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Hairpin
A double helical region formed by base pairing between adjacent
(inverted) complementary sequences in a single strand of RNA or DNA.
Haloenzyme
An enzyme that contains a non-protein component.
Halogen
One of the chlorine group (bromine, chlorine, fluorine, iodine) of
elements, all univalent; they form monobasic acids with hydrogen,
and their hydroxides (fluorine forms none) are monobasic acids. The
radioactive element, astatine, also belongs to the halogen group.
Halophile
An organism that displays accelerated growth or is dependent on
high salt concentrations.
Handshake
Requires the recipient of an electronic data record to acknowledge
to the sender that the record has been received.
Handwritten Signature
The scripted name or legal mark of an individual handwritten by
that individual and executed or adopted with the present intention
to authenticate a writing in a permanent form. The act of signing
with a writing or marking instrument such as a pen or stylus is
preserved. The scripted name or legal mark, while conventionally
applied to paper, may also be applied to other devices that capture
the name or mark. (also see:
Haploid
A single set of chromosomes (half the full set of genetic
material), present in the egg and sperm cells of animals and in the
egg and pollen cells of plants. Human beings have 23 chromosomes in
their reproductive cells.
Hardness
Concentration of calcium and magnesium salts in water. Hardness
originally referred to the soap-consuming power of water; as such it
is sometimes also taken to include iron and manganese. "Permanent
hardness" also known as "noncarbonated hardness " is
the excess of hardness over alkalinity. "Temporary hardness"
also known as "carbonated hardness" is equal or less than
the alkalinity. Permanent hardness can cause boiler or pipe scale
and failure of reverse osmosis membranes.
Harvesting
The separation of cells from growth media. It can be accomplished
by filtration, precipitation, or centrifugation.
Hazardous Chemical Reaction
A reaction which generates pressure or byproducts which could cause
injury, illness or harm to humans, domestic animals, livestock or
wildlife.
Hazardous Occupancy - Group H - (California
Building Code)
Group H occupancies include buildings or structures, or portions
thereof, that involve the manufacturing, processing, generation or
storage of materials that constitute a high fire, explosion, or
health hazard. There are eight divisions in this Group:
- 1. Division 1 - Occupancies with a quantity of material in
the building exceeding regulation set limits and that present a
high explosion hazard, such as blasting agents, fireworks, black
powder, certain oxidizers and detonatable unstable (reactive)
materials, and other materials (refer to Code for more details).
- 2. Division 2 - Occupancies where combustible dust is
manufactured, used, or generated in such a manner that
concentrations and conditions creates fire or explosion
potential, or occupancies where materials exceeding regulation
set limits present a moderate explosion hazard or a hazard from
accelerated burning, such as some organic peroxides, pyrophoric
gases, flammable or oxidizing gases, some nondetonatable
unstable (reactive) materials, and other materials (refer to
Code for more details).
- 3. Division 3 - Occupancies where flammable solids, other
than combustible dust, are manufactured, used or generated, or
occupancies where materials exceeding regulation set limits
present a high physical hazard, such as some organic peroxides
and oxidizers, pyrophoric liquids or solids, flammable solids in
storage, flammable or oxidizing cryogenic fluids, and other
materials (refer to Code for more details).
- 4. Division 4 - Repair garages not classified as Group S,
Division 3 Occupancies.
- 5. Division 5 - Aircraft repair hangars not classified as
Group S, Division 5 Occupancies, and heliports.
- 6. Division 6 - Semiconductor fabrication facilities and
comparable research and development areas in which hazardous
production materials (HPM) are used and the aggregate quantity
of materials exceeds those set by regulations. Such facilities
and areas shall be designed and constructed following a
different set of regulations.
- 7. Division 7 - Occupancies having quantities of materials in
excess of those set by regulations, and that are health hazards,
such as corrosives (except stationary lead-acid battery
systems), toxic and highly toxic materials, irritants,
sensitizers, and other health hazards (refer to Code).
- 8. Division 8 - Laboratories and similar areas used for
scientific experimentation or research having quantities of
materials not in excess of those set by regulations, and not
otherwise classified as Group B, Division 2 Occupancies (refer
to Code for more details).
- Hazardous Substance
A substance which by reason of being explosive, flammable, toxic,
poisonous, corrosive, oxidizing, irritant or otherwise harmful, is
likely to cause injury.
Haze
The abnormal appearance of a localized diminishing in brightness
or luster of a surface when compared to the adjacent surfaces.
Health Hazard
Classification of a chemical for which there is statistically
significant evidence based on at least one study conducted in
accordance with established scientific principles that acute or
chronic health effects may occur in exposed persons. The term "health
hazard" includes chemicals that are carcinogens, toxic or
highly toxic agents, reproductive toxins, irritants, corrosives,
sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents that
act on the hematopoietic system, and agents that damage the lungs,
skin, eyes or mucous membranes.
Heat
A form of energy associated with the motion of atoms or molecules
in solids and capable of being transmitted through solid and fluid
media by conduction, through fluid media by convection, and
through empty space by radiation. Two important characteristics of
heat are:
- 1. Heat cannot be destroyed, only transferred from on body to
another, or converted to another form of energy.
- 2. Heat always flows from the warmer to the colder substance.
- Heat Affected Zone (HAZ)
That portion of the base metal that has not been melted but whose
microstructure or mechanical properties have been altered by the
heat of welding, brazing, soldering, forming, or cutting.
Heat Labile
Able to be destroyed or altered by high temperature. Heat labile
pharmaceuticals are sterilized by filtration.
Heat Number
An alphanumeric identification of a stated tonnage of metal
obtained from a continuous melting in a foundry furnace.
Heat of Vaporization
The amount of heat needed to change a unit volume from a liquid
to a vapor at a given pressure without a temperature change.
Heavy Metals
High molecular weight metal ions, such as lead. Known for their
interference with many processes, and "poisoning" of
catalysts, membranes, and resins.
HeLa Cells
An established line of human cervical carcinoma cells used to
study the biochemistry and genetics of human cell growth.
Helix
A spiral, staircase-like, structure with a repeating pattern
described by two simultaneous operations, rotation, and
translation. It is the natural conformation of many biological
polymers.
Hematin
An iron protoporphyrin differing from heme in that the central
iron atom is in the ferric (Fe+++) rather than the ferrous (Fe++)
state; the prosthetic group of methemoglobin.
Hematopoietic
Heme
Hemoglobin
The red, respiratory conjugated protein of erythrocytes,
consisting of approximately 6 percent heme and 94 percent globin
(a protein).
Hemophilia
A hereditary, plasma-coagulation disorder, principally affecting
males but transmitted by females, and characterized by excessive,
sometimes spontaneous, bleeding.
Hemopoietic
Pertaining to or related to the formation of blood cells.
HEPA (High Efficiency Particulate Air) Filters
Filters with a minimum efficiency of 99.97% for 0.3µm
particle size as determined by test. The test can be by the
monodispersed dioctyl phthalate (DOP) method or other equally
sensitive method. When operated at design velocity, larger and
smaller particles are captured at higher efficiencies. HEPA
filters are made of compressed and bonded micro-fiberglass or
Teflon® corrugated to produce a high surface area in a small
area panel of filter medium. Employed in unidirectional airflow
benches, air handlers, and as terminal air supply filters in
cleanrooms.
Heparin
A sulphur containing polysaccharide that stops blood from
clotting by preventing the conversion of prothrombin to thrombin
and by neutralizing thrombin. It is contained in the mast cells
and is extractable from various tissues, notably the lung.
Hepatotoxin
A toxin that is destructive to parenchymal (specific tissue)
cells of the liver.
Heredity
Transfer of genetic information from parent cells to progeny.
Heterotrophs
One of two categories in which microorganisms are classified on
the basis of their carbon source. Heterotrophs use organic
compounds such as carbohydrates, lipids, and hydrocarbons as a
carbon and energy source.
Heterozygosity
The presence of different alleles at one or more loci on
homologous chromosomes.
High Purity Process Systems
The equipment that includes the stainless steel vessels, tube,
pipe, fittings, and valves used to manufacture and transport drug
products.
Hold-up Volume
The volume of liquid remaining in a vessel or piping system after
it has been allowed to drain.
Hollow Fiber
Refers to reverse osmosis and ultrafiltration membranes formed
into small diameter (about 0.05" I.D.) tubes. The inner
surface is a very thin (RO or UF) membrane skin supported by a
thicker porous outer layer that gives the tube its strength.
Hollow fibers are used in bundles of 1,000 or more in a single
cartridge shell. Water is forced through the center (upstream
surface) of each tube and purified permeate is collected from the
outer wall (downstream surface).
Homeobox
A short stretch of nucleotides whose base sequence is virtually
identical in all the genes that contains it. It has been found in
many organisms from fruit flies to human beings. In the fruit fly,
a homeobox appears to determine when particular groups of genes
are expressed during development.
Homologous Chromosome
Chromosome containing the same linear gene sequences as another,
each derived from one parent.
Homology
Similarity in DNA or protein sequences between individuals of the
same species or among different species.
Hormone
A type of chemical messenger, occurring both in plants and
animals, that acts to inhibit or excite metabolic activities. Its
site of production is distant from the site of biological
activity.
Host Vector (HV) System
The host is the organism into which a gene from another organism
is transplanted. The guest gene is carried by a vector, which is a
larger DNA molecule, such as a plasmid, or a virus into which that
gene is genetically engineered and which then propagates in the
host. NIH Guidelines under Appendix E. - Certified Host-Vector
Systems contains a list of derivatives host-vector systems
previously classified as Host-Vector 1 Systems or Host-Vector 2
Systems, they are: Bacillus subtilis, Saccharomyces Cerevisiae,
Escherichia coli, Neurospora crassa, Streptomyces, and Pseudonomas
putida. (also see:
HPLC (High Pressure Liquid Chromatography)
Sometimes called high-performance liquid chromatography, is a
separation technique based on a solid stationary phase and a
liquid mobile phase. Separations (into distinct bands) are
achieved by partition, adsorption, or ion-exchange processes,
depending upon the type of stationary phase used. Each band is
then profiled as the solvent flows through a UV detector, or by
fluorescence, or refractive index detectors.
HSA (Human Serum Albumin)
The main protein constituent of human serum. It has no prosthetic
group and is soluble in water and dilute salt solution. It is
sometimes used in the treatment of shock, hypoproteinemia, and
erythroblastosis fetalis.
Human Gene Therapy
Insertion of normal DNA directly into cells to correct a genetic
defect.
Human Genome
The full collection of genes needed to produce a human being.
Human Genome Initiative
Collective name for several projects begun in 1986 by DOE to:
- 1. Create an ordered set of DNA segments from known
chromosomal locations.
- 2. Develop new computational methods for analyzing genetic
map and DNA sequence.
- 3. Develop new techniques and instruments for detecting and
analyzing DNA.
- This DOE initiative is now known as the Human Genome Program.
The national effort, led by DOE and NIH, is known as the Human
Genome Project.
- Human Genome Project
Humidity Ratio
Huntington's Disease
An adult-onset disease characterized by progressive mental and
physical deterioration; it is caused by an inherited dominant gene
mutation.
Hybrid Systems
Combination of electronic and paper records, common in today's
analytical labs, in which raw data is recorded electronically to
reconstruct the analysis, but the final results are printed and
signed on paper. FDA does not prohibit hybrid systems but has
expressed some concerns about their usefulness.
Hybridization
The process of joining two complementary strands of DNA or one
each of DNA and RNA to form a double-stranded molecule.
Hybridoma
A hybrid cell resulting from the fusion of a specific antibody
producing spleen cell with a myeloma cell. The hybrid cell has the
growth characteristics of the myeloma component and the antibody
secreting characteristics of the spleen cell and will multiply to
become a source of large quantities of pure, monoclonal antibody.
Hydrogen Peroxide (H2O2)
A colorless, heavy, strongly oxidizing, unstable liquid used
principally in aqueous solutions as an antiseptic, bleaching
agent, oxidizing agent, and laboratory reagent. In the vapor
phase, as an airborne sterilant.
Hydrolysis
A chemical reaction between water and organic compounds,
particularly esters, ketones, and alcohols. This reaction can lead
to breakdown of some proteins.
Hydrophilic
Having a strong affinity for water. Its opposite, hydrophobic.
Hydrophobic
Non-wetting; water repelling.
Hydrotest
A pressure test of piping, pressure vessels, or
pressure-containing parts, usually performed by pressurizing the
internal volume with water at a pressure determined by the
applicable code or to test the integrity of a process system.
Hygienic
Of, or pertaining to, equipment and piping systems that by
design, materials of construction, and operation provide for the
maintenance of cleanliness (pyrogen free but not sterile) so that
products produced by these systems will not adversely affect human
or animal health.
Hygienic Clamp Joint
A tube outside diameter union consisting of two neutered ferrules
having flat faces with a concentric groove and mating gasket that
is secured with a clamp, providing a nonprotruding, recessless
product contact surface. Tri-clamp is a Tri-Clover
proprietary name; consequently, it should not be used to describe
the above-mentioned fitting unless that particular brand is used.
Hygroscopicity
The affinity for absorbing water.
Hypochlorite
A weak, unstable salt of hypochlorous acid used in aqueous
solutions as a bleach, oxidizer, deodorant, and disinfectant.
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Pharmaceutical
Abbreviations | Abbreviations
in product information leaflets and literature
Acronyms |
Glossary of Terms |
Abbreviations used in
the British Pharmaceutical
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