thehistory

thehistory

the raw materialthe raw material

The 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 to determine their wall thickness, ovality, weldability and compatibility with our electropolishing process and desired RAfinish.

Cardinal Systems, Inc. was founded in1983 to address the need for sanitary and electropolished tubing and fittings in thepharmaceutical and semiconductor industries. 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’s pharmaceutical products under the name ofthe parent company. Cardinal continued toconcentrate their sales efforts on the semiconductor and other high purity markets. After ten years of ownership andastounding growth, the parent companydecided that Cardinal was not a core competency in their new corporate strategy.In December of 1999 O’Brien Corporation,a manufacturer of high quality componentsfor the petrochemical and hydrocarbon processing industries, acquired Cardinaland we changed our name to Cardinal UHPand Cardinal BPE.

Cardinal BPE is once again dedicated to serving 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 the development of new standards andprocedures. Our ISO 9002 quality system isinternationally recognized and our compliance 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 purity sanitary piping products.

mechanical polishingmechanical polishingIt’s

abo

ut pu

rity.

Mechanical polishing uses abrasive materials to reduce surface irregularities.Although it smoothes the surface, sometimes mechanical polishing is notenough.

All fittings are chemically passivatedafter fabrication and mechanical polishing to restore the passive layer ofthe original base material. Dependingupon the specification, fittings are alsoelectropolished to further reduce surfaceroughness and improve corrosion resistance.

biopharmaceutical

passivationpassivation

Passivation dissolves free iron particlespresent following forming, machining, andelectropolishing processes. This is accomplished by bathing the material in aheated solution of nitric acid. If these particles 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 perform-ance is dramatically improved by the formation of a thick chromium enrichedoxide layer.

research & developmentresearch & development

As 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 increased standardization in the electropolishingprocess in order to achieve a more predictable 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 first ALC-300 digitally controlled electropolishprocess monitoring equipment. This equipment is capable of producing consis-tent quality products without variance fromoperator to operator.

Through our research, we have come tounderstand that many inconsistencies in thefinal product are directly attributed to variation in the microchemistry and grainsize of the raw material. This is why we takespecial care to procure only materials providing optimal conditions for electropolishing.

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 process variables allows Cardinal BPE to transformthe art of electropolishing into a controlledscience.

It’s about quality.

b i o p h a r m a c e u t i c a l

It’s about control.

quality assurancequality assurance

Cardinal BPE bioPure tubing and fittings aremanufactured to meet or exceed ASME BPEstandards. Cardinal BPE was the first company in the high purity tubing and fittingindustry to be registered to international ISO9002 standards. Our unyielding commitmentto quality is evident in every step of our manufacturing process. From the start of procurement we specify stringent materialstandards. When raw materials arrive at ourloading dock they are quarantined until wallthickness, ovality, smoothness, surface morphology, and chemical composition havebeen verified to insure it will meet our rigorous electropolishing procedures.

All measuring instruments and analyticalequipment are calibrated and traceable toNIST standards. Finally, every employee is empowered 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 utilizing

a Meeco Aquamatic Plus moisture analyzer• Scanning Tunneling Microscope (STM)

surface analysis tests• Testing for presence of particles down to

0.01 micron utilizing a MET1CNC particle counter

• Certification for oxygen and medical gas • Image processing (video probe and/or

boroscoping capabilities)

Electropolishing creates a smooth clean surface that enhances corrosion resistanceand reduces bioburden in microscopiccrevices. With our innovative and proprietaryALC-300 process, Cardinal BPE has greatlyincreased our ability to deliver quality electropolished components for dependableperformance.

The Cardinal BPE electropolishing systemcreates a leveling action so effective that thefinished surface often has only one tenth thesurface area of a mechanically or chemicallypolished surface. During the electropolishingprocess the wall thickness is carefully monitored, ensuring excellent weldabilitywith all automatic welding equipment.

Our ALC-300 controller uses statisticalprocess control to bring the electropolishingprocess into the twenty-first century. Everyvital parameter is monitored and regulatedwith this innovative computer controlled system. Since process parameters are storedin a database, the ultimate in material tracking is available.

electropolishingelectropolishingfittingsfittings

Fittings are produced to ASME BPE standards. We begin the process with aheavier wall to offset the thinning thatoccurs during manufacturing. Cardinal BPEfittings undergo a thorough preparationprocess to insure corrosion resistance aswell as stringent dimensional specificationsfor economical installation.

First, welds are mechanically polished, andwhen required, fittings are electropolishedand passivated. All welds are 100% visuallyinspected. Finally, the fittings are cleaned,capped, and bagged to meet the requiredspecification.

It’s about innovation.

cleaningcleaning

Cleaning for bioPURE products is done with18 meg ohm RO/DI water produced to the same standards used to clean integrated circuits. Cardinal’s RO/DI system is monitored to the following purity levels:

• Bacteria: Less than 6 colonies/100ml• TOC: Less than 25 ppb• Filtration: 0.1 micron absolute

Drying and purging is done with UHP nitrogen procured to the following, minimum purity specifications:

• Moisture: Less than 1 ppm• Oxygen: Less than 2 ppm• Total hydrocarbons: Less than 1 ppm

It’s about commitment.

bioPURE 10

product classificationsproduct classifications

bioPURE 15 • Surface designation SFT4

and SFF4 per ASME BPE.• Electropolished to 10 Ra

µin / 0.25 Ra µm ave., 15 Ra µin / 0.38 Ra µm max.

• Produced from highest quality 316L seamless andwelded stainless steel.

• Meets or exceeds current ASME-BPE and ASTM Standards.

• Fully passivated with nitric acid, then cleaned with Cleaned with 0.1 micron filtered, 18 megohm RO/DIwater.

bioPURE 20• Electropolished to 7 Ra

µin / 0.18 Ra µm ave., 10 Ra µin / 0.25 Ra µm max.

• Produced from highest quality 316L seamless and welded stainless steel.

• Meets or exceeds current ASME-BPE and ASTM Standards.

• Fully passivated with nitric acid, then cleaned with Cleaned with 0.1 micron filtered, 18 megohm RO/DIwater.

bioPURE BA• Surface designation SFT1

and SFF1 per ASME BPE• Mechanically polished to

15 Ra µin / 0.38 Ra µm ave., 20 Ra µin / 0.51 Ra µmmax.

• Produced from highestquality 316L seamless and welded stainless steel

• Meets or exceeds current ASME-BPE and ASTM Standards.

• Cleaned with 0.1 micron filtered, 18 megohm RO/DI water.

• Surface to be mill finished fully BA bright annealed

• Produced from highest quality 316L seamless andwelded stainless steel.

• Produced to meet or exceed current ASME-BPEand ASTM Standards.

• Cleaned with 0.1 micron filtered, 18 megohm RO/DIwater.

servicesservices

Cardinal BPE provides specialized servicessuch as electropolishing, passivation, cleaning and bagging of materials supplied byour customers. These services can be provided on an as needed or contract basis.

Electropolishing: With our carefully regulated andautomated electropolishing process, we canprovide surface levels of less than 5 Ra. When electropolishing customer supplied material wecan often provide a surface twice as smoothas received. Our in-house capabilities accom-modate a wide variety of products includingtanks, valve and regulator bodies, specialty fittings, filter housings, pipe and tubing, manifolds, heat exchangers and pump casings.

Passivation: Nitric acid passivation providesimproved corrosion resistance, even if the partis not electropolished. We control pH, temperature, flow, suspended contaminants,and time in our passivation process to maximize the effectiveness of the passivatedfinished part. We can effectively passivate awide variety of products including long lengthsof coiled tubing.

Cleaning and Bagging: Cardinal BPE offers arange of cleaning services including cleaningfor oxygen service and specialized cleaning tocustomer specifications requiring solvent andheated deionized water processing. In additionto providing cleaning services we also providepackaging services such as capping, bagging,double bagging and sealing in a clean roomenvironment – certified according to ISO andFederal Standard #209 as class 10.

Fabrication/Machining/Welding: Our experiencedcraftsmen and engineers can design and fabricate components to your specificationsincluding special fittings, gas manifolds, faceseal fittings, containment systems, and pipe-to-tubing transitions. With the capability towork with most metals including stainlesssteel, Hastelloy, AL6XN®, Monel, tantalum, titanium, aluminum, and copper, Cardinal UHPcan design and fabricate your high purity system components.

b i o p h a r m a c e u t i c a l

* All products are subject to numerous quality tests options utilizing image processing (video probe and/or boroscoping capabilities) and certification for oxygen and medical gas service. Electropolished products are also available with SEM, Auger, and ESCA certification.

Member of International Societyof Pharmaceutical Engineering

1 9 1 0 C r y s t a l I n d u s t r i a l C o u r t • S a i n t L o u i s , M i s s o u r i • P h : 3 1 4 . 4 7 3 . 2 1 2 1 • F a x : 3 1 4 . 4 7 3 . 2 1 2 0

9002

Mallekotstraat 65 • B 2500 Lier Belgium • Ph: (+32) 3 491 9875 • Fax: (+32) 3 491 9876

©20

01 C

ardi

nal U

HP •

Bul

letin

CLT

-BPE

BR •

1 J

UL 0

1

w w w . c a r d i n a l b p e . c o m