ASEPTIC FILLING SOLUTIONS

Ultimate flexibility for clinical-scale aseptic filling

Behind the fillingand cappingsystems lie themeticulous skill anddedication ofWatson-MarlowFlexicon designengineers. Watson-Marlow PumpsGroup is also anISO9001 company.

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FLEXICONAseptic Fillers

For over 50 years the Watson-MarlowPumps Group has led the world inperistaltic pumping innovation, thetechnology of choice for high purity fluidhandling in the pharmaceutical, biotechand diagnostics industries.

PRECISIONFor Watson-Marlow Flexicon customers it is

vital that our machines work with highprecision. Not only do we satisfy that demand;we deliver exactly what has been ordered ontime, every time. Today’s industry also requiressafe operation with minimum risk to process,product and personnel. We accomplish thisthrough our unique peristaltic filling systems.

EFFICIENCYOur customers can produce small and

medium sized batches securely and profitably.Watson-Marlow Flexicon’s equipment isreliable, easy to operate and requires minimalmaintenance at long intervals. We offer firstclass after-sales service and full documentationfor all our products. In performance as well asquality, we deliver what we say we will.

Our Flexicon range of filling and cappingequipment provides solutions with theprecision, efficiency and flexibility thatcustomers have come to know and trustfrom Watson-Marlow.

A peristaltic pump’s low-shear action is created bycompressing a tube. Insidethe single-use tube the fluidis driven forward by rollerswhile the tube’s recovery

behind each roller draws in more fluid. Thepump is perfect for moving fluid asepticallybecause the fluid stays within the tube. Unlike

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Peristaltic pumping - the solution for high puritypiston pumps there are no seals, valves or movingparts in its path to lead to contamination.

Watson-Marlow peristaltic pumps and fillers arerecognized by process engineers for high quality,reliability and performance. Our equipment helpsengineers simplify validation, improve yield andreduce expensive downtime.

FLEXIBILITYOur fillers are easily and quickly adjustable

for a huge range of fill volumes, fluids,capacities and caps. We can customizeproducts to your exact requirements and youcan visit our plant to assure yourself that ourperformance matches our promise. We offer a short response time from initial contact to delivery.

Lab - R&D Clinical I Clinical II Clinical III

DAFPA - Disposable FS and FC - Crimp and Screw Cappers (pages 10-11)

PF6 and PF22 - Dispensing System (pages 8-9)

FF20 - Vial/Bottle Handling

FP50 - Filling and

FPC50 - Filling, Plugging

FPC50ISO - FPC50 under

Aseptic liquid filling and capping equipment

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Flexicon - flexible enough togrow with your changing needs

YourChoice

Tabletop units Semi-automaticsystems

Filling

Filling and cappingCappers

Fillers

Small Production Full Production High Speed

Aseptic Fluid Path (pages 6-7)

(pag es 12-13)

FF30 - Filling/Screw Capping (pages 14-15)

Plugging (pages 16-17)

and Capping (pages 18-19)

an Isolator (pages 18-19)

FMB210 - Fully Automatic Monobloc (pages 20-21)

FMB210ISO - FMB210 under an Isolator (pages 20-21)

OEM Solutions - Master Controllers, Trolleys and Pumps/Fillers (pages 22-23)

Watson-Marlow Flexicon offers a range of products that grow with you, from stand-alone units for hand filling, throughsemi-automatic systems, to fully automatic

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Fully-automaticsystems

Wide range of systems for automation of filling, plugging,

capping and weight check

Range of monobloc systems

Solutions forintegration or retrofit

OEM panel mount fillers

Trolley solutions for piston pump replacement

filling, stoppering and capping machines. Thefully automatic systems are customized to fitany glass vial, plastic bottle, test tube, eye-dropper or non-self standing microtube.

FLEXICONAseptic Fillers

Your answer for aseptic filling

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DAFPA and single-use filling

Top quality whatever the scaleFlexicon peristaltic pumpheads and our

own precision tubing offer pulsation-free,accurate dispensing from a benchtopsystem to full batch production.

DAFPA is a ready-to-use, disposable fillingsystem: Disposable Aseptic Fluid PAth. Itoptimizes Watson-Marlow Flexicon’s peristalticliquid fillers in the biopharmaceutical industries.

DAFPA eliminates the need for cleaning andvalidation and allows drug segregation and fastbatch change with no cross-contamination risk,thus reducing costs by eliminating expensivedowntime.

Watson-Marlow Flexicon’s fillers provideunparalleled flexibility. Unlike piston fillers andother dispensers, your sterile product contactsonly the FDA approved silicone tubing.

Fully assembled, ready-to-use fluid path usingaccurate peristaltic dispensing

Gamma sterilization and single-use mean zerocross-contamination and easy validation

Aseptic conditions extend to the tip of the filling nozzle, removing operator intervention

Customized configurations available

Your answer for aseptic filling

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Simplify your cleaning validationImagine a USP Class VI fluid path that is fullytraceable from end-to-end, is simple to validateand you have DAFPA. From the bag, to thetubing through the pump, to the filling needle onyour machine, DAFPA provides an entire wetend, which is fully assembled and lot traceable.And best yet, its single use design eliminatescostly cleaning validation

DAFPAenhances acomplete filling system,such as theFP50 shownhere

Flexicon tabletop fillers are designed for use incleanrooms for production processes complyingwith cGMP.

Setting up a filling regime for vials, bottles, testtubes or other containers is achieved by loadingthe peristaltic pump tube and entering theparameters required using the intuitive keypad.

The pump maintains a closed fluid path fromthe bulk product container to the end of the fillingnozzle. Change the path and the pump is clean,sterile and ready for the next batch. You cancontrol the filler with a foot switch or integrate itinto an automatic bottle handling system.

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4.00

3.50

3.00

2.50

2.00

1.50

1.00

0.50

0.00

Filling volume (ml)

Filling time (sec)

PF6 - capacity diagram (based on water)

The simplest filling set-upwith accuracy and flexibility

No cross-contamination Accuracy: ±0.5% Drip-free One-minute set-up and changeover Fill volumes from 5ml to 5 liters RS232 port for printer connection and real-time documentation

The PF22:setting up abatch is a one-minute job

Peristalticpumping combines sterility and precision

0.1 1 10 100 1000

Fillers Tabletop dispensing

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4.00

3.50

3.00

2.50

2.00

1.50

1.00

0.50

0.000.1

Filling volume (ml)

Filling time (sec)

DF32 - capacity diagram (based on water)4.00

3.50

3.00

2.50

2.00

1.50

1.00

0.50

0.00

Filling volume (ml)

Filling time (sec)

PF22 - capacity diagram (based on water)

The PF6 is thesmallest of theFlexicon tabletopfiller range

1 10 100 10000.1 1 10 100 1000

Tabletop dispensing

Cappers

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Tabletop screw and crimp capping

A range of vial and cap sizes and tools are available for all cappers

Cappers offer consistentquality crimps and torque

When there is need to increase productivity, while minimizing operator fatigue and injury, ourcappers can be added to your current process. Features offered by both crimp and screw cappers are Consistent quality closure Cap up to 1,000 units/hour Fast change-overs

Deciding which capper is right for the process depends on the capping needs. Each capper hasspecific benefits.

Screw cappers No tools needed for changeover Handles caps up to 65mm and bottle sizes to 1,000ml

Adjustable closing torque

Crimp cappers High quality aluminum overseal Low particle release Crimp heads, bottle tools and custom tools are available

Capper Name

Max. Cap Size Max Bottle Size

Air SupplyDiameter Height Diameter HeightFC10 Screw 50 mm 40 mm 55 mm 180 mm 6 bar 85 l/minFC32 Screw 65 mm 40 mm 100 mm 240 mm 6 bar 85 l/minFS10 Crimp 8-20 mm DIN standard 55 mm 180 mm 35 l/min. free airFS32 Crimp 20-32 mm DIN standard 95 mm 240 mm 50 l/min. free air

15"6.8"

18.7"

Tabletop screw and crimp capping

12.2"5.7"

12.2"

FS32 FS105.8" 13.8"

14.6"

15-22.4"

12.2"5.7"

12.2"

FC10 FC32

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If space is at a premium in your current setting, take a look at the small foot print offered by our cappers.

As the need for more automation grows theWatson-Marlow Flexicon’s product line meets theneeds of labs/clinical trails. There is also greatcare taken to minimize production downtime. Ourdesign ensures sterile production.

The speed at which the vials/bottles arepresented at the filling needle is fully adjustable,allowing light vials and bottles to be filled.Solutions can be designed to handle bottles withspecial shapes.

The FF20, used in conjunction with one of ourcrimp or screw capping machines, provides asimple and flexible means of production.

TabletopAutomation

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Low cost 0.1ml to 150ml fills Complete change-over in less than five minutes

Up to 2,000 units/hour Consistent production quality Designed for cleanroom environments Tabletop-mounted or placed inside a laminarair flow cabinet

Up to 2,000 fills/hour and fiveminute size changes

Are you already a Watson-Marlow 520Didispensing pump user? GOOD NEWS, the FF20 isfully compatible with Watson-Marlow’s 520Di.

Automatic filling and tabletop vial/bottle handling system

Adjustablefilling needle

allows for a widerange of bottles and

vials to be filled

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33.9" 15.8"

15.8"

14.6"

15.8"

17.3"

6"

4"

2.8"

17.7"

11"

The FF20 fills up to2,000 units an hour in a space ofapproximately 15 sq ft

Automatic filling and tabletop vial/bottle handling system

14"

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Semi-automatic filling and capping bottle handling system

Easy to clean 0.1ml to 100ml fills Attractive cost/benefit Up to 1,200 units/hour Complete product and bottle change in 15 minutes

Fill bottles from 12mm-50mm in diameter

From time to time there is a need for a differenttype of filling and capping. Watson-MarlowFlexicon’s product line adapts to the changingneeds of our customers.

The FF30 is made of stainless steel andanodized aluminum for cleanroom use inpharmaceutical, biotech and diagnosticophthalmic industries. It is the ideal cappingsystem for clinical environments.

A key element is to ensure clean productionwith no chance of cross-contamination. The FF30is perfect for flexible small batch production ofliquids, oils and creams in bottles or jars withscrew caps.

The flexible FF30: consistent,small-scale production quality

TabletopAutomation

Are you already a Watson-Marlow 520Didispensing pump user? GOOD NEWS, the FF30 isfully compatible with Watson-Marlow’s 520Di.

Fill andscrew cap withthis modular bottle

handing system

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Semi-automatic filling and capping bottle handling system

22.6"

31.5"

49.2"

Automating the key steps of aseptic filling cutsthe risk of operator error and related contamination.The peristaltic filling system like a FP50, eliminatesthe costs and issues of volumetric filling pumps.

The FP50 is a very popular tabletop filling systemfor pharmaceutical research and developmentdepartments and biopharmaceutical companies.

FP50 users can avoid sending delicate,expensive and critical products to outside fillingfacilities, which saves money, especially duringclinical trial phases.

FP50 Fully-automatic filling and plugging

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The FP50 is built into an isolator so that the fluid andthe filled vials are completely contained. It is controlled

from a panel, which also allows the operator tomanage the isolator and the vapor generator which

kills any micro-organisms within the isolator.

Filling accuracy better than ±1% Single-use filling with no risk of cross-contamination

0.1ml to 100ml fills of 2R to 100H vials Up to 25 units/minute Quick and simple format changes Full or partial plugging Size for LAF bench installations Prepared for isolatorMeets cGMP standards for aseptic filling

FP50 automates two keyfeatures: vial filling and plugging

Milled vibrator bowl instainless steel toaccurately deliverthe plugs forplacement

Fully-automatic filling and plugging

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53.8"

15.8"

8.4"

27.2"

Optional tray position 61.8"

21.7"

33.6"

17.7"

Tray width min. 8" - max. 12"

Plugging with13mm and20mmstoppersrequires noadditionalformat parts

Crevice-free, unidirectional airflow stainless steel filler

Overseals 13mm and 20mm flip-off and standard aluminum caps

Small footprint fits inside small cleanrooms Fast and easy changeover between batches Optional weight-check system Up to 20 vials/minute IQ/OQ documentation available

Easy-to-clean touch screen control panel

The FPC50 adds aluminum cap placement andcap sealing to the extensive facilities of the FP50.It provides a ready-to-use and easy-to-validatefilling system for small batch production.

The universal format parts of the FPC50 allowfor a wide range of vials, stoppers and caps withno special parts.

The peristaltic filling system eliminates havingproduct-dedicated or volume-dedicated pumps instock.

The FPC50ISO is a variation designed forintegration into an isolator or restricted accessbarrier system.

FPC50

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The versatile FPC50 for clinicaltrial and small scale production

Fully-automatic filling, plugging and capping

The FPC50'scrimping head

Rounded edgesfacilitate cleaning

Optional weight-checkWeighing cell measuresevery fill to ±0.002g andensures automatic pumprecalibration during a batch

Easy height changeHeight adjustment isachieved using a simpleand intuitive crank

47"

53.4"

38.2"

31.4"

24.1"

10.9"

94.8"61.1"25.8"

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Fully-automatic filling, plugging and capping

Rounded edgesfacilitate cleaning

The FMB210 is perfect for fully automatedfilling and capping medium size batches. It canhandle a wide range of container and closuretypes.

Designed to meet the latest cGMP standard foraseptic filling of injectable drugs, the FMB210 is ahigh-quality, fully automated filler for aseptic drug,ophthalmic and diagnostic applications.

A unique tool platform allows simple, fast andaccurate format changes where multiple productsneed to be processed on a single filler. It can beconfigured for a choice of infeed and outfeedoptions.

Fully-automatic filling, plugging and cappingMonobloc

An FMB210 fed by a bottle unscramblerunit and, right, an FMB210 installed within

a laminar air flow cabinet

Two high-accuracy peristalticpumps are fullyintegrated

Roller closing of caps forconsistent high-quality crimps

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Aseptic filling of injectable drugs: filling, stoppering and capping

Ophthalmics and diagnostics: filling, dropperinsert and screw capping including micro-tubes

Customized design allows for various applications/configurations

Compact design maintains a small footprint that fits inside small cleanrooms

Up to 75 units/minute Completely closed peristaltic system ensuring no cross-contamination

FDA validated sterile production

FMB210: larger production witheasy setup and changeover

Fully-automatic filling, plugging and capping

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The sensorfor theFMB210’sno-vial-no-fill feature

49.2"

80.7"

61.1" 22.6"

32.5"

80.7"

Once there is a need for larger scaleproduction, we can provide fully automatic fillingsolutions for new or existing systems.

Watson-Marlow Flexicon’s OEM solutionsconsist of dispensers, master controllers, trolleys,gating and electronic bottom-up systems.

OEM applications include High capacity filling lines for the biopharm industry

Filling lines for bottles with an awkward shape for the diagnostics industry

Existing filling lines where piston pumps should be replaced

OEM andTrolley

Flexible, production-scale filling

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A vast number of OEM customers and machinemanufacturers have already successfullyincorporated our solutions into their filling lines,adding value to their product. Faster changeover between batches Less product waste during changeover betweendifferent liquids to be filled

Easy cleaning, validation and programming No need for format parts for different fill volumesor products to be filled

Minimum need for maintenance Functions to prevent after dripping and splashing

OEM system components tocomplete your filling line

TrolleysWatson-Marlow Flexicon’s trolleys are cabinets on castors fittedwith two or more pumps and complete integral control. Trolleysolutions are supplied for integration into new or existing fillinglines. We have several standard designs or will build to fit customrequirements.

MC12 control unit for multi-filling system

The unit fulfils all usual requirements andcan be extended to include several fillingstations, an electronic bottom-up fillsystem, a printer for documentationlogging, a direct link to a balance fordynamic recalibration and more.

Flexible, production-scale filling

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Master controllersMaster controllers, such as the MC100, cancontrol 16 pumps in a filling line. We supplystand-alone controllers, panel mounts andcontrollers for communication with filling linesystems. The MC100 receives filling datathrough an industrial fieldbus, calculatesoperating values for the pumps then transmitsthose through a FlexNet protocol to the pumps.

OEM peristalticdispenser to maximize

integrationflexibility

Parallel Production Set-Up

Dynamic Recalibration Set-Up

Watson-Marlow Pumps Manual, Automatic and PROFIBUScontrolled pumps for metering,transfer or dosing

The information in this document is believed to be correct, but Watson-MarlowPumps Group accepts no liability for any errors it contains and reserves the rightto alter specifications without notice. WARNING: These products are notdesigned for use in and should not be used for, patient-connected applications.Watson-Marlow, Pumpsil, LoadSure, LaserTraceability, Bioprene and Marpreneare registered trademarks of Watson-Marlow Limited. STA-PURE® and CHEM-SURE® are trademarks of WL Gore & Associates Inc. Fluorel is a trademarkof 3M.

Tel: 800-282-8823support@wmpg.us

Watson-Marlow Pumps Group37 Upton Technology Park

Wilmington, MA 01887

Watson-Marlow TubingBiopharmaceutical grade tubing forperistaltic pumping and transferincluding platinum-cured silicone, weldable Bioprene thermoplastic tubingand additional USP Class VI materials.

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www.wmpg.com

Watson-Marlow Pumps Group has five world-classfactories supported by direct sales operations in 17countries and distributors in more than 50 countries.For contact details visit our website:

Watson-Marlow Bredel Alitea Flexicon MasoSine

Watson-Marlow onlineOur engineers around the world can help youchoose the perfect pump and tubing for yourneeds.

More information? Our brochures are on ourwebsite - www.wmpg.com Validation Packs and

Certifications Our pumps, fillers and tubing are idealfor cGMP applications. Comprehensivevalidation packs make validation easy.Our products meet or exceed thestandards laid down by quality testingauthorities worldwide.

• USP Class VI requirements• European Pharmacopoeia 3.1.9• ISO10993 requirements