ASEPTIC FILLING SOLUTIONS

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. Today’s 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. 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.
Peristaltic filling – the solution for
high purity and low risk
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 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.
2
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.
3
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)
4
5
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
6
7
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
Flexicon’s 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
8
0.00
2.50
2.00
1.50
1.00
0.50
0.1
1
10
Filling volume (ml)
100
1000
0.00
0.1
1
10
100
1000
Filling volume (ml)
9
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 Flexicon’s 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
FMB210’s
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
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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. 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.
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.