Glossary

An iterative operating procedure for ascertaining and analyzing the causes of operations problems in an effort to determine what can be done to solve or prevent them. Root cause analysis deals with finding real causes of a problem rather than continuing to deal with the immediate obvious symptoms.

A rotational fluid flow can contain streamlines that loop back on themselves. Hence, fluid particles following such streamlines will travel along closed paths. Bounded (and hence nonuniform) viscous fluid exhibit rotational flow, typically within their boundary layers. Since all real fluids are viscous to some amount, all real fluid exhibit a level of rotational flow somewhere in their domain. Regions of rotational flow correspond to the regions of viscous losses in a fluid. Inviscid fluids flows can also be rotational, but these are special nonphysical cases. For an inviscid fluid flow to be rotational, it must be set up that way by initial conditions. The amount of rotation (called the velocity circulation) in an inviscid fluid flow is conserved, provided that the fluid is also barotropic and subject only to conservative body forces. This conservation is known as Kelvin’s Theorem of constant circulation.

In stainless steel systems utilized in the biopharmaceutical/life science industry, is a general term used to describe a variety of discolorations on the product contact surfaces, caused by variations in hydration agents and the formation of metallic (primarily iron) oxides and/or hydroxides from either external sources, or from alteration of the chromium rich “passive” layer.

A general term used to describe a variety of discolorations in high purity stainless steel biopharmaceutical systems. It is composed of metallic (primarily iron) oxides and/or hydroxides. Three types of rouge have been categorized:Class I rouge: a rouge that is predominantly particulate in nature. It tends to migrate downstream from its origination point. It is generally orange to red-orange in color. These particles can be wiped off a surface and are evident on a wipe. Surface composition of the stainless steel under the rouge remains unchanged.Class II rouge: a localized form of active corrosion. It occurs in a spectrum of colors (orange, red, blue, purple, grey, black). It can be the result of chloride or other halide attack on the surface of the stainless steel.Class III rouge: a surface oxidation condition occurring in high temperature environments such as pure steam systems. The system’s color transitions to gold, to blue, to various shades of black, as the layer thickens. This surface oxidation initiates as a stable layer and is rarely particulate in nature. It is an extremely stable form of magnetite (iron sesquioxide, Fe3O4).

Consists of the finer irregularities of the surface texture usually including those irregularities that result from the manufacturing process. These are considered to include traverse feed marks and other irregularities within the limits of the roughness sampling length.

The arithmetic average of the absolute values of the profile height deviations recorded within the evaluation length and measured from the mean line. Ra is equal to the sum of the areas of the profile (above and below the mean line) divided by the evaluation length L, which generally includes several sampling lengths or cutoffs. For graphical determination of roughness, the height deviations are measured normal to the chart centerline.This measurement conforms to ANSI/ASME B46.1 “Surface Texture – Surface Roughness, Waviness and Lay”. Ra [also known as centerline arithmetic average (AA) and centerline average (CLA)] 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.

(IEEE) A subprogram that is called by other programs and subprograms. Note: This term is defined differently in various programming languages.

Lubrication, minor adjustments, inspection, monitoring, and other activities where skilled individuals perform the maintenance and step by step procedures are not required. The determination is made by the frequency of the activity and skill of the person relative to the complexity of the activity such that detailed instructions are not required.

Recommended Practice

Recombinant Protein

Respiratory Protective Equipment

Retinal Pigment Epithelium

Revolutions Per Minute

Risk Priority Number

Recovery Point Objective

The RNA molecules which are essential structural and functional components of ribosomes, the organelles responsible for protein synthesis. The different rRNA molecules are known by their sedimentation (Svedberg; symbol S) values. E. coli ribosomes contain one 16S rRNA molecule (1541 nucleotides long) in the same (small) sub-unit and a 23S rRNA (2904 nucleotides) and a 5S rRNA (120 nucleotides) in the large sub-unit. These three rRNA molecules are synthesized as part of a large precursor molecule which also contains the sequences of a number of tRNAs. Special processing enzymes cleave this large precursor to generate the functional moieties.

Requirements Specification

An Electronic Industries Association (EIA) standard for connecting electronic equipment. Data is transmitted and received in serial format.

Recommended Standard number 232, revision C from the Electronic Industries Association (EIA). It provides an interface between data terminal equipment and data communications equipment employing serial binary data interchange.

Relative Standard Deviation

Reference Standard Endotoxin

Respiratory Syncytial Virus

Resistance Temperature

Resistance Temperature Detector

Recovery Time Objective