Try Excellence in Biotechnology - GEA Westfalia Separator

Liquids to ValueTry Excellence in BiotechnologyWestfalia Separator ® caretechnologyGEA Mechanical Equipment / GEA Westfalia Separator

What You Purchaseis a Separator ….. what you get is more than 115 years ofexperience in centrifuge construction.Aseptic process management, optimumcleaning capability, closed product handling,gentle product treatment, reliablecompliance with GMP requirements, efficientrecovery of active ingredients andreliable scale-up – the requirements ofbiotechnology are demanding.With separators designed specificallyfor biotechnology, Westfalia Separator ®caretechnology stands for reliable compliancewith these requirements.2GEA Westfalia Separator

Pioneers from theBeginningGEA Westfalia Separator built the first centrifuge in 1893 in Oeldein Westphalia. Since that time, the company has been at the forefrontof shaping progress in centrifugal separation technology.Today, it is a key technology in the recovery of pharmaceuticalactive ingredients with considerable potential for optimisingproduction processes and products.The separators, decanters and processlines from GEA Westfalia Separator havea proven track record throughout theworld in high-performance companies ofall types and sizes and under a widerange of conditions. Experience andknowledge gained in these fields supportthe optimsation of separating systems andprocesses as well as the development offundamentally new concepts, e.g. in drivesystems, design and functionality.Proven innovative strengthA striking aspect of the success of thecompany in biotechnology is the speedwith which new developments are translatedinto marketable processes andsystems which take account of the complexrequirements of biotechnology rightdown to the smallest detail. This is basedon the decades of experience in thedesign and production of separators forbiotechnology, the use of new researchfindings as well as the implementation ofthe latest design and production methods.For instance, GEA Westfalia Separator hasdeveloped numerous forward-lookingimprovements of separating processesand has ensured that they are marketablethroughout the world by means of firstclassengineering. Overall, the company cannow handle more than 2500 applications.Under the designation WestfaliaSeparator ® caretechnology, GEAWestfalia Separator uses this potential inpharmaceutical biotechnology.Customers are benefiting particularlyin this dynamically expanding marketsector from the design implementationof stringent technical standards, hygienicdesign and gentle product treatmentright through to the reliable compliancewith all GMP requirements and a reliablescale-up.3GEA Westfalia Separator

Innovations –Engineered with CareIn biotechnology, the separators from GEA Westfalia Separatorare used for processing mammalian cell cultures, recoveringpharmaceutical proteins and vaccines, producing hormones suchas insulin, fractionating human blood plasma and also forrecovering many other pharmaceutical active ingredients.Improvements and new developmentswith Westfalia Separator ® caretechnologyfocus entirely on the safety of biotechnologyprocesses and the efficiencyof recov-ering the active ingredients.In order to comply with the stringentsafety requirements applicable for productionprocesses in biotechnology, centrifugesfrom GEA Westfalia Separatorincorporate a wide range of specialfeatures which stand for high yieldsof valuable substances, gentle producttreatment and optimum CIP and SIPcapability.The Westfalia Separator ® hydrostopsystemensures better utilisation of the resourcesused, and thus guarantees a highyield of valuable substances. The systemdramatically reduces ejection times, thusminimising product losses. It permits partialejections in 30-second cycles withprecisely reproducible discharge quantities.With total ejections during cleaningin-place,it also ensures very strong flowturbulence in the bowl, so that solids arereliably flushed out of the separator.The full-sterilisation principleWith regard to sterilisation, WestfaliaSeparator ® caretechnology exclusivelyuses the full-sterilisation concept in whichthe entire installation including the separatoris sterilised. Compared with otherprocedures, in which only certain areasare covered by this procedure, the risk ofrecontamination can be reliably excluded.This concept has been validated by GBFin accordance with FDA requirements.The hydrohermetic feed systemis gentle on sensitive products. Thispatented feed system reduces shearingforces when product enters the separator,and thus retains the vitality of fragilecells. Unlike completely hermeticmachines, there are no seals which aresubject to wear-and-tear in the chamberwhich comes into contact with the product,and product contamination from thissource is thus avoided.4GEA Westfalia Separator

Viscosity-controlled nozzle-typeseparators Westfalia Separator ®viscon ®also improve the treatment of starter culturesand the recovery of hormones andpharmaceutical proteins. Even in conjunctionwith fluctuating feed conditions,Westfalia Separator ® viscon ® nozzles automaticallyensure a constant discharge concentration.By placing the Westfalia Separator ®viscon ® nozzles on the bowl head insteadof the periphery, the pressure on theseparated cells is also much lower.Hygienic designWith a welding method developed byGEA Westfalia Separator, the spacers canbe welded on to the discs without anygaps. The result: dead legs in whichbacteria can collect and pose a risk toproduct purity are reliably prevented. Afurther benefit is the fact that seals andseal grooves do not feature any deadlegs, and maximum surface qualitiesensure optimum cleaning capability ofthe separators.Tested safetyThe function entity comprising the separator,control and sterile package whichis configured to meet the user’s specificrequirements is assembled on a baseframe, automated and subjected to afunction test (FAT) before being deliveredto the customer. The latter also comprisesa steam sterilisation test for eachpackage unit on up to six measuringpoints. On the premises of the user, it isonly necessary to connect the lines forproduct and operating media.GMP-compliant documentationWestfalia Separator ® caretechnologyof course includes the complete documentationin accordance with currentGMP requirements. For this purpose,GEA Westfalia Separator set up a separateGMP group a few years ago, and thisgroup comprises all relevant departments.The team meets at frequent intervals towork new market developments into thedocuments and accordingly implementnew requirements. The documents andstaff are consequently always kept up todate which means safety for the user.5GEA Westfalia Separator

Reliability from theTest Tube Right Through toMarketabilityAs far as product development in biotechnology is concerned,GEA Westfalia Separator assists you as an experienced partnerwhen the need is to convert your lead as a pioneer and developerof a new product into permanent market success. This involvesthe reliable route from the initial laboratory tests and the pilotinstallation right through to the full-scale installation.Numeric flow simulation CFD (ComputationalFluid Dynamics) can be used, for example,to examine the flow characteristics of liquidsand liquids with particles. Particularly withregard to the scale-up of separators inbiotechnology, CFD simulations have provento be a useful additional tool whose resultsare utilised for optimisation of the centrifugesduring the construction phase.GEA Westfalia Separator guarantees areliable scale-up based on decades ofexperience, computer-aided simulationsand a comprehensive range of separatorsfor biotechnology.Up to ten years development time andinvestments running into ten digits, e.g.in the production of medical products,again show that methods such as “trialand error”, “test, study and test again”constitute an unforeseeable risk on theroute from the initial test tube throughto the marketable industry batch.In this context, Westfalia Separator ®caretechnology involves reliably transferringresults achieved with the new activeingredients in the laboratory scale to fullscaleproduction. A wide range of separatorsfor biotechnology with differentproduction capacities and designsis available for this purpose. Fromthe smallest nozzle-type separatorWestfalia Separator ® viscon ® rightthrough to the largest steam-sterilisablecentrifuge in the world, namelyCSE 170, GEA Westfalia Separator offersa comprehensive range of separators toenable all customer needs and capacityranges to be satisfied.With regard to designing separatorsfor pharmaceutical biotechnology,GEA Westfalia Separator relies not onlyon its know-how established overdecades. By using computer-aided CFDcalculations, the conditions in the centrifugeare simulated on the basis of therelevant product and machine para-6GEA Westfalia Separator

CSA 8 CSC 15 CSE 80meters. In this way, the separators areprovided with optimum design in thedesign phase for the requirements ofpharmaceutical biotechnology, irrespectiveof the product capacity for whichthey are designed. The results of pilot trialscan thus be reliably transferred to theindustrial scale.Customers benefit in two ways from thisscale-up safety. They can reliably andquickly launch their product on the marketby generating basic data, and by evaluatingand simulating the product andprocess parameters. In this way, they takeadvantage of all benefits provided by aseparator in the downstream process.CSE 170CFD calculations split the flow area intonumerous control volumes. In this process,conservation equations are formulated formass, momentum and energy. The solutionsderived from these systems of equations canthen describe the complete flow field. Herefor instance, the relative pressure in the inletarea is illustrated.7GEA Westfalia Separator

Beverage TechnologyDairy TechnologyRenewable ResourcesChemical / Pharmaceutical TechnologyMarineEnergyOil & GasEnvironmental TechnologyEngineeringSecond Hand MachineryOriginal Manufacturer ServiceThe information contained in this brochure merelyserves as a non-binding description of our productsand is without guarantee.Binding information, in particular relating to capacitydata and suitability for specific applications, can only beprovided within the framework of concrete inquiries.Westfalia ® , Westfalia Separator ® and viscon ®are registered trademarks of GEA Westfalia Separator GmbH.Printed on chlorine-free bleached paper9997-1262-020/0810 ENPrinted in GermanySubject to modificationGEA Mechanical EquipmentGEA Westfalia SeparatorWerner-Habig-Straße 1 · 59302 Oelde (Germany)Phone +49 2522 77-0 · Fax +49 2522 77-2828www.westfalia-separator.com