Glossary

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.

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

Engineering Line Diagram

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.

Changes in electric usage by demand-side resources from their normal consumption patterns in response to changes in the price of electricity over time, or to incentive payments designed to induce lower electricity use at times of high wholesale market prices or when system reliability is jeopardized.

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.

Chips which may be programmed and erased numerous times like an EPROM. However an EEPROM is erased electrically. This means this IC does not necessarily have to be removed from the circuit in which it is mounted in order to erase and reprogram the memory.

Technology combining ion-exchange resins and ion-selective membranes with direct current to remove ionic impurities from water and maintain the resin regenerated condition.

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.

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

Low frequency electromagnetic waves that emanate from electromechanical devices. An electromagnetic disturbance caused by such radiating and transmitting sources as heavy-duty motors and power lines can induce unwanted voltages in electronic circuits, damage components and cause malfunctions.

Electromagnetic waves, including ultraviolet (UV), X-rays, and gamma radiation (gamma rays). Electromagnetic radiation is used to produce mutant cells or organisms, or, in the case of UV, disinfestation and sterilization, in tissue culture.

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.

A type of an EPR that is a store of data and information for a batch or continuous processes.

Electronic records in one or more systems/applications comprised of the elements of paper Master Batch Records as well as production batch records. These elements typically include Work Instructions and recipes equivalent to Master Batch Records, as well as actual results, e-signatures, and data from execution equivalent to paper production batch records.

One or more systems/applications that facilitate the creation/revision, approval, distribution, execution, and data collection of Electronic Batch record elements; a computer system that stores, in electronic format, the batch record information required by healthcare regulations.

Electronic records in one or more systems/applications comprised of the elements of paper master device history records as well as production records for medical device manufacture. These elements typically include Work Instructions and recipes equivalent to Master Device records, as well as results, e-signatures, and data from execution equivalent to paper device history production records.

A type of an EPR that is a compilation of records containing the production history of a finished medical device.

Hardware intended to store binary data; e.g., integrated circuit, magnetic tape, magnetic disk.

A record that is a store of data and information from production-related activities created by, and/or manually entered into systems, typically during execution of control recipes. The EPR may be located in one or more systems or databases.

A term to mean either EBR (Electronic Batch Record) or EDHR (Electronic Device History Record).

(FDA) 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.

(FDA) 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. As well as being used in place of a handwritten signature, an electronic signature also may be used to authenticate a signed document as still having the same content as when it was signed.

A technique that separates charged molecules – such as DNA, RNA or protein – on the basis of relative migration in an appropriate matrix (such as agarose gel or polyacrylamide gel) subjected to an electric field.