Serialization a global approach Emanuele Tellaroli Key Account Manager ANTARES VISION Beirut 02 June 2016
Serialization concept THE SMALLEST ITEM PUT ON SALE (selling unit) IS IDENTIFIED BY THE COMBINATION OF AN IDENTIFIER AND A UNIQUE SERIAL NUMBER INFORMATION IS BOTH IN HUMAN READABLE CODE AND ENCODED IN A CARRIER (1D code -2D code-rf-id) CONTROL IS AT THE ORIGIN POINT (Pharmaceutical Companies) AND AT THE DISPENSING POINT (Pharmacy, Hospital) THROUGH A NATIONAL DATABASE
Serialization concept Serialization at different levels carton bundle case EACH DEFINED UNIT LEVEL IS IDENTIFIED BY A UNIQUE COMBINATION OF AN IDENTIFIER AND A SERIAL NUMBER CONTROL IS LIMITED TO EACH ITEM AT EACH STEP pallet
Aggregation concept From carton to pallet: building the parent child relationship carton bundle case pallet EACH UNIT LEVEL HAS A UNIQUE COMBINATION of SERIAL NUMBER and IDENTIFIER SERIAL NUMBERS OF UNITS ARE BEARING A PARENT-TO-CHILD RELATIONSHIP CONTROL IS THROUGHOUT THE WHOLE CHAIN, FROM MANUFACTURE TO DISPENSING
Regulatory overview - Europe EU Serialization, Aggregation, Integrity, Reporting Ukraine Serialization Slovenia Coding Turkey Serbia Phase 1 & 2 completed: Unit track level, reporting Serialization (stickers) Russia Unit level tracking Group 1 Unit level tracking Group 2 Unit level tracking Group 3 Greece Belgium Serialization (stickers) Expected to maintain stickers Italy Bollino (Law update expected) Serialization, reporting (stickers, 2D datamatrix) Deadline for deployment France Denmark Coding up to 2014 2015 2016 2017 2018 2019 2023 Status: Q4 2015 With different requirements and across independent time frames, legislators worldwide are defining their own rules for pharmaceutical Track & Trace.
Regulatory overview North & South America Mexico Serialization, Reporting (expected) Colombia Proposal: Serialization, Tracking Chile Phase 2: Coding, Lot tracking Costa Rica Serialization, Reporting Argentina USA Canada Unit level tracking, Reporting Coding Brazil Lot tracking, Verification Updates positive list Step wise implementation Unit level tracking, Reporting Pilot 3 lots Step wise Supply chain mobilization Unit level tracking, Reporting Full rollut Coding Serialization, Reporting Adapt US FDA guidelines expected Serialization, Aggregation, Reporting Unit level tracking up to 2014 2015 2016 2017 2018 2019 2023 Status: Q4 2015 With different requirements and across independent time frames, legislators worldwide are defining their own rules for pharmaceutical Track & Trace.
Regulatory overview - Asia Taiwan Coding Serialization, Reporting Japan Coding Australia Coding Serialization, NBA products only Serialization, all products Expected 2-5 yrs after NBA Philippines Singapore Coding South Korea Coding Serialization Serialization, Reporting Unit level tracking, Reporting China EDL 2009/2012 PEDL updates Unit level tracking, reporting India Serialization, Coding Import / Export Unit level tracking Primary level up to 2014 2015 2016 2017 2018 2019 2023 Status: Q4 2015 With different requirements and across independent time frames, legislators worldwide are defining their own rules for pharmaceutical Track & Trace.
Regulatory overview Middle East and Africa Algeria Serialization, expected Cameroon Libya Serialization Serialization Expected no deadline Jordan Coding Serialization S. Africa Unknown requirements Egypt Coding Saudi Arabia Coding Serialization Iran Serialization Nigeria MAS Serialization up to 2014 2015 2016 2017 2018 2019 2023 Status: Q4 2015 With different requirements and across independent time frames, legislators worldwide are defining their own rules for pharmaceutical Track & Trace.
EU-FMD Delegated Acts released: February 2016 Deadline for compliance: February 2019 EU member states EEA: Norway,Iceland,Liechtenstein + Switzerland Italy, Belgium, Greece: 6-year deadline extension GTIN-Batch-Exp-S/N-(RN) ANTI-TAMPER measures (glue, seals) Aggregation is mentioned but not mandatory Positive notes on coding constraints
Why Track&Trace? 10
Track & Trace across the supply chain MANUFACTURER WHOLESALER RETAILER PHARMACY HOSPITAL PATIENT Serialization is a part of the Track & Trace process, aiming at controlling the location of an item across time and space within the supply chain. EU-FMD Falsified Medicines Directive and DSCSA drug supply chain security act - require only controls at the item level and at the point of dispense. But..
Aggregation in Track & Trace Builds parent/child relation among all logistic unit based on hierarchy of serial numbers Allows the monitoring of the complete product flow Adds value to the supply chain management Not currently required by EU-FMD and DSCSA (USA)
Pharma companies: The impact of traceability Processes are to be modified Physical space needs to be found in the lines OEE - Overall Equipment Effectiveness - of the lines will be impacted New responsibilities are showing up Down-time needs to be made available for installations IT infrastructure is impacted (serialization servers - communication with regulatory agencies) Investment becomes important particularly with aggregation on automated lines Team work is essential for the choice of the partner and of the solution: Engineering, Production, IT, Maintenance, QA 13
Traceability issues - good side effects Renewal: Oftentimes the need to alter the physical layout of the line is the occasion for the renewal of obsolete/old peripherals that would otherwise have continued to other operate and impair line efficiency (e.g. embossing in cartoning machines and mechanically set prints, oftentimes not controlled) Lower costs of consumables: It has been calculated that when new TIJ2.5 Thermal inkjet systems, belonging to Track&Trace solutions, replace obsolete/old printing devices (like, for example, hot stamp printing systems), the cost of servicing and the cost of consumables decreases Flexibility: The new printing and verification systems system allow for high flexibility and can manage markings of different kinds and responding to different needs (internal market, export to countries with or without a T&T legislation) 15
T&T Viable print technologies - cartons TIJ 2.5 Thermal Inkjet LASER PRINTING SYSTEMS TIJ2.5 LASER DOD Print accuracy GOOD GOOD BEST Space occupation GOOD POOR POOR Linear Speed GOOD POOR GOOD Printing on varnished carton FAIR GOOD (*) GOOD Printing on laquered carton POOR GOOD (*) GOOD Printing on unvarnished carton YES NO YES COST REF HIGH HIGH (*) ON DARK BACKGROUNDS ONLY DOD ISO/IEC 15415 ISO/IEC 15416 ISO/IEC 15426 GRADING: a technical inaccuracy
The inspection technology Hi-Res Camera with illuminator + Analyzer SMART CAMERA with illuminator 2D Reader 2D Manual Reader (wired or wireless)
Track& Trace solutions ANTARES TRACKING SYSTEM architecture PRINT&CHECK BUNDLING CASE PACKING PALLETIZING MATRIX STATION WAREHOUSING STATIONS SERIALIZATION MODULES AGGREGATION EXPERIENCE
Print&Check - Stand-alone serialization modules for cartons A complete range to fulfill all application needs
Case aggregation integration in case packer Several solutions fitting case packers of virtually any manufacturer Camera array: one High Resolution or up to 6 sliding cameras to acquire multiple images for each case (up to 120 Mbytes in one sweep) Intelligent layer reconstruction: images taken from different cameras are integrated to reconstruct the complete layer thus minimizing rejects due to non-read codes. CASE PACKERS: Make sure when ordering a new case packer that it includes a pre-disposition for T&T checked!
Semiautomatic aggregation Matrix Station Top View designed to maximize productivity in the manual packaging operations, it performs a top view recognition of Datamatrix codes of cartons when fit into a case (reading window 500x 300 mm). Multi-layer cases are managed by means of an automatic format related adjustment of the camera position. Matrix HRC Station Ideal for single-layer cases, it is designed to maximize productivity in the manual packaging operations, such manual filling of cases (reading window 550x 430 mm)
ATS - Antares Tracking System architecture
T&T SW Layout when interfacing to level F4 I-Docs (SAP) Xml files Web services Plant Database Line Level Line Level
T&T impacts production directly SLA PREVENTIVE MAINTENANCE REMOTE ASSISTANCE SOFTWARE MAINTENANCE SPARE PARTS CORRECTIVE MAINTENANCE TRAINING REPAIR CENTER
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