Try Excellence in Biotechnology - GEA Westfalia Separator

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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
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