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Macofar VF Series Aseptic Liquid Fi l l ing of Vials

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VF Series

A new concept for vials f i l l ing with injectable drugs

High production performance in advanced aseptic conditions

The VF Series is your ideal solution for vial filling with liquid parenteral drugs in advanced aseptic conditions, suitable for liquid or lyophilized products.The machines, thanks to their compact, modular and versatile design make easy the location in any line configuration, such as center room, through wall, connection to downstream capping machine, to a tray-loader or to a freeze-dryer automatic loading system.

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VF Series

Main Features

• Slimdesign

• Compactstructure

• Tightseparationbetween‘white’and‘grey’ areas

• Maximumergonomy

• Continuousmotion

• Linearmachine

• Fullliquiddrainability

• ProductcontactpartsmadeofAISI316Lorother cGMP approved materials

• Stainlesssteelisdescaledandpassivated

Key Benefits

• Extremelycompactfootprint

• MechanicalconstructionaimedatachievinghighSAL(SterilityAssuranceLevel)

• Flexible,repeatableandaccurateopera-tions thanks to the use of brushless motors

• Comfortableaccessibilityto‘white’and‘grey’areas

• Easycleanibilityof‘whitearea’surfaces

• Quickandeasyremoval/assemblyofproduct contact parts

• Veryquickandrepeatablesemi-automatedsize parts change-over with minimum manual interventions

• Highfillingaccuracy

• Advancedin-lineprocesscontrolsystems

Access to grey area from back side

Highly suitable for through-wall installation

No turbolences around vials coming from the machine base plate

Less than 600 mm

350 mm

Linear flow of vials

Slim design structure

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The slim design of the VF machines offer several advantages:

full accessibility to ‘white area’ from operator’s side

high suitability to equip the machine with an Isolator or a RABS (Restricted Access Barrier System)

access to the backside for maintenance from a technical room if the machine is installed through-the-wall

ideal for wash-down cleaning

1 Vials inlet2 Empty vials check-weighing3 Filling4 Filled vials check-weighing

5 Stoppering6 Vials rejection and sampling7 Vials outlet

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Pharmaceutically dedicated vial handling

Vials are positively conveyed throughout all process stations. The transport system is extremely easy to clean and allows quick removal and repeatable assembly of size parts for change-over and sanitization operations. An auto-matic lateral adjustment of the linear transport system according to vial diameter is provided to minimize change-over time.

Accurate filling

Ceramic or stainless steel volumetric rotary piston pumps guarantee very accurate filling even for very small volumes. No vial – no filling and automatic filling adjustment by check-weighing are available. Fill cycle optimization is obtained thanks to the brushless servomotor driven pumps and nozzle.

Clean stoppering

Rubber stoppers can either be completely or partially (for subsequent freeze-drying) inserted into the filled vials. The stoppering operation is extremely clean thanks to the total lack of mechanical components above vials while they are still open and in addition, the stopper lower side is exposed to the unidirectional air flow until its insertion into the vial.

Stoppering unit

height automatic adjustment through operator’s panel

no vial – no stopper

stopper presence check on the vial

stoppers contact components as well as the vacuum distributor parts quick and easy to be removed and assembled for changeover or sterilization

stoppers level control inside the feeding bowl

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High rel iable easy to val idate technology

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In line check-weighing system

The machine can be optionally supplied with a statistical check weighing system. Empty and filled vials are weighed by means of high precision and accuracy load cells. Its effectiveness is very high, thanks to the high sampling rate (approximately 4%) obtainable at full machine speed. This option verifies the filling weights and enables automatic volumes adjust-ment, continuously providing batch production data. The same system can also operate at 100% rate to fine tuning the pumps at the beginning of the batch processing and to minimize the waste of liquid at the end of the batch.

Other available options

• CleaningInPlace–SterilizingInPlace(CIP-SIP)for product feeding and filling systems

• Vialrejectionandsamplingafterstoppering

• Nitrogenpurgingbefore,duringandafterfilling

• Tray-loaderforvialcollectionatmachineexit

• Provisionforviableandnon-viableparticles monitoring

• Handlingofunstablevials

Options

Barrier and containment technology

In order to meet your requirements to fill vials with high-active drugs and/or to improve the machine aseptic processing conditions where sterile depyrogenated vials are open and therefore exposed to potential contami-nations, we can equip our VF machines with RABS (Restricted Access Bar-rier Systems) and Isolators. VF series is highly suitable for barrier and isolator technology thanks to its slim construction, very small processing area and ergonomic location of the operating groups.The Laminar Air Flow hood is also an available solution for traditional Clean Room aseptic processing.

Automation and Human Machine Interface

improved filling process is achieved by a programmable logic and motion control by ELAU

user-friendly HMI touch screen panel

automatic adjustments of transport system, nozzles motion, filling volumes and stoppering unit height via HMI

receipes parameters are set and stored via HMI

PC and SCADA system for production data recording and management available upon request

compliance to FDA 21 cfr part 11 available as option

Interface Check-weigher

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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.

Ful l aseptic

l ine competence

1 WasherMacofar automatic washing machines, which have a mechanical speed of between 9.000 and 24.000 vials/ampoules per hour, handle vials and/or ampoules through a unique system of universal grip-pers to ensure stable, reliable and efficient transport of cylindrical containers. The key features of the balcony design machine includes separated working and mechanical areas, modular washing cycles and self draining washing circuits.

2 Depyrogenation TunnelMacofar depyrogenation tunnels are designed to sterilize and depyrogenate ampoules, vials, bottles and other glass containers based on the laminar flow principleusinghotsterileair(max.340°C).

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3a Powder Dosing Micro 9/18Macofar offers a range of intermittent motion machines, with mechanical speeds of 9.000 and 18.000 vials per hour, featuring volumetric vacuum/pressure dosage for filling sterile antibiotic powders into round glass vials closed by rubber stopper.

4 Capping MachineThe automatic continuous motion capping machineoffers a mechanical speed from 10.000 up to 24.000 vialsperhour.Therangeofcappingmachinesissuit-able to close cylindrical glass or plastic containers with simply flanged alu-caps with or without plastic cover(FLIP-OFF),pilfer-proofcaps,press-onplugsorscrewcaps(withproperequipment).

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3b Liquid Filling VF Series (alternativetopowderdosingmachine)Macofar offers a family of aseptic liquid filling ma-chines with speeds up from 12.000 up to 24.000 vials perhour.Thisslimdesignmachinefeaturesoutstand-ing performance and reliability and is the benchmark in aseptic liquid filling.

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1624

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2100

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1970

650

Mac

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MAC

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VF Series

A Unit of Robbins & Myers, Inc.

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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

Romaco S.r.l.Via Marzabotto, 540065 Pianoro Bologna – Italy

Phone +39 051 620 2611Fax +39 051 620 2600

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.

Key Technical Data

VF 12 VF 18 VF 24

Vials diameter, in mm 14–68 14–68 14–68

Vials height, in mm 35–140 35–140 35–140

Filling volume, in ml 0.25–250 0.25–250 0.25–250

Stoppers for liquid and lyophilized injectable products

Max output rate, in vials/h 12.000 18.000 24.000

Number of filling pumps 4 6 8