Serialization – a global approachExpected 2-5 yrs after NBA Serialization, NBA products only PEDL...
Transcript of Serialization – a global approachExpected 2-5 yrs after NBA Serialization, NBA products only PEDL...
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 conceptSerialization at different levels
carton
bundle
case
pallet
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
Aggregation conceptFrom 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
With different requirements and across independent time frames, legislatorsworldwide are defining their own rules for pharmaceutical Track & Trace.
2015up to 2014 20172016 20192018 2023
Denmark
France
Italy
Belgium
Greece
Turkey
Serialization, reporting(stickers, 2D datamatrix)
Deadline fordeployment
EU
Bollino
Serialization(stickers)
Coding
Serialization(stickers)Serbia
Slovenia Coding
Serialization, Aggregation,Integrity, Reporting
Expected to maintainstickers
Phase 1 & 2 completed:Unit track level, reporting
Regulatory overview - Europe
Status: Q4 2015
SerializationUkraine
RussiaUnit leveltrackingGroup 1
Unit leveltrackingGroup 2
Unit leveltrackingGroup 3
(Law updateexpected)
With different requirements and across independent time frames, legislatorsworldwide are defining their own rules for pharmaceutical Track & Trace.
2015up to 2014 20172016 20192018 2023
USA
Argentina
Canada
Regulatory overview – North & South America
Status: Q4 2015
Coding
Serialization, Reporting (expected)
Serialization, Reporting
Lot tracking,Verification
Unit level tracking, Reporting
Step wiseSupply chainmobilization
Serialization,Reporting
Serialization,Aggregation, Reporting
Unit leveltracking
Updates positive list
Unit level tracking, ReportingPilot – 3 lots
BrazilUnit level tracking, ReportingFull rollut
Costa Rica
Chile Phase 2: Coding, Lot tracking
Proposal: Serialization, Tracking
Step wiseimplementation
Adapt US FDAguidelines expected
Coding
Mexico
Colombia
With different requirements and across independent time frames, legislatorsworldwide are defining their own rules for pharmaceutical Track & Trace.
2015up to 2014 20172016 20192018 2023
Japan
Singapore
Philippines
South Korea
India
China
Serialization, Reporting
Coding
EDL 2009/2012
Serialization, CodingImport / Export
Regulatory overview - Asia
Status: Q4 2015
Coding
Australia Coding
Unit level tracking,reporting
Taiwan Coding
Coding Serialization Serialization, Reporting
Unit level tracking,Reporting
Unit level trackingPrimary level
Serialization, all productsExpected 2-5 yrs after NBA
Serialization,NBA products only
PEDL updates
Serialization
With different requirements and across independent time frames, legislatorsworldwide are defining their own rules for pharmaceutical Track & Trace.
2015up to 2014 20172016 20192018 2023
Iran
Saudi Arabia
Nigeria
Regulatory overview – Middle East and Africa
Status: Q4 2015
Coding
Coding
Serialization
SerializationExpected no deadline
Unknownrequirements
Egypt
S. Africa
Jordan
Libya
Cameroon
Algeria
Coding
MAS Serialization
Serialization,expected
Serialization
Serialization
Delegated Acts released: February 2016 Deadlinefor 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
EU-FMD
Why Track&Trace?
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Track & Trace across the supply chain
RETAILERWHOLESALERMANUFACTURER PHARMACYHOSPITAL
PATIENT
Serialization is a part of the Track & Trace process, aiming at controllingthe 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
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• 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
Traceability issues - good side effects
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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 operate and impair line efficiency (e.g. embossing in cartoning machines and
other mechanically set prints, oftentimes not controlled)
Lower costs of consumables: It has been calculated that when new TIJ2.5 Thermal inkjet systems, belongingto Track&Trace solutions, replace obsolete/old printing devices (like, for example,
hot stamp printing systems), the cost of servicing and the cost of consumablesdecreases
Flexibility: The new printing and verification systems system allow for high flexibility andcan manage markings of different kinds and responding to different needs(internal market, export to countries with or without a T&T legislation)
T&T – Viable print technologies - cartons
TIJ 2.5Thermal Inkjet
LASER
DOD ISO/IEC 15415ISO/IEC 15416ISO/IEC 15426
GRADING: a technical inaccuracy
PRINTING SYSTEMS TIJ2.5 LASER DODPrint accuracy GOOD GOOD BEST
Space occupation GOOD POOR POORLinear Speed GOOD POOR GOOD
Printing on varnished carton FAIR GOOD (*) GOODPrinting on laquered carton POOR GOOD (*) GOOD
Printing on unvarnished carton YES NO YESCOST REF HIGH HIGH
(*) ON DARK BACKGROUNDS ONLY
The inspection technology
Hi-Res Camera with illuminator
+ Analyzer
SMART CAMERA with illuminator
2D Reader2D Manual
Reader (wired or wireless)
Track& Trace solutions
ANTARES TRACKING SYSTEM architecture
SERIALIZATION MODULES
PRINT&CHECK BUNDLING
AGGREGATIONEXPERIENCE
CASE PACKING PALLETIZING MATRIX STATION WAREHOUSINGSTATIONS
Print&Check - Stand-alone serialization modules for cartons
A complete range to fulfill all application needs
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!
Case aggregation – integration in case packer
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.
Semiautomatic aggregation
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
Line Level
Line Level
PlantDatabase
I-Docs (SAP)Xml filesWeb services
T&T impacts production directly – SLA
SOFTWAREMAINTENANCE
PREVENTIVEMAINTENANCE
REMOTEASSISTANCE
SPAREPARTS
CORRECTIVEMAINTENANCE
REPAIRCENTER
TRAINING
www.antaresvision.com
Antares Vision
Via del Ferro 16 / 25039 Travagliato (Brescia)
T. +39-030-7283500
F. +39-030-5109958
THANK YOU FOR YOUR KIND ATTENTION