ASME BPE:2002 pdf download

ASME BPE:2002 pdf download.BIOPROCSSING EOUIPMENT
anincaling: a treatment process for stccl for the purpose of reducing hardness, improving machinability, facilitat- ing cold working, or producing a desired mechanical, physical, or other property. anomaly: a localized surface area that is out of speci- fications to the surrounding area, and is classified as abnormal. urc sirike: a discontinuiy consisting o{ any localized remelted metal, heat-affected metal, or change in the surface profile of any part of a wcld or basc mctal resulting from an arc， generated by the passage of electrical current between the surface of the weld or base material and a current source, such as a welding electrode, magnetic particle prod, or electropolishing electrode. asepiic: free of pathogenic (causing σπ capabie 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 also gas iungsien-arc weiding.) uuiormatic weiding: welding with equipment that per-. forms the welding operation without adjustmcnt of the controls by a welding operator. The equipment may or may not perform the loading and unloading of the work. (See also machine welding.) biologics: therapeutic or diagnostic products generated and prified from natural sources. biopharmaceuticals: ethical pharmaceutical drugs de- rived through bioprocessing. bioprocessing: the creation of a product utilizing a living organisn. bioprocessing equipment:- equipment, systcms, or facilitics uscd in thc crcation of products utilizing living organisms. break: 2 discontinuity in the face of a fitting. burn-through: excessive melt-through or a hole through the root bead of a weld. burr: excess material protruding from the edge typi- cally resulting from operations such as cutting or facing. buit joini: a joint between two members iying approxi- mately in the same plane. cavitation: a condition of liquid flow where, after vaporization of the liquid, the subsequcnt collapsc of vapor bubbles can produce surface damage. certification: documented testimony by qualifed au thorities that a system qualification, calibration, valida- tion, or revalidation has been performed appropriately and that the results are acceptable. cGMPs: current Good Manufacturing Practices. Cur- rent design and operating practices developed by the pharmaceutical industry to meet FDA requitements as publishcd 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 contam- inants that may affect or aduiterate the product or process.
clean-in-place (CIP): internally cleaning a piece of equipment without relocation or disassembly. The equip- ment is cleaned but not necessarily sterilized. The cleaning is normally done by acid, caustic, or a combina- tion of botn, with Waier for-njection (WT) inse. ciean steam: steam fee from boiler additives thai may be purified, filtered, or separated. Usually used for incidental heating in phamaceutical applications. cloudiness: the appearance of a miky white huc across some pourtion of a surface resulting from the clcctropol- ish process. cluster porosity: porosity that occurs in. clumps or clusters. concavity: a condition in. which the surface of a welded joint is depressed rclative to the surface of the tube or pipe. Concavity is mcasured as a maximum distance from the outside or inside diameter surface of 2 welded joint along 2 line perpendicular to 2 line joining the weld toes. consumable insert:. 2 ring of meta! 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 muiltipie pass weld with the addition of fller wire (also called insert ring). convexiry: a condition in which the surface of a weided joint is extended relative to the surface of the tube or pip. Coivexity is measucd s a maximumn disiauice from the outside or inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes.