ASEPTIC FILLING SOLUTIONS

Ultimate flexibility for clinical-scale aseptic filling

For over 50 years the Watson-Marlow

Pumps Group has led the world
in peristaltic filling innovation, the
technology of choice for high purity
fluid handling in the pharmaceutical,
biotech and diagnostics industries.

PRECISION
For Flexicon customers it is vital that our systems work
with high precision. Not only do we satisfy that demand;
we deliver exactly what has been ordered on time, every
time. Todays industry also requires safe operation with
minimum risk to process, product and personnel. We
accomplish this through our unique peristaltic filling
systems, providing validated processes from clinical trials
to production.

EFFICIENCY
Our customers can produce small and medium sized
batches securely and profitably. Flexicons 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.

Peristaltic filling the solution for

high purity and low risk
A peristaltic pumps low shear action is created
by compressing a tube. Inside the single-use tube
the fluid is driven forward by rollers while the tubes
recovery behind each roller draws in more fluid. The
pump is perfect for moving fluid aseptically because
the fluid stays within the tube. Unlike piston pumps
there are no seals, valves or moving parts in its path
to lead to contamination.
Flexicon peristaltic fillers are recognised by
production managers for high quality, reliability and
performance. Our equipment simplifies validation,
improves yield and reduces expensive downtime.

Our range of filling and capping equipment provides

solutions with the precision, efficiency and flexibility that
customers have come to know and trust.

FLEXIBILITY
Our fillers are easily and quickly adjustable for a huge
range of fill volumes, fluids, capacities, bottles and caps.
We can customise 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.
Flexicon offers a range of products that grow with you,
from stand-alone units for hand filling, through semiautomatic systems, to fully automatic filling, stoppering
and capping machines. The fully automatic systems are
customised to fit any glass vial, plastic bottle, test tube,
eye-dropper or non-self-standing microtube.
A tabletop dispenser can be connected to a bottle
handling unit, if the need for automation arises. This
reduces validation costs and limits extra investment as
demand for production capacity increases. The added
benefit of such easy up-scaling is that only a minimum of
operator training is needed.

We are the only global supplier of

peristaltic filling equipment with
our own tubing production facility,
therefore ensuring full control of the
complete solution, reducing risk,
providing consistent performance and
saving customers time and money.

Aseptic liquid filling and capping equipment

Flexicon - flexibility to grow with

your changing needs
Tabletop units

Flexicon offers a range of products that grow with

your business, from stand-alone units for hand filling,
through semi-automatic systems, to fully automatic
filling, stoppering and capping machines.

Semi-automatic
systems

Fillers

Fully-automatic
systems

Filling

Cappers

Solutions for
integration or retrofit

Wide range of systems for

automation of filling, stoppering,
capping and weight check

Filling and capping

The fully automatic systems are customised to fit any

glass vial, plastic bottle, test tube, eye-dropper or
non-self standing microtube.

OEM peristaltic fillers and controllers

Customised monobloc systems

Trolley solutions for piston

pump replacement

Single-use sterility throughout. Flexicon Accusil and asepticsu

single-use fluid path technology makes validation and scale-up easy
Lab - R&D

Clinical I

Clinical II

Clinical III

Small Production

Full Production

High Speed

Sterile, single-use fluid path - asepticsu (pages 6-7)

Tabletop Dispensing Systems - PF6, 520Di, PF22 (pages 8-9)
Tabletop Screw and Crimp Cappers - FS and FC (pages 10-11)
Vial/Bottle Handling - FlexFeed15 and FlexFeed20 (pages 12-13)
Filling/Screw Capping - FlexFeed30 (pages 14-15)
Filling and Stoppering - FP50 (pages 16-17)
Filling, Stoppering and Capping - FPC50 (pages 18-19)
FPC50 for integration into an Isolator - FPC50ISO (pages 18-19)
Fully Automatic Monobloc - FMB210 (pages 20-21)
Master Controllers, Trolleys and Pumps/Fillers - OEM Solutions (pages 22-23)

Your answer for aseptic filling

single-use fluid path and

Accusil platinum-cured silicone tubing
for sterility throughout
Single-use technology asepticsu

Simplify your cleaning validation

asepticsu is a sterile, single-use fluid path perfected

for aseptic filling by Flexicon, the world leader in
peristaltic filling systems for over 25 years. The
combination of asepticsu and Flexicon peristaltic
technology lowers your risk in high purity, high
accuracy filling applications.

Imagine a USP Class VI fluid path that is fully traceable

from end-to-end, is simple to validate, and you have
asepticsu. From the bag, to the tubing through the
pump, to the filling nozzle on your machine, asepticsu
provides an entire wet end, which is fully assembled
and lot traceable. And best yet, its single-use design
eliminates costly cleaning validation.

Flexicon peristaltic filling units with asepticsu singleuse technology deliver rapid product changeover, no
line-cleaning, no cross-contamination and simplified
validation.

Accusil precision
tubing prevents costly overfilling
Accusil tubing provides perfect filling accuracy, fill speed,
minimum foaming and no dripping between fills for
volumes from less than 0,2ml to more than 250ml. This
prevents costly overfilling and eliminates production stops
due to spillage between the fills.
For full details on Accusil tubing, see page 23

Huge validation savings and faster to market

Contamination risks are eliminated
Prevents costly overfilling
Small batch production is easy and efficient
Simplified inventory management

Filling equipment and single-use fluid paths

from just one supplier makes validation easy
and prevents costly overfilling

asepticsuTM enhances
a complete filling
system, such as the
FPC50W shown here

Accusil with laser-etched

lot number, part number and use-by-date

Tabletop dispensing

The simplest filling set-up with

accuracy, flexibility and reliability
Flexicon tabletop fillers are designed for use in cleanrooms
for production processes complying with cGMP.

No cross-contamination

Setting up a filling regime for vials, bottles, test tubes or

other containers is achieved by loading the peristaltic
filler tube and entering the parameters required using the
intuitive keypad.

No foaming, splashing or dripping between fills

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.

Accuracy: 0.5% and no costly overfilling

A complete solution from just one supplier

makes validation easy and prevents costly overfilling

One-minute set-up and changeover

Unmatched filling flexibility over a very wide range of fill

volumes, from less than 0.2ml to more than 250ml from

the same pumphead
Designed with the operator in mind higher productivity

and less risk of human error

Flexicon peristaltic
pumpheads and Accusil
platinum-cured silicone
tubing provide excellent
dispensing accuracy

Flexicons unique peristaltic

pumphead enables product
changeover in less than one minute

PF22 - capacity diagram (based on water)

4.00

3.50

3.50

3.00

3.00

Filling time (sec)

Filling time (sec)

PF6 - capacity diagram (based on water)

4.00

2.50
2.00
1.50
1.00
0.50

PF22 for less than 5ml

to more than 5000ml

0.00

2.50
2.00
1.50
1.00
0.50

0.1

10

Filling volume (ml)

100

1000

0.00

0.1

10

100

1000

Filling volume (ml)

Tabletop screw and crimp capping

Cappers ensure consistent quality

crimps and torque
When there is need to increase productivity, while
minimising operator fatigue and repetitive strain 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 changeovers

Screw cappers

A range of format parts is available to handle

different types and sizes of caps, bottles and vials

No tools needed for changeover

Handles caps up to 65mm and bottle

sizes up to 100mm in diameter

Adjustable closing torque

Crimp cappers
High quality aluminium overseal
Low particle release

Deciding which capper is right for the process

depends on the capping needs. Each capper has
specific benefits.

Capper Name
FC10 Screw
FC32 Screw
FS10 Crimp
FS32 Crimp

Max. Cap Size

Diameter
Height
50mm
40mm
65mm
40mm
8-20mm DIN standard
13-32mm DIN standard

Easy to mount crimp heads and bottle tools

in standard or customised sizes are available

Collection of used compressed air

Max. Bottle Size

Diameter
Height
55mm
180mm
100mm
240mm
55mm
180mm
95mm
240mm

Air Supply
6 bar 85 l/min
6 bar 85 l/min
35 l/min. free air
50 l/min. free air

Screw capper FC10

Crimp capper FS10

Crimp capper FS32

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

FS10

FS32

FC10

FC32

Dimensions in mm/inch

10

11

Automatic filling and tabletop vial/bottle handling system

FlexFeed 15 and 20
automatic filling systems
As the need for more automation grows Flexicons product
line meets the needs of flexible production of small batches
in contract filling and diagnostics operations where there
are many different sizes of bottles.

12mm to 50mm (FF15) / 67mm (FF20) diameter

The speed at which the vials/bottles are presented at the

filling needle is fully adjustable, allowing light vials or bottles
to be filled. Customised solutions can be designed to
handle bottles with special shapes.

Small foot print and designed for cleanroom

Ideal for contract filling where there are many

different sized bottles/vials

bottles without any format parts

Complete changeover in less than five minutes
Prevents repetitive strain injuries

environments
Unique cost of ownership

The FlexFeed15 and FlexFeed20, used in conjunction with

one of our crimp or screw capping machines, provides
a simple and very flexible means of production and
customers can achieve a fast return on investment.

Go from manual to automatic filling

and get a fast return on investment

FlexFeed15

The 520Di dispensing pump can also be used with the

FlexFeed 15 and 20 vial/bottle handling systems

12

FlexFeed20

Dimensions in mm/inch

13

Semi automatic filling and capping system

FlexFeed30 filling and capping system

for small batches
Fills bottles from 12mm to 50mm in diameter

For a higher productivity, a more consistent screw capping

and no more repetitive strain injuries, the FlexFeed30 is
the answer for contract manufacturers and diagnostic
companies.
Reduced production costs and increased productivity
Consistent cap torque prevents leakage of liquid
Up to 1,200 units/hour
Protects operators from repetitive strain injuries
Complete cap and bottle change in less than five minutes
Fills bottles from 12mm to 50mm in diameter

Small batch production - easy and efficient

Filling is done automatically, cap is placed manually
and capping torque is applied automatically

A 520Di/L pump can also be used with the

FlexFeed30 filling and capping system

Dimensions in mm/inch

14

15

Fully automatic filling and stoppering

FP50 automates two key features:

vial filling and stoppering
Automating the key steps of aseptic filling cuts the risk
of operator error and related contamination. The FP50
peristaltic filling system also eliminates the costs and risk
issues of volumetric filling pumps.
The FP50 is a tabletop filling system used for
biopharmaceutical research and development
departments during clinical trial phases, or for contract
manufacturing companies where it will increase flexibility
and save costs.

Up to 25 units/minute

Increase your flexibility when filling smaller

batches - just one machine will fill all your vials
Fills from less than 0.2ml up to 100ml. Maximum
25 vials per minute

Filling accuracy better than 0.5%

From less than 0,2ml to 100ml fills of 2R to 100H

vials
Full or partial stoppering
Quick and simple format changes
Universal format parts reduce costs
Small footprint for LAF bench or RABS installations

Stoppering with 13mm and

20mm stoppers requires no
additional format parts

A customised FP50 is built into an isolator so that the

fluid and the filled vials are completely contained.

Dimensions in mm/inch

16

17

Fully automatic filling, stoppering and capping

FPC50 offers superior filling technology

with optional 100% in-line check
weighing
The FPC50 provides a ready-to-use and easy-to-validate
filling, stoppering and capping system for flexible small
batch pharma production.
It is a modular system which offers options for 100% inline check-weighing and usage under a standard LAF or a
RABS.
The FPC50 can also be customised for integration into
an isolator with easy access to all areas of the machine
through glove ports.
The universal format parts of the FPC50 allow for filling of a
wide range of vials, stoppers and caps. The peristaltic filling
system eliminates having product-dedicated or volumededicated pumps in stock.
We have an excellent record in providing short and reliable
delivery times and performing seamless FAT, IQ and OQ
tests, avoiding costly project delays.

Universal format parts allow filling, stoppering and

capping of a wide range of vials

High accuracy filling for less than 0.2ml up to 100ml

with no splashing, dripping or foaming

Master controller can

be situated outside an
LAF hood or RABS unit

Fast and easy changeover between batches with

very limited product waste at start-up
Universal format parts reduce costs and increase
flexibility
Up to 25 units/minute
Batch report after each production run and full
audit trail
First class documentation and test protocols for FAT,
SAT, IQ and OQ
Software designed and qualified according to GAMP5
Optional software to support 21 CFR Part 11

FPC50 crimping head for minimum air

turbulence and fast changeover between caps

A filling machine and single-use fluid path from one

supplier makes validation easy and prevents costly overfilling
Dimensions in mm/inch

18

19

Fully automatic filling, stoppering and capping

FMB210 for medium sized batches

with easy setup and changeover
The FMB210 is perfect for fully automated filling and capping
for aseptic drug, ophthalmic and diagnostic applications. It
can handle a wide range of container and closure types.

Ophthalmic and diagnostics: filling, dropper insert

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 or other peripherals.

Aseptic filling of injectable drugs: filling, stoppering

and crimp capping

A filling machine and single-use fluid path from one

supplier makes validation easy and prevents costly overfilling
Handles a wide range of containers and closure
types

and precise screw capping better than 10 Ncm

(0.9 lbs/inch)

Roller closing of caps for consistent high quality

crimps
Compact design means a small footprint that fits

inside small cleanrooms

Up to 75 units/minute: depending on type of cap,

vial size and fill volume

Completely closed peristaltic filling system ensuring

no cross-contamination

The sensor
for the
FMB210s
no-vial-nofill feature

20

An FMB210 fed by a bottle unscrambler unit

top, and bottom, an FMB210 installed within a
laminar air flow cabinet

Modular design allows for

customised infeed, outfeed
and capping technology

Dimensions in mm/inch

21

Flexible, production-scale filling

OEM system components to

complete your filling line
Many filling machine manufacturers have already
successfully incorporated Flexicon solutions into their filling
lines, thereby adding value to their product and increased
satisfaction from their clients.
Full flexibility in fill volumes
Prevent spillage between fills, foaming and splashing
Fast changeover
High filling accuracy reduces production costs

Master controllers
Master controllers, such as the MC100 and the
MC12, can control up to 16 pumps on 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.

Accusil platinum-cured silicone

tubing for accurate dispensing
TM

Accusil precision tubing prevents

costly overfilling

Reduce your costs and increase

your productivity with Accusil

Accurate and consistent dispensing requires having

the right tubing inside the right pump. Accusil is
manufactured in our state-of-the-art extrusion facility
to the highest quality, with a consistent wall thickness
and a specific hardness for optimal tubing restitution.

Excellent filling accuracy on PF6 and PD12

OEM applications include:

Accusil fulfills biopharmaceutical

requirements and is ideal for single-use
filling

Existing filling lines where piston pumps need to be

Full biopharmaceutical compliance with USP Class

Global support and high quality filling accessories

replaced

Parallel Production Set-Up

New high capacity filling lines for the biopharm industry

VI, Ph. Eur. 6.8 Chapter 3.1.9, ISO 10993 and FDA
CFR 177.2600.
Validation pack available

Filling lines for bottles with an awkward shape for the

diagnostics industry

100% traceability with laser-etched part number, lot

number and use-by date

Lot specific certificate of conformance in each box

Dynamic Recalibration Set-Up

and accessible online

Manufactured in an ISO 14644-1Class 7

environment at state-of-the art tubing production

facility

peristaltic pumps
Peristaltic filling technology provides fast and easy

changeover between liquids to be filled

Cross-contamination between liquids to be filled is

prevented
Enhanced safety as contact between liquid and

operator can be avoided

Tubing sizes for fill volumes from less than 0.2ml

up to more than 250ml

Fast delivery service

Accessories
Flexicon also offers filling nozzles and other
accessories which can ensure aseptic filling with the
highest possible accuracy.

Replace hard to validate piston fillers

with Flexicon single-use technology

Double-bagged for protection against contamination

Post-cured after extrusion for superior purity
Fully sterilisable by gamma radiation, autoclave or

ethylene oxide
Animal Derived Content Free

MC12 control unit with multiple

PD12 fillers
The unit fulfils all the usual requirements and
can be extended to include several filling
stations, an electronic bottom-up fill system, a
printer, a direct link to a balance for dynamic
recalibration and more.

Trolley solutions are supplied for integration into new or

existing filling lines fitted with up to sixteen peristaltic fillers

22

The PD12 filler is available in several versions as

a stand-alone unit or for panel mounting. Panel
mount versions can be ordered for vertical or
horizontal integration and with a pump head in
either anodized aluminium or in stainless steel.

We are the only global supplier of

peristaltic filling equipment with
our own tubing production facility,
therefore ensuring full control of the
complete solution, reducing risk,
ensuring consistent performance and
saving customers time and money.

23

A Spirax-Sarco Engineering Company

Watson-Marlow Pumps Group has six world-class

factories supported by direct sales operations in 23
countries and distributors in more than 50 countries.
For contact details visit our website:

www.wmpg.com
Watson-Marlow

Bredel

Watson-Marlow

Bredel

Alitea

Flexicon

Flexicon

MasoSine

MasoSine

ASEPTIC FILLING AND CAPPING SOLUTIONS

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

Ultimate flexibility
for aseptic filling

PRECISION
For 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. Todays industry also requires
safe operation with minimum risk to
process, product and personnel. We
accomplish this through our unique
peristaltic filling systems.

Med

tekster

FPC50 - Aseptic filling, stoppering and capping ...

more

pege

WORLD LEADERS IN ASEPTIC PERISTALTIC FILLING

FLEXIBILITY
Our fillers are easily and quickly adjustFlexicon
has range
joinedofthe
Watsonable for a huge
fill volumes,
Marlow
Group and caps. We can
fluids, capacities
customize products to your exact rethe 11th of February
2008visit
Flexicon
quirements
and you can
our plant
joined
Watson-Marlow
and performance
is now part of
to
assure
yourself that our
the worlds
group
matches
ourlargest
promise.
Weofoffer a short
response time from initial contact to
delivery.
EFFICIENCY
Our customers can produce small and
medium sized batches securely and
profitably. Watson-Marlows Flexicon
equipment is reliable, easy to operate
and requires minimal maintenance at
long intervals. We offer first class aftersales service and full documentation
for all our products. In performance as
well as quality, we deliver what we say
we will.

Flexicon online

www.flexicon.dk
The information in this document is believed to be correct, but Watson-Marlow
Flexicon A/S accepts no liability for any errors it contains, and reserves the right to
alter specifications without notice. WARNING: These products are not designed for
use in, and should not be used for, patient-connected applications. asepticsu and
Accusil are registered trademarks

HB0332 Issue 2 79-401-000 Issue 3

Learn more about Flexicon by downloading

detailed brochures and viewing videos of our
full range of aseptic liquid filling solutions.