Glossary

An examination, measurement, or test result that does not comply with preestablished criteria.

A seal that is outside the product area in the outermost part of a mechanical seal assembly.

The ultimate result of a medical test or treatment given to patient. General, patient-oriented outcomes are overall survival rates, disease-free survival rates, treatment-related morbidity, and mortality.

Release of molecular substances in the gaseous or vapor state from a material.

Genes the sequence characteristics of which are sufficiently outside the normal range to create problems for ab initio (from the beginning) gene prediction.

(ICH Q10) Activities conducted by a contract acceptor under a written agreement with a contract giver.

Operational Verification

Ovalbumin

Drugs that can be sold from licensed dealers without professional supervision and without prescriptions. These drugs are suitable for self-medication for minor diseases and symptoms.

OEE is a hierarchy of metrics which focus on how effectively a manufacturing operation is utilized. The results are stated in a generic form which allows comparison between manufacturing units in differing industries.

The liquid portion of a broth after centrifugation when solid particulates have settled out; describes the part of the centrifuge apparatus that holds the liquid separate from the solids (the underflow).

(ISO) In a calculator, the state in which the calculator is unable to accept or process the number of digits in the entry or in the result.

(IEEE) An exception that occurs when the result of an arithmetic operation exceeds the size of the storage location designated to receive it.

A cycle that results in a complete kill of a bioindicator with a population of no less than 10 to the fifth spores.

The protrusion of weld metal beyond the weld toes or weld root. Also, in an orbital weld, that amount by which the end of the weld bead overlaps the beginning of the weld bead (not including the downslope) on a single-pass weld.

Capping and crimping.

Organic Volatile Impurity

Considered to be the entity that “owns” the product, usually the manufacturer. The Owner may be represented by corporate management or by a process engineer.

The body upon which final possession or use rests.

Substance that, upon deposition onto a surface or product of interest, results in the formation of an oxide (O2/O3) or participates in a redox reaction.

A common form of electrochemical reaction that is the combining of oxygen with various elements and compounds. NOTE: When addressing issues relating to stainless steel, oxidation can be beneficial if it is involved with the forming of the passive layer; detrimental if it is involved in the formation of corrosion.

An area usually located in the heat-affected zone of the weldment where an oxidation reaction has taken place.

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).

Any 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.