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Macofar Micro Series Microdosing Machines

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Main Features

• Vialsamplingachievedwithoutmachineproductionstopping

• Nitrogenflushingunit,beforeandafterfilling

• Liquidfillingunitformediafilltest

• Airdryingunittoreducehumiditypercentageinthefillingarea

• Verticallaminarflowoverthedosing,stopperingandcappingstations

• Laminarflowairspeedcontrol

• Vacuumcreationinsidethevialbeforeplacingthestopper

• Possibilitytodose2differentpowdersintothesamevial

• Singletrayvialdischarge

The Romaco Micro 6 is an intermittent motion monobloc machine, suitable for loading round stable glass vials, for dosing powder and for sealing them at low and medium speed.

The Micro 6 is the ideal machine for applications that do not require an in line solution, where static ovens are used to obtain sterilization. The compact size of this machine, its GMP-design and its ergonomic features make it an outstanding solution for powder dosing. The Micro 6 can be linked to washing, sterilization and depyro-genation of a low production complete sterile line.

Micro 6 is the state of the art answer to satisfy flexibility, reliability and small batch produc-tion.

Monoblock-Microdosing Machine

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Monoblock-Microdosing Machine

Micro 6Key Benefits

• Compactmonoblocmachine,featuring loadingandunloadingturntables,allwith minimumofspacerequirements

• Vacuumpressureassisted,highlyaccuratedosingsystem

• Simultaneousadjustmentofdosingport volume

• Simple,fastandrepeatablechangeover

• Positivevialtransport:starwheelsguide thevialsthroughthefilling,stoppering andcappingstations,ensuringtheyremain uprightandguaranteeingcorrect placement

• VacuumassistedPickandPlaceStoppering station:themotionthatappliestherubber stoppertravelsoppositetothevial direction.Productcontaminationwith rubberparticlesisavoidedbyconveying thevialtothepluggingstationwiththe stopperalreadyplacedintotheirneck

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The Romaco Micro 9 and 18 are machines for dosing and filling sterile phar-maceutical powders into vials under aseptic conditions. The Micro range are intermittent motion machines, with mechanical speeds ranging from 9.000 to 18.000 vials per hour, at medium and high production speeds. They prove their performance in aseptic lines for dosage of antibiotic powders into round and stable glass vials sealed with rubber stoppers. Designed for cGMP compliance, thanks to their balcony design, the Micro machines are recognized world wide as leading powder microdosing machines, carrying on the decades of Macofar tradition.Leading edge technology Micro 9 – 18 anticipates the market needs in terms of automation and controls, with features such as statistical weight checking, available as an option on both machines.

Designed for modern manufacturing, security and quality in powder microdosing

Micro 9/18

Key Benefits

• Positivevialtransport:Starwheelsguidethevialsthroughthefilling,weighingandstopperingstations,ensuringtheyremainuprightandguaranteeingtheiridentifica-tionduringtheweighingprocedure

• Vacuumpressureassisteddosingsystem

• Minimumresidualpowderatbatchendisguaranteedbythevacuumpressuredosingsystem,utilizingonesingledosingdiscandoneintermediatehopper

• Highspeedstatisticalweighingsystemthatverifiesapproximatively4%ofthecompleteproduction,byverifyingvialweighttwice:empty(tare)andfilled(grossweight),foreachdosingchamber

• Automaticsimultaneousadjustmentofdosingportvolume:theweightcellssendafeedbacktothedosingportswhichareautomaticallyadjusted.Thedosingportscanalsobeadjustedviathecontrolpanelbytheoperator

• MultipledosingintothesamevialcanbeperformedthroughHMI

• Stopperingstationoperatingbypick&placesystem,vacuumassisted,thatappliestherubberstopperbackwardstotherunningdirectionofthevials.Thevialrunsunderthepluggingstationwiththestopperalreadyplacedontothevialneck,avoidingtheriskofproductcontaminationwithrubberparticles

• Thankstothebalconydesignallareasofthemachineareeasilyaccessibleandalloperationsareclearlyvisibleduringproduction

• TheThrough-wallinstallationgrantsacostreduction,thatislessfloorspacerequiredinsterileroom.Onlythevialtransport,fillingandstopperingstationsmustbelocatedinthesterileroom.Allthemechanicalpartsarefittedonaverticalframe,givingeasyaccessandvisibilityfromthemachinerear.Hence,maintenanceisperformedfromoutsidethesterilearea

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Tare Gross weight

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Transport System

1 Inletbelt:minimumload2 1stand2ndstarwheel:transporttodosingstation3 Powderdosingstation:vialscentringdosingchambertraceabilityfromPLC4 3rdstarwheel:onlytransport5 4thstarwheel:liquidfilling(opt.)formediafilltest,withpowderdosingunitin

place(powderand/orliquidfilling)6 5thstarwheel:possibilityofnitrogenflushing(opt.)7 Stopperingstation8 Outletbelt:maxload,stopperpresencecontrol9 Samplingstationandnopluggedvialejection

Transport System: C.W. path

10 C.W. Starwheels system: movement in phase with machine, motion throughbrushlessmotors,sameprincipletodetermineTareandGrossweight

11 C.W. station: vertical movements pneumatically driven, vial mouth alwaysprotectedbyLAF,LoadCellsPC-PLCcommunication

Positivevialtransport

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Main Features

• Simple,fastandrepeatablechangeover

• Automaticheightadjustmentoffillingandclosinggroups,nomanualadjustmentsrequired

• Productformatdataisrecordedinanelectronicdatabaseandcanberecalledviathetouchscreen

• Nitrogenflushingbefore,duringandafter filling

• Liquidfillinggroupformediafilltest

• Airdryingunittoreachalowerhumiditypercentageinthefillingarea

• Verticallaminarflowoverthedosingandstopperingstations

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Built on Macofar’s early reputation as an expert in aseptic powder handling by developing a range of equipment to complement its superb microdosing machines, Macofar is now a recognized global supplier of technologically advanced and highly innovative aseptic lines for both solids and liquids. Macofar does not only offer a machine, but full lines for aseptic filling. We can offer lines including washers for vials and ampoules, sterilizing tunnels, filling and dosing equipment for both liquids and powders as well as capping machines. And to complete the line, we can also offer cartoners and case packers. Romaco is your single source supplier for fully customized, state of the art aseptic lines. Starting from the first project meeting, integration into existing equipment, set up, training qualification, validation and service Romaco is your partner.

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1 WasherMacofar automatic washing machines, which have amechanical speed of between 9.000 and 24.000vials/ampoules per hour, handle vials and/orampoulesthroughauniquesystemofuniversalgrip-perstoensurestable,reliableandefficienttransportof cylindrical containers. The key features of thebalconydesignmachineincludesseparatedworkingand mechanical areas, modular washing cycles andselfdrainingwashingcircuits.

2 Depyrogenation TunnelMacofar depyrogenation tunnels are designed tosterilize and depyrogenate ampoules, vials, bottlesandotherglasscontainersbasedonthelaminarflowprincipleusinghotsterileair(max.340°C).

3a Powder Dosing Micro 9/18Macofar offers a range of intermittent motionmachines, with mechanical speeds of 9.000 and18.000 vials per hour, featuring volumetric vacuum/pressure dosage for filling sterile antibiotic powdersintoroundglassvialsclosedbyrubberstopper.

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4 Capping MachineThe automatic continuous motion capping machineoffersamechanicalspeedsupto10.000and24.000vialsperhour.Therangeofcappingmachinesissuit-able to close cylindrical glass or plastic containerswith simply flanged alu-caps with or without plasticcover(FLIP-OFF),pilfer-proofcaps,press-onplugsorscrewcaps(withproperequipment).

3b Liquid Filling VF 18(alternativetopowderdosingmachine)Macofar offers an aseptic liquid filling machine withspeedsupto18.000vialsperhour.Thisslimdesignmachine features outstanding performance andreliability and is the benchmark in aseptic liquidfilling.

5 Cartoning MachineWith speeds up to 400 cartons per minute Promaticcartonersdeliveroptimumperformanceandversatility.IncombinationwiththePromaticcasepackers,thisistheperfectsolutionforsecondarypackaging.

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Micro 9 / Micro 18

AUnitofRobbins&Myers,Inc.

Key Technical Data

Micro6 Micro9 Micro18Outputsingledose(vials/hour) 5.000 9.000 18.000Vialdiameter(min–max),inmm 18–52 15–52 15–52Vialheight(min–max),inmm 35–110 35–120 35–120Minimumdose,inmg 50 80 80Maximumdose(singledose),inmg 1.500 1.500 1.500Dosingdisc 1 1 1Dosingportperdisc 12 12 12Powerconsumption,inkW 5.4 5 5Compressedairforpowderejection,inl/min 70 70 120Vacuumpumpcapacity,inm3h 100 100 100PLCstandard Siemens Siemens SiemensNetweight,inkg 1.800 2.000 2.100Width,inmm 1.490 1.530 1.530Length,inmm 3.130 2.465 2.465Height(withlaminarflowhood),inmm 1.900 2.750 2.750

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Pharmaceutical expertise

Romaco Macofar has built its reputation in over 30 years of outstanding performance, with over 1.800 installations worldwide and an exceptional record in service and support. Macofar is a recognized global

Romaco Macofar

RomacoS.r.l.ViaMarzabotto,540065PianoroBologna–Italy

Phone +390516202611Fax +390516202600

macofar@romaco.comwww.romaco.com

supplier of capsule fillers, liquid fillers, powder microdosing machines, powder macrodosing machines, aseptic liquid fillers, vial and am-poules washing machines as well as sterilization tunnels.

Macofar is the expert partner to assist any phar-maceutical company in the process of installing a new aseptic filling line, from feasibility study to validation. Our Romaco Macofar team is looking forward to the next challenge.