Building Radio frequency IDentification solutions for the Global Environment

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Building Radio frequency IDentification
solutionsfor the Global Environment

• BRIDGE - Pharma Traceability Pilot
• Project Overview

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Outline

• About the BRIDGE project
• Outline of the Pharma Traceability Pilot
• Pilot Objectives
• The Project Partners
• Major Achievements Deliverables
• Lessons learned and experiences gained
• Conclusions and recommendations
• Summary

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BRIDGEBuilding Radio frequency IDentification
solutionsfor the Global Environment

• a project funded by the European Union

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The BRIDGE Project

• The objective is to do the necessary research and
  actions to facilitate the implementation of
  EPCglobal in Europe. The project will link pilot
  implementations in various sectors with Research
  and Development.

Pharma traceability
SC mgt textiles
Manufacturing process
Re-usable assets
Products in service
Tagging non-food items
anti counterfeiting
B R I D G E
hardware
lookup service
supply chain control
security
training e-learning
adoption tools
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BRIDGE PartnersNote WP6 Partners shown in bold

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The Pharma Traceability PilotOutline of the
Pilot
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What are the key issues?

• Medication errors
• Mis-identification of medicines
• Harm and death to patients
• The growing and imminent threat of counterfeit
  medicines
• for branded and generic products
• Significant threats to
• Patient safety
• Trust in safety of medicines
• Supply chain inefficiency
• Lack of automation
• too much administrative overhead
• Multi-application requirement

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Pharma Traceability Pilot end to end
traceability

• Full supply chain traceability
• From point of manufacture to point of use
• i.e. From the manufacturers production line to
  hospital Goods In
• Mass serialisation - track and trace to the item
  (patient pack) level
• Product code serial number (SGTIN), batch
  number, expiry date (4 string dataset)
• Case and Pallet uniquely identified
• Data aggregation pack to case to pallet
• Product and trading partner authentication at
  each node in the chain
• Transparency and common standards are key
• Distributed database (the EPC Network
  architecture) as the information repository
• Data carrier independent
• A common dataset across data carriers
• Mix of linear, 2-D Data Matrix and RFID/EPC tags
• For all levels of packaging (patient pack, case,
  pallet)

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High level objectives

• Implement a complete supply chain traceability
  system for pharma products in a real life
  operational environment
• Inline coding, marking, QA for all levels of
  product packaging
• Multi-application support capability e.g.
• Electronic pedigree, Product authentication,
  Recall, Inventory management, Financial
  reconciliation
• Demonstrate a business case and feasibility, cost
  efficiency, and interoperability of the
  technology suite, regardless of
• Pharma product packaging level and and product
  type
• Serialised data tag (RFID and/or Data Matrix
  code)
• Full supply chain representation
• Compliant with open standards (GS1)
• Speed to result (24 month timeframe)
• Easy to use, robust system
• Project transparency open to all

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Pharma Traceability Pilote-Traceability
enabling multiple applications
Distributor
Wholesaler
3PL
Contract Packer
Carrier
Traceability kernel
Manufacturer
Hospital Pharmacy
Application interface
Inventorymanagement
Application environment
Authentication
Electronic Pedigree(anti-counterfeit)
Recall
Financial reconciliation
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PRIMARY
SECONDARY
TERTIARY
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AUTHENTICATION
MANUFACTURING
DISTRIBUTION
LOGISITICS
PHARMACY
IDENTIFICATION
information collection via
SYNCHRONISATION
INFORMATIONANALYSIS SUBSCRIPTION
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Access to the EPCglobal service collecting
traceability data

• Each user had a hardware/software standalone
  system that provided easy (internet-based)
  access to the EPCglobal system
• EPCIS instances provided and hosted by VeriSign
  Inc.
• Incoming and outgoing products scanned/read by
  appropriate equipment thereby collecting the
  traceability data
• Fixed and mobile scanning technology
• Easy to use screen-based systems

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Pharma Traceability Pilot participantssolution
and technology suppliers
Provision and deployment of the inline equipment
and printing solution
Provision of standards and RFID consultancy
Project management, business consulting
marketing
Technical design and software development
EPCIS database provision
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Our User Community

• Manufacturers
• Actavis (UK)
• Athlone Laboratories (Ireland)
• Sandoz (UK)
• Contract packer
• Tjoapack (The Netherlands)
• Pre-wholesaler
• CPG Logistics (UK)
• Distributor/Storage
• Actavis (UK)
• Kent Pharmaceuticals (UK)
• Transport Logistics
• Movianto (integrated) and others
• Wholesaler
• UniChem (UK)
• Hospital
• Barts and The London NHS Trust (UK)

KENT
Pharmaceuticals
Our sincere thanks to them all!
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Pharma Traceability PilotAchievements and
Deliverables
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Major Achievements (1)

• Nine supply chain end users recruited
• Across Ireland, Netherlands and UK
• 19 product lines selected
• one years pharmacy stock ordered and manufactured
• Different packs and forms, includes 2 controlled
  drugs
• Production line encoding/printing equipment
  specified, acquired, configured and installed at
  Contract Packer and one Manufacturer
• Application software specified, developed and
  QAd
• 4 modules manufacturers, distributors,
  wholesaler pharmacy
• User briefings, interviews (e.g. Business Case
  input), internal process flow analysis, supply
  chain model - all completed and agreed

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Major Achievements (2)

• Audio Visual of the pilot experiences (user
  interviews, processes) commissioned and filming
  undertaken
• Extensive publicity / promotion achieved (e.g.
  media conference platforms) network of
  interested parties established (over 130
  organisations)
• Pilot preparations procedures, processes, IT
  equipment provision all completed
• Product runs of marking/encoding completed 15
  product lines distributed downstream to UniChem
• 17 product lines successfully encoded on the line
• Preparations for the pilot operation undertaken
  training, documentation, support processes
• Operational pilot commenced October 2007
  completed end May 2008
• Including order/replenishment process, Barts /
  UniChem
• Considerable traceability data collected (inc GPS
  based)
• Full analysis undertaken

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Pilot Products 19 lines
Product Form Pack   Aqueous Cream
500mg Tubs 1 Warfarin 1/3/5mg Tabs 28 Clind
amycin 150mg Caps 24 Dihydrocodeine
30mg Tabs 28 Prednisilone E/C
5mg Tabs 28 Co-Codamol 8/500mg Tabs 30 Fluc
loxacillin 250 / 500mg Caps 28 Penicillin V
250mg abs 28 Amoxicillin 125 /
250mg Susp/Sugar Free 100ml Amoxicillin 250 /
500mg Caps 21 Penicillin 125 / 250 mg
Susp/Sugar Free 100ml Flucloxac
illin 125 / 250mg Susp 100ml
controlled substances
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Promotion and Publicity

• Contact Database now over 130 organisations
• Project has been presented in many conferences /
  meetings all around Europe e.g. Helsinki,
  Amsterdam, Brussels, Dublin, London, Dusseldorf,
  Cambridge, Cork
• Significant interest from media
• Latest Irish Times, RFID Journals of US and
  Spain
• Regular update newsletters distributed to over
  130 organisations globally
• WP13 animated story board developed
• AV based case study produced
• the process, action shots, user interviews

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WP6 Deliverables (1)

• Key conclusions
• Improving patient safety is the No. 1 priority
  for all players
• Medication error is one of the most significant
  hazards
• Counterfeit threat exacerbates the risk
• Supply chain inefficiency creates significant
  overheads
• End to end traceability supported by Bar Code and
  RFID technologiesoffers significant benefits for
  not only patient safety but multiple other
  applications

See http//www.bridge-project.eu/index.php/Publ
ic20Deliverables/en/
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WP6 Deliverables (2)

• Key conclusions
• Track and trace is the critical element
• Mass serialisation needed to trace to item level
• Industry supported carriers e.g. Data Matrix, as
  well as RFID at higher levels of packaging
• Product code, serial number, expiry date and
  batch number data elements
• Use of GS1 standard keys adds to completeness of
  traceability system
• EPC Network offers information access and
  visibility for all parties
• Requirement is broader than just pedigree
  financial reconciliation, inventory management,
  product recall, authentication are all key, all
  enabled by the traceability application.

See http//www.bridge-project.eu/index.php/Publ
ic20Deliverables/en/
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WP6 Deliverables (3)

• Key conclusions
• Patient safety is the most significant benefit
  for all parties- but how can one value peoples
  lives in a financial model?
• Mass serialisation and the granularity it
  provides strengthens the Business Case
• Financial benefits of cost reduction, efficiency
  gains, opportunities for additional revenue and
  cash generation ability to respond faster to
  regulatory changes
• Level of benefits depends upon supply chain role
  and extent of integrationwith internal and
  supply chain systems

See http//www.bridge-project.eu/index.php/Publ
ic20Deliverables/en/
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WP6 Deliverables (4)

• Key conclusions
• Hardware solution outline - EPCglobal Network,
  coding and tagging by laser and inline inkjet
  printing, Class 1 Gen 2 UHF tags, Data Matrix
  codes, various inline data verification
  equipment,
• Software solution - web based software
  manufacturer, distributor, wholesaler, pharmacy
  modules
• GPS tracking system for additional pallet level
  security
• User pilot process defined, installation and user
  training
• Pilot product processes defined
• Performance and evaluation processes
• Pilot operations
• Promotion and publicity plans

See http//www.bridge-project.eu/index.php/Publ
ic20Deliverables/en/
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WP6 Deliverables (5)

• Key conclusions
• Pilot Operation Phase
• - all development, installation training
  completed
• - 17 of the 19 products successfully encoded /
  marked
• all products shipped tracked (inc GPS) to
  UniChem (by early 2008)
• order/replenishment cycle (Barts to UniChem)
  completed end May
• all RFID data matrix traceability data
  collected (for analysis, ongoing)
• traceability system operated satisfactorily
• all key activities filmed for promotional AV
  (for Dissemination phase)
• work commenced to establish Centre of Excellence
  (in The Netherlands)
• based on Bridge experience

See http//www.bridge-project.eu/index.php/Publ
ic20Deliverables/en/
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WP6 Deliverables (6)

• Key conclusions
• Full supply chain traceability, end to end, is
  feasible with technologies available today
• Inline printing and marking of products at all
  levels of packaging is possible now at production
  line speeds
• Hybrid data carriers Data Matrix RFID,
  supporting 4 element data string and data
  collected via EPCIS architecture, supported by
  GS1 Standards, operates most effectively
• Positive Business Case regardless of supply chain
  function although the degree varies
• Multi-application support, including encoding of
  batch number and expiry date, broadens
  attractiveness of the business case
• Wholesaler automation of high-speed tote assembly
  process for traceability recording requires
  further investigation
• Consideration necessary when designing packaging
  for appropriate placement of Data Matrix codes

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WP6 Deliverables (7)

• Key conclusions
• IN DEVELOPMENT NOW

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Supply Chain Modelthe manufacturing and storage
cycle
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Supply chain mapcustomer delivery cycle
Manufacturing Distribution, Storage
Wholesaling
Customer
1. Repeat orders
1. Repeat orders (small batches)
UniChem
Manufacturing Storage flow
Barts London NHS Trust
2. Daily deliveries
Repeat invoices
Physical Goods Flow
Document flow
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Overall process flow manufacturing (creating
stock)
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Overall process flow finished product to
pharmacy
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System Workflow at Tjoapack
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Conclusions Recommendations (1)

• Supply chain wide traceability totally feasible
  with
• Good planning resourcing
• User commitment (senior level) and prioritisation
• Easy to use, intuitive, robust user systems
• Robust processes, tightly managed
• Clear policy on integration with in-house systems
• Good user training for all operatives involved
• Full trading partner collaboration
  communication
• However, business drivers/motivations different
  for different supply chain partners
  Government/Regulator regulation would help!!
• Accordingly, In / Out data model might be a
  good place to start
• Business Case varies according to supply chain
  role function
• Clear patient safety benefits all parties buy-
  in to that
• Electronic chain of custody (electronic pedigree)
  as counterfeit combatant
• Recall Efficiency check-in efficiencies at the
  back door inventory management
• financial reconciliation, recall systems are
  all integration dependent

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Conclusions Recommendations (2)

• Integration of traceability data into back office
  systems is key
• For inventory management, exploiting batch
  expiry date data
• For financial reconciliation order/goods
  received/invoice
• For product recall
• For traceability purposes product locations,
  sales made, consumption
• But integration will require investment
  (considerable?)
• But will vary from partner to partner
• More research needed to determine precision of
  costs/benefit case
• Focus on the traceability data, not the carrier
• Data Matrix / RFID operates effectively in hybrid
  environment generally provided good quality
  reads

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Conclusions Recommendations (3)

• Inline production equipment installation is a
  complex, precise and resource intensive
  operation
• Product packaging
• must accommodate space for codes at time of
  design
• colours must offer contrast for good reading
• Pack handling is critical
• Line configuration/equipment installation must
  allow firm base for encoding to avoid product
  wobble or other vibration
• Presentation of pack to the printing device must
  be consistent incorrect shape and form can
  create poor quality printing/verification but
  get it right, very high print speeds can be
  achieved
• Industry should get together and develop
  packaging standards
• Related to pack handling printing
• The case label
• Beware unplanned pallet consolidation (for cost
  reduction)
• Beware damage to Case Labels (e.g. by fork lift)

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Conclusions Recommendations (4)

• EPCglobal architecture (VeriSign) operated well
  for information gathering
• But response issues for on-line product
  verification
• EPCglobal standards should be reviewed to address
  this requirement
• For the wholesaler, automating the A Frame
  (Automat) for high speed Tote box assembly is
  critical
• Currently a road block for the wholesaler
• More research needed here to determine technology
  needs

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Plan for final months of the project

• Completion of remaining deliverables
• Delivery of the Dissemination Report (Q2 2009)
• Continuing and increasing focus on
  information/experiences dissemination
• Global audience
• Publication of the Audio Visual
• Preparation of articles, public presentation,
  case studies
• Distribution of collateral
• European conference platforms
• Workshops and seminars
• Website
• Including Partner distribution channels

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In Summary

• The Pilot has been successful and met pre-set
  objectives
• It has provided a very positive learning and
  proving environment
• Huge amount of data collected for analysis
• Invaluable hands-on knowledge and experience
  gained
• Solid platform for future mass serialisation and
  traceability systems for Europe
• Experiences and information gained will be
  available to all
• see www.bridgewp6.eu/

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BRIDGE WP6Thank You for taking the time to view
this presentation. For more information
including contact details of the Technology
Partners involved please see www.bridgewp6.eu