Trazabilidad de los Productos...

Trazabilidad de los Productos Farmacéuticos medidas contra la falsificación y

un desafío para la armonización de la identificación de Fármacos

Trazabilidad de los Productos

Farmacéuticos medidas contra la falsificación y un desafío

para la armonización de la identificación de

Fármacos

Incrementar la eficiencia de los controles

dentro de la supply chain y establecer

reglas comunes para la identificación y el

control de la distribución del producto

terminado, a través de la serialización de

los productos y de la introducción del

sistema Track&Trace. Análisis del

panorama de los Proyectos y de las

reglamentaciones internacionales

2 Trazabilidad de los Productos Farmacéuticos medidas contra la falsificación y un desafío para la armonización de

la identificación de Fármacos – ExpoFybi – 3 Noviembre 2011

1. Analysing Technology using

SWOT Analysis Techniques .........................................3

2. Existing Technologies ...................................................6

3. RFID ...........................................................................12

4. 2D Data Matrix.............................................................17

5. Practical Application.....................................................27

6. SWOT Analysis ............................................................31

7. Conclusion ...................................................................40

Contents



1. Analysing Technology

Using SWOT Analysis Techniques

What the SWOT analysis Methodology is and

when is commonly applied (highlight)

Scope of SWOT Analysis applied to

Traceability



What a SWOT Methodology is and when

it’s commonly applied

It’s a kind of analysis methods used to support strategic

choice, when it’s necessary to identify the key point in

order to take a decision, comparing different scenarios

to which the same evaluation scheme is applied

Usually it’s applied to better identify elements to support

“internal” changes or development, mainly inside

commercial organization

In that case we will partially use that methodology to

perform a sort of summary of the application scenarios

SWOT Analysis



Scope of SWOT Methodology applied to

Traceability Solution

It’s an exercise, because mot of the request related to

the coding system have to come by Government and

regulatory body

Regarding the specific contest of Traceability we

suggest to use that methodology only to briefly “list” by

an impartial point of view advantage and constrains of

different technology in a scenario in which we need to

Codify, Identify and Collect the same type of data (Product Code, Batch Nr., Expiry Date, Unique Serial Number)

…

SWOT Analysis



2. Existing Technologies

Autmoatic ID – data collection defintions

Barcode

RFID



Refers to the methods of automatically identifying

objects, collecting data about them, and entering that

data directly into computer systems - with/without

human involvement

Technologies typically considered as part of AIDC

include bar codes, Radio Frequency Identification

(RFID), biometrics, magnetic stripes, Optical Character

Recognition (OCR), smart cards, and voice

recognition.

AIDC is also commonly referred to as “Automatic

Identification,” “Auto-ID,” and "Automatic Data Capture.

Auto ID & Data Collection

http://en.wikipedia.org/wiki/Computer

http://en.wikipedia.org/wiki/Bar_codes

http://en.wikipedia.org/wiki/RFID

http://en.wikipedia.org/wiki/RFID

http://en.wikipedia.org/wiki/Biometrics

http://en.wikipedia.org/wiki/Magnetic_stripe

http://en.wikipedia.org/wiki/Optical_character_recognition

http://en.wikipedia.org/wiki/Optical_character_recognition

http://en.wikipedia.org/wiki/Smart_cards

http://en.wikipedia.org/wiki/Voice_recognition

http://en.wikipedia.org/wiki/Voice_recognition



Barcode Symbols



Hand Held Industrial

Barcode Readers



RFID Transponder



Hand Held Industrial

RFID Readers



3. RFID Technologies

RFID Components

RFID Block Diagram

RFID Main Features



RFID Components



RESPONSES

COMMANDS

Tag Physical Memory

APPLICATION

RESPONSES

APPLICATION INTERROGATOR RF TAG

APPLICATION

COMMANDS Command /

Response

Unit

PHYSICAL

INTERROGATOR

DATA PROTOCOL

PROCESSOR

Encoder

Logical Memory

AIR

INTERFACE Logical

Memory Map

Note:

The Logical Memory Map in the

Tag Physical Memory is given by

the Tag architecture and the

mapping rules in the Tag Driver.

All the information in the Logical

Memory is represented in the

Logical Memory Map

Decoder

Tag Driver

and

Mapping

Rules

Ap

plicatio

n P

rog

ram In

terface

DEVICE

COMMANDS

DEVICE

RESPONSES

RFID Block Diagram



RFID Transponder



ACTVIVE RFID Passive RFID

Tag Power Source Internal TAG Energy Transferred

Using RF from reader

Tag Battery YES NO

Availability of Power Continuous Only in field form

READER

Required Signal

Strength to TAG Low High

Range More than 50 mt 3 TO 5 Mt, usually less

Multi Tag Reading 1000 TAGS recognised

(at high speed)

Few hundreds TAGs

within 3 mt

Data Storage 128 KB R/W 128B R/W

RFID Features



4. 2D Data Matrix

2D Data Matrix Defintion and Highlights



A Data Matrix code is a two-dimensional matrix barcode consisting of black and

white "cells" or modules arranged in either a square or rectangular pattern

The information to be encoded can be text or raw data

Usual data size is from a few bytes up to 2 kilobytes

The length of the encoded data depends on the symbol dimension used

Error correction codes are added to increase symbol strength: even if they are

partially damaged, they can still be read

A Data Matrix symbol can store up to 2,335 alphanumeric characters

Data Matrix symbols are rectangular in shape and usually square, they are made of

cells: little elements that represent bits

Depending on the situation a "light" module is a 0 and a "dark" module is a 1, or vice

versa

Every Data Matrix is composed of two solid adjacent borders in an "L" shape (called

the "finder pattern") and two other borders consisting of alternating dark and light

"cells" or modules (called the "timing pattern"). Within these borders are rows and

columns of cells encoding information. The finder pattern is used to locate and orient

the symbol while the timing pattern provides a count of the number of rows and

columns in the symbol

As more data is encoded in the symbol, the number of cells (rows and columns) will

increase. Symbol sizes vary from 8×8 to 144×144

2D Data Matrix Code

http://en.wikipedia.org/wiki/Matrix_(mathematics)

http://en.wikipedia.org/wiki/Barcode

http://en.wikipedia.org/wiki/Square_(geometry)

http://en.wikipedia.org/wiki/Rectangle

http://en.wikipedia.org/wiki/Kilobyte

http://en.wikipedia.org/wiki/Error_detection_and_correction

http://en.wikipedia.org/wiki/Alphanumeric

http://en.wikipedia.org/wiki/Bits



The symbol is square and can range from 0.001 inch per side up

to 14 inches per side. As an example of density, 500 numeric

only characters can be encoded in a 1-inch square using a 24-

pin dot matrix printer.

DataMatrix is being used to encode product and serial number

information on electrical rating plates, to mark of surgical

instruments in Japan, to identify lenses, circuit boards, and other

items during manufacturing

DataMatrix symbols require a 2-D scanner; they cannot be read

using an ordinary linear barcode scanner. A number of scanners

are on the market using both laser and CCD camera

technologies

DataMatrix symbols can be printed using most professional-

grade thermal transfer label printers on the market

2D Data Matrix Code



Compared to other barcode types, DataMatrix is approximately 30

times smaller than a Code 39 barcode representing the same data

The 2D Data Matrix is barcode also the recommended choice when

sending barcodes over faxed documents, because the symbol can

withstand many poor resolution and scanning issues

The required Reed-Solomon error correction built into Data Matrix

ECC200 is able to reconstruct and verify the data scanned for

improved accuracy

In a study at The Center for Automatic Identification at Ohio

University, the statistical probability of a misread error with Data

Matrix is 1 in 10.5 million scans, compared to a misread error

probability of 1 in 1.7 million with the Code 39 barcode

2D Data Matrix Code

http://www.idautomation.com/barcoding4beginners.html







http://www.ent.ohiou.edu/autoid/research.htm

http://www.ent.ohiou.edu/autoid/research.htm



Specific standards and specifications for the 2D Data Matrix barcode

symbology include the following:

ISO/IEC 15418 – symbol data format semantics

ISO/IEC 15434 – symbol data format syntax

ISO/IEC 15415 – 2-D print quality standard

MIL-STD-130 - US DOD Department of Defense

standard

NASA-STD-6002 - aerospace parts marking

NASA-HDBK-6003 - aerospace direct part marking

methods and techniques

SAE AS9132 – Society of Automotive Engineers (SAE)

aerospace industry marking standard

Semiconductor Equipment and Materials International

(SEMI):

T2-0298E – silicon wafers marking

T3-0302 – wafer box labels

T7-0302 – double sided wafers

T8-0698E – flat panel display substrates

T9-0200E – lead-frame strips marking

T10-0701 – direct mark quality test method

X6721 - Korean standard

AS9132 - Society of Automotive Engineers (SAE)

parts marking

Air Transportation Association's (ATA) Spec 2000

Automotive Industry Action Group (AIAG):

AIAG B-4 - parts identification

AIAG B-8 - shipping labels

AIAG B-11 - tire and wheel identification

AIAG B-13 - symbology white paper

AIAG B-17 - direct parts making

DOD UID - Department of Defense Guide to

Uniquely Identify items

EIA 706 - Electronics Industry Marking Standard

EIA 802 - Electronics Industry Marking Standard

GS1 DataMatrix - standard for encoding

GTIN numbers on small items with camera-

based readers

2D Data Matrix Code

http://www.idautomation.com/barcode/iso-iec-15434.html

http://www.idautomation.com/barcode/mil-std-130-uid-label.html






http://www.idautomation.com/upceanfaq.html

http://www.idautomation.com/upceanfaq.html



L shape locator pattern (FINDER Pattern)

Clock pattern

off on sequence

Clock pattern off on

pattern (TIMING

Pattern)

This cell is always white

for ECC200

One cell quiet zone

surrounds the matrix

Cell size is important- 0.015 inches/0.33mm seems to give best read rates-

and is GS-1 recommended

2D Data Matrix Code



It is a EAN.UCC (GS 1) standard since July 2004

It is using international syntax EAN.UCC (GS1) 128

It is the smallest symbology available for a given quantity of

information

It is robust : the Reed Solomon error correction system allow

readability v/s code damage (information redundancy)

Data matrix can be printed with technologies currently used in

Pharmacy

It is cost competitive (0.1 to 0.3 cents of €)

Data Matrix has been used successfully by IFAH for coding all

animal health products worldwide

2D Data Matrix Code



2D Data Matrix Code



Linear and 2D Barcode Simbology Evaluation Chart

Code 39 without check digit:

Code 128 Auto:

Aztec:

Data Matrix ECC200 with ASCII encoding

mode:

PDF417 in Text encoding mode:

QR-Code with Error Correction L

2D Data Matrix Code



Because of the required Reed Solomon error correction

built in to ECC200 Data Matrix, it is very dependable and

can even be read in with a scanner when part of the

symbol has been destroyed

With Data Matrix, the worst case chance of a misread is

1 error in 10.5 million scans

In a Code 39 barcode, the worst case chance of a

misread is 1 error in 1.7 million*

Barcode Type Worst Case Accuracy Best Case Accuracy

Data Matrix 1 error in 10.5 million 1 error in 612.9 million

PDF417 1 error in 10.5 million 1 error in 612.4 million

Code 128 1 error in 2.8 million 1 error in 37 million

Code 39 1 error in 1.7 million 1 error in 4.5 million

UPC 1 error in 394 thousand 1 error in 800 thousand

2D Data Matrix Code



5. Practical Application

Applications

....

.... So??



Wireless Batch Fixed Station

Bill of Lading

Material Tracking

Application



Application



Both Technology could be used to Codify,

Identify and read object through contact less

operation..

We’ve already seen that both technology could

cover the needs

... we want to do only as an exercise a

comparison, even to understand (in a very rough

way!!) how they could better used....

... So??



6. SWOT Analysis (Technologies Comparison using SWOT

Techniques)

2D Data Matrix v/s RFID

SWOT Analysis (rough)

Applied to Serialization

Aggregation??

Conclusions



Economic Printing/Coding Support (Label,

direct Print)

Barcode Rader and 2D Reader are standard

product (even portable)

Barcode reader has standard PC Connection

(Keyboard emulation, Serial, USB)

Multiple reading, WITH the possibility to

identify the physical position of any single

readable code on an inspected area

Reading Accuracy

Easy to Produce on demand / on line

Optical Reading

Print only once

Need Line Reading Line

Less flexible in Time

More Expensive Support (Special Label)

Dedicated Device

Multiple Reading, WITHOUT the possibility to

identify SINGLE code physical position on an

inspected area

Integration with other sensors

TAG’s CODE could be modified/integrated with

additional information (physical e-Pedegree)

Doesn’t need Direct Linear Contact

More flexible in time (re-use of label/support)

Higher Impact on Environment

Dimension / Position of the Antenna

COMPATIBILITY WITH BIO PRODUCT (to be

investigated)

Disturbs on other Instrument

NOT 100% affordable with many simultaneous

object

2D Data Matrix V/S RFID

Printed Symbologies RF ID



SWOT Analysis

Strength Points

Opportunity

Weackness

Threats

2D 2D

2D 2D RFID

RFID RFID

RFID

Economic Printing

Multiple reading

Possibility to identify

physical position

Reading Accuracy

Easy to Produce

2D Reader are standard

product

Standard Connection

Print only once

Need Line Reading

Line

NOT 100% affordable with

many simultaneous object

Higher Impact on

Environment

COMPATIBILITY WITH BIO

PRODUCT (to be

investigated)

Disturbs on other Instrument

More Expensive Support

Dedicated Device

Multiple Reading, WITHOUT

the possibility to identify

SINGLE code position

Multiple reading

Integration with other

sensors

Doesn’t need

Physical/Direct Contact

TAG’s CODE could be

modified/integrated with

additional information

(physical e-Pedegree)

More flexible in time

Less flexible in

Time



Applied to Serialization

Strength Points

Opportunity

Weackness

Threats

2D 2D

2D 2D RFID

RFID RFID

RFID

Economic Printing

Multiple reading

Possibility to identify

physical position

Reading Accuracy

Easy to Produce

2D Reader are

standard

product

Standard

Connection

Need Line Reading

Line

Higher Impact on

Environment

COMPATIBILITY WITH

BIO PRODUCT (to be

investigated)

Disturbs on other

Instrument

More Expensive

Support

Dedicated Device

Multiple Reading,

WITHOUT the

possibility to identify

SINGLE code position

Multiple reading

Integration with

other sensors

Doesn’t need

Direct Linear

Contact

TAG’s CODE

could be

modified/integrate

d with additional

information



2D Data Matrix Readers (camera/s)

The system reads all codes layer by

layer when the case is being filled

Aggregation??

Scansione Abbott + P&A.MOV



Can read up to 150 datamatrix

codes in one case with dimension

500x300 mm.

o Multiple GigE Camera Module

configurable in order to reach the

required resolution

o Vision Box Analyser

Reading modes:

o single shot

o scanning

Polarized lighting system to

maximize recognition even under

overwrapping film

2D Data Matrix Readers

(camera/s

Aggregation??

filmati/Cartonatrice.mpg



Every Datamatrix is recognized and geometrically identified in

its position in the case, for proper handling.

Logical status are managed

Aggregation??

2D Data Matrix Readers (camera/s



Aggregation??

…they HAVE A

“GOOD AUDITORY

SYSTEM, but do not

see!

Scansione Abbott + P&A.MOV



Aggregation??

Why not a combination,

were applicable ??

http://www.tattile.com/new.site/M0_sensor.htm



7. Conclusion

Conclusion



RFID remain more expensive, and have higher impact in

implementation and on environment

RFID (because of read/write) could be more efficient

where Supply Chain is complex, but still not 100%

affordable

For sales unit serialization 2D Data Matrix is for sure

more efficient and offer lower impact in implementation

and about 0 impact on environment

The Highest impact, is in Production & Packaging:

feasibility studies are required to reduce the impact of

introduction of “serialization line” and single/Unique box

checks

Conclusion 1



For the Step of filling multi-packs (CASE) with the sales

unit, controls done by 2D Codes & reader are for sure

less expensive and more efficient

Multiple readings done by RFID still not affordable

RFID, could be (in the next future) a good

complementary solution for the latest step of aggregation

along the production line, may be used in combination

with 2D Data Matrix to manage the “packing list”

In any case a printing station is needed to print on

line Human Readable Variable Data, which have to

be verified with automatic OCR &/or OCV techniques

Conclusion 2



www.ctpsystem.com

www.latconsultores.com.ar

Gilberto Rossi [email protected]

0039.348.7216946 0054.911.50608387

Thanks for the Attention!

www.comex.mde.buenosaires.gov.ar

Myriam Tevez [email protected]

(005411) 4126 2950

Para bajar la presentacion conectarse a la pagina

www.latconsultores.com.ar/novedades.asp

http://www.ctpsystem.com/



mailto:[email protected]

http://www.comex.mde.buenosaires.gov.ar/

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