ASEPTIC FILLING SOLUTIONS - Find The Needlepdfs.findtheneedle.co.uk/83765-3331.pdf · ASEPTIC...

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ASEPTIC FILLING SOLUTIONS

Transcript of ASEPTIC FILLING SOLUTIONS - Find The Needlepdfs.findtheneedle.co.uk/83765-3331.pdf · ASEPTIC...

ASEPTIC FILLING SOLUTIONS

Ultimate flexibility for clinical-scale aseptic filling

Behind the filling and capping systems lie the meticulous skill and dedication of Watson-Marlow Flexicon design engineers. Watson-Marlow Pumps Group is also an ISO9001 company.

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FLEXICONAseptic Fillers

For over 50 years the Watson-Marlow Pumps Group has led the world in peristaltic pumping innovation, the technology of choice for high purity fluid handling in the pharmaceutical, biotech and diagnostics industries.

Ultimate flexibility for clinical-scale aseptic filling

PRECISIONFor Watson-Marlow Flexicon customers

it is vital that our machines work with high precision. Not only do we satisfy that demand; we deliver exactly what has been ordered on time, every time. Today’s industry also requires safe operation with minimum risk to process, product and personnel. We accomplish this through our unique peristaltic filling systems.

EFFICIENCYOur customers can produce small and

medium sized batches securely and profitably. Watson-Marlow Flexicon’s equipment is reliable, easy to operate and requires minimal maintenance at long intervals. We offer first class after-sales service and full documentation for all our products. In performance as well as quality, we deliver what we say we will.

Our range of filling and capping equipment provides solutions with the precision, efficiency and flexibility that customers have come to know and trust.

A peristaltic pump’s low-shear action is created by compressing a tube. Inside the single-use tube the fluid is driven forward by rollers while the tube’s recovery behind each roller

draws in more fluid. The pump is perfect for moving fluid aseptically because the fluid stays 3

Peristaltic pumping - the solution for high puritywithin the tube. Unlike piston pumps there are no seals, valves or moving parts in its path to lead to contamination.

Watson-Marlow peristaltic pumps and fillers are recognized by process engineers for high quality, reliability and performance. Our equipment helps engineers simplify validation, improve yield and reduce expensive downtime.

FLEXIBILITYOur fillers are easily and quickly

adjustable for a huge range of fill volumes, fluids, capacities , bottles and caps. We can customize products to your exact requirements and you can visit our plant to assure yourself that our performance matches our promise. We offer a short response time from initial contact to delivery.

Lab - R&D Clinical I Clinical II Clinical III Small Production Full Production High Speed

DAFPA - Disposable Aseptic Fluid Path (pages 6-7)FS and FC - Crimp and Screw Cappers (pages 10-11)

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

FF20 - Vial/Bottle Handling (pag es 12-13)

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

FP50 - Filling and Stoppering (pages 16-17)

FPC50 - Filling, Stoppering and Capping (pages 18-19)

FPC50ISO - FPC50 for integration into an Isolator (pages 18-19)

FMB210 - Fully Automatic Monobloc (pages 20-21)

FMB210ISO - FMB210 for integration into an Isolator (pages 20-21)

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

Aseptic liquid filling and capping equipment

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Flexicon - flexible enough to grow with your changing needs

Your Choice

Tabletop units Semi-automatic systems

Filling

Filling and cappingCappers

Fillers

Cappers

Fillers

Lab - R&D Clinical I Clinical II Clinical III Small Production Full Production High Speed

DAFPA - Disposable Aseptic Fluid Path (pages 6-7)FS and FC - Crimp and Screw Cappers (pages 10-11)

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

FF20 - Vial/Bottle Handling (pag es 12-13)

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

FP50 - Filling and Stoppering (pages 16-17)

FPC50 - Filling, Stoppering and Capping (pages 18-19)

FPC50ISO - FPC50 for integration into an Isolator (pages 18-19)

FMB210 - Fully Automatic Monobloc (pages 20-21)

FMB210ISO - FMB210 for integration into 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 fi lling, through semi-automatic systems, to fully automatic

Aseptic liquid filling and capping equipment

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Flexicon - flexible enough to grow with your changing needs

Fully-automatic systems

Wide range of systems for automation of fi lling, stoppering,

capping and weight check

Customized monobloc systems

Solutions for integration or retrofit

OEM panel mount fi llers

Trolley solutions for piston pump replacement

fi lling, stoppering and capping machines. The fully automatic systems are customized to fi t any 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

silicone precision tubing offer pulsation-free, accurate dispensing from benchtop units to

fully automatic production equipment.

DAFPA is a ready-to-use, disposable filling system: Disposable Aseptic Fluid PAth. It optimizes Watson-Marlow Flexicon’s peristaltic liquid fillers in the biopharmaceutical industries.

DAFPA eliminates the need for cleaning validation and allows drug segregation and fast batch change with no cross-contamination risk, thus reducing costs by eliminating expensive downtime.

Watson-Marlow Flexicon’s fillers in combination with DAFPA provide unparalleled flexibility. Unlike

piston fillers and other dispensers, your sterile product contacts only disposable materials approved for pharmaceutical use.

• Designed for peristaltic filling units

• Sterile and ready-to-use

• Major reduction in cleaning and validation costs

• Prevention of cross contamination

• Enhancement of operator safety

• Customized configurations available

Your answer for aseptic filling

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Simplify your cleaning validationImagine a USP Class VI fl uid path that is fully traceable from end-to-end, is simple to validate and you have DAFPA. From the bag, to the tubing through the pump, to the fi lling nozzle on your machine, DAFPA provides an entire wet end, which is fully assembled and lot traceable. And best yet, its single use design eliminates costly cleaning validation

DAFPA enhances a complete filling system, such as the FP50 shown here

Flexicon tabletop fillers are designed for use in cleanrooms for production processes complying with cGMP.

Setting up a filling regime for vials, bottles, test tubes or other containers is achieved by loading the peristaltic pump tube and entering the parameters required using the intuitive keypad.

The pump maintains a closed fluid path from the bulk product container to the end of the filling nozzle. Change the path and the pump is clean, sterile and ready for the next batch. You can control the filler with a foot switch or integrate it into 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)

Fill

ing

time

(sec

)

PF6 - capacity diagram (based on water)

The simplest filling set-up with accuracy and flexibility

• No cross-contamination

• Accuracy: ±0.5%

• Drip-free

• One-minute set-up and changeover

• Fill volumes from 0,5 to 250 ml for PF6 and from 5 to 5000 ml for PF22

• RS232 port for printer connection and real-time documentation

The PF22 is the largest of the Flexicon tabletop filler range

Peristaltic pumping combines sterility and precision

0.1 1 10 100 1000

Fillers Tabletop dispensing

The simplest filling set-up with accuracy and flexibility

No cross-contamination

One-minute set-up and changeover

Fill volumes from 0,5 to 250 ml for PF6 and from 5 to 5000 ml for PF22

RS232 port for printer connection and real-time documentation

The PF22 is the largest of the Flexicon tabletop filler range

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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)

Fill

ing

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)

Fill

ing

time

(sec

)

PF22 - capacity diagram (based on water)

The PF6 is the smallest of the Flexicon tabletop filler range

0.1 1 10 100 10000.1 1 10 100 1000

Tabletop dispensing

The PF6 is the smallest of the Flexicon tabletop filler range

PF22 - capacity diagram (based on water)

A range of vial and cap sizes and tools are

available for all cappers

A range of vial and cap sizes and tools are

available for all cappers

Cappers

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Tabletop screw and crimp capping

Cappers offer consistent quality crimps and torque

When there is need to increase productivity, while minimizing operator fatigue and injury, our cappers 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 has specific benefits.

Crimp cappers • High quality aluminum overseal

• Low particle release

• Crimp heads and bottle tools in standard or customized sizes are available

• Collection of used compressed air

Capper NameMax. Cap Size Max Bottle Size

Air SupplyDiameter Height Diameter Height FC10 Screw 50 mm 40 mm 55 mm 180 mm 6 bar 85 l/min FC32 Screw 65 mm 40 mm 100 mm 240 mm 6 bar 85 l/min FS10 Crimp 8-20 mm DIN standard 55 mm 180 mm 35 l/min. free air FS32 Crimp 13-32 mm DIN standard 95 mm 240 mm 50 l/min. free air

Screw cappers • No tools needed for changeover

• Handles caps up to 65mm and bottle sizes to 1,000ml

• Adjustable closing torque

Tabletop screw and crimp capping

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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.

FC10 FS32 FS10

Dimensions in mm/inch

146 / 5.8” 320 / 12.6”

FS10

320-

400

/ 12.

6”-1

5.7”

350 / 13.8”

FS32

146 / 5.8”

390-

480

/ 15.

4”-1

8.9”

310 / 12.2”

350-

520

/ 13.

8”-2

0.5”

145 / 5.7”

FC10

310 / 12.2”

350-

520

/ 13.

8”-2

0.5”

145 / 5.7”

FC10

350 / 13.8”146/ 5.7”

400-

590

/ 15.

7”-2

3.2”

FC32

350 / 13.8”146/ 5.7”

400-

590

/ 15.

7”-2

3.2”

FC32

As the need for more automation grows the Watson-Marlow Flexicon’s product line meets the needs of flexible production of small batches. There is great care taken to minimize production downtime. Our design ensures sterile filling.

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

The FF20, used in conjunction with one of our crimp or screw capping machines, provides a simple and flexible means of production.

TabletopAutomation

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• Low cost

• 0.1ml to 150ml fills

• Ø12 to Ø60 mm bottles

• Complete change-over in less than five minutes

• No format parts

• Prevents repetitive strain injuries

• Consistent production quality

• Designed for cleanroom environments

• Tabletop-mounted or placed inside a laminar air flow cabinet

FF20 - up to 2,000 fills/hour and five minute size changes

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

Automatic filling and tabletop vial/bottle handling system

Adjustable filling needle

allows for a wide range of bottles and vials to be filled

0.1ml to 150ml fills

Ø12 to Ø60 mm bottles

Complete change-over in less than five minutes

Prevents repetitive strain injuries

Consistent production quality

Designed for cleanroom environments

Tabletop-mounted or placed inside a laminar air flow cabinet

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Automatic filling and tabletop vial/bottle handling system

Dimensions in mm/inch

150

/ 6” 45

0 / 1

7.7”

70 /

2.8”

100

/ 4”

860 / 33.9” 400 / 15.8”

400 / 15.8”

Optional

370 / 14.6”

400

/ 15.

8”

355

/ 14”

440

/ 17.

3”28

0 / 1

1”

860 / 33.9” 400 / 15.8”

400 / 15.8”

Optional

370 / 14.6”

400

/ 15.

8”

355

/ 14”

440

/ 17.

3”28

0 / 1

1”

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Semi-automatic filling and capping bottle handling system

• Ideal for flexible small-scale production

• Protects operators from repetitive strain injuries

• Consistent cap torque prevents leakage of liquid

• Handles a wide range of bottles and caps

• Up to 1,200 units/hour

• Attractive cost/benefit

• Complete cap and bottle change in 5 minutes

• Fill bottles from 12 mm - 50 mm in diameter

From time to time there is a need for a different type of filling and capping. Watson-Marlow Flexicon’s product line adapts to the changing needs of our customers.

The FF30 is mainly made of stainless steel and anodized aluminum for cleanroom use in pharmaceutical, biotech, diagnostic andophthalmic industries.

A key element is to ensure clean production with no chance of cross-contamination. The FF30 is perfect for flexible small batch production of liquids, oils and creams in bottles or jars with screw caps.

The flexible FF30: consistent, small-scale production quality

TabletopAutomation

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

Filling and capping of

bottles with pipette caps or spray caps

Consistent cap torque prevents leakage

Handles a wide range of bottles and caps

Up to 1,200 units/hour

Attractive cost/benefit

Complete cap and bottle change in

Fill bottles from 12 mm - 50 mm in diameter

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Semi-automatic filling and capping bottle handling system

575

/ 22.

6”80

0 / 3

1.5”

1250 / 49.2”

1000

/ 39

.4”

whe

n op

en

575

/ 22.

6”80

0 / 3

1.5”

1250 / 49.2”

1000

/ 39

.4”

whe

n op

en

Dimensions in mm/inch

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

The FP50 is a very popular tabletop filling system for pharmaceutical research and development departments and biopharmaceutical companies.

FP50 users can avoid sending delicate, expensive and critical products to outside filling facilities, which saves money, especially during clinical trial phases.

FP50

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A customized FP50 is built into an isolator so that the fl uid and the fi lled vials are completely contained. It is

controlled from a panel, which also allows the operator to manage the isolator and the vapor generator which

kills any micro-organisms within the isolator.

• Up to 25 units/minute

• Quick and simple format changes

• Single-use filling with no risk of cross-contamination

• Filling accuracy better than ± 1%

• 0.1 ml to 100 ml fills of 2R to 100H vials

• Universal format parts reduce costs

• Full or partial stoppering

• Size for LAF bench installations

FP50 automates two key features: vial filling and stoppering

Milled vibrator bowl in stainless steel to

accurately deliver the stoppers for

placement

Fully-automatic filling and stoppering

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FP50 automates two key features: vial filling and stoppering

Fully-automatic filling and stoppering

Dimensions in mm/inch

Stoppering with 13 mm and 20 mm stoppers requires no additional format parts

Min

. 695

/ 27

.4"

Max

. 785

/ 30

.9"

214

/ 8,

4"

366 / 14.4"Tray length

487

/ 19

.2"

625 / 24.6"

170

/ 6.

7"

1250 / 49.2"197 / 7.8"

Max

. 305

/ 12

.0"

550

/ 21

.7"

450 / 17.7"

Max

. 305

/ 12

.0"

1679 / 66.1"

Min

. 185

/ 7.

3"

Min

. 180

/ 7.

1"

Min

. 695

/ 27

.4"

Max

. 785

/ 30

.9"

214

/ 8,

4"

366 / 14.4"Tray length

487

/ 19

.2"

625 / 24.6"

170

/ 6.

7"

1250 / 49.2"197 / 7.8"

Max

. 305

/ 12

.0"

550

/ 21

.7"

450 / 17.7"

Max

. 305

/ 12

.0"

1679 / 66.1"

Min

. 185

/ 7.

3"

Min

. 180

/ 7.

1"

• Peristaltic filling from 0.1 ml to 100 ml

• Overseals 13 mm and 20 mm flip-off and standard aluminium caps

• Fast and easy changeover between batches

• Universal format parts reduce costs

• Up to 25 vials/minute

• Small footprint fits inside small cleanrooms

• Optional weight-check system

• IQ/OQ documentation available

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

The universal format parts of the FPC50 allow for a wide range of vials, stoppers and caps.

The peristaltic filling system eliminates having product-dedicated or volume-dedicated pumps in stock.

The FPC50ISO is a variation designed for integration into an isolator or a restricted access barrier system.

FPC50

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The versatile FPC50 for clinical trial and small scale production

Fully-automatic filling, stoppering and capping

The FPC50’s crimping head

Rounded edges facilitate cleaning

Optional weight-checkWeighing cell ensures automatic pump recalibration during a batch and up to 100% check weighing.

Easy height changeHeight adjustment is achieved using a simple and intuitive crank

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Fully-automatic filling, stoppering and capping

Rounded edges facilitate cleaning

1356

/ 53

.4"

970

/ 38

.19"

800

/ 31

.5"

612

/ 24

.1"

1552 / 61.1"

Min

. 179

/ 7.

3"M

ax. 3

05 /

12" 88

4 /

34.8

"

Min. 185 / 7.3"Max. 305 / 12"

1198

/ 47

.2"

659 / 25.9"2400 / 94.5"

1356

/ 53

.4"

970

/ 38

.19"

800

/ 31

.5"

612

/ 24

.1"

1552 / 61.1"

Min

. 179

/ 7.

3"M

ax. 3

05 /

12" 88

4 /

34.8

"

Min. 185 / 7.3"Max. 305 / 12"

1198

/ 47

.2"

659 / 25.9"2400 / 94.5"

Dimensions in mm/inch

Two high-accuracy peristaltic pumps

are fully integrated

The FMB210 is perfect for fully automated filling and capping medium size batches. It can handle a wide range of container and closure types.

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

A unique tool platform allows simple, fast and accurate format changes where multiple products need to be processed on a single filler. It can be configured for a choice of infeed and outfeed options.

Fully-automatic filling, stoppering and cappingMonobloc

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

a laminar air flow cabinet20

• Aseptic filling of injectable drugs: filling, stoppering and capping

• Ophthalmics and diagnostics: filling, dropper insert 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 with easy setup and changeover

Roller closing of caps for

consistent high-

quality crimps

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

a laminar air flow cabinet

Fully-automatic filling, stoppering and capping

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The sensor for the FMB210’s no-vial-no-fill feature

The sensor for the FMB210’s no-vial-no-fill feature

Dimensions in mm/inch

1725

/ 67

.9”

825

/ 32.

5”

1130 / 44.5”

2050

/ 80

.7”

1250

/ 49

.2”

Acc. to customer tray

1725

/ 67

.9”

825

/ 32.

5”

1130 / 44.5”

2050

/ 80

.7”

1250

/ 49

.2”

Acc. to customer tray

Once there is a need for larger scale production, we can provide fully automatic filling solutions for new or existing systems.

Watson-Marlow Flexicon’s OEM solutions consist of fillers, 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 solutions

Flexible, production-scale filling

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A vast number of OEM customers and machine manufacturers have already successfully incorporated our solutions into their filling lines, adding value to their product.

• Faster changeover between batches

• Less product waste during changeover between different liquids to be filled

• Easy cleaning, validation and programming

• No need for format parts for different fill volumes or products to be filled

• Minimum need for maintenance

• Functions to prevent after dripping and splashing

OEM system components to complete your filling line

TrolleysWatson-Marlow Flexicon’s trolleys are cabinets on castors fitted with two or more fillers. Trolley solutions are supplied for integration into new or existing filling lines. We have several standard designs or will build to fit custom requirements.

MC12 control unit for multi-filling system

The unit fulfils all usual requirements and can be extended to include several filling stations, an electronic bottom-up fill system, a printer for documentation logging, a direct link to a balance for dynamic recalibration and more.

Flexible, production-scale filling

Master controllersMaster controllers, such as the MC100, can control 16 pumps in a filling line. We supply stand-alone controllers, panel mounts and controllers for communication with filling line systems via Profibus or DeviceNet. The MC100 receives filling data through an industrial fieldbus, calculates operating values for the fillers then transmits those through a FlexNet protocol to the fillers.

Parallel Production Set-Up

Dynamic Recalibration Set-Up

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MC12 control unit for multi-filling system

Watson-Marlow Flexicon online

Our engineers can help you choose the perfect filling and capping equipment for your needs.

Accessories

Watson-Marlow Flexicon provide silicone tubing, filling nozzles and other accessories, which can ensure aseptic filling and the highest possible filling accuracy. All designed for use within the pharmaceutical and biotech industries.

It gives you a fast and easy change-over between batches and prevents cross-contamination between liquids to be filled.

Let us assist you find the right accessories for your Watson-Marlow Flexicon equipment.

Watson-Marlow Bredel Alitea Flexicon MasoSine

www.wmfl exicon.dk

79-4

01-0

00 IS

SU

E 1

011

0

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

You are also welcome to download detailed brochures and evaluate films of the entire product range at www.wmflexicon.dk

Watson-Marlow Flexicon cannot be held responsible for any errors or omissions. Subject to change without notice.

home profile technology products product guide distributors contact brochures download

FPC50 - Aseptic filling, stoppering and capping ... more

NEW PRODUCT- RABS for FPC50

Watson-Marlow Flexicon is very proud to present our brand new product for FPC50 - RABS (Restricted Access Barrier System)

Flexicon has joined the Watson-Marlow Group

the 11th of February 2008 Flexicon joined Watson-Marlow and is now part of the world’s largest group of

WORLD LEADERS IN ASEPTIC PERISTALTIC FILLING

news |||||||||

NEWS

home profile technology products product guide distributors contact brochures download

Ultimate flexibility for aseptic fillingPRECISIONFor Watson-Marlow Flexicon custom-ers it is vital that our machines work with high precision. Not only do we satisfy that demand; we deliver exactly what has been ordered on time, every time. Today’s industry also requires safe operation with minimum risk to process, product and personnel. We accomplish this through our unique peristaltic filling systems.

FLEXIBILITYOur fillers are easily and quickly adjust-able for a huge range of fill volumes, fluids, capacities and caps. We can customize products to your exact re-quirements and you can visit our plant to assure yourself that our performance matches our promise. We offer a short response time from initial contact to delivery.

EFFICIENCYOur customers can produce small andmedium sized batches securely and profitably. Watson-Marlow’s Flexicon equipment is reliable, easy to operate and requires minimal maintenance at long intervals. We offer first class after-sales service and full documentation for all our products. In performance as well as quality, we deliver what we say we will.

news |||||||||

Med pegetekster

ASEPTIC FILLING AND CAPPING SOLUTIONS

Watson-Marlow FlexiconFrejasvej 2–6DK-4100 RingstedDenmarkTel. +45 5767 1155 • Fax +45 5767 [email protected] • www.wmflexicon.dk