Pharmaceutical Drug Manufacturers

E Coli (Escherichia Coli)
A fast growing, Gram-negative bacteria commonly found in the body with a comparatively simple structure. The genetic make up of E. coli is the best known of any organism, having been widely studied during the development of genetic engineering. It has been used extensively as the host cell for novel proteins made by rDNA technology.

Ecology
The study of the interrelationships between organisms and their environment.

Edge Failure
A control parameter value that, if exceeded, may result in adverse effect on state of control and/or fitness for use of the product.

Efficacy
The ability of a substance to produce a desired effect.

Effluent
The output or discharge from a process, such as a wastewater treatment process.

Elastin
An albuminoid, or scleroprotein present especially in yellow elastic fibrous tissue.

Elastomer
Long chain co-polymers or terpolymers (two or three different monomers in one chain) that contain adequate crosslinks among individual chains. Fluorinated elastomers are more stable than hydrocarbon or silicon elastomers because C-F bonds are approximately 30% stronger than C-H bonds. There are five major FDA compliant elastomers used in the pharmaceutical and biopharmaceutical industries: EPDM (ethylene-propylene-diene rubber), fluororelastomers (FKM), platinum-cured silicon (pt-Si), and finally Kalrez® parts using compounds KLR-6221 and KLR-6230, which are perfluoroelastomers.

Elastomeric Material
A material that can be stretched or compressed repeatedly and, upon immediate release of stress, will return to its approximate original size.

Electrical Area Classifications
Facilities, or portions of facilities are classified electrically according to the type of material present and its flammability and/or explosive potential. Each area classification carries with it specific requirements for the construction requirements found within that space to guard against sparking. The Class of an area refers to the type of material; the Division of the area refers to whether that material is normally found in that area or not. Electrical classifications are covered by the National Electrical Code (NEC) adopted by the National Fire Protection Association (NFPA) as Volume 6 of the National Fire Codes. They are:

1. Class I, Division 1: A Class I, Division 1 location (1) is that in which ignitable concentrations of flammable gases/vapors can exist under normal operating conditions; or (2) in which ignitable concentrations of such gases/vapors may exist frequently because of repair, maintenance operations or because of leakage; or (3) in which breakdown or faulty operation of equipment or process may release ignitable concentrations of flammable gases/vapors, and might also cause simultaneous failure of electric equipment. 2. Class I, Division

2: A Class I, Division 2 location (1) is that in which volatile flammable liquids or flammable gases are handled, processed, or used, but in which the liquids, vapors, or gases will normally be confined within closed containers or closed systems from which they can escape only in case of accidental rupture or breakdown of such containers or systems, or in case of abnormal operation of equipment; or (2) in which ignitable concentrations of gases or vapors are normally prevented by positive mechanical ventilation, and which might become hazardous through failure or abnormal operation of the ventilating equipment; or (3) that is adjacent to a class I, Division 1 location, and to which ignitable concentrations of gases or vapors might occasionally be communicated unless such communication is prevented by adequate positive-pressure ventilation from a source of clean air, and effective safeguards against ventilation failure are provided.

3. Class II, Division 1: A Class II, Division 1 location (1) is that in which combustible dust is in the air under normal operating conditions in quantities sufficient to produce explosive or ignitable mixtures; or (2) where mechanical failure or abnormal operation of machinery or equipment might cause such explosive or ignitable mixtures to be produced, and might also provide a source of ignition through simultaneous failure of electric equipment, operation of protection device, or from other causes; or (3) in which combustible dusts of an electrically conductive nature may be present in hazardous quantities.

4. Class II, Division 2: A Class II, Division 2 location (1) is that in which combustible dust is not normally in the air in quantities sufficient to produce explosive or ignitable mixtures, and dust accumulations are normally insufficient to interfere with the normal operation of electrical equipment or other apparatus but combustible dust may be in suspension in the air as a result of infrequent malfunctioning of handling or processing equipment and where combustible dust accumulations on, in, or in the vicinity of the electrical equipment may be sufficient to interfere with the safe dissipation of heat from electrical equipment or may be ignitable by abnormal operation or failure of electrical equipment.

5. Class III, Division 1: A Class III, Division 1 location is that in which easily ignitable fibers or materials producing combustible filings are handled, manufactured, or used.

6. Class III, Division 2: Class III, Division 2 location is that in which easily ignitable fibers are stored or handled.

Electrical Code (also see: National Electrical Code®)
Electrical Groups Electrical groupings are based on the characteristics of the materials involved. These include the following:

1. Class I, Group A: Atmospheres containing acetylene.

2. Class I, Group B: Atmospheres containing hydrogen, fuel and combustible process gases containing more than 30 percent hydrogen by volume, or gases or vapors of equivalent hazard such as butadiene, ethylene oxide, propylene oxide, and acrolein.

3. Class I, Group C: Atmospheres such as ethyl ether, ethylene, or gases or vapors of equivalent hazard.

4. Class I, Group D: Atmospheres such as acetone, ammonia, benzene, butane, cyclopropane, ethanol, gasoline, hexane, methanol, methane, natural gas, naphtha, propane, or gases or vapors of equivalent hazard.

5. Class II, Group E: Atmospheres containing combustible metal dusts, including aluminum, magnesium and their commercial alloys, or other combustible dusts whose particle size, abrasiveness, and conductivity present similar hazards in the use of electrical equipment.

6. Class II, Group F: Atmospheres containing combustible carbonaceous dusts, including carbon black, charcoal, coal, or coke dusts that have more that 8 percent entrapped volatiles, or dusts that have been sensitized by other materials so that they present an explosion hazard.

7. Class II, Group G: Atmospheres containing combustibles dusts not included in Group E or F, including flour, grain, wood, plastic, and chemicals.

Electrodialysis (ED)
A membrane separation method used for the separation of charged molecules from a solution by application of a direct current. The membranes contain ion-exchange groups and have a fixed electrical charge. This method is very effective in the concentration of electrolytes and proteins.

Electrolyte
A chemical compound which when dissolved or ionized in water allows it to conduct electric current.

Electron Microscopy (EM)
A technique for visualizing material that uses beams of electrons instead of light rays and that permits greater magnification than is possible with an optical microscope. Electron microscopes have been used to examine the structure of viruses and bacteria, to identify and classify pollen grains, etc.

Electronic Record
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

Electronic Signature or e-sig
According to FDA, an electronic signature is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

Electrophoresis
The migration of electrically charged proteins, colloids, molecules, or other particles when dissolved or suspended in an electrolyte through which an electric current is passed. The most important use of electrophoresis is in the analysis of blood proteins. Since the proportion of these proteins varies widely in different diseases, electrophoresis can be used for diagnostic purposes. Electrophoresis is used to study bacteria and viruses, nucleic acids, and some types of smaller molecules, including amino acids.

Electropolishing
Also known as "chemical machining" and "reverse plating", electropolishing is an electrochemical process far superior to any available mechanical process for the removal of minute surface imperfections in stainless steel. It levels and brightens the material surface by anodic dissolution in an electrolyte flowing solution with an imposed electrical current. When the proper combination of electrolyte current & temperature is attained, the high points of surface irregularities, or high current density areas, are selectively removed at a greater rate than the remainder of the surface, resulting in improved surface smoothness. During electropolishing, the polarized surface film is subjected to the combined effects of gassing (oxygen) that occurs with electromechanical metal removal, saturation of the surface with dissolved metal, and the agitation and temperature of the electrolyte.

Electrolyte
Any compound which in solution conducts a current of electricity and is decomposed by it.

Electrostatic Fluidized Bed
A container holding powder coating material which is aerated from below so as to form an air-supported expanded cloud of such material which is electrically charged with a charge opposite to the charge of the object to be coated. Such object is transported through the container immediately above the charged and aerated materials in order to be coated.

ELISA (Enzyme Linked Immunosorbent Assay)
A test to measure the concentration of antigens or antibodies.

Elute
To separate one solute from another by washing. Elution may include the removal by means of a suitable solvent of one material (absorbed material) from another (adsorbent) that is insoluble in that solvent.

Ellinghausen's Medium
A complex medium for growing Leptospira (also see; DHL vaccine). Contains numerous salts, nutrients, and BSA (Bovine Serum Albumin).

Embriology
The study of the early stages in the development of an organism. In these stages a single highly specialized cell, the egg, is transformed into a complex, many-celled organism resembling its parents.

Endemic
A disease present in a community or among a group of people; used to describe a disease prevailing continually in a region.

Endergonic Reaction
A chemical reaction with a positive standard free energy change, an "uphill" reaction.

Endocrine Glands
The glands that secrete their products (hormones) into the blood that then carries them to their specific target organs. Endocrine glands are the pituitary, thyroids, adrenals, pancreas, ovaries (in females), and testes (in males). Endocrine glands are found in some invertebrates as well as in vertebrates.

Endocrine Hormones
The products secreted by the endocrine glands. These help control long-term processes, such as growth, lactation, sex cycles, and metabolic adjustment. The endocrine system and the nervous system are interdependent and are often referred to collectively as the neuroendocrine system. For example, the juvenile hormone, found in insects and annelids, affects sexual maturation. There is currently great interest in the possible use of such hormones in the control of destructive insects.

Endonuclease
An enzyme that cleaves its nucleic acid substrate at internal sites (other than the terminal bonds) in the nucleotide sequence.

Endorphins
Endogenous opiates having morphine-like effects consisting of small polypeptides such as enkephalin and leu-enkephalin and longer polypeptides such as alpha-, ß-, and gamma-endorphins. They bind to opiate receptors in the brain. Endorphins induce analgesia when injected intraventricularly but not when administered peripherally, presumably because of their inability to cross the blood/brain barrier. The amino acid sequence of the endorphins is short enough to allow the gene sequences coding for them to be synthesized.

Endospore
A highly heat and chemical resistant dormant inclusion (spore) occurring within the substance of certain genera of bacteria, mainly Bacillus and Clostridium.

Endothelial Cells
A layer of flat cells that line the tumor blood vessel structure.

Endotoxin
A poisonous complex molecule (lipopolysaccharide) that forms an integral part of the bacterial (gram-negative bacteria) cell wall and is only released when the integrity of the wall is disturbed. Certain organisms may release endotoxins (e.g. E. coli) during biosynthesis of a recombinant DNA product, thus necessitating purification steps to ensure their removal. In water treatment, it most often refers to pyrogens.

Enhanced Documentation
Collection of Engineering, Quality Control, and Regulatory Affairs documents, which will be required for the operation, validation, maintenance, and regulatory compliance of a pharmaceutical plant.

Enhanced Documentation
Adds change control and validation to Good Engineering Practice in the Qualification process.

Enthalpy
A thermodynamic property that indicates the total energy in a sample of dry air and water vapor, measured in Btu/lb dry air. Dry air at zero degrees Fahrenheit and atmospheric pressure is designated as zero enthalpy.

Enzyme
Any of numerous proteins or conjugated proteins produced by living organisms and functioning as complex biochemical catalysts. They not only promote reactions but also function as regulators making sure the organism does not produce too much or too little of any chemical substance. Although all enzymes are proteins, many contain additional non-protein components essential for catalytic activity. Such enzymes are termed haloenzymes. The protein part of this enzyme is termed an apoenzyme and the non-amino acid part is termed a coenzyme.

Equine
Of, pertaining to, or characteristic of a horse, such as equine hormones.

Equipment Suitability
The established capacity of process equipment and ancillary systems to operate consistently within established limits and tolerances.

Epidemic
A disease attacking many people in a community simultaneously; distinguished from endemic, since the disease is not continuously present but has been introduced from outside.

Epithelium
The layer(s) of cells between an organism or its tissues or organs and their environment (skin cells, inner linings of lungs or digestive organs, outer linings of kidneys, etc.).

EPO (Erythropoietin)
A glycoprotein hormone that stimulates the production of red blood cells. It is a commercialized product of recombinant DNA technology.

Epoxy
These materials are based on the reactive oxirane group, which are characterized by the attachment of one oxygen atom to two different adjacent carbon atoms. Standard epoxy resins are the reaction product of bisphenol A and epichlorohydrin. Curing of epoxy resins generally occurs at ambient temperatures and is achieved by the chemical reaction of the epoxy with a second reactant such as amines, polyamines, amine products, or other reactants. Cure can occur at higher temperatures when reacted with anhydrides, carboxylic acids, phenol or novolac (phenol-formadehyde) thermoplastic resins. These reactants are sometimes referred to as catalysts, which is a misnomer.

Erythrocyte
The red blood cell consisting largely of hemoglobin and carrying nearly all the oxygen contained in the blood. Erythrocytes are biconcave discs that are manufactured in the bone marrow.

Erythromycin
An antibiotic that binds to the 50S subunit of prokaryotic ribosomes and inhibits translocation of mRNA along the ribosome.

ESCA (Electron Spectroscopy for Chemical Analysis)
(also see: XPS (X-Ray Photoelectron Spectroscopy))

Essential Amino
Acids Amino acids that cannot be synthesized by human and other vertebrates and must be obtained from the diet.

Essential Fatty Acids
The group of polyunsaturated fatty acids of plants required in the human diet.

EST (Expressed Sequence Tag)

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

Ethylene Oxide (ETO)
A toxic compound used in gaseous form as a sterilizing agent, usually as a 10% mixture with carbon dioxide or 12% mixture with freon (referred as 12-88). Sterilization using ETO leaves residual chemicals such as ethylene chlorohydrin and ethylene glycol.

Etiologic Agent
A disease-causing organism or toxin.

Eukaryote
An organism that carries its genetic material physically constrained within a nuclear membrane, separate from the cytoplasm. All animal and plant cells except bacteria, viruses, and bluegreen algae are eukaryotic. Eukaryotes are five to ten times larger than prokaryotes in diameter.

Eutectic
Of, pertaining to, or formed at the lowest possible temperature of solidification for any mixture of specified constituents. A common term used to describe metal alloys.

Evaporator
Apparatus used in distillation to heat a liquid and create a phase change from the liquid to the vapor state. A steam boiler is an evaporator.

Excipient
A more or less inert substance added in a prescription drug compound as a diluent or vehicle or to give form or consistency when the remedy is given in a pill form; simple syrup, aromatic powder, honey, and various elixirs are examples of excipients.

Exergonic reaction
Referring to a chemical reaction that takes place with release of negative standard energy to its surroundings, a "downhill" reaction.

Exfiltration
Leakage of air out of a room through cracks in doors and pass-throughs through material transfer openings, etc. due to a difference in room pressures.

Exhaustion
Occurs when absorbents, such as activated carbon or ion exchange resins, have depleted their capacity by using up all active sites. Ion exchange resins may be regenerated to reverse the process.

Exogenous DNA
DNA originating outside an organism.

Exon
The proteincoding DNA sequence of an eukaryotic gene.

Exonuclease
An enzyme that cleaves nucleotides sequentially from free ends of a linear nucleic acid substrate.

Exotic Organism
A biological agent where either the corresponding disease does not exist in a given country or geographical area, or where the disease is the subject of prophylactic measures or an eradication program undertaken in the given country or geographical area.

Exotoxins
Proteins produced by bacteria that are able to diffuse into a medium through the bacterial cell membrane and cell wall. They are generally more potent and specific in their actions than endotoxins.

Expiration Date
The date placed on the container/labels of an API (Active Pharmaceutical Ingredient) designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.

Explosion Resistance
A type of construction used to house solvents in sufficiently large quantities, to qualify the space electrically as an explosion potential area. Typically the internal walls, ceiling, and floor are constructed of material strong enough to withstand a specified intensity of explosion, and at least one wall has explosion relief devices that direct the explosion outwardly. In a single story arrangement, or if the explosion resistant area is on the top floor, the roof may also have devices that can be used to relieve the explosion.

Explosive
A chemical that causes a sudden, almost instantaneous release of pressure, gas and heat when subjected to sudden shock, pressure, or high temperatures, or a material or chemical, other than a blasting agent, that is commonly used or intended for the purpose of producing an explosive effect.

Exposed or Open Process
The drug substance is exposed to the room environment during processing.

Express
To translate the genetic information stored in the DNA into protein.

Expression System
A host organism combined with a genetic vector (such as virus or circular DNA molecule called a plasmid) that is loaded with a gene of interest. The expression system provides the genetic context in which a gene will function in the cell - that is, the gene will be expressed as a protein.

Extractables
Undesirable foreign substances that are leached or dissolved by water or process streams from the materials of construction used in filters, storage vessels, distribution piping, and other wetted surfaces.

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