BBS-Systems Fachwortverzeichnis

A
Annealing
A treatment process for steel for the purpose of reducing hardness, improving machinability, facilitating cold working, or producing a desired mechanical, physical, or other property.

Anomaly
A localized surface area that is out of specifications to the surrounding area, and is classified as abnormal.

Arc strike
A discontinuity consisting of any localized remelted metal, heat-affected metal, or change in the surface profile of any part of a weld or bas metal resulting from an are.

Aseptic
Free of pathogenic (causing or capable of causing disease) microorganisms.

Aseptic processing
Operating in a manner that prevents contamination of the process

Autogenous weld
A weld made by fusion of the base material without the addition of filler (see gas tungsten arc welding).
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B
Biologics
Therapeutic or diagnostic products generated and purified from natural sources.

Biopharmaceuticals
Ethical pharmaceutical drugs derived through bioprocessing.

Bioprocessing
The creation of a product utilizing a living organism.

Bioprocessing equipment
Equipment, systems, or facilities used in the creation of products utilizing living organisms.

Break
A discontinuity in the face of a fitting.

Burn-through
Excessive melt-through or a hole through the root bead.

Burr
Excess material protruding from the edge resulting from cutting

Butt joint
A joint between two members lying approximately in the same plane.
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C
Cavitation
A condition of liquid flow where, after vaporization of the liquid, the subsequent collapse of vapor bubbles can produce surface damage.

Certification
Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable.

CGMPs
Current Good Manufacturing Practices. Current design and operating practices developed by the pharmaceutical industry to meet FDA requirements as published in the Code of Federal Regulations, Chapter 1, Title 21, Parts 210 and 211.

Chromatography
The purification of substances based on the chemical, physical, and biological properties of the molecules involved.

Clean
Free of dirt, residues, detergents, or any contaminants that may affect or adulterate the product or process.

Clean-in-place (CIP)
Internally cleaning a piece of equipment without relocation or disassembly. The equipment is cleaned but not necessarily sterilized. The cleaning is normally done by acid, caustic, or a combination of both, with Water-for-Injection (WFI) rinse.

Clean steam
Steam free from boiler additives that may be purified, filtered, or separated. Usually used for incidental heating in pharmaceutical applications.

Cloudiness
The appearance of a milky white hue across some portion of a surface resulting from the electropolish process.

Cluster porosity
Porosity that occurs in clumps or clusters.

Concavity
A condition in which the surface of a welded joint is depressed relative to the surface of the tube or pipe. Concavity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes.

Consumable insert
A ring of metal placed between the two elements to be welded that provides filler for the weld, when performed with fusion welding equipment. A consumable insert can also be used for the root pass in a multiple pas weld with the addition of filler wire (also called insert ring).

Convexity
A Condition in which the surface of a welded joint is extended relative to the surface of the tube or pipe. Convexity is measured as a maximum distance from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes.

Cracks
Fracture-type discontinuities characterized by a sharp tip and high ratio of length and width to opening displacement. A crack may not be detected with a stylus. A linear crack will produce a liquid penetrant indication during liquid penetration inspection, x-ray, or ultrasound.

Crater
A depression at the termination of a weld bead.

Crater cracks
Cracks that form in the crater, or end, of the weld bead.
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D
Dead leg
An area of entrapment in a vessel or piping ring that could lead to contamination of the product.

Defects
Discontinuities that by nature or accumulated effect (for example, total crack length) render a part or standards or specifications. This term designates rejectability. See also discontinuity.

Delamination
Separation into constituent layers.

Demarcation
A localized area that is dissimilar to the surrounding areas with a defined boundary after electropolishing.

Dent
A large, smooth-bottomed depression whose diameter or width is greater than its depth and which will not produce an indication.

Dirty
A relative term indicating the condition of being contaminated.

Discoloration
Any change in surface color from that of the base metal. Usually associated with oxidation occurring on the weld and heat-affected zone on the outside diameter and inside diameter of the weld joint as a result of heating the metal during welding. Colors may range from pale bluish-gray to deep blue, and from pale straw color to a black crusty coating.

Discontinuity
Interruption of the typical structure of a weldment, such as a lack of homogeneity in the mechanical, metallurgical, or physical characteristics of the material or weldment. A discontinuity is not necessarily a defect.

Downslope
That part of an automatic orbital weld sequence during which the welding current is gradually reduced prior to extinguishing of the welding arc. The downslope portion of a welded joint is seen as a tapering of the end of the weld bead with a reduction of penetration from the beginning to the end of the downslope so that the final weld bead is small with minimal penetration.

Dross
A concentration of impurity formed in the weld puddle. It floats to the surface when the metal solidifies (also called slag).
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E
Elastomeric material
A material that can be stretched or compressed repeatedly and, upon immediate release of stress, will return to its approximate original size.

Ethical pharmaceutical
A controlled substance for the diagnosis or treatment of disease.

Excessive penetration
Weld penetration that exceeds the acceptance limit for inside diameter convexity (see convexity).
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F
Fermentation
The biochemical synthesis of organic compounds by microorganisms or cultivated cells.

Fermentor (fermenter)
A vessel for carrying out fermentation

Full penetration
A weld joint is said to be fully penetrated when the depth of the weld extends from its face into the weld joint so that the joint is fully fused. For a tube-to-tube weld, no unfused portions of the weld joint shall be visible on the inside diameter of a fully penetrated weld.

Fusion
The melting together of filler metal and base metal, or of base metal only, that results in coalescence.

Fusion welding
Welding in which the base material is fused together without the addition of filler material to the weld (see gas tungsten-arc welding).
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G
Gas tungsten-arc welding (GTAW)
An arc welding process that produces coalescence of metals by heating them with an arc between a tungsten (nonconsumable) electrode and the work. Shielding is obtained from a gas or gas mixture. (This process is sometimes called TIG welding, a nonpreferred term). GTAW may be performed by adding filler material to the weld, or by a fusion process in which no filler is added.

GMP facility
A facility designed, constructed, and operated in accordance with cGMP guidelines established by the FDA.
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H
Harvesting
The separation of cells from growth media. This can be accomplished by filtration, precipitation, or centrifugation.

Heat number
An alphanumeric identification of a stated tonnage of metal obtained from a continuos melting in a furnace.

Heat-affected zone
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 or cutting.

Hold-up volume
The volume of liquid remaining in a vessel or piping system after it has been allowed to drain.

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.

Hygienic
of or pertaining to equipment and piping systems that by design, materials of construction, and operation provide for the maintenance of cleanliness 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.

Hygienic joint
A tube outside diameter union providing a nonprotruding, recessless product contact surface.
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I
Icicles
Localized regions of excessive penetration, which usually appear as long, narrow portions of weld metal on the weld underbead (see convexity and excessive penetration).

Inclusions
Particles of foreign material in a metallic matrix. The particles are usually compounds such as oxides, sulfides, or silicates, but may be any substances foreign to and essentially insoluble in the matrix.

Incomplete fusion (or lack of fusion)
A weld discontinuity in which fusion did not occur between weld metal and faces or between adjoining weld beads. Also, in welding of tubing, when the weld fully penetrates the wall thickness but misses the joint, leaving some portion of the inner (inside diameter) weld joint with unfused edges.

Incomplete penetration (or lack of penetration)
A groove weld in which the weld metal does not extend completely through the joint thickness.

Indication
A condition or an anomaly of a localized area that has not been classified as being accepted or rejected.
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J
Joint penetration
The depth that a weld extend from its face into a joint, exclusive of reinforcement.
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L
Lack of fusion after reflow
A discontinuity in welding of tubing where, after a reflow or second weld pass has been made, the original joint has still not been consumed, leaving the weld joint with unfused edges on the inner surface.

Lamellar tears
Terrace-like fractures in the base metal with a basic orientation parallel to the wrought surface: caused by the high stress in the thickness direction that results from welding.

Laminations
Clongated defects in a finished metal product, resulting from the rolling of a welded or other part containing a blowhole. Actually, the blowhole is stretched out in the direction of rolling.

Linear porosity
Porosity that occurs in a linear pattern. Linear porosity generally occurs in the root pass from inadequate joint penetration.

Liquid penetrant indication
Refer to ASME BPVC, Section V, Article 6, para. T-600, for testing an anomaly or an indication.
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M
Machine welding
Welding with equipment that performs the welding operation under the constant observation and control of a welding operator. The equipment may or may not perform the loading and unloading of the works (see automatic welding).

Manual welding
Welding in which the entire welding operation is performed and controlled by hand.

Material type
A commercial designation for a given chemistry range.

Maximum working pressure
The pressure at which the system is capable of operating for a sustained period of time.

Maximum working temperature
The temperature at which the system must operate for a sustained period of time. The maximum working temperature should relate to the maximum working pressure and the fluids involved.

Meandering
Of or pertaining to a weld bead that deviates from side to side across the weld joint rather than tracking the joint precisely.

Micron or micrometer (µm)
One-millionth of a meter.

Misalignment (mismatch)
Axial offset of the joint members

Miter
Two or more straight sections of tube matched and joined in a plane bisecting the angle of junction so as to produce a change of direction.
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N
Nick
A surface void anomaly caused by material removal or compression from the surface, whose bottom surface is usually irregular.

Nominal outside diameter
A numerical identification of outside diameter to which tolerances apply.

Nominal wall thickness
A numerical identification of wall thickness to which tolerances apply.

Nonuniform mechanical polishing marks
A localized surface polishing pattern that is dissimilar to the surrounding area.
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O
Off angle
A measurement of face-to-face squareness.

Off plane
A measurement of the offset between port centerlines or two planes.

Orange peel
An appearance of a pebbly surface.

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.

Overlap
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.

Owner/user
The body upon which final possession or use rests.

Oxidation
The formation of an oxide layer on a metal surface. When oxidation occurs as a result 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 layer
An area usually located in the heat affected zone of the weldment where an oxidation reaction has taken place.
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P
Passivation
A final treatment/cleaning process used to remove free iron or other anodic contaminants from the surfaces of corrosion-resistant steel parts such that uniform formation of a passive layer is obtained.

Passive layer
A passive oxidized film that form naturally on the stainless steel surface when exposed to air or similar oxidizing environment protecting the underlying base metal from corrosion.

Pope
Pope size is determined by diameter and schedule. For bioprocessing equipment, pipe does not include tube.

Pit
A small surface void resulting from a localized loss of base metal by corrosion or etching, or by the removal of surface inclusions during electropolishing or passivation. A pit may or may not produce an indication during liquid penetrant inspection.

Pitch
To cause to be set at a particular angle or slope. Degree of slope or elevation.

Porosity
Cavity-type discontinuities formed by gas entrapment during solidification.

Pressure rating
Pressure at which a system is designed to operate, allowing for applicable safety factors.

Product contact surface
A surface that contacts raw materials, process materials, and/or product.

Progressive polishing
A mechanical grinding procedure where a coarse grit material is used first and the successive operations use a finer and finer grit until the desired surface roughness is achieved.

Pure steam
Steam that is produced by a steam generator which, when condensed, meets requirements for Water-for-injection (WFI).

Pyrogen
a fever-producing substance.
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R
Ra
Leg of the arithmetic mean of the surface profile. Usually expressed in µ-in. As related to roughness (see ASME B46..).

Reflow
A second weld pass made to correct a lack of fusion or missed joint.

Reinforcement
See convexity
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S
Sanitar
See hygienic

Seal weld
A weld used to obtain fluid tightness as opposed to mechanical strength.

Self-draining
The elimination of all fluid from the system due to the force of gravity alone.

Semi-automatic arc welding
Arc welding with equipment that controls only the filler metal feed. The advance of the welding is manually controlled.

Service life
The life expectancy or number of cycles for which the unit will maintain its performance.

Size classification
The size of surface deficits is classified in two groups: macro, referring to indications that can be seen in adequate lighting without magnification, and micro, referring to indications that can be seen only with the aid of magnification.

Slag
A concentration of nonmetallic impurities (often oxides or nitrides) that forms in the weld pool and solidifies on the underbead or weld top surface. Sometimes referred to as dross.

Slope
An incline or deviation from the horizontal. A tube or pipe installed in the horizontal plane is said to slope if one end is positioned higher than the other.

Sparger
A device used to agitate, oxygenate, or aerate a liquid by means of compressed air or gas.

Spatter
The metal particles expelled during welding that do not form part of a weld.

Square cut
A tube end cut perpendicular to the tangent plane.

Squareness
Face-to-face perpendicularity.

Star burst
A type of indication created during the reaction of electrochemical etching process on the foreign or refractory material (dross) on the welds or base metal.

Steam in place (SIP)
The use of steam to sanitize or sterilize a piece of equipment without the use of an autoclave.

Sterile
Free from living organisms.

Sterility
The absence of all life forms.

Surface inclusion
Particles of foreign material in a metallic matrix. The particles are usually compounds such as oxides, sulfides, or silicates, but may be a substance foreign to and essentially insoluble in the matrix.

Surface residual
A foreign substance that adheres to a surface by chemical reaction adhesion, adsorption, or ionic bonding (for example, corrosion, rouging and staining).

System volume
Total volume of liquid in the system, including equipment, piping, valving and instrumentation.
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T
Transfer panel
A panel to which process and/or utilities are piped that mechanically precludes erroneous cross-connections.

Tube
Tube is sized by its nominal outside diameter. For bioprocessing equipment, tube does not include pipe.

Tungsten inclusions
Tungsten particles transferred into the weld deposit by occasional touching of the tungsten electrode used in the gas tungsten-arc process to the work or to the molten weld metal. These inclusions are often considered defects that must be removed and the weld repaired prior to final acceptance. Tungsten inclusions may be invisible to the unaided eye, but are readily identified in a radiograph.
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U
Unacceptable leakage
Leakage level above which the system performance is considered unacceptable by the system user and applicable regulating body.

Undercut
A groove melted into the base metal adjacent to the weld toe or weld root and left unfilled by weld metal.

Underfill
A depression on the weld face or root surface extending below the adjacent surface of the base metal (see concavity).

Uniformly scattered porosity
Porosity that is distributed in a weldment in a uniform pattern.

User
See Owner/user
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V
Validation
Establishing documented evidence that the system does what it purports to do.
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W
Waviness
Undulations or rippling of the surfaces.

Weld joint design
The shape, dimensions, and configuration of the weld joint.

Welding operator
One who operate machine or automatic welding equipment.