aseptic filling solutions

ASEPTIC FILLING SOLUTIONS
FLEXICON
Aseptic Fillers
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. WatsonMarlow Pumps
Group is also an
ISO9001 company.
2
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. Our range of filling and capping
equipment provides solutions with the
precision, efficiency and flexibility that
customers have come to know and
trust.
PRECISION
EFFICIENCY
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. Today’s industry also requires
safe operation with minimum risk to process,
product and personnel. We accomplish this
through our unique peristaltic filling systems.
Our 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.
FLEXIBILITY
Our 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.
Peristaltic pumping - the solution for high purity
A peristaltic pump’s lowshear 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
within 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.
3
Your
Choice
Aseptic liquid filling and capping equipment
Flexicon - flexible enough to
grow with your changing needs
Tabletop units
Semi-automatic
systems
Fillers
Filling
Cappers
Filling and capping
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
4
FP50 - Filling and
FPC50 - Filling, Stoppering
FPC50ISO - FPC50 for
Watson-Marlow Flexicon offers a range
of products that grow with you, from
stand-alone units for hand filling, through
semi-automatic systems, to fully automatic
Fully-automatic
systems
Wide range of systems for
automation of filling, stoppering,
capping and weight check
Customized monobloc systems
Small Production
filling, stoppering and capping machines. The
fully automatic systems are customized to fit
any glass vial, plastic bottle, test tube, eyedropper or non-self standing microtube.
Solutions for
integration or retrofit
OEM panel mount fillers
Trolley solutions for piston
pump replacement
Full Production
High Speed
Aseptic Fluid Path (pages 6-7)
(pag­­es 12-13)
FF30 - Filling/Screw Capping (pages 14-15)
Stoppering (pages 16-17)
and Capping (pages 18-19)
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)
5
FLEXICON
Aseptic Fillers
Your answer for aseptic filling
DAFPA
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
6
and singleuse filling
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
Top quality whatever the scale
Flexicon peristaltic pumpheads and
silicone precision tubing offer pulsation-free,
accurate dispensing from benchtop units to
fully automatic production equipment.
DAFPA
enhances a
complete
filling system,
such as the
FP50 shown
here
Simplify your cleaning validation
Imagine a USP Class VI fluid 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 filling 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
7
Fillers
Tabletop dispensing
The simplest filling set-up
with accuracy and flexibility
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.
• 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
Peristaltic pumping
combines sterility
and precision
PF6 - capacity diagram (based on water)
4.00
8
The PF22 is
the largest of
the Flexicon
tabletop filler
range
Filling time (sec)
3.50
3.00
2.50
2.00
1.50
1.00
0.50
0.00
0.1
1
10
Filling volume (ml)
100
1000
The PF6 is the smallest
of the Flexicon tabletop
filler range
DF32 - capacity diagram (based on water)
4.00
3.50
3.50
3.00
3.00
Filling time (sec)
Filling time (sec)
PF22 - capacity diagram (based on water)
4.00
2.50
2.00
1.50
1.00
2.00
1.50
1.00
0.50
0.50
0.00
2.50
0.1
1
10
Filling volume (ml)
100
1000
0.00
0.1
1
10
Filling volume (ml)
100
1000
9
Cappers
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.
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 and bottle tools in standard
or customized sizes are available
• Collection of used compressed air
A range of vial and cap
sizes and tools are
available for all cappers
10
Capper Name
FC10 Screw
FC32 Screw
FS10 Crimp
FS32 Crimp
Max. Cap Size
Diameter
Height
50 mm
40 mm
65 mm
40 mm
8-20 mm DIN standard
13-32 mm DIN standard
Max Bottle Size
Diameter
Height
55 mm
180 mm
100 mm
240 mm
55 mm
180 mm
95 mm
240 mm
Air Supply
6 bar 85 l/min
6 bar 85 l/min
35 l/min. free air
50 l/min. free air
FC10
FS32
FS10
320 / 12.6”
FS10
Dimensions in mm/inch
350-520 / 13.8”-20.5”
390-480 / 15.4”-18.9”
320-400 / 12.6”-15.7”
146 / 5.8”
146 / 5.8”
350 / 13.8”
FS32
400-590 / 15.7”-23.2”
If space is at a premium in your current setting, take a look at the small foot print offered by our cappers.
145 / 5.7”
310 / 12.2”
FC10
146/ 5.7”
350 / 13.8”
FC32
11
Tabletop
Automation
Automatic filling and tabletop vial/bottle handling
FF20 - up to 2,000 fills/hour
and five minute size changes
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.
• 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
Adjustable
filling needle
allows for a wide
range of bottles
and vials to be filled
12
Are you already a Watson-Marlow 520Di dispensing
pump user? GOOD NEWS, the FF20 is fully
compatible with Watson-Marlow’s 520Di.
system
100 / 4”
450 / 17.7”
150 / 6”
370 / 14.6”
70 / 2.8”
Optional
400 / 15.8”
355 / 14”
400 / 15.8”
Dimensions in mm/inch
400 / 15.8”
440 / 17.3” 280 / 11”
860 / 33.9”
13
Tabletop
Automation
Semi-automatic filling and capping bottle handling
The flexible FF30: consistent,
small-scale production quality
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 and
ophthalmic 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.
• 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
Filling and
capping of
bottles with pipette
caps or spray caps
14
Are you already a Watson-Marlow 520Di dispensing
pump user? GOOD NEWS, the FF30 is fully
compatible with Watson-Marlow’s 520Di.
1250 / 49.2”
Dimensions in mm/inch
575 / 22.6”
1000 / 39.4” when open
800 / 31.5”
575 / 22.6”
1000 / 39.4” when open
system
1250 / 49.2”
15­
FP50
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 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.
• 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
Milled vibrator bowl
in stainless steel to
accurately deliver
the stoppers for
placement
16
A customized FP50 is built into an isolator so that the
fluid and the filled 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.
Stoppering with
13 mm and 20 mm stoppers
requires no
additional
format parts
Max. 785 / 30.9"
Min. 695 / 27.4"
550 / 21.7"
Max. 305 / 12.0"
1679 / 66.1"
1250 / 49.2"
Min. 180 / 7.1"
Min. 185 / 7.3"
Max. 305 / 12.0"
Max. 785 / 30.9"
Min. 695 / 27.4"
487 / 19.2"
170 / 6.7"
214 / 8,4"
625 / 24.6"
197 / 7.8"
Tray length
366 / 14.4"
487 / 19.2"
214 / 8,4"
170 / 6.7"
Tray length
366 / 14.4"
450 / 17.7"
625 / 24.6"
Dimensions in mm/inch
197 / 7.8"
17
1679 / 66.1"
1250 / 49.2"
FPC50
Fully-automatic filling, stoppering and capping
The versatile FPC50 for clinical
trial and small scale production
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.
• 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’s
crimping head
Easy height change
Height adjustment is
achieved using a simple
and intuitive crank
18
Optional weight-check
Weighing cell ensures automatic
pump recalibration during a batch
and up to 100% check weighing.
1356 / 53.4"
800 / 31.5"
2400 / 94.5"
1552 / 61.1"
1198 / 47.2"
612 / 24.1"
884 / 34.8"
2400 / 94.5"
1552 / 61.1"
Max. 305 / 12"
Min. 179 / 7.3"
1356 / 53.4"
800 / 31.5"
Dimensions659in/ 25.9"
mm/inch
970 / 38.19"
659 / 25.9"
970 / 38.19"
Rounded edges
facilitate cleaning
Max. 305 / 12"
Min. 185 / 7.3"
19
Monobloc
Fully-automatic filling, stoppering and capping
FMB210: larger production with
easy setup and changeover
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.
Two high-accuracy
peristaltic
pumps
are fully
integrated
20
An FMB210 fed by a bottle unscrambler
unit and, right, an FMB210 installed within
a laminar air flow cabinet
• 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
Roller closing of
caps for
consistent
highquality
crimps
825 / 32.5”
1725 / 67.9”
The sensor
for the
FMB210’s
no-vial-nofill feature
Dimensions in mm/inch
825 / 32.5”
1725 / 67.9”
1250 / 49.2”
2050 / 80.7”
Acc. to
1130 / 44.5”customer tray
21
Acc. to
1130 / 44.5”customer tray
OEM
solutions
Flexible, production-scale filling
OEM system components to
complete your filling line
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
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
Trolleys
Watson-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.
22
Parallel Production Set-Up
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.
Dynamic Recalibration Set-Up
Master controllers
Master 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.
23
Watson-Marlow Pumps Group has five world-class
factories supported by direct sales operations in 17
countries and distributors in more than 50 countries.
For contact details visit our website:
www.wmflexicon.dk
Watson-Marlow
Bredel
Alitea
Flexicon
MasoSine
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.
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. Today’s 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 world’s
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-Marlow’s 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.
Watson-Marlow Flexicon online
Our engineers can help you
choose the perfect filling and
capping equipment for your needs.
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 Flexicon
Frejasvej 2–6
DK-4100 Ringsted
Denmark
Tel. +45 5767 1155 • Fax +45 5767 0541
flexicon@flexicon.dk • www.wmflexicon.dk
Watson-Marlow Flexicon cannot be held responsible for
any errors or omissions. Subject to change without notice.
79-401-000 ISSUE 1 0110
You are also welcome to
download detailed brochures and
evaluate films of the entire product
range at www.wmflexicon.dk