OQ (Operational Qualification)
Documented verification that aspects of a facility system that can affect
product quality perform as intended throughout anticipated operating ranges.
Oral
Relating to the mouth.
Oral Product
A pharmaceutical product meant to be introduced through the mouth in the
form of a tablet, capsule, or suspension.
Oral Solid Dosage Drug
Formulated in a solid or powder form for patient to ingest orally.
Orbital Welding
Automatic or machine welding of tubes or pipe in-place with the electrode
rotating (or orbiting) around the work. Orbital welding can be done with the
addition of filler material or as a fusion process without the addition of
filler.
Organelles
Membrane-surrounded structures found in eukaryotic cells; they contain
enzymes and other components required for specialized cell function.
Organic
Organic matter is a broad category that includes both natural and man-made
molecules containing carbon and hydrogen. All living matter in water is made
up of organic molecules. The most common are by-products of vegetative decay
such as tannins, lignins, and humic acid.
Organic Peroxide
An organic compound that contains the bivalent -0-0- structure and which
may be considered to be a structural derivative of hydrogen peroxide where
on or both of the hydrogen atoms have been replaced by an organic radical.
Organic peroxides can present an explosion hazard (detonation or
deflagration) or they can be shock sensitive. They can also decompose into
various unstable compounds over an extended period.
Organism
A single, autonomous living thing. Bacteria and yeasts are organisms;
mammalian and insect cells used in culture are not.
Origin
Point or region where DNA replication is begun. Often abbreviated Ori.
Orphan Drug
The FDA grants Orphan Drug status to one company for a drug that is
believed to substantially increase the life expectancy of the treated
patient for a particular disease. This excludes other companies from
receiving an FDA license to produce a similar drug for a finite period
(usually 7 years), thereby allowing the company producing the drug to
recuperate their R&D expenses.
OS
Osmosis
The diffusion of a solvent through a semipermeable membrane from a solution
of higher concentration to one of lower concentration until there are equal
concentrations of fluid on both sides of the membrane.
Osmotic Pressure
Pressure generated by the osmotic flow of water through a membrane into a
(aqueous) phase containing a solute in a higher concentration.
Out of Specification
An examination, measurement, or test result that does not comply with
preestablished criteria.
Overlapping Clones
Oxidation (on metals)
The formation of an oxide layer on a metal surface. When oxidation occurs
because of welding, it is visible as discoloration. The discoloration or
heat tint produced by oxidation has been associated with the onset of
corrosion in stainless steel piping systems.
Oxide Thickness
The depth at which the oxide signal has fallen to half the maximum peak
height. Typical values for well electropolished 316L stainless steel range
from 20 to 50 angstroms (Å).
Oxide Layer
In welding, an area usually located in the heat-affected zone (HAZ) of the
weldment where an oxidation reaction has taken place.
Oxidizer
A material other than a blasting agent or explosive, that readily yields
oxygen or other oxidizing gas, or that readily reacts to promote or initiate
combustion of combustible materials. Oxidizers are subdivided as follows:
- 1. Class 4 - An oxidizer that can undergo an explosive reaction due
to contamination or exposure to thermal or physical shock. In addition,
the oxidizer will enhance the burning rate and may cause spontaneous
ignition of combustible materials.
- 2. Class 3 - An oxidizer that will cause a severe increase in the
burning rate of combustible materials with which it comes in contact or
that will undergo vigorous, self-sustained decomposition due to
contamination or exposure to heat.
- 3. Class 2 - An oxidizer that will cause a moderate increase in the
burning rate or that may cause spontaneous ignition of combustible
materials with which it comes in contact.
- 4. Class 1 - An oxidizer whose primary hazard is that it slightly
increases the burning rate but does not cause spontaneous ignition when
it comes in contact with combustible materials.
Ozone
Formed by an electric discharge or by the slow combustion of
phosphorus, ozone is a modified and condensed form of oxygen, in which
three atoms of oxygen are combined to form the molecule, O3. Because it
is a powerful oxidizing agent it is used in deionized water systems to
kill bacteria and to reduce by oxidation the amount of Total Organic
Carbon (TOC) in the water. Air containing a perceptible amount of ozone
has an odor suggesting chlorine or sulfurous acid gas.