BPE BROCHURE - Cardinal BPE

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thehistorythehistoryCardinal Systems, Inc. was founded in1983 to address the need for sanitary andelectropolished tubing and fittings in thepharmaceutical and semiconductorindustries. In 1987 we acquired CapitalEquipment of Madison, WI, a manufacturerof sanitary fittings for the pharmaceuticalindustry. Throughout the 1980’s we grewrapidly attracting the attention of severalmuch larger companies.In 1989 a Swedish food and dairy sanitaryproducts manunfacturer acquired Cardinal.At that time over half of Cardinal’s saleswere to the pharmaceutical industry. Thenew owners decided to market Cardinal’spharmaceutical products under the name ofthe parent company. Cardinal continued toconcentrate their sales efforts on thesemiconductor and other high puritymarkets. After ten years of ownership andastounding growth, the parent companydecided that Cardinal was not a corecompetency in their new corporate strategy.In December of 1999 O’Brien Corporation,a manufacturer of high quality componentsfor the petrochemical and hydrocarbonprocessing industries, acquired Cardinaland we changed our name to Cardinal UHPand Cardinal BPE.Cardinal BPE is once again dedicated toserving the pharmaceutical and biotechindustries. Under the new ownershipCardinal BPE has made serious capitalinvestment, creating a new facility with themost advanced systems in the industry.Every vital parameter of the cleaning andelectropolishing process is monitored andregulated with innovative computer controlsystems. Fittings and tubing capacity hasbeen increased multifold. As a member ofISPE we actively participate in thedevelopment of new standards andprocedures. Our ISO 9002 quality system isinternationally recognized and ourcompliance with ASME BPE specificationsand industry practices insure consistentverifiable quality products at a completiveprice.We believe that the more you know aboutCardinal BPE the more you will agree thatwe should be your choice for high puritysanitary piping products.the raw the material raw materialThe material of choice in the biotech andpharmaceutical markets is 316L stainlesssteel because of its good weldability andinherent corrosion resistance. However,316L may contain impurities in the form oftrapped gases and non-metallic inclusions.To prevent this from becoming a problemfor our customer, we select only specificgrades of 316L and purchase materials toour own specifications.Cardinal BPE also produces high puritytubing copper tubing and fittings as well asother materials such as 304SS, Hastelloy,AL6XN and Monel.Prior to placing any material in productionwe test representative samples todetermine their wall thickness, ovality,weldability and compatibility with ourelectropolishing process and desired RAfinish.mechanical mechanical polishing polishingMechanical polishing uses abrasivematerials to reduce surface irregularities.Although it smoothes the surface,sometimes mechanical polishing is notenough.All fittings are chemically passivatedafter fabrication and mechanicalpolishing to restore the passive layer ofthe original base material. Dependingupon the specification, fittings are alsoelectropolished to further reduce surfaceroughness and improve corrosionresistance.It’s about purity.biopharmaceutical
passivation passivationPassivation dissolves free iron particlespresent following forming, machining, andelectropolishing processes. This isaccomplished by bathing the material in aheated solution of nitric acid. If theseparticles are allowed to remain they canattach themselves to the base material,eventually oxidizing and contaminating yoursystem.When used in conjunction with our provenelectropolishing process, passivationimproves upon the original corrosionresistance of the alloy. Material performanceis dramatically improved by theformation of a thick chromium enrichedoxide layer.research & developmentresearch & developmentAs part of our extensive ongoing researchand development programs Cardinal BPEhas funded metallurgy research at theUniversity of Missouri’s Center for MaterialsResearch. Surface treatment studies havefocused on developing increasedstandardization in the electropolishingprocess in order to achieve a morepredictable and consistent finished product.Two areas that have been targeted to dateare the variables involved in the processand the effect that raw materials have onthe final product.The knowledge gained through our R&Defforts led to the creation of the firstALC-300 digitally controlled electropolishprocess monitoring equipment. Thisequipment is capable of producing consistentquality products without variance fromoperator to operator.Through our research, we have come tounderstand that many inconsistencies in thefinal product are directly attributed tovariation in the microchemistry and grainsize of the raw material. This is why we takespecial care to procure only materialsproviding optimal conditions forelectropolishing.Today we have improved on the industrialspecifications for raw stainless steel alloy,establishing our own proprietary standardsfor material procurement. Our continuinginvestigation of the effects of processvariables allows Cardinal BPE to transformthe art of electropolishing into a controlledscience.qualityqualityassuranceassuranceCardinal BPE bioPure tubing and fittings aremanufactured to meet or exceed ASME BPEstandards. Cardinal BPE was the firstcompany in the high purity tubing and fittingindustry to be registered to international ISO9002 standards. Our unyielding commitmentto quality is evident in every step of ourmanufacturing process. From the start ofprocurement we specify stringent materialstandards. When raw materials arrive at ourloading dock they are quarantined until wallthickness, ovality, smoothness, surfacemorphology, and chemical composition havebeen verified to insure it will meet ourrigorous electropolishing procedures.All measuring instruments and analyticalequipment are calibrated and traceable toNIST standards. Finally, every employee isempowered to declare piping and fittings unfitfor sale if deviations from our standards arediscovered.Fittings and tubing are not only inspectedvisually, but stylus measurement devices andmass spectrometer helium leakdetectors areutilized. Additionally, the following qualityassurance options are available:• Scanning Electron Microscope (SEM)photographs• Auger Electron Spectroscopy (AES) tests• Electron Spectroscopy Chemical Analysis(ESCA) tests• Testing for presence of moisture utilizinga Meeco Aquamatic Plus moisture analyzer• Scanning Tunneling Microscope (STM)surface analysis tests• Testing for presence of particles down to0.01 micron utilizing a MET1CNC particlecounter• Certification for oxygen and medical gas• Image processing (video probe and/orboroscoping capabilities)It’s about quality.It’s about control.biopharmaceutical
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BPE BROCHURE - Cardinal BPE

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