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?

10

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

15

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

info@antaresvision.com

THANK YOU FOR YOUR KIND ATTENTION