ISPE Technology Showcase

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New Technologies for Product Protection, Identifi
cation, Authentication and Anti - Counterfeiting

ISPE Technology Showcase 20 September, 2007

Bill Cairns bill_at_bcmgroup.net 973-766-2697
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• Traceability and
• anti-counterfeiting measures
• using laser marking
• on pharmaceutical glass

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Technology

• use standard glass
• on and below surface marking
• impossible to remove
• semi-covert

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Syringe marking

• Position on the barrel, on the flange
• Type visible, invisible
• Handling single-file, nested

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Vial marking

• Position on the neck, body bottom
• Type of code visible, invisible

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DataMatrix some data
12x12 up to 10 digits up to 6 alpha-numeric
Example Product 1234 Lot 123456 Expiration
date 01/01/2007S/N 123456
16x16 up to 24 numeric up to 16 alpha-numeric
Example 96-bit EPC Global 28 numeric
18x18 up to 36 numeric up to 25 alpha-numeric
Standard ECC 200 (ISO 16022) GS1 - AI
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Details on Syringe Marking
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Real code
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Business cases
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Case 1

• Product Vaccine, liquid
• Container Syringe
• Speed 600/min, in-line
• Type of coding invisible DM on the barrel
• Coding Product Lot
• Marking Before inspection
• Objective
• Avoid mix-up
• Long storage between filling and labelling
• Low cost per container

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Case 2

• Product Biotech, lyo
• Container Vial
• Speed 200/min, in-line
• Type of coding invisible DM on the barrel
• Coding Lot S/N
• Marking after filling
• Objective
• 100 reconciliation and accounting counterfeit
• Filling in one site and labelling in 4 overseas
  sites, with sub-contractors

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Case 3

• Product Biotech, liquid
• Container Syringe
• Speed 800/min, tub
• Type of coding visible DM on the flange
• Coding Lot
• Marking after filling
• Objective
• Product identification (20 products)
• Reliable solution, no ink jet

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Case 4

• Product Biotech, liquid
• Container Syringe
• Speed 200/min, in-line
• Type of coding invisible DM on the barrel
• Coding Product
• Marking after filling
• Objective
• Product identification (concentration)
• Anti-counterfeit
• Avoid mylar label

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Case 5

• Product Insulin
• Container Cartridge
• Speed 600/min, in-line
• Type of coding invisible DM on the barrel
• Coding Product Lot
• Marking after filling
• Objective
• Product identification
• Large volume, global low cost per container

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Case 6

• Product Biotech, lyo
• Container Vial
• Speed 300/min, in-line
• Type of coding visible DM on the neck
• Coding S/N
• Marking before washing
• Objective
• Anti-counterfeiting

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Case 7

• Product Pharma
• Container Ampoule
• Speed 400/min, in-line
• Type of coding visible DM on the bottom
• Coding Lot
• Marking after filling
• Objective
• avoid mix-up

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Compatible with

• freeze-drying
• sterilization
• humidity
• silicone
• water

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Performance

• Speed up to 600/min
• Reliable lt 10 ppm reject rate
• Capacity (typical)
• - 16x16 Datamatrix ( 24 digits)
• - 2x2 mm

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Rychiger AG

• Product Protection Utilizing Heat Sealing
  Technologies

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Automated High Integrity Sealing of Rigid
Containers

• Process approach of short dwell times, high
  pressure and low temperature, results in the
  highest seal integrity and easy peelability
• Rychigers innovative machine concepts take into
  consideration durable and completely tight
  sealing seams, and the highest demands in heat
  sealing technology for modern packaging designs.
• The all-integrated and modular machines concept
  combines the following process steps
• - De stacking of containers / trays
• - Transport through the machine
• - Filling technology for Food, Pet Food and
  Pharmaceutical products
• - Cutting Sealing technology

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Automatic Loading of Components into Cups for
Primary Packaging
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Atlantic Zeiser GmbH

• Late Stage Customization
• Camera Systems
• Hot Foil Stamping
• Database Management
• Ink Jet Inks
• Ink Jet Printing
• Laser Technology
• Magnetic Encoding
• RFID

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Opportunties for Automation - Late Stage
Customization

• SituationA cosmetic company has to manage more
  than 3000 package variants for lipstick and nail
  polish products
• GoalPrinting of variable high quality
  information only at the point of final packaging
• Benefit
• COST reduction through reduction to 40 package
  variants

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Examples of Late Stage Customization

• Item level content - specific identificationLot
  and expiration dateSpecial patient
  instructionsDose/concentration
• Special offers Marketing
• Anti counterfeit marking
• Small runs Rule of thumb 15 of the products
  have batch sizes, which are below economic
  threshold of modern packaging machines
• Country specific information

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What are the benefits of Automating Late Stage
Customization?

• Reduction in package cost for small order volumes
  
• Reduction of inventory investment
• Reduction in inventory storage area
• Fast change over
• Multiple feeding stations allow format change on
  the fly
• Lower administration cost
• Eliminates write-off cost for discontinued
  inventory
• Quick response lowers lead times
• Prevents potential lost opportunities to meet
  market demand
• Mo minimum order quantity penalty

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Financial Impact of late Stage Customization

• 25 million packages a year
• Savings by ordering larger volumes US0.01 per
  package
• US 268K savings only in purchasing
• US0.01 cent/package will be saved by admin,
  storage and handling cost
• Lost opportunity is soft factor, ( hard to
  calculate )
• TOTAL US 446K per year savings

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When you need to knownow
XT250 Technology Overview
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Protecting the Pharmaceutical Distribution Network

• Filling Checkpoint Gaps
• Our breakthrough XT250TM Material Identification
  System offers an end to end verification method
  to the pharmaceutical industry - from bulk
  supplier through manufacturer, distributor and on
  to the consumer.
• Revolutionizing Authentication Technology
• Our patented systems are based on Energy
  Dispersive X-Ray Diffraction (EDXRD), a highly
  penetrating, sensitive and accurate technology
  previously available only in expensive, high-end
  systems used by major research laboratories.
• Partnering to Take Detection to the Next Level
• XStream Systems, Inc. evolved after refinement
  and development of our technology in the
  nineties. Our vision provides solutions in
  anticipation of where they are needed most.

07/2007
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XT250 Material Identification System
Fast
Easy
Accurate
Compact
Affordable

• High performance lab results at a fraction
  of the cost.

Tests materials within minutes, while competitors
take hours.
Just load a sample, and hit START, its that easy.
Identifies material by its crystalline structure.
Fits almost anywhere.
24"
23"
40"

• X-ray diffraction made simple
• Beta field test starts Q4 2006
• First customer delivery in Q1 2007

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The Basics of X-ray Diffraction
X-ray diffraction is governed by Braggs Law,
which describes how X-rays are scattered (i.e.,
diffracted) when they interact with a crystalline
material having a periodic structure.
Substance Seen At Molecular Level
Diffraction Angle
X-Ray Source Of Wavelength ?
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d-spacing
Braggs Law n? 2dsin? n an integer ?
wavelength of X-ray d d-spacing of the
analyte (distance between symmetry planes) ?
X-ray diffraction angle
Sample
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Breakthrough Technology Completely Changes How
X-Ray Diffraction Is Done
With EDXRD, source detector are Fixed
1.) An X-ray beam is generated by an X-ray
source, 2.) A primary collimator is used to
control the beam, 3.) The beam passes through
the sample material, 4.) The beam is diffracted
when passed through the sample and a secondary
collimator allows a key portion of the beam to
hit an energy dispersive detector, 5.) A
Material Recognition Software Engine (MRSE) is
used to identify the unique fingerprint.
1. 2. 3. 4.
5.
07/2007
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Value Proposition - XT250 System Comes Out Ahead

Forensic Lab XStream Systems
XT250 Maximum samples per year
2,500 190,000 Analysis time (mins.)
per sample 150 2.5 Per sample cost
400 43 Total Annual
Cost 1M 80,000
07/2007
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Technology Features

• High Penetration The X-rays used in our
  products allow deep penetration, even through
  metals.
• High Speed The method used for gathering
  diffraction data allows rapid spectra
  generation.
• Scalability Our EDXRD technology is fully
  scalable, allowing miniaturization for handheld
  units and scaling up for parcel screening.
• Upgradeable Software New software applications
  are easily downloaded and installed.

• Automated Operation Our software gathers data
  and performs matching, so human interpretation of
  results is not necessary.
• No Sample Preparation Material samples can be
  processed without any preparation.
• Non-Destructive There is no harm done to the
  sample.

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The Teams flywheel value Services

• Strategic Vision and Consulting
• New Market Development Strategies and Execution
• Identification Introduction to Potential
  Customers Partners
• Brand Development Strategy
• Marketing Communications Programs
• Project Management
• Exploration of MA Opportunities
• Translation and Consultative Assistance in
  Meetings
• Introduction to Trusted Advisors and Business
  Service Providers
• Media Contact with Industry Publications
• Trade Show Exhibition Design Development
• Development of Special Events
• Design Development of PR, Brochures, Sales
  Materials Graphics
• IP Protection

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Thank You
New Strategies for New Markets