildings, and in
multi-unit residences, which does not require the range of sizes,
pressures, and temperatures covered in B31.1.
7. B31.11 Slurry Transportation Piping Systems: piping transporting
aqueous slurries between plants and terminals and within terminals,
pumping, and regulating stations.
Assay
A technique (test) for measuring a biological response or for
determining characteristics such as composition, purity, activity,
and weight.
Assimilation
The formation of cellular material utilizing small food molecules
and energy.
Atmospheric Tank (Fire Code)
A storage tank designed to operate at pressures from atmospheric
through 0.5 pounds per square inch (psig) (3.4 kPa).
Atomic Absorption Spectrophotometry
A highly sensitive instrumental technique for identifying and
measuring metals in water.
At Rest
HVAC room condition when unmanned, and without machinery operating.
Previously called "static condition".
"At-Rest" Cleanroom
ISO 14644-1 defines "at rest" occupancy state as "condition
where the installation is complete with equipment installed and
operating in a manner agreed upon by the customer and supplier, but
with no personnel present".
European Community (EC) defines "at rest" state as "the
condition where the installation is complete with production
equipment installed and operating but with no operating personnel
present". The Medicines Inspectorate, however, further
clarifies, "It should normally be taken to mean that
ventilation systems are operating and other equipment is present in
an operational condition but not in use".
Audit Comment
A feature of the audit trail that aids both originator and reviewer
in understanding why the originator performed a specific action. CFR
21 Part 11 does not require entering the reason for a record change,
but some predicate rules (such as GLPs) do expect an explanation. It
is important that the user interface for entering audit comments
prevents users from changing the audit trail itself.
Audit Trail
A computer-generated and time-stamped record of who did what, when.
CFR 21 Part 11 requires audit trails to be generated independently
of operators. An audit trail must capture all activities related to
creating, modifying, and destroying records on a system.
Auger Electron Spectroscopy (AES)
An alternative surface analysis that can detect all elements with
an atomic number greater than that of helium with the additional
ability to analyze sub micron-diameter features. It is not as
quantitative as ESCA and cannot determine the chemical state of an
element. The primary advantage of Auger is that when combined with
etching, a chemical depth profile can be measured rapidly and can
image the distribution on the surface of spatial limitation
resolution of 100 to 1,000 angstroms (depending on the equipment
capability).
Austenite
A face-centered cubic crystal with high solubility for carbon
(about 2%); an allotropic form of iron resulting from steel being
heated above the transformation temperature.
Autegoneous Weld
A weld made by fusion of the base material without the addition of
filler.
Authentication
The process of identifying a person, system, or company
sufficiently to allow access to a system or part of a system.
Authentication Mechanisms
Also known as authority checks, or authorized signers are
mechanisms distinct from authorization that grants or denies access
to a network resource, authentication programs are used by system
administrators to establish and verify as conclusively as possible
that a person logging in to the network is who he or she claims to
be. FDA says that "authority checks" are to "ensure
that only authorized individuals can use the system, electronically
sign a record, access the operation or computer system, input or
output device, alter a record, or perform operations".
Autoclave
An apparatus into which moist heat (steam) under pressure is
introduced to sterilize or decontaminate materials placed within
(e.g. filter assemblies, glassware, etc.). Steam pressure is
maintained for pre-specified times and then allowed to exhaust.
There are two types of autoclaves:
1. Gravity displacement autoclave: this type of autoclave operates
at 121ºC. Steam enters at the top of the loaded inner chamber,
displacing the air below through a discharge outlet.
2. Vacuum autoclave: this type of autoclave can operate with a
reduced sterilization cycle time. The air is pumped out of the
loaded chamber before it is filled with steam.
Auto Immune Disease
A disease in which the body produces an immunogenic response
against self-antigens. In some cases, predominantly one organ is
affected (e.g. hemolytic anemia and chronic thyroiditis); in others,
the disease process is diffused through many tissues (e.g. SLE
(Systemic Lupus Erythematosis)).
Automated System
Any facility system or piece of equipment that is controlled with
limited or no manual intervention.
Automatic Welding
Welding with equipment that performs the welding operation without
adjustment of the controls by a welding operator. The equipment may
or may not perform the loading and unloading of the work.
Autoradiography
A technique that uses X-ray film to visualize radioactively labeled
molecules or fragments of molecules; used in analyzing length and
number of DNA fragments after they are separated by gel
electrophoresis.
Autosome
A chromosome not involved in sex determination. The diploid human
genome consists of 46 chromosomes, 22 pairs of autosomes, and 1 pair
of sex chromosomes.
Autotrophs
One of two categories in which microorganisms are classified on the
basis of their carbon source. Autotrophs use carbon dioxide as a
carbon source.
A
| B |
C |
D |
E |
F |
G |
H |
I |
K |
L |
M |
N |
O |
P |
Q |
R |
S |
T |
U |
V |
W |
X |
Y |
Z
Pharmaceutical
Abbreviations | Abbreviations
in product information leaflets and literature
Acronyms |
Glossary of Terms |
Abbreviations used in
the British Pharmaceutical
|