ASEPTIC FILLING SOLUTIONS

adERT

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.

2

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. Todays 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 Flexicons 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 pumps low-shear action is created bycompressing a tube. Insidethe single-use tube the fluidis driven forward by rollerswhile the tubes recovery

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

3

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

4

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

5

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

6

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 Flexicons 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 Flexicons 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

7

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.

8

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

9

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

10

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

11

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 Flexicons 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

12

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 cab