Try Excellence in Biotechnology - GEA Westfalia Separator
Try Excellence in Biotechnology - GEA Westfalia Separator
Try Excellence in Biotechnology - GEA Westfalia Separator
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Liquids to Value<strong>Try</strong> <strong>Excellence</strong> <strong>in</strong> <strong>Biotechnology</strong><strong>Westfalia</strong> <strong>Separator</strong> ® caretechnology<strong>GEA</strong> Mechanical Equipment / <strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>
What You Purchaseis a <strong>Separator</strong> ….. what you get is more than 115 years ofexperience <strong>in</strong> centrifuge construction.Aseptic process management, optimumclean<strong>in</strong>g capability, closed product handl<strong>in</strong>g,gentle product treatment, reliablecompliance with GMP requirements, efficientrecovery of active <strong>in</strong>gredients andreliable scale-up – the requirements ofbiotechnology are demand<strong>in</strong>g.With separators designed specificallyfor biotechnology, <strong>Westfalia</strong> <strong>Separator</strong> ®caretechnology stands for reliable compliancewith these requirements.2<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>
Pioneers from theBeg<strong>in</strong>n<strong>in</strong>g<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> built the first centrifuge <strong>in</strong> 1893 <strong>in</strong> Oelde<strong>in</strong> Westphalia. S<strong>in</strong>ce that time, the company has been at the forefrontof shap<strong>in</strong>g progress <strong>in</strong> centrifugal separation technology.Today, it is a key technology <strong>in</strong> the recovery of pharmaceuticalactive <strong>in</strong>gredients with considerable potential for optimis<strong>in</strong>gproduction processes and products.The separators, decanters and processl<strong>in</strong>es from <strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> havea proven track record throughout theworld <strong>in</strong> high-performance companies ofall types and sizes and under a widerange of conditions. Experience andknowledge ga<strong>in</strong>ed <strong>in</strong> these fields supportthe optimsation of separat<strong>in</strong>g systems andprocesses as well as the development offundamentally new concepts, e.g. <strong>in</strong> drivesystems, design and functionality.Proven <strong>in</strong>novative strengthA strik<strong>in</strong>g aspect of the success of thecompany <strong>in</strong> biotechnology is the speedwith which new developments are translated<strong>in</strong>to marketable processes andsystems which take account of the complexrequirements of biotechnology rightdown to the smallest detail. This is basedon the decades of experience <strong>in</strong> thedesign and production of separators forbiotechnology, the use of new researchf<strong>in</strong>d<strong>in</strong>gs as well as the implementation ofthe latest design and production methods.For <strong>in</strong>stance, <strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> hasdeveloped numerous forward-look<strong>in</strong>gimprovements of separat<strong>in</strong>g processesand has ensured that they are marketablethroughout the world by means of firstclasseng<strong>in</strong>eer<strong>in</strong>g. Overall, the company cannow handle more than 2500 applications.Under the designation <strong>Westfalia</strong><strong>Separator</strong> ® caretechnology, <strong>GEA</strong><strong>Westfalia</strong> <strong>Separator</strong> uses this potential <strong>in</strong>pharmaceutical biotechnology.Customers are benefit<strong>in</strong>g particularly<strong>in</strong> this dynamically expand<strong>in</strong>g marketsector from the design implementationof str<strong>in</strong>gent technical standards, hygienicdesign and gentle product treatmentright through to the reliable compliancewith all GMP requirements and a reliablescale-up.3<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>
Innovations –Eng<strong>in</strong>eered with CareIn biotechnology, the separators from <strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>are used for process<strong>in</strong>g mammalian cell cultures, recover<strong>in</strong>gpharmaceutical prote<strong>in</strong>s and vacc<strong>in</strong>es, produc<strong>in</strong>g hormones suchas <strong>in</strong>sul<strong>in</strong>, fractionat<strong>in</strong>g human blood plasma and also forrecover<strong>in</strong>g many other pharmaceutical active <strong>in</strong>gredients.Improvements and new developmentswith <strong>Westfalia</strong> <strong>Separator</strong> ® caretechnologyfocus entirely on the safety of biotechnologyprocesses and the efficiencyof recov-er<strong>in</strong>g the active <strong>in</strong>gredients.In order to comply with the str<strong>in</strong>gentsafety requirements applicable for productionprocesses <strong>in</strong> biotechnology, centrifugesfrom <strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong><strong>in</strong>corporate a wide range of specialfeatures which stand for high yieldsof valuable substances, gentle producttreatment and optimum CIP and SIPcapability.The <strong>Westfalia</strong> <strong>Separator</strong> ® hydrostopsystemensures better utilisation of the resourcesused, and thus guarantees a highyield of valuable substances. The systemdramatically reduces ejection times, thusm<strong>in</strong>imis<strong>in</strong>g product losses. It permits partialejections <strong>in</strong> 30-second cycles withprecisely reproducible discharge quantities.With total ejections dur<strong>in</strong>g clean<strong>in</strong>g<strong>in</strong>-place,it also ensures very strong flowturbulence <strong>in</strong> the bowl, so that solids arereliably flushed out of the separator.The full-sterilisation pr<strong>in</strong>cipleWith regard to sterilisation, <strong>Westfalia</strong><strong>Separator</strong> ® caretechnology exclusivelyuses the full-sterilisation concept <strong>in</strong> whichthe entire <strong>in</strong>stallation <strong>in</strong>clud<strong>in</strong>g the separatoris sterilised. Compared with otherprocedures, <strong>in</strong> which only certa<strong>in</strong> areasare covered by this procedure, the risk ofrecontam<strong>in</strong>ation can be reliably excluded.This concept has been validated by GBF<strong>in</strong> accordance with FDA requirements.The hydrohermetic feed systemis gentle on sensitive products. Thispatented feed system reduces shear<strong>in</strong>gforces when product enters the separator,and thus reta<strong>in</strong>s the vitality of fragilecells. Unlike completely hermeticmach<strong>in</strong>es, there are no seals which aresubject to wear-and-tear <strong>in</strong> the chamberwhich comes <strong>in</strong>to contact with the product,and product contam<strong>in</strong>ation from thissource is thus avoided.4<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>
Viscosity-controlled nozzle-typeseparators <strong>Westfalia</strong> <strong>Separator</strong> ®viscon ®also improve the treatment of starter culturesand the recovery of hormones andpharmaceutical prote<strong>in</strong>s. Even <strong>in</strong> conjunctionwith fluctuat<strong>in</strong>g feed conditions,<strong>Westfalia</strong> <strong>Separator</strong> ® viscon ® nozzles automaticallyensure a constant discharge concentration.By plac<strong>in</strong>g the <strong>Westfalia</strong> <strong>Separator</strong> ®viscon ® nozzles on the bowl head <strong>in</strong>steadof the periphery, the pressure on theseparated cells is also much lower.Hygienic designWith a weld<strong>in</strong>g method developed by<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>, the spacers canbe welded on to the discs without anygaps. The result: dead legs <strong>in</strong> 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 clean<strong>in</strong>g capability ofthe separators.Tested safetyThe function entity compris<strong>in</strong>g 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 be<strong>in</strong>g deliveredto the customer. The latter also comprisesa steam sterilisation test for eachpackage unit on up to six measur<strong>in</strong>gpo<strong>in</strong>ts. On the premises of the user, it isonly necessary to connect the l<strong>in</strong>es forproduct and operat<strong>in</strong>g media.GMP-compliant documentation<strong>Westfalia</strong> <strong>Separator</strong> ® caretechnologyof course <strong>in</strong>cludes the complete documentation<strong>in</strong> accordance with currentGMP requirements. For this purpose,<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> set up a separateGMP group a few years ago, and thisgroup comprises all relevant departments.The team meets at frequent <strong>in</strong>tervals towork new market developments <strong>in</strong>to thedocuments and accord<strong>in</strong>gly implementnew requirements. The documents andstaff are consequently always kept up todate which means safety for the user.5<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>
Reliability from theTest Tube Right Through toMarketabilityAs far as product development <strong>in</strong> biotechnology is concerned,<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> assists you as an experienced partnerwhen the need is to convert your lead as a pioneer and developerof a new product <strong>in</strong>to permanent market success. This <strong>in</strong>volvesthe reliable route from the <strong>in</strong>itial laboratory tests and the pilot<strong>in</strong>stallation right through to the full-scale <strong>in</strong>stallation.Numeric flow simulation CFD (ComputationalFluid Dynamics) can be used, for example,to exam<strong>in</strong>e the flow characteristics of liquidsand liquids with particles. Particularly withregard to the scale-up of separators <strong>in</strong>biotechnology, CFD simulations have provento be a useful additional tool whose resultsare utilised for optimisation of the centrifugesdur<strong>in</strong>g the construction phase.<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> guarantees areliable scale-up based on decades ofexperience, computer-aided simulationsand a comprehensive range of separatorsfor biotechnology.Up to ten years development time and<strong>in</strong>vestments runn<strong>in</strong>g <strong>in</strong>to ten digits, e.g.<strong>in</strong> the production of medical products,aga<strong>in</strong> show that methods such as “trialand error”, “test, study and test aga<strong>in</strong>”constitute an unforeseeable risk on theroute from the <strong>in</strong>itial test tube throughto the marketable <strong>in</strong>dustry batch.In this context, <strong>Westfalia</strong> <strong>Separator</strong> ®caretechnology <strong>in</strong>volves reliably transferr<strong>in</strong>gresults achieved with the new active<strong>in</strong>gredients <strong>in</strong> the laboratory scale to fullscaleproduction. A wide range of separatorsfor biotechnology with differentproduction capacities and designsis available for this purpose. Fromthe smallest nozzle-type separator<strong>Westfalia</strong> <strong>Separator</strong> ® viscon ® rightthrough to the largest steam-sterilisablecentrifuge <strong>in</strong> the world, namelyCSE 170, <strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> offersa comprehensive range of separators toenable all customer needs and capacityranges to be satisfied.With regard to design<strong>in</strong>g separatorsfor pharmaceutical biotechnology,<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> relies not onlyon its know-how established overdecades. By us<strong>in</strong>g computer-aided CFDcalculations, the conditions <strong>in</strong> the centrifugeare simulated on the basis of therelevant product and mach<strong>in</strong>e para-6<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>
CSA 8 CSC 15 CSE 80meters. In this way, the separators areprovided with optimum design <strong>in</strong> 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 the<strong>in</strong>dustrial scale.Customers benefit <strong>in</strong> two ways from thisscale-up safety. They can reliably andquickly launch their product on the marketby generat<strong>in</strong>g basic data, and by evaluat<strong>in</strong>gand simulat<strong>in</strong>g the product andprocess parameters. In this way, they takeadvantage of all benefits provided by aseparator <strong>in</strong> the downstream process.CSE 170CFD calculations split the flow area <strong>in</strong>tonumerous 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 <strong>in</strong>stance, the relative pressure <strong>in</strong> the <strong>in</strong>letarea is illustrated.7<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>
Beverage TechnologyDairy TechnologyRenewable ResourcesChemical / Pharmaceutical TechnologyMar<strong>in</strong>eEnergyOil & GasEnvironmental TechnologyEng<strong>in</strong>eer<strong>in</strong>gSecond Hand Mach<strong>in</strong>eryOrig<strong>in</strong>al Manufacturer ServiceThe <strong>in</strong>formation conta<strong>in</strong>ed <strong>in</strong> this brochure merelyserves as a non-b<strong>in</strong>d<strong>in</strong>g description of our productsand is without guarantee.B<strong>in</strong>d<strong>in</strong>g <strong>in</strong>formation, <strong>in</strong> particular relat<strong>in</strong>g to capacitydata and suitability for specific applications, can only beprovided with<strong>in</strong> the framework of concrete <strong>in</strong>quiries.<strong>Westfalia</strong> ® , <strong>Westfalia</strong> <strong>Separator</strong> ® and viscon ®are registered trademarks of <strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong> GmbH.Pr<strong>in</strong>ted on chlor<strong>in</strong>e-free bleached paper9997-1262-020/0810 ENPr<strong>in</strong>ted <strong>in</strong> GermanySubject to modification<strong>GEA</strong> Mechanical Equipment<strong>GEA</strong> <strong>Westfalia</strong> <strong>Separator</strong>Werner-Habig-Straße 1 · 59302 Oelde (Germany)Phone +49 2522 77-0 · Fax +49 2522 77-2828www.westfalia-separator.com