ASEPTIC FILLING SOLUTIONS - Flexicon.dk

Ultimate flexibility for clinical-scale aseptic fillingFor over 50 years the Watson-MarlowPumps Group has led the worldin peristaltic filling innovation, thetechnology of choice for high purityfluid handling in the pharmaceutical,biotech and diagnostics industries.PRECISIONFor Flexicon customers it is vital that our systems workwith high precision. Not only do we satisfy that demand;we deliver exactly what has been ordered on time, everytime. Today’s industry also requires safe operation withminimum risk to process, product and personnel. Weaccomplish this through our unique peristaltic fillingsystems, providing validated processes from clinical trialsto production.EFFICIENCYOur customers can produce small and medium sizedbatches securely and profitably. Flexicon’s equipment isreliable, easy to operate and requires minimal maintenanceat long intervals. We offer first class after-sales service andfull documentation for all our products. In performance aswell as quality, we deliver what we say we will.Our range of filling and capping equipment providessolutions with the precision, efficiency and flexibility thatcustomers have come to know and trust.Peristaltic filling – the solution forhigh purity and low riskA peristaltic pump’s low shear action is createdby compressing a tube. Inside the single-use tubethe fluid is driven forward by rollers while the tube’srecovery behind each roller draws in more fluid. Thepump is perfect for moving fluid aseptically becausethe fluid stays within the tube. Unlike piston pumpsthere are no seals, valves or moving parts in its pathto lead to contamination.Flexicon peristaltic fillers are recognised byproduction managers for high quality, reliability andperformance. Our equipment simplifies validation,improves yield and reduces expensive downtime.FLEXIBILITYOur fillers are easily and quickly adjustable for a hugerange of fill volumes, fluids, capacities, bottles and caps.We can customise products to your exact requirementsand you can visit our plant to assure yourself that ourperformance matches our promise. We offer a shortresponse time from initial contact to delivery.Flexicon offers a range of products that grow with you,from stand-alone units for hand filling, through semiautomaticsystems, to fully automatic filling, stopperingand capping machines. The fully automatic systems arecustomised to fit any glass vial, plastic bottle, test tube,eye-dropper or non-self-standing microtube.A tabletop dispenser can be connected to a bottlehandling unit, if the need for automation arises. Thisreduces validation costs and limits extra investment asdemand for production capacity increases. The addedbenefit of such easy up-scaling is that only a minimum ofoperator training is needed.We are the only global supplier ofperistaltic filling equipment withour own tubing production facility,therefore ensuring full control of thecomplete solution, reducing risk,providing consistent performance andsaving customers time and money.23

Aseptic liquid filling and capping equipmentFlexicon - flexibility to grow withyour changing needsFlexicon offers a range of products that grow withyour business, from stand-alone units for hand filling,through semi-automatic systems, to fully automaticfilling, stoppering and capping machines.The fully automatic systems are customised to fit anyglass vial, plastic bottle, test tube, eye-dropper ornon-self standing microtube.Tabletop unitsSemi-automaticsystemsFully-automaticsystemsSolutions forintegration or retrofitFillersFillingWide range of systems forautomation of filling, stoppering,capping and weight checkOEM peristaltic fillers and controllersCappersFilling and cappingCustomised monobloc systemsTrolley solutions for pistonpump replacementSingle-use sterility throughout. Flexicon Accusil and asepticsusingle-use fluid path technology makes validation and scale-up easyLab - R&D Clinical I Clinical II Clinical III Small Production Full Production High SpeedSterile, single-use fluid path - asepticsu (pages 6-7)Tabletop Dispensing Systems - PF6, 520Di, PF22 (pages 8-9)Tabletop Screw and Crimp Cappers - FS and FC (pages 10-11)Vial/Bottle Handling - FlexFeed15 and FlexFeed20 (pag es 12-13)Filling/Screw Capping - FlexFeed30 (pages 14-15)Filling and Stoppering - FP50 (pages 16-17)Filling, Stoppering and Capping - FPC50 (pages 18-19)FPC50 for integration into an Isolator - FPC50ISO (pages 18-19)Fully Automatic Monobloc - FMB210 (pages 20-21)Master Controllers, Trolleys and Pumps/Fillers - OEM Solutions (pages 22-23)45

Your answer for aseptic fillingsingle-use fluid path andAccusil platinum-cured silicone tubingfor sterility throughoutSingle-use technology asepticsuasepticsu is a sterile, single-use fluid path perfectedfor aseptic filling by Flexicon, the world leader inperistaltic filling systems for over 25 years. Thecombination of asepticsu and Flexicon peristaltictechnology lowers your risk in high purity, highaccuracy filling applications.Flexicon peristaltic filling units with asepticsu singleusetechnology deliver rapid product changeover, noline-cleaning, no cross-contamination and simplifiedvalidation.• Huge validation savings and faster to market• Contamination risks are eliminated• Prevents costly overfilling• Small batch production is easy and efficient• Simplified inventory managementSimplify your cleaning validationImagine a USP Class VI fluid path that is fully traceablefrom end-to-end, is simple to validate, and you haveasepticsu. From the bag, to the tubing through thepump, to the filling nozzle on your machine, asepticsuprovides an entire wet end, which is fully assembledand lot traceable. And best yet, its single-use designeliminates costly cleaning validation.Filling equipment and single-use fluid pathsfrom just one supplier makes validation easyand prevents costly overfillingAccusil precisiontubing prevents costly overfillingAccusil tubing provides perfect filling accuracy, fill speed,minimum foaming and no dripping between fills forvolumes from less than 0,2ml to more than 250ml. Thisprevents costly overfilling and eliminates production stopsdue to spillage between the fills.For full details on Accusil tubing, see page 23asepticsu TM enhancesa complete fillingsystem, such as theFPC50W shown hereAccusil with laser-etchedlot number, part number and use-by-date67

Tabletop dispensingThe simplest filling set-up withaccuracy, flexibility and reliabilityFlexicon tabletop fillers are designed for use in cleanroomsfor production processes complying with cGMP.Setting up a filling regime for vials, bottles, test tubes orother containers is achieved by loading the peristalticfiller tube and entering the parameters required using theintuitive keypad.The pump maintains a closed fluid path from the bulkproduct container to the end of the filling nozzle. Changethe path and the pump is clean, sterile and ready for thenext batch. You can control the filler with a foot switch orintegrate it into an automatic bottle handling system.• No cross-contamination• Accuracy: ±0.5% and no costly overfilling• No foaming, splashing or dripping between fills• One-minute set-up and changeover• Unmatched filling flexibility over a very wide range of fillvolumes, from less than 0.2ml to more than 250ml fromthe same pumphead• Designed with the operator in mind – higher productivityand less risk of human errorA complete solution from just one suppliermakes validation easy and prevents costly overfillingFlexicon peristalticpumpheads and Accusilplatinum-cured siliconetubing provide excellentdispensing accuracyFlexicon’s unique peristalticpumphead enables productchangeover in less than one minuteFilling time (sec)PF6 - capacity diagram (based on water)4.003.503.002.502.001.501.000.50Filling time (sec)4.003.503.002.502.001.501.000.50PF22 - capacity diagram (based on water)PF22 for less than 5mlto more than 5000ml0.000.000.1 1 10 100 1000 0.11101001000Filling volume (ml)Filling volume (ml)89

Tabletop screw and crimp cappingCappers ensure consistent qualitycrimps and torqueWhen there is need to increase productivity, whileminimising operator fatigue and repetitive strain injury,our cappers can be added to your current process.Features offered by both crimp and screw cappersare:• Consistent quality closure• Cap up to 1,000 units/hour• Fast changeoversDeciding which capper is right for the processdepends on the capping needs. Each capper hasspecific benefits.Screw cappers• No tools needed for changeover• Handles caps up to 65mm and bottlesizes up to 100mm in diameter• Adjustable closing torqueCrimp cappers• High quality aluminium overseal• Low particle release• Easy to mount crimp heads and bottle toolsin standard or customised sizes are available• Collection of used compressed airA range of format parts is available to handledifferent types and sizes of caps, bottles and vialsMax. Cap SizeMax. Bottle SizeCapper Name Diameter Height Diameter Height Air SupplyFC10 Screw 50mm 40mm 55mm 180mm 6 bar 85 l/minFC32 Screw 65mm 40mm 100mm 240mm 6 bar 85 l/minFS10 Crimp 8-20mm DIN standard 55mm 180mm 35 l/min. free airFS32 Crimp 13-32mm DIN standard 95mm 240mm 50 l/min. free airScrew capper FC10Crimp capper FS10Crimp capper FS32If space is at a premium in your current setting, take a look at the small foot print offered by our cappers.FS10FS32 FC10 FC32Dimensions in mm/inch1011

Automatic filling and tabletop vial/bottle handling systemFlexFeed 15 and 20automatic filling systemsAs the need for more automation grows Flexicon’s productline meets the needs of flexible production of small batchesin contract filling and diagnostics operations where thereare many different sizes of bottles.The speed at which the vials/bottles are presented at thefilling needle is fully adjustable, allowing light vials or bottlesto be filled. Customised solutions can be designed tohandle bottles with special shapes.The FlexFeed15 and FlexFeed20, used in conjunction withone of our crimp or screw capping machines, providesa simple and very flexible means of production andcustomers can achieve a fast return on investment.• 12mm to 50mm (FF15) / 67mm (FF20) diameterbottles without any format parts• Complete changeover in less than five minutes• Prevents repetitive strain injuries• Small foot print and designed for cleanroomenvironments• Unique cost of ownershipIdeal for contract filling where there are manydifferent sized bottles/vialsGo from manual to automatic fillingand get a fast return on investmentFlexFeed15FlexFeed20The 520Di dispensing pump can also be used with theFlexFeed 15 and 20 vial/bottle handling systemsDimensions in mm/inch1213

Semi automatic filling and capping systemFlexFeed30 filling and capping systemfor small batchesFor a higher productivity, a more consistent screw cappingand no more repetitive strain injuries, the FlexFeed30 isthe answer for contract manufacturers and diagnosticcompanies.Fills bottles from 12mm to 50mm in diameter• Reduced production costs and increased productivity• Consistent cap torque prevents leakage of liquid• Up to 1,200 units/hour• Protects operators from repetitive strain injuries• Complete cap and bottle change in less than five minutes• Fills bottles from 12mm to 50mm in diameterSmall batch production - easy and efficientFilling is done automatically, cap is placed manuallyand capping torque is applied automaticallyA 520Di/L pump can also be used with theFlexFeed30 filling and capping systemDimensions in mm/inch1415

Fully automatic filling and stopperingFP50 automates two key features:vial filling and stopperingAutomating the key steps of aseptic filling cuts the riskof operator error and related contamination. The FP50peristaltic filling system also eliminates the costs and riskissues of volumetric filling pumps.The FP50 is a tabletop filling system used forbiopharmaceutical research and developmentdepartments during clinical trial phases, or for contractmanufacturing companies where it will increase flexibilityand save costs.• Up to 25 units/minute• Filling accuracy better than ±0.5%• From less than 0,2ml to 100ml fills of 2R to 100Hvials• Full or partial stoppering• Quick and simple format changes• Universal format parts reduce costs• Small footprint for LAF bench or RABS installationsIncrease your flexibility when filling smallerbatches - just one machine will fill all your vialsFills from less than 0.2ml up to 100ml. Maximum25 vials per minuteStoppering with 13mm and20mm stoppers requires noadditional format partsA customised FP50 is built into an isolator so that thefluid and the filled vials are completely contained.Dimensions in mm/inch1617

Fully automatic filling, stoppering and cappingFPC50 offers superior filling technologywith optional 100% in-line checkweighingThe FPC50 provides a ready-to-use and easy-to-validatefilling, stoppering and capping system for flexible smallbatch pharma production.It is a modular system which offers options for 100% inlinecheck-weighing and usage under a standard LAF or aRABS.The FPC50 can also be customised for integration intoan isolator with easy access to all areas of the machinethrough glove ports.The universal format parts of the FPC50 allow for filling of awide range of vials, stoppers and caps. The peristaltic fillingsystem eliminates having product-dedicated or volumededicatedpumps in stock.We have an excellent record in providing short and reliabledelivery times and performing seamless FAT, IQ and OQtests, avoiding costly project delays.• High accuracy filling for less than 0.2ml up to 100mlwith no splashing, dripping or foaming• Fast and easy changeover between batches withvery limited product waste at start-up• Universal format parts reduce costs and increaseflexibility• Up to 25 units/minute• Batch report after each production run and fullaudit trail• First class documentation and test protocols for FAT,SAT, IQ and OQ• Software designed and qualified according to GAMP5• Optional software to support 21 CFR Part 11Master controller canbe situated outside anLAF hood or RABS unitUniversal format parts allow filling, stoppering andcapping of a wide range of vialsFPC50 crimping head for minimum airturbulence and fast changeover between capsA filling machine and single-use fluid path from onesupplier makes validation easy and prevents costly overfillingDimensions in mm/inch1819

Flexible, production-scale fillingOEM system components tocomplete your filling lineAccusil TMplatinum-cured siliconetubing for accurate dispensingMany filling machine manufacturers have alreadysuccessfully incorporated Flexicon solutions into their fillinglines, thereby adding value to their product and increasedsatisfaction from their clients.• Full flexibility in fill volumes• Prevent spillage between fills, foaming and splashing• Fast changeover• High filling accuracy reduces production costs• Global support and high quality filling accessoriesOEM applications include:• Existing filling lines where piston pumps need to bereplaced• New high capacity filling lines for the biopharm industryMaster controllersMaster controllers, such as the MC100 and theMC12, can control up to 16 pumps on a filling line.We supply stand-alone controllers, panel mounts andcontrollers for communication with filling line systemsvia PROFIBUS or DeviceNet. The MC100 receivesfilling data through an industrial fieldbus, calculatesoperating values for the fillers then transmits thosethrough a FlexNet protocol to the fillers.Parallel Production Set-UpAccusil precision tubing preventscostly overfillingAccurate and consistent dispensing requires havingthe right tubing inside the right pump. Accusil ismanufactured in our state-of-the-art extrusion facilityto the highest quality, with a consistent wall thicknessand a specific hardness for optimal tubing restitution.Accusil fulfills biopharmaceuticalrequirements and is ideal for single-usefilling• Full biopharmaceutical compliance with USP ClassVI, Ph. Eur. 6.8 Chapter 3.1.9, ISO 10993 and FDACFR 177.2600.Reduce your costs and increaseyour productivity with Accusil• Excellent filling accuracy on PF6 and PD12peristaltic pumps• Peristaltic filling technology provides fast and easychangeover between liquids to be filled• Cross-contamination between liquids to be filled isprevented• Enhanced safety as contact between liquid andoperator can be avoided• Tubing sizes for fill volumes from less than 0.2mlup to more than 250ml• Fast delivery service• Filling lines for bottles with an awkward shape for thediagnostics industryDynamic Recalibration Set-Up• Validation pack available• 100% traceability with laser-etched part number, lotnumber and use-by date• Lot specific certificate of conformance in each boxand accessible online• Manufactured in an ISO 14644-1Class 7environment at state-of-the art tubing productionfacilityAccessoriesFlexicon also offers filling nozzles and otheraccessories which can ensure aseptic filling with thehighest possible accuracy.Replace hard to validate piston fillerswith Flexicon single-use technology• Double-bagged for protection against contamination• Post-cured after extrusion for superior purity• Fully sterilisable by gamma radiation, autoclave orethylene oxide• Animal Derived Content FreeMC12 control unit with multiplePD12 fillersTrolley solutions are supplied for integration into new orexisting filling lines fitted with up to sixteen peristaltic fillersThe unit fulfils all the usual requirements andcan be extended to include several fillingstations, an electronic bottom-up fill system, aprinter, a direct link to a balance for dynamicrecalibration and more.The PD12 filler is available in several versions asa stand-alone unit or for panel mounting. Panelmount versions can be ordered for vertical orhorizontal integration and with a pump head ineither anodized aluminium or in stainless steel.We are the only global supplier ofperistaltic filling equipment withour own tubing production facility,therefore ensuring full control of thecomplete solution, reducing risk,ensuring consistent performance andsaving customers time and money.2223

home profile technology products product guide distributors newscontact brochures downloadWORLD LEADERS IN ASEPTIC PERISTALTIC FILLINGNEW PRODUCT- RABS for FPC50Watson-Marlow Flexicon is very proud topresent our brand new product for FPC50- RABS(Restricted Access Barrier System)PRECISIONFor Watson-Marlow Flexicon customersit is vital that our machines workwith high precision. Not only do wesatisfy that demand; we deliver exactlywhat has been ordered on time, everytime. Today’s industry also requiressafe operation with minimum risk toprocess, product and personnel. Weaccomplish this through our uniqueperistaltic filling systems.FLEXIBILITYOur fillers are easily and quickly adjustablefor a huge has range joined of the fill volumes, Watson-FlexiconMarlow fluids, capacities Groupand caps. We cancustomize products to your exact requirements11th of February and you can 2008 visit Flexicon our plantthejoined to assure Watson-Marlow yourself that our and performanceis now part ofthe matches world’s our largest promise. group We of offer a shortresponse time from initial contact todelivery.EFFICIENCYOur customers can produce small andmedium sized batches securely andprofitably. Watson-Marlow’s Flexiconequipment is reliable, easy to operateand requires minimal maintenance atlong intervals. We offer first class aftersalesservice and full documentationfor all our products. In performance aswell as quality, we deliver what we saywe will.| | | | | | | | |A Spirax-Sarco Engineering CompanyWatson-Marlow Pumps Group has six world-classfactories supported by direct sales operations in 23countries and distributors in more than 50 countries.For contact details visit our website:www.wmpg.comWatson-Marlow Bredel Alitea Flexicon MasoSineWatson-Marlow Bredel Flexicon MasoSineASEPTIC FILLING AND CAPPING SOLUTIONSNEWSUltimate flexibilityfor aseptic fillingMed pegeteksterFPC50 - Aseptic filling, stoppering and capping ... moreFlexicon onlineLearn more about Flexicon by downloadingdetailed brochures and viewing videos of ourfull range of aseptic liquid filling solutions.www.flexicon.dkThe information in this document is believed to be correct, but Watson-MarlowFlexicon A/S accepts no liability for any errors it contains, and reserves the right toalter specifications without notice. WARNING: These products are not designed foruse in, and should not be used for, patient-connected applications. asepticsu andAccusil are registered trademarksHB0332 Issue 2 79-401-000 Issue 3