Ultra Low Penetration Air filters (ULPA)
Extended media dry filters in a rigid frame that have a minimum
particle-collection efficiency of 99.999% for particles greater than or
equal to 0.12µm in size. Most commonly used in microelectronics, few
uses in pharmaceuticals.
Ultracentrifugation
The separation of macromolecules on the basis of their density and shape
using the gravitational field generated in a high-speed centrifuge. It is
used in rDNA work for the separation of RNA and DNA, and for purification
of plasmids.
Ultrafiltration
Molecular sieves; membranes with pores small enough to remove large
molecules. Rated in terms of nominal molecular weight cutoff. A 10,000
Dalton (molecular weight) UF membrane, for example, will remove bacterial
pyrogens that are typically in the range of 20,000 Daltons.
Ultrafine Particle
Particle with an equivalent diameter less than 0,1µm. ISO 14644-1
Ultrapure Water
Water with a specific resistance higher than 1 megohm-cm. In the
laboratory, it usually refers to Type I reagent grade water. Anything in
laboratory water that is not H2O is an impurity. Although chemically pure
water is not attainable, ultrapure water systems are now capable of
reducing impurities down to the limits of detection.
Ultraviolet Oxidation
Ultraviolet radiation is employed in water purification for the
photochemical oxidation of organic impurities resulting in HPLC grade
water with organic impurity levels below 0.0005 absorbance units.
Ultraviolet Radiation
Light in the wavelength region 200-300 nm, used to detect RNA or DNA that
has the fluorescent dye, ethidium bromide, bound to it.
Ultraviolet Sterilizer
Ultraviolet lamps used to kill microorganisms in water.
Ultraviolet TOC Reduction
An ultraviolet source, which partially oxidizes organic compounds to
ionic species that can be removed. It relies on 185 nm (nanometer)
radiation from "ozone producing" mercury lamps (along with 254nm
germicidal radiation). Generally has a longer contact time than
sterilization alone.
Unicellular
Composed of only a single cell.
Unidirectional Airflow
Previously referred as "laminar" airflow, is the "rectified
airflow through the entire cross section of a clean zone with a steady
velocity and approximately parallel streamlines. This type of airflow
results in a directed transport of particles from the clean zone".
ISO 14644-4.
Uniform Building Code (UBC)
The most widely adopted model building code in the United States is a
performance based document meeting the needs of government units charged
with the enforcement of building regulations.
Uniform Fire Code™
The premier model fire code in the United States sets forth provisions
necessary for fire prevention and fire protection. Published by the
International Fire Code Institute (IFCI) and endorsed by the Western Fire
Chiefs Association, the International Association of Fire Chiefs, and the
International Conference of Building Officials (ICBO), it contains code
provisions compatible with the Uniform Building Code, and standards
referenced from the code provisions.
Uniform Mechanical Code™
A document that provides a complete set of requirements for the design,
construction, installation, and maintenance of heating, ventilating,
cooling and refrigeration systems; incinerators and other heat-producing
appliances.
Uniform Zoning Code™
A code dedicated to intelligent community development and to the benefit
of the public welfare by providing a means of promoting uniformity in
zoning laws and enforcement.
Unit Dose Defines an SVP that must be administered in one dose.
Unused contents must be discarded.
United States Pharmacopeia (U.S.P.)
Universal Precautions
Precautions taken when handling, storing, transporting, or shipping items
or specimens containing, or contaminated with human blood and body fluids:
all such materials are treated as infectious.
Unsaturated Fatty Acid
A fatty acid containing one or more double bonds.
Unstable (Reactive) Material
A material other than an explosive, which in the pure state or as
commercially produced will vigorously polymerize, decompose, condense or
become self-reactive and undergo other violent chemical changes, including
explosion, when exposed to heat, friction or shock, or in the absence of
an inhibitor or in the presence of contaminants or in contact with
noncompatible materials. Unstable, reactive materials are subdivided as
follows:
1. Class 4 - Materials that in themselves are readily capable of
detonation or of explosive decomposition or explosive reaction at normal
temperatures and pressures. This class includes materials that are
sensitive to mechanical or localized thermal shock at normal
temperatures and pressures.
2. Class 3 - Materials that in themselves, are capable of detonation
or of explosive decomposition or explosive reaction but which require a
strong initiating source or which must be heated under confinement
before initiation. This class includes materials that are sensitive to
thermal or mechanical shock at elevated temperatures and pressures.
3. Class 2 - Materials that in themselves are normally unstable and
readily undergo violent chemical change but do not detonate. This class
includes materials which can undergo chemical change with rapid release
of energy at normal temperatures and pressures and which can undergo
violent chemical change at elevated temperatures and pressures.
4. Class 1 - Materials that in themselves are normally stable but
which can become unstable at elevated temperatures and pressures.
Upward Compatibility
Refers to software that runs not only on the computer for which it was
designed, but also on newer and more powerful models. In the context of
CFR 21 Part 11, compatibility plays an important role in ensuring that
legacy data can be moved (copied) accurately and completely to a new
system. Without it, legacy systems would have to be maintained as long as
the records contained in them are kept. (also see:
Uracil
A pyrimidine base important as a component of ribonucleic acid (RNA).
Uracil is capable of forming a base pair with adenine.
User Interface
Dials, knobs, operating system commands, graphical display formats, and
other devices provided by a computer or a program to allow users to
communicate and use the computer or program. A Graphical User Interface
(GUI) provides its user with a "picture oriented" way to
interact with technology.
U.S.P. (United States Pharmacopeia)
A compendium of testing and purity criteria for pharmaceuticals,
ancillaries, and raw materials. (also see: National Formulary (NF))
Utility Systems
Facility wide systems not tailored to a specific process and that do not
have contact with the drug substance or potential drug substance.