Flexicon isolator filling and capping solutions

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Flexicon isolator filling and capping solutions
FMB210ISO for filing plugging and capping from
Flexicon
FMB210ISO combined with isolator
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Contents of presentation

• What is an isolator
• Where are isolators applied
• Advantages of using isolators
• Disadvantages of using isolators
• The complete production line example
• Economic considerations
• Example of isolator filling and capping machine
  from Flexicon
• Specifications of isolator machine, FMB210ISO
• How to transfer vials into the FMB210ISO
• How to transfer stoppers and caps into the
  FMB210ISO
• How to transfer filled vials out of the FMB210
• Suppliers of isolator units to be mounted on the
  FMB210
• Prices
• Advantages of peristaltic filling
• Leak testing of FMB210ISO
• Format change
• Case stories
• Time frame and activities related to a new
  project
• Individual Flexicon OEM pumps for integration
  into an isolator

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What is an isolator?

• An isolator is a leak tight enclosure designed to
  protect operators from hazardous/potent processes
  or protect processes from people or detrimental
  external environments or both.
• A basic enclosure consists of a shell, viewing
  window, glove ports and gloves, supply and
  exhaust filters, lights, gauges, input and output
  openings (equipment door airlocks, rapid transfer
  ports, etc.) and various other penetrations.

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Where are isolators applied for filling purposes

• Toxic products (cytostatica)
• Sterile products
• Products being very sensitive to changes in
  humidity
• Products sensitive to contact with eg. oxygen
• Production facilities with-out an existing
  cleanroom
• General protection of the operators

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Advantages of using isolator systems

• Less risk of contamination of product
• Less risk of recalling finished goods from the
  market
• Compliance with future more strict FDA rules
• Protection of product
• Protection of operators
• Protection of environment
• Less validation work after installation has taken
  place
• Less investments in cleanroom

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Disadvantages of using isolators

• Large investment
• Overall capacity of the system is likely to be
  lower compared to non-isolator systems
• More validation work prior to and during
  installation of the system
• Special trolleys for transfer of trays and format
  parts to and from the isolator

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The complete production line example
Filling, plugging and/or capping
Liquid into product tank
Manufacturing of liquid
Washing of vials
Sterilization of vials
Washing of stoppers and caps
Sterilisation of stoppers and caps
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The complete production line example
Filling, plugging and/or capping
Lyophilization
Capping and labelling
Labelling
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Economic considerations

• Equipment costs
• Validation costs
• Costs for cleanroom etc.
• Costs for daily use of system
• Capacity of system
• Costs related to a potential contamination of a
  product
• Costs related to future up-grading to future
  FDA-rules
• Costs related to linking the various modules
  together
• Costs related to getting sufficient space for the
  foot print of the system

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Illustration of FMB210ISO
Vibrator feeders for caps and stoppers
Vial infeed by trays
Outfeed on trays
Sensors for gloves
Filling plugging Capping
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FMB210ISO - Workstations
Vial infeed on trays
Rotary table
Peristaltic filler
Filling plugging Capping
Automatic transfer of empty trays
Outfeed on trays
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FMB210ISO - Dimensions
Control unit
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Main specifications of isolator machine FMB210ISO

• Capacity for filling, plugging and capping up
  to 50/minute
• Capacity for filling and plugging - up to
  50/minute
• Change-over time approx. 45 minutes

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Supply of product

• Small tank placed inside machine
• Sterile plastic bag fixed on stand inside machine
• Tank placed outside the machine

Product tank
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Infeed of vials
Trays with vials are loaded onto a 500 mm rotary
table
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Filling/Dispensing
filling nozzle
Pump head
One station peristaltic filler
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Plugging
plugging station
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Capping
Cap head
Bottle disc
Rolling disc
Capping station
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Outfeed
Tray loading of filled and/or capped vials
Tray transfer
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Transfer of trays
1
2
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FPC50-ISO
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FPC50-ISO
FPC50ISO inside isolator from Walker Barrier
Systems
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FPC50ISO
FPC50ISO inside isolator from Walker Barrier
Systems
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Illustration of a Flexicon peristaltic pump head
Tube bridge
Pump head

• Stainless steel tube rollers with ball bearings.
  Long tube life and no maintenance
• Two tubes in parallel with rollers offset between
  the two tube tracks. This minimizes pulsations,
  which gives outstanding accuracies and very high
  output
• Soft and gentle handling of the tubes. - Higher
  accuracy over time
• Special tube track design to maximize the spring
  effect in the tubing
• Tube bridge with an individual force on both
  tubes. Higher accuracy

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Advantages of peristaltic filling

• Less cleaning validation
• No product contamination
• Very short change-over times
• Limited waste of expensive products
• High precision (eg. 0.5 on filling of 1 ml)
• Easy to adjust and calibrate
• Back-suction prevents after dripping
• Filling speed and acceleration can easily be
  adjusted when filling eg. foaming products or
  lyophilization products that is not allowed to
  splash during filling
• Very gentle to products containing living cells,
  eg. blood products

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Leak test prior to integration with isolator
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Format change
Work position of tool plate and vibrator bowls
Automatic lifting of vibrators and tool plate for
easy format change
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Points of access for operator through glove ports
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How to transfer vials into the FMB210ISO - La
Calhène design Example 1
Port for infeed of trays with vials
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How to transfer vials into the FMB210ISO - La
Calhène design Example 2
Transfer isolator
Docking station for transfer isolator
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How to transfer vials into the FMB210ISO
IsoTech design
Infeed for trays with vials
Container for transfer of stoppers and caps
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How to transfer vials out of the FMB210ISO La
Calhène Example 1
Transfer isolator to be docked onto the in-feed
or out-feed ports
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How to transfer vials out of the FMB210ISO La
Calhène design Example 2
Docking station
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How to transfer vials out of the FMB210ISO
IsoTech Design
Port for removal of filled trays
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Transfer of stoppers and caps
Autoclavable containerMade out of stainless
steel with vent filter for steam and vacuum. La
Calhène Design
DPTE-BetaBag A simple solution for sterile
transfer of various materials Applicable for
disposal of potent materials La Calhène design.
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Turbulent airflow in isolator
Source La Calhène
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Laminar airflow in isolator
Source La Calhène
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Examples of suppliers of isolator units to be
mounted on the FMB210ISO

• IsoTech Canada
• La Calhène France or USA
• SKAN AG Switzerland

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Prices

• FMB210ISO with one set of formats for one type of
  vial, stopper and cap cost ex. works approx.
  198,000 EURO
• Extra format parts for one extra vial 1,620 EURO
• Extra format parts for one extra stopper 9,900
  EURO
• Extra format parts for one extra cap 9,700 EURO
• IQ/QO cost approx. 12,000 16,000 EURO
• Isolator on top of FMB210ISO 140-350,000 EURO

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OEM peristaltic filling units
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OEM peristaltic filler unit for isolator purposes
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MC12 control unit
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Semi-automatic equipment inside isolator -
examples
FF30
MC12
PD12
This unit is from IsoTech Design and is called
IsoSphere AFTM
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Semi-automatic equipment inside isolator -
examples
FlexFeed 20
Bench Stopper
FlexSeal
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Sources of information on isolator technology

• www.isotechdesign.com
• www.lacalhene.com
• www.skan.ch
• www.walkerbarrier.com

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More information on FMB210ISO
Please contact Flexicon A/S Frejasvej 2-6 4100
Ringsted Denmark Phone [phone] Fax 45
57670541 flexicon_at_flexicon.dk