Pharmaceutical Drug Manufacturers

Saccharomyces Cerevisiae
Better known as beer yeast, ordinary yeast. Yeast used in rDNA research.

Safranin
A base, obtained from aniline; aniline pink; used as a stain in histology.

Salinity
The concentration of soluble minerals (mainly salts of the alkali metals or of magnesium) in water.

Salmonella
A large genus of the tribe Salmonellae, family Enterobacteriaceae, containing motile, gram-negative, rod-shaped organisms that ferment dextrose, forming acid and usually gas. Several species occur as intestinal pathogens in acute inflammations in humans and domestic animals. Salmonella typhimurium causes food poisoning in humans.

Salt
A compound formed by the interaction of an acid and a base, the hydrogen atoms of the acid being replaced by another positive ion derived from the base.

Salt Rejection
In reverse osmosis, the ratio of salts removed (rejected) to the original salt concentration.

"Salvage" Plasma
Plasma obtained by centrifugation of outdated (older than 21 days) whole blood. This type of plasma is difficult to convert to serum because most coagulation factors have lost their activity

Sanitization
That part of decontamination that reduces viable microorganisms to a defined acceptance level, normally achieved by using a chemical agent or heat.

Saponification
Alkaline hydrolysis of triacyl glycerols to yield fatty acids as soaps.

Sarcoma
A type of cancer that starts in bone or muscle.

Saturated Air
When there is a state of mutual equilibrium between the moist air and the liquid or solid phases of water. Saturated air holds as much water vapor as it can for a given temperature and pressure.

Saturated Fatty Acids
Fatty acids containing fully saturated alkyl chains.

Saturation Humidity
The air is saturated when the partial pressure of water vapor in the air at a given temperature equals the vapor pressure of water at the same temperature.

Saturation Index
The relation of calcium carbonate to the pH, alkalinity, and hardness of water to determine its scale-forming tendency.

Scale
The mineral deposit that can coat the insides of boilers or the surfaces of RO membranes. It consists mainly of calcium carbonate that precipitates out of solution under certain conditions of pH, alkalinity, and hardness.

Scale-up
To take a biopharmaceutical manufacturing process from the laboratory scale to a scale at which it is commercially feasible.

Scratch
An elongated mar in the metal's surface not associated with the predominant surface texture pattern, which is visible to the unaided eye.

SDR

Secondary Containment
Level of containment that is external to and separate from primary containment.

Secure Retention
The ability to generate accurate and complete copies of records in both human-readable and electronic form suitable for inspection, review, and copying by FDA. Records must be protected to enable their accurate and ready retrieval through the records retention period.

Seed Lot
Seed Lot System - A seed lot system is a system according to which successive batches of a product are derived from the same master seed lot at a given passage level. For routine production, a working seed lot is prepared from the master seed lot. The final product is derived from the working seed lot and has not undergone more passages from the master seed lot than the vaccine shown in clinical studies to be satisfactory with respect to safety and efficacy. The origin and the passage history of the master seed lot and the working seed lot are recorded.

Master Seed Lot - A culture of a microorganism distributed from a single bulk into containers in a single operation in such a manner as to ensure uniformity, to prevent contamination and to ensure stability. A master seed lot in liquid form is usually stored at or below -70ºC. A freeze-dried master seed lot is stored at a temperature known to ensure stability.

Working Seed Lot - A culture of microorganism derived from the master seed lot and intended for use in production. Working seed lots are distributed into containers and stored as described above for master seed lots.

Seed Stock
The initial inoculum, or the cells placed in growth medium from which other cells will grow.

Seed Tank Industrial fermentations are generally started in tanks smaller than a 1,000 to 50,000 gallon main fermenter. This small "seed" tank may be up to 100 gallons and propagate enough organisms to "kick-off" the main fermentation. Often, a seed tank may be large enough to require its own seed tank.

Sedimentation
A primary step in municipal water treatment. Water is allowed to stand long enough for solids to settle by gravity. Also called settling.

Segregated
Storage in the same room or inside area, but physically separated by distance from incompatible materials.

SEM (Scanning Electron Microscopy)
Utilizes an electron beam to produce images over a very broad magnification range of 10X to 105X. The technique is somewhat limited by the conductivity of the material but works very well to inspect 316L stainless steel. Typical magnification levels for surface defect evaluation are from 100 to 4,000.

Semipermeable
Membranes that do not have measurable pores but through which smaller molecules can pass.

Self Draining
Capable of elimination of all fluid from the system due to the force of gravity alone.

Sensible Heat (SH)
Heat that causes a change of temperature without causing a change of state.

Sensible Heat Ratio
The ratio of room sensible heat to room total heat as expressed in the formula: Sensible Heat ratio (SHR) = Room Sensible Heat (SH)/Room Total Heat (TH)

Sensitizer
A chemical that causes a substantial proportion of exposed people or animals to develop an allergic reaction in normal tissue after repeated exposure to the chemical.

Semiautomatic Arc Welding
Arc welding with equipment that controls only the filler metal feed. The advance of the welding is manually controlled.

Sepsis
The presence of various pus-forming and other pathogenic organisms or their toxins in the blood or tissues; septicemia.


Sequence Tagged Site (STS)
Short (200 to 500 base pairs) DNA sequence that has a single occurrence in the human genome and whose location and base sequence are known. Detectable by polymerase chain reaction, STSs are useful for localizing and orienting the mapping and sequence data reported from many different laboratories and serve as landmarks on the developing physical map of the human genome. Expressed sequence tags (ESTs) are STSs derived from cDNAs.

Sequencing (of DNA or RNA) Determination of the order of nucleotides (base sequences) in a DNA or RNA molecule or the order of amino acids in a protein.

Sera
One of the plural forms of serum.

Serratia Marcescens
They are minute, rod-shaped or coccoid, aerobic, gram-negative organisms, found on various foodstuffs as a pink or reddish growth, nonpathogenic. Used to validate 0.45µm removal rated filters.

Serum
The liquid portion remaining after clotting whole blood or plasma.

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

Sex Chromosomes
Those whose content is different in the two sexes - usually labeled X and Y (or W and Z), female sex has XX (or WW), male is XY (or WZ).

Shielded Metal-Arc Welding (SMAW)
An arc welding process that produces coalescence of metals by heating them with an arc between a covered metal electrode and the work. Shielding is obtained from decomposition of the electrode covering. Pressure is not used and filler metal is obtained from the electrode.

Shotgun Method
Sequencing method that involves randomly sequencing tiny cloned pieces of the genome, with no foreknowledge of where on a chromosome the piece originally came from. This can be contrasted with "directed" strategies, in which pieces of DNA from adjacent stretches of a chromosome are sequenced. Direct strategies eliminate the need for complex reassembly techniques. Because there are advantages to both strategies, researchers expect to use both random (or shotgun) and directed strategies in combination to sequence the human genome.

Signature (signed)
See definition for signed

Signed (signature)
(ICH API definition) The record of who performed a particular action or review. This record may be initials, full handwritten signature, personal seal, or authenticated and secure electronic signature.

Single Gene Disorder
Hereditary disorder caused by a mutant allele of a single gene (e.g., Duchenne muscular dystrophy, retinoblastoma, sickle cell disease).

Sickle-cell Anemia
An inherited, potentially lethal disease in which a defect in hemoglobin, the oxygen-carrying pigment in the blood, causes distortion (sickling) and loss of red blood cells, producing damage to organs throughout the body.

Signed (signature)
The record of who performed a particular action or review. This record may be initials, full handwritten signature, seal, or authenticated and secure electronic signature.

Silica Silicon
Dioxide (SiO2) and its hydrated forms are classified as reactive and nonreactive. Generally, reactive Silica is removed by the anion exchange resin. Reactive Silica is only slightly ionized and is held lightly by the anion resin. It is for this reason that Silica is the first thing to break through when the resin nears exhaustion. Nonreactive Silica is generally considered to be particulate (colloidal) in nature.

SIP (Steam In Place)
The introduction of steam to sanitize or sterilize a piece of equipment without relocating the equipment.

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.

Smoke Control
The use of physical barriers and mechanical ventilation to control the spread of smoke from a fire.

Smoke Purge
The use of mechanical ventilation to remove smoke resulting from fire.

Smoke Test
Visualization of airflow streams in a clean space using artificially generated smoke, such as Titanium smoke, CO2, or glycol fog.

Softener
Water treatment equipment that uses a sodium-based ion-exchange resin, principally to remove cations.

Softening
A pretreatment process which uses cation exchange resin to remove hardness elements (calcium and magnesium) from water. The cation resin is regenerated with Sodium Chloride (NaCl) and during the exchange process, the calcium and magnesium are removed from the water and replaced with sodium ions (Na+). The resulting sodium salts are much more soluble and do not precipitate, which provides better feed water to the RO system.

Software
An executable program that operates on an automated system.

Soldering
A metal joining process wherein coalescence is produced by heating to suitable temperatures and by using a nonferrous alloy fusible at temperatures below 427°C (800ºF) and having a melting point below that of the base metals being joined. The filler metal is distributed between closely fitted surfaces of the joint by capillary attraction. In general, solders are lead-tin alloys and may contain antimony, bismuth, and other elements.

Solid Tumors
Cancer cells which grow as a solid mass.

Soluble Antigen
Generally used in reference to vaccine production. As opposed to a whole live or attenuated virus, a soluble antigen is a fragment of the virus that produces immunity. Also refers to large molecular weight polysaccharides from some bacteria which can act as vaccines.

Solute
The substance that dissolves to form ions in solution.

Solvent
A liquid capable of dissolving a solute.

Solvent
An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API (Active Pharmaceutical Ingredient).

Somatic Cell
Any cell in the body except gametes and their precursors.

Somoclonal Variation
Genetic variation produced from the culture of plant cells from a pure breeding strain; the source of the variation is not known.

SOP (Standard Operating Procedures)
The description of necessary activities to respond to normal and abnormal situations in an operating system. The SOP may include a troubleshooting checklist, list of personnel to contact, etc. SOPs should also describe normal operation, maintenance, and cleaning of the system, and normal operating parameters. An SOP may be created for any system but an SOP must be created for each system requiring qualification.

Source Code
An original computer program either in human readable or machine-readable form.

Southern Blotting
Transfer by absorption of DNA fragments separated in electrophoretic gels to membrane filters for detection of specific base sequences by radiolabeled complementary probes.

Sparger
A device used to agitate, oxygenate, aerate, or add a chemical to a liquid by means of compressed air or gas entering through small holes in a pipe below the liquid surface.

Specific Conductance
The reciprocal of specific resistance usually expressed in micromhos/cm.

Specific Humidity
Also known as Humidity Ratio, and Absolute Humidity, is the weight of water vapor in each pound of dry air expressed in grains of moisture per pound of dry air, or pounds of moisture per pound of dry air. (also see: Saturation Humidity) NOTE: 7,000 grains = 1.0 pound. Humidity of air mixtures is normally discussed in terms of grains of moisture per pound rather than the more common term of relative humidity because the grains of moisture in an air stream do not change when it is heated or cooled, unless condensation takes place.

Specific Ion Determinations
Electrochemical measurement of trace ion levels in solution.

Specific Resistance
The resistance of a one-centimeter cube of water to the passage of electricity under standard conditions, expressed in ohms/cm. A measure of the Total Ionized Solids concentration.

Specific Volume
In Psychrometry, the cubic feet of the mixture per pound of dry air.

Specification
A list of testes, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which an intermediate or API (Active Pharmaceutical Ingredient) should conform to be considered acceptable for its intended use. "Conformance to Specifications" means that the intermediate or API, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

Specificity
Exerting a definitive and distinctive influence on a particular part of the body and on the course of a particular disease.

Spinner Flasks
Small laboratory bioreactors used for the initial growth of mammalian cells lines.

Spore
A reproductive cell or seed of algae, fungi, or protozoa.

Spore, bacterial
A bacterial spore is a resistant body formed as part of the life cycle of some bacteria. Bacterial spores are able to withstand severe environmental conditions (e.g., heat, drying, chemicals) for many years. When conditions are favorable, spores germinate into vegetative bacterial cells capable of replication.

Sporicide
An agent that destroys bacterial and fungal spores.

Spray Drying
Process by which a material in suspension is converted into droplets that may be coated by a substance, either melted or dissolved in the droplet's media. The action in spray drying is primarily that of evaporation, energy is applied to the droplet forcing evaporation of the media with both energy and mass transfer through the droplet. Examples of this technology include, pharmaceutical tablet granulation, and rapid drying which results in free-flowing powders on a continuous basis. Spray drying process consists of the following steps:

1. Formation of a slurry to be sprayed; this slurry may be a simple concentrated solution or the dispersion of an insoluble material in a solution.

2. Liquid atomization into droplets; this action is critical as the droplet size will dictate the equipment size as well as the final product size. There are four types of atomization devices: air, airless, disk (or rotary) spray, and ultrasonic.

3. Exposure of the droplet to a heated gas flow; this gas (normally air) supplies the energy required to vaporize the solvent. Collection of the dry free-flowing powder or encapsulated liquid or solid.

Stability
Generally, stability refers to the physico-chemical condition of a parenteral, biological, or shelf life of labile drugs. Certain drugs must pass U.S.P. or CFR stability tests. For example, human serum albumin must pass certain limits of nephelometric turbidity. Also manufacturers must have documentation of potency of labile products under labeled storage conditions.

Stability Index
An empirical modification of the saturation index used to predict scaling or corrosive tendencies in water systems.

Stainless Steel
There are more than 70 standard types of stainless steel and many special alloys. These steels are produced in the wrought form (AISI types) and as cast alloys (ACI types). Generally, all are iron based, with 12 to 30 percent chromium, 0 to 22 percent nickel, and minor amounts of carbon, columbium, copper, molybdenum, selenium, tantalum, and titanium. There are three groups of wrought stainless steels:

1. Martensitic Alloys: characteristically magnetic and hardenable by heat treatment are oxidation resistant. They are exemplified by Type 410 (UNS S41000). Contain 12 to 20 percent chromium with controlled amount of carbon and other additives. Their corrosion resistance is inferior to austenitic stainless steels, and is generally used in mildly corrosive environments and for cutlery, turbine blades, and high-temperature parts.

2. Ferritic Stainless: characteristically magnetic but not hardenable by heat treatment. Contain 15 to as much as 30 percent Cr with low carbon content (0.1 percent). The higher chromium content improves its corrosive resistance. Type 430 (UNS S43000) widely used in nitric acid plants is a typical example. Corrosion resistance is rated good, although ferritic alloys are not good against reducing acids such as HCl.

3. Austenitic Stainless: widely used in bioprocessing, are characteristically non-magnetic, not hardenable by heat treatment, and are the most corrosion resistant of the three groups. These steels contain 16 to 26 percent chromium, 6 to 22 percent nickel. Carbon is kept low (0.08 percent) to minimize carbide precipitation. To avoid precipitation, special stainless steels stabilized with titanium, columbium, or tantalum, have been developed (types 321, 347, 348). Another approach to the problem is the use of low-carbon steels such as 304L and 316L, with 0.03 percent maximum carbon. Type 302 is the basic alloy of this group. Types 304 (UNS S30400) and 304L are low-carbon versions of 302. Types 316 (UNS S31600), 316L, and 317 (UNS S31700), with 2.5 to 3.5 percent molybdenum, are the most corrosion resistance.

Cast Stainless Alloys: are widely used in pumps, valves, and fittings. All corrosion resistant alloys have the letter C plus a second letter (A to N) denoting increasing nickel content. Numerals indicate maximum carbon. Typical members of this group are CF-8, similar to 304 stainless, CF-8M, similar to 316, and CD-4M Cu, which has improved resistance to nitric, sulfuric, and phosphoric acids.

Standard Atmospheric Conditions
At sea level these conditions are: 1. Temperature - 59°F. 2. Pressure - 29.921 Inches of mercury 3. Density - 0.0765 lbs dry air/cubic foot

Standard Dimensional Ratio (SDR)
The most commonly accepted means for providing a pipe wall thickness category and constant mechanical properties for many plastic materials. Used for solid, homogeneous pipe, the SDR is found by dividing the average outside diameter of a pipe by the wall thickness.

Standard Operating Procedures


Standpipe System
A wet or dry system of piping, valves, outlets, and related equipment designed to provide water at specified pressures and installed exclusively for the fighting of fires.

Start-Up
The initial operation of equipment to prove that it is installed properly and operates as intended. Start-Up is considered complete when the selected equipment will adequately process product as specified.

State of Control
A condition in which all operating variables that affect performance remain within such ranges that the system or process performs consistently and as intended.


Statistical Process Control (SPC)
A process control method to demonstrate mathematically that a process or system is operating within the limitations established for the parameter(s) in question.

Steam In Place (also see: SIP)
Sterile Absence of life; usually refers to absence of viable microorganisms.

Sterile Water
For Injection, U.S.P. A form in which water is distributed in sterile packages. Sterile Water for Injection is intended mainly for use as a solvent for parenteral products such as sterile solids that must be distributed dry because of limited stability of their solutions. It must be packaged only in single-dose containers of not larger than 1-liter size.

Sterile Water for Irrigation, U.S.P.
This form of water meets most, but not all, of the requirements for Sterile Water for Injection. The exceptions are with respect of container size (i.e., the container may contain a volume of more than 1 liter), container design (i.e., the container may be designed so as to empty rapidly the contents as a single dose), particulate matter requirements (i.e., need not meet the requirement for Large Volume Injections for single-dose infusions), and labeling requirements (e.g., the designation "For Irrigation Only" and "Not For Injection" appear prominently on the label).

Sterile Engineering Design (Fermentation)
The application of techniques to prevent contamination of a fermentation process by undesirable organisms. It includes three basic phases relating to the operation of the plant. First, the fermenter with the ancillary equipment, pipework, and valves must be brought to a sterile state. Secondly, the fermenter feed must be sterilized, and finally, sterile barriers at the interface between the fermenter and the outside environment must be maintained.

Sterilization
The act or process, physical or chemical, that destroys or eliminates all viable microbes including resistant bacterial spores from a fluid or a solid. Despite being stated as an absolute, the action of sterilization is usually stated in terms of probability. Examples of sterilization methods are: steam treatment at 121°C, dry heat at 450°F, flushing with a sterilizing solution such as Hydrogen Peroxide (H2O2) or ozone (O3), irradiation, and filtration.

Sterilizing Filter
A filter that, when challenged with the microorganisms Brevundimonas diminuta, at a minimum concentration of 107 organisms per square centimeter of filter surface, produces a sterile effluent.

Steroids
Classified as lipids, naturally occurring steroids are hormones that are important regulators of animal development and metabolism at very low concentrations. A well known steroid, cholesterol, is present in membranes of animal tissues. Other steroids include testosterone (a male sex hormone), cortisone (an adrenocortical hormone), estrone (a female sex hormone), and progesterone.

Strain
A population of cells all descended from a single cell.

Strength
The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or the potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).

STS

Sublimation
The process of vaporizing a solid substance by heat and then condensing it (without its having passed through a liquid state in either direction), a process of purification by separating the nonvaporizable impurities, a process analogous to the distillation of liquids.

Submerged Arc Welding (SAW)
An arc welding process that produces coalescence of metals by heating them with an arc or arcs between a bare metal electrode or electrodes and the work. A blanket of granular, fusible material on the work shields the arc. Pressure is not used and filler metal is obtained from the electrode and sometimes from a supplemental source (welding rod, flux, or metal granules).

Substrate
Reactive material - the substance on which an enzyme acts.

Subsurface Carbon Enrichment
In metals, a rise in the carbon signal at depths from 15 to 20 angstroms (Å). This indicates that organic material is buried in cracks, crevices, pits, or smeared material. Subsurface carbon is most commonly found in materials having rough morphology generally associated with machining processes.

Supernatant
The material floating on the surface of a liquid mixture (often the liquid component that has the lowest density).

Surface Finishes
This term shall apply to all interior surface finishes accessible and inaccessible, that directly or indirectly come in contact with the designated product in bioprocessing equipment and distribution system components (ASME BPEa-2000). Final criteria shall be determined by Ra values rather than polishing methods.

For Piping, Tubing, and Fittings:

1. As fabricated

2. Pickled and/or passivated

3. Bright hydrogen annealed

4. Mechanically polished

5. Mechanically buffed

6. Chemically polished

7. Electropolished

For Sheet, Strip, and Plate:

1. As fabricated. Without any specific surface treatments.

2. Rolled Finish. Manufactured by either hot or cold rolled process.

3. No. 1. A dull, hot rolled finish, annealed and pickled.

4. No. 2D. A dull, cold rolled finish, annealed and pickled.

5. No. 2B. A bright, cold rolled finish, annealed and pickled.

6. No. 4. A general purpose polished finish widely used for architectural panels, trim, and sanitary equipment. Following initial grinding with coarse abrasives, the surface is finally finished with lubricated 150 grit abrasive belts.

7. No. 4S. Processed as No. 4 except the final surface is polished to a smother finish. The purchaser must specify this alternative finish; the specification must state a No. 4 finish, using a 240 or 320 grit mechanical polish, whose particular surface roughness must meet the specified Ra value.

8. No. 6. A dull finish having a lower reflectivity than No. 4. It is produced by a tampico brushing in a medium of abrasive and oil and is used primarily for architectural applications.

9. No. 7. A finish with a high degree of reflectivity, produced by buffing to a finely ground surface without removing the grit lines.

10. No. 8. The most reflective finish, obtained by polishing with successively finer abrasives and buffing extensively with very fine buffing rouges. This finish is most widely used for press plates, mirrors, etc.

For Wrought and Cast Forgings:

1. As fabricated or machined

2. Mechanically ground, polished, or buffed

3. Abrasive blast cleaned, using one of the following methods:

  a. Sand blast

  b. Shot blast

  c. Glass blast

  d. Wet blast

4. Slurry polished

5. Roll deburred

6. Chemically cleaned

  a. Acid washed (pickled and passivated)

  b. Solvent washed

7. Electropolished

Surface Iron Oxide Layer
Surface iron oxide layer present when the 316L stainless steel's iron composition signal is higher than its chromium signal at the surface.

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

Surface Texture
The repetitive or random deviations of the nominal metal surface from the three-dimensional topography of the surface. Surface texture includes roughness, waviness, lay, and flaws.

Surface Water
Any water where the source is above ground such as rivers, lakes, and reservoirs. Surface waters are usually higher in suspended matter and organic material and lower in dissolved minerals than well water.

Surfactant
Any substance that changes the nature of a surface, such as lowering the surface tension of water.

Suspended Solids
Undissolved solids that can be removed by filtration. Determined by a filter paper before and after filtration of a water sample.

Suspension
A specific category of pharmaceutical product that must be in a colloidal dispersion (suspension) for proper action. For example, Kaolin/Pectin works as an adsorbant because its high surface area in suspension.

Symbiosis
The phenomenon of two entities performing a joint function that neither entity can perform alone.

Synthesis
Creating products through chemical and enzymatic reactions.

System Specifications
Descriptions of how the system will meet the functional requirements.

Pharmaceutical Abbreviations | Abbreviations in product information leaflets and literature
Acronyms | Glossary of Terms | Abbreviations used in the British Pharmaceutical