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Emerging Technologies in Plastic Packaging

Emerging Technologies in Plastic Packaging. 30 October 2006 - 10:00 - 11:00 . RFID: In what direction is the pharmaceutical industry headed and why. By: Craig K. Harmon, Q.E.D. Systems President & CEO. Craig K. Harmon • President & CEO Q.E.D. Systems http://www.autoid.org.

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Emerging Technologies in Plastic Packaging

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  1. Emerging Technologies in Plastic Packaging 30 October 2006 - 10:00 - 11:00 RFID: In what direction is the pharmaceutical industry headed and why By: Craig K. Harmon, Q.E.D. Systems President & CEO

  2. Craig K. Harmon • President & CEOQ.E.D. Systems http://www.autoid.org • Chair, ISO TC 122/104 JWG - Supply Chain Applications of RFID • Chair, RFID Experts Group (REG) • Chair, U.S. TAG to ISO/IEC JTC 1/SC 31/WG 4 “RFID” • Senior Project Editor ISO/IEC JTC 1/SC 31/WG (RFID) • Chair, ISO TC 122/WG 4 (Shipping Labels) & ISO TC 122/WG 7 (Product Packaging) • Vice-chair, ASC MH 10 and U.S. TAG to ISO TC 122 (Packaging) • Project Editor, ISO 18185-7 (Electronic Container Seal - Physical Layer) • AIAG Bar Code, Applications, 2D, Tire, Returnables, & RFID Committees • Member, EPCglobal HAG (UHFGen2), FMCG BAG, HLS BAG, SAG, TLS, TDS, AIWG, SBAC • JTC 1 Liaison Officer to the International Telecommunications Union (ITU-R & ITU-T) • Past Chair, ASC INCITS T6 (RFID) - ANS INCITS 256:1999, 2001 • ASC MH 10/SC 8 Liaison Universal Postal Union (UPU) Physical Encoding Group (PEG) • Advisor and Member of USPS Strategic Technology Council • ISO TC 104 & 122 (Freight Containers / Packaging) Liaison Officer to JTC 1/SC 31 • Chairman & Project Editor, ANS MH10.8.2 (Data Application Identifiers) • Vocabulary Rapporteur to ISO/IEC JTC 1/SC 31 • Project Editor, EIA Shipping Label, Product, Product Package, & Component Marking • Original Advisor, U.S. Department of Defense in Migration to Commercial Standards • Original Project Editor, NATO STANAG 2233 (RFID for NATO Asset Tracking) • CompTIA RFID Subject Matter Expert and RFID Certified Professional (CRCP) - RFID+ • Recipient of the 2004 Richard Dilling Award

  3. Abstract This session will examine the underlying reasons why the pharmaceutical industry is looking toward radio-frequency identification (RFID) for item level tagging. The attendee will learn of the differing needs between a pharmaceutical manufacturer and large mass merchandisers and why a solution from one may not necessarily serve the other. You will take a sneak peak into the deliberations of EPCglobal and ISO, each of whom are developing item level tagging solutions. Finally, you will have the opportunity to learn about the influence of RFID in packaging and the packaging recycling stream.

  4. International Standards

  5. Standards Organizations International Universal Postal Union (UPU) (United Nations) International Telecommunications Union (ITU) (United Nations) International Electrotechnical Commission (IEC) International Organization for Standardization (ISO) ISO/IEC Joint Technical Committee 1 (JTC 1) TC 122 Packaging SC 31 Automatic Data Capture ITU-T (fka CCITT) Telecommunications SC 17 IC Cards TC 104 Freight Containers WG 1 - Symbology WG 2 - Data Content ITU-R (fka CCIR & IFBR) Radio-frequency Issues TC 122/104 JWG SC Apps RFID SC 6 Telcom & info exchbtwn systems WG 3 - Conformance WG 4 - RFID ITU-D (fka BDT) Telecommunications Development TC 8 Ships & Marine Tech WG 5 - RTLS Regional Comité Européen Normalisation Electrotechnique (CENELEC) Comité Européen Postal & Telegraph (CEPT) Comité Européen Normalisation (CEN) ECMA ODETTE National British Standards Institution (BSI) Deutches Institut fur Normung (DIN) Standards Assoc of China (SAC) ANSI AFNOR JISC MHI GS 1 CEA IEEE INCITS AIM Other T6 B10 Industry ATA DoD CEA HIBCC GS 1 AIA Other VDA AIAG

  6. Types of Standards • Technology • Symbology, RFID, I.C. Card • Data Content • Semantics (DIs or AIs), Syntax • Conformance • Print Quality, Test Specifications, Conformance to Air Interface • Network • Object-to-object communications • Application Standards • Freight container, RTI, Ship Label, Product Package, Product Mark/Tag, eSeal

  7. ISO/IEC JTC 1/SC 31(Automatic Identification & Data Capture Techniques)

  8. ISO/IEC JTC 1/SC 31 (ADC) U.S. TAG TAG Administrator AIMUSA TG 4 RFID TG 4 RTLS TG 1 Data Carrier TG 2 Data Structure TG 3 Conformance Convener C. Harmon Convener S. Halliday Convener R. Schuessler Convener Convener F. Sharkey Air Interface API Code 39 DAI Linear Print Quality ITF Transfer Syntax 2450 MHz Data Syntax 2D Print Quality MaxiCode Data Objects License Plate Printing Specs Unique RF Tag ID Data Matrix Test Specs BC Printers Unique RF Tag ID EAN/U.P.C. Application Profiles Test Specs BC Readers Code 128 Test Specs BC Verifiers PDF417 RFID Performance RFID Conformance QR Code RFID Quality Symbology Identifiers RTLS Conformance

  9. ISO TC 122/104Joint Working Group (JWG)(Supply chain applications of RFID)

  10. The Layers of Logistic Units (Radio Frequency Identification - RFID) Layer 5 Movement Vehicle (truck, airplane, ship, train) Layer 4 (433 MHz)ISO 17363(Freight containers) Container (e.g., 40 foot Sea Container) Layer 3 (860-960 MHz)(Other 18000 with TPA) ISO 17364(Returnable transport items) Unit Load “Pallet” Unit Load “Pallet” Layer 2 (860-960 MHz)(Other 18000 with TPA) ISO 17365(Transport units) Transport Unit Transport Unit Transport Unit Transport Unit Layer 1 (860-960 MHz with TPA)(13.56 MHz with TPA)ISO 17366(Product packaging) Pkg Pkg Pkg Pkg Pkg Pkg Pkg Pkg Layer 0 (860-960 MHz with TPA)(13.56 MHz with TPA)ISO 17367(Product tagging) Item Item Item Item Item Item Item Item Item Item Item Item Item Item Item Item “TPA” - Trading Partner Agreement Concept Source: Akira Shibata, DENSO-Wave Corporation

  11. ISO TC 122/104 JWG project status • ISO 17363,Supply chain applications of RFID - Freight containers • FDIS balloting underway • ISO 17364,Supply chain applications of RFID - Returnable transport items • FDIS balloting underway • ISO 17365,Supply chain applications of RFID - Transport units • FDIS balloting underway • ISO 17366,Supply chain applications of RFID - Product packaging • 2nd DIS balloting underway • ISO 17367,Supply chain applications of RFID - Product tagging • 2nd DIS balloting underway

  12. Working Group (WG) 4RFID for Item Management ISO/IEC JTC 1/SC 31Automatic Identification and Data Capture Techniques

  13. Technical StandardsRadio Frequency Identification (RFID) • ISO/IEC JTC 1/SC 31/WG 4/SG 3 • RFID for Item Management Air Interface (ISO 18000) • ISO/IEC 18000-1 - Generic parameters - Air interface • ISO/IEC 18000-2 - Parameters for air interface below 135 kHz • ISO/IEC 18000-3 - Parameters for air interface at 13.56 MHz • includes Mode 1 (15693) and Mode 2 (PJM) • draft includes Mode 3 (13,56/ASK physical - Gen 2 logical) • ISO/IEC 18000-4 - Parameters for air interface at 2.45 GHz • ISO/IEC 18000-6 - Parameters for air interface at 860-960 MHz • includes Type A and B (INCITS 256) • includes Type C (EPCglobal Gen2) • draft includes battery-assist (PowerPaper and Intelleflex) • ISO/IEC 18000-7 - Parameters for active air interface at 433.92 MHz

  14. Terms & Definitions • ISO/IEC 19762-1, Information Technology, Automatic identification and data capture (AIDC) techniques — Harmonized vocabulary — Part 1: General terms relating to AIDC • ISO/IEC 19762-2, Information Technology, Automatic Identification and data capture (AIDC) techniques — Harmonized Vocabulary — Part 2: Optically readable media (ORM) • ISO/IEC 19762-3, Information technology, Automatic identification and data capture (AIDC) techniques — Harmonized vocabulary — Part 3: Radio frequency identification (RFID) • ISO/IEC 19762-4, Information technology, Automatic identification and data capture (AIDC) techniques — Harmonized vocabulary — Part 4: General terms relating to radio communications • ISO/IEC 19762-5, Information technology, Automatic identification and data capture (AIDC) techniques — Harmonized vocabulary — Part 5: Locating systems

  15. SC 31/WG 4 (RFID) Technology Projects http://www.autoid.org/standards/StandardsSummary_20060924.htm

  16. RFID Experts Group (REG)

  17. AIM Global RFID Experts Group (REG) Guidelines • WG 5-I: Interrogator System Implementation & Operations • WG 5-B: Back-up • WG 5-L: Enabled Labels & Packaging • WG 5-R: Recyclability • WG 5-Q: Tag Quality • WG 5-E: Education & Certification • WG 5-G: Global Operation (Regulatory Database) • WG 5-P: Privacy (Public Policy) • WG 5-F: Safety (Public Policy) • WG 5-C: Security (Public Policy) • WG 5-T: Sensors and Transducers • WG 5-S: Technology Selection • WG 5-M: Software & Middleware • AIM Global RFID Emblem

  18. REG Chapters • AIM Global - Coordinator • JAISA - Japan • AIM Global EMEA - Europe, Middle East, & Africa • KARUS - Korea

  19. ISO/IEC Implementation TRsto SC 31/WG 4/SG 5 • ISO/IEC 24729-1,Information technology — Radio frequency identification for item management — Implementation guidelines – Part 1: RFID-enabled labels and packaging Source: REG WG 5-L & 5-B • ISO/IEC 24729-2,Information technology — Radio frequency identification for item management — Implementation guidelines – Part 2: Recyclability of RF tags Source: REG WG 5-R • ISO/IEC 24729-3,Information technology — Radio frequency identification for item management — Implementation guidelines – Part 3: RFID interrogator/antenna installation Source: REG WG 5-I

  20. ISO/IEC RFID Tag Quality • ISO/IEC xxxxx-1,Information technology — Radio frequency identification for item management — Conformance – Part 1: Qualification of Design and Manufacture for RFID Source: REG WG 5-Q • ISO/IEC xxxxx-2,Information technology — Radio frequency identification for item management — Conformance – Part 2: Verification of RFID tag quality Source: REG WG 5-Q

  21. REG/ISO Quality References ISO 17363— Supply chain applications of RFID — Product tagging, Annex A: Proposed guidelines for the verification and qualification of design and manufacture for RFID chips and transponders for tires • To be proposed to ISO/IEC JTC 1/SC 3/WG 3/SG 1 for new RFID tag quality standard

  22. EPCglobal

  23. EPCglobal Board Software Action Group (SAG) Hardware Action Group (HAG) Fast-Moving Consumer Goods (FMCG BAG)RSC Healthcare Life Sciences (HLS BAG) Transportation and Logistic Services (TLS BAG) Business Steering Committee Technical Steering Committee GS1 GS1 US EPCglobal President Architectural Review Committee (ARC) Staff EPCglobal Structure

  24. Pilot and Implementation Woking Group Healthcare Life Sciences (HLS BAG) HLS BAG Information WG HLS BAG Medical Devices WG HLS BAG Strategy WG Fast-Moving Consumer Goods (FMCG BAG)RSC Reusable Transport Items Working Group Sub Group A API, Data Sync, and Data Validation Sub Group C Data Ownership, Security, and Retention Sub Group B Numbering System and Assignment Transportation and Logistic Services (TLS BAG) 4 Walls Working Group Import/Export Clearance Working Group Integration Working Group Transportation Working Group EPCglobal Business Action Groups

  25. Item Level Tagging Joint Requirements Group (ILTJRG) EPCglobal Hardware Action Group (HAG) Testing and Certification Working Group UHF Generation 2 Protocol Maintenance UHF Class 2 Class 0 Working Group Class 1 Working Group UHF Air Interface Working Group Tag, Label, Reader, and Printer Performance WG HF Air Interface Working Group Sensor & Battery-Assist Passive Tag Joint Requirements Group (SBAPTJRG) Product Data Protection Ad Hoc Health & Science Ad Hoc EPCglobal Hardware Action Group ISO/IEC 18000-6c ISO/IEC 18000-3m3

  26. EPCglobal Software Action Group (SAG) Reader Operations WG Reader Protocol WG Reader Management WG Tag Data & Translation Standard WG Security 2 WG EPCIS Phase 2 WG ONS WG Drug Pedigree Messaging WG Filtering and Collection WG EPCglobal Software Action Group ISO/IEC 24752Part 6 Security ISO/IEC 24752Part 5 DeviceInterface ISO/IEC 24752Part 3 DeviceMgmnt ISO/IEC 24752Part 2 DataMgmnt ISO/IEC15962+ ISO/IEC 24752Part 4 Applica-tionInterface ITU-T NRFID

  27. EPCglobal Industry Specifications

  28. EPCglobal Industry Specifications 94 Groups (as of 2006-09-24) 63 Groups requiring participation

  29. New EPCglobal Activities of Interest • UHF Air Interface Working Group • HF Air Interface Working Group • Item Level Tagging JRG, Phase 2 • Tag Data JRG • Active Tagging JRG • Sensors and Battery-Assist JRG

  30. Joint Requirements Groups Retail Supply Chain FMCG/ AFF WG WG WG WG Reusable Transport Items Item Level Tagging Active Tagging Tag Data HLS ??? TLS SAG HAG Product Data Protection Sensors & Batteries WG WG WG WG WG WG WG WG WG WG Data Exchange WG WG WG WG WG WG WG WG WG WG Industry Action Groups Proposed Structure No Opt-In/ IP Joint Working Groups Opt-In/ IP No Opt-In/ IP Pilot & Implementation Technical Action Groups Adoption Programmes Opt-In/ IP

  31. Document Exchange 26 September 2006 - SC 31/WG 4 Meeting - Graz, AT

  32. Liaison management • Set up a committee tasked to monitor the work programme and collaboration opportunities between EPCglobal and SC31 • Would comprise the • EPCglobal President • EPCglobal Standards Director • EPCglobal Technical Steering Committee • EPCglobal Legal Counsel • The two liaison representatives (to and from ISO) • The chairpersons / project editors of the relevant ISO groups • + + + 26 September 2006 - SC 31/WG 4 Meeting - Graz, AT

  33. PharmaceuticalIndustry

  34. The HypeCycle Peak of Inflated Expectations Visibility Plateau of Productivity RFID Today! Slope of Enlightenment Source: Jackie Fenn, Gartner Group Trough of Disillusionment Technology Trigger Time

  35. Pharmaceutical Industry • To minimize counterfeiting a secure chain of custody is required • Technology by itself does not solve the problem. Trading partners must know who, what, when, why, which, where and how • Who shipped/received the product • What product type was shipped/received • When was the product shipped/received • Under which release order was the product shipped/received (Why) • Which specific license plates were shipped/received • From/to where were products shipped/received • Via whichconveyance were products shipped/received (How)

  36. Pharmaceutical Industry • RFID has a feature to enable ePedigree WITH a secure chain of custody • Unique Item Identification - UII (serial number) programmed by the pharmaceutical manufacturer • Unique Tag ID (TID) programmed AND LOCKED by the semiconductor manufacturer • It would be possible to replicate the UII but not both the UII and TID

  37. Pharmaceutical Industry • Issues with UHF (860 - 960 MHz) • Tag transmission is detuned around liquids • Liquids (large molecule and biologics) absorb UHF signal • UHF absorption may elevate the temperature of the liquid • Near-field UHF transmission also includes far-field radio waves, currently limited by several national regulations

  38. Pharmaceutical Industry • Issues of HF (13.56 MHz) • Tag transmission is detuned less around liquids • Liquids (large molecule and biologics) do not absorb HF signal • No elevation of temperature

  39. Pharma Scenarios

  40. EPCglobal HF Air Interface WG • Two alternatives proposed • Modification of 18000, Part 3, Mode 2 • Supported by Magellan, Infineon, EM Micro, Zebra, & HighTech Aid • High speed • Modification of 18000, Part 3, Mode 1 • Referred to as 18000, Part 3, Mode 3 • 13.56 MHz physical layer / Gen 2 (18000-6C) logical layer • Same memory layout as Gen 2 (18000-6C) • High speed / high volume of tags in field of view • Supported by NXP (Philips), Texas Instruments, ST Micro, Impinj, TagSys, FEIG, SkyeTek, Sirit, & Q.E.D. Systems

  41. EPCglobal HF Air Interface WG • Decision • Implement tag data structure of UHF Gen 2 • Implement UHF Gen 2 logical layer • Recommend ISO/IEC 18000, Part 3, Mode 3 (13.56/ASK) • Provide an updated 18000, Part 3, Mode 2 (13.56/PJM) as an optional air interface (not required) • Coordinate with UHF AI WG for 4 new features • Bit 15 - Indication of existence and data in user memory (XOR) • Bit 16 - XPC - Extended PC bits (XOR) • Block permalock • Tag re-commissioning

  42. Recycling

  43. Recycling - ISO/IEC 24729-2 • Using RFID to Improve the Environment • Waste Electrical and Electronic Equipment Directive in the European Union (WEEE) • End of Life Vehicle (ELV) in the European Union • Home Electronics Recycling Law (HERL) in Japan • Extended Producer Responsibility Program (EPRP) in Korea • Would require an “non-killed” field that identifies the recycle stream • A data element in the publicly available central data base that identifies the recycle stream

  44. Recycling - ISO/IEC 24729-2Passive tag constituent parts

  45. Recycling - ISO/IEC 24729-2Active tag constituent parts

  46. Recycling - ISO/IEC 24729-2Waste Streams Considered

  47. Recycling Process - PE • Bales straps are cut • Bales are broken up, usually in rotating trommels (near horizontal drums 6 ft x 10 ft x 20 ft with 1” diameter holes to allow caps and trash to fall out) • Bottles are examined by human or machine inspection. Errant bottles and other mistakes taken out. • Bottles pass by magnets to remove ferrous contamination • Bottle ground to ¼” chips. Most grinding is done dry. • An air elutriation is done to blow away light trash from the heavier bottle flakes. (some RF tags on labels will be removed here) • Flake is washed at 120 - 170°F in water with pH of 8 to 11 with surfactants and high agitation. • Constant circulation of wash water removes pulped paper and other materials that have similar specific gravities. • Washed flake is placed in a sink/float tank to allow heavy trash to sink and HDPE product to float • If RFID is separated from label, it should sink • If RFID is part of label still, the label piece may sink or not • Washed HDPE flake is skimmed off, dried and elutriated again to remove any light trash fraction liberated during washing. • HDPE flake is melt filtered against nominal 100 mesh screens and pelletized. • RF tags not made of conductive silver paint should be trapped on the screens along with other insoluble trash.

  48. Recycling Issues - PE Overall, the RFID would seem to either separate in the elutriation, sink/float, or melt filtering. The silver particles would likely sink. If silver particles did survive the process with the HDPE, the effect on HDPE product for molding and thick extrusions (not bags) would appear minimal.

  49. Recycling Process - PET • Bales straps are cut • Bales are broken up, usually in rotating trommels (near horizontal drums 6 ft x 10 ft x 20 ft with 1” diameter holes to allow caps and trash to fall out) • Bottles are examined by human or machine inspection. Errant bottles and other mistakes taken out. • Bottles pass by magnets to remove ferrous contamination • Bottle ground to ¼” chips. Most grinding is done dry. Some reclaimers pre-wash bottles and grind wet. • An air elutriation is done to blow away light trash from the heavier bottle flakes. (some RF tags on labels will be removed here) • Flake is washed at 180°F in water with pH of 11 to 12 with surfactants and high agitation. • Constant circulation of wash water removes pulped paper and other materials that have similar specific gravities. • Washed flake is placed in a sink/float tank to allow polyolefins to float as PET, and other materials with specific gravities greater than 1.0 to sink. • If RFID is separated from label, it should sink with the PET • If RFID is part of label still, the label piece may sink or not • Washed PET flake is augured from the bottom of the tank, dried, and elutriated again to remove any light trash fraction liberated during washing. • Some reclaimers may run flake through a Carpco aluminum separator to remove pieces of aluminum bottle closures. • Many reclaimers will pass flakes through a flake sorter (Satake is one manufacturer) to remove discolored flake and particles that do not appear as PET. • Some reclaimers may add a caustic roasting to etch the surface of the PET flakes

  50. Recycling Issues - PET • RPET for fiber: Fiber makers will use the flake as feed and dry in desiccant dryers, melt, and filter as fibers are made. • RPET for strapping: Strapping makers will raise the molecular weight by solid state polymerization of either melt-filtered pellets or of just the flake. • RPET for bottles and sheet: RPET must be clear. Reclaimers often raise the molecular weight by solid state polymerization of either melt-filtered pellets or of just the flake. Overall, RF tags appear to be more problematic for PET reclaimers because of fewer current exit points from the process and perhaps greater negative effect for retained material. The RFID would leave as part of a label or be melt filtered. If silver particles are used, the particles may follow the PET and become incorporated in the PET. We do not know if the silver, after the caustic treatment, may be catalytic or if it would cause unwanted crystallization or if it would cause problems with food contact acceptability. If the silver is present at 15 mg/tag and bottles weigh 30 grams (actual weights are 15 to 80 grams) and 1/3 of the tags are removed before the silver binder dissolves, the silver content could be 166 ppm if every bottle had a tag. As PET catalysts are usually present at 5 to 200 ppm, the silver could be present at a significant level and so is worthy of closer examination and problem avoidance.

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