Trazabilidad de los Productos Farmacéuticos medidas contra la

Transcripción

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
Trazabilidad de los Productos Farmacéuticos medidas contra la falsificación y
un desafío para la armonización de la identificación de Fármacos
Contents
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
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
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3
What the SWOT analysis Methodology is and
when is commonly applied (highlight)
Scope of SWOT Analysis applied to
Traceability
SWOT Analysis
What a SWOT Methodology is and when
it’s commonly applied
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4
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
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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)

5
…
2. Existing Technologies
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6
Autmoatic ID – data collection defintions
Barcode
RFID
Auto ID & Data Collection
7

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.
Barcode Symbols
8
Barcode Readers
Hand Held
9
Industrial
RFID Transponder
10
RFID Readers
Hand Held
11
Industrial
3. RFID Technologies
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12
RFID Components
RFID Block Diagram
RFID Main Features
RFID Components
13
RFID Block Diagram
APPLICATION
INTERROGATOR
RF TAG
Tag Physical Memory
Decoder
AIR
Application Program Interface
INTERFACE
Encoder
DEVICE
COMMANDS
APPLICATION
COMMANDS
APPLICATION
RESPONSES
Command /
Response
Unit
Tag Driver
and
Mapping
Rules
DEVICE
RESPONSES
COMMANDS
RESPONSES
Note:
Logical Memory
DATA PROTOCOL
PROCESSOR
14
Logical
Memory Map
PHYSICAL
INTERROGATOR
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The Logical Memory Map in the
Tag Physical Memory is given by
the Tag architecture and the
mapping rules in the Tag Driver.
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All the information in the Logical
Memory is represented in the
Logical Memory Map
RFID Transponder
15
RFID Features
ACTVIVE RFID
16
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
4. 2D Data Matrix
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17
2D Data Matrix Defintion and Highlights
2D Data Matrix Code
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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
19

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 24pin 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
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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 professionalgrade thermal transfer label printers on the market
2D Data Matrix Code
20
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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
Specific standards and specifications for the 2D Data Matrix barcode
symbology include the following:
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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 camerabased readers
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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
2D Data Matrix Code
One cell quiet zone
surrounds the matrix
Clock pattern
off on sequence
This cell is always white
for ECC200
Clock pattern off on
pattern (TIMING
Pattern)
L shape locator pattern (FINDER Pattern)
Cell size is important- 0.015 inches/0.33mm seems to give best read ratesand is GS-1 recommended
22
2D Data Matrix Code
23
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It is a EAN.UCC (GS 1) standard since July 2004
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It is using international syntax EAN.UCC (GS1) 128
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It is the smallest symbology available for a given quantity of
information
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It is robust : the Reed Solomon error correction system allow
readability v/s code damage (information redundancy)
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Data matrix can be printed with technologies currently used in
Pharmacy
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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
24
2D Data Matrix Code
Linear and 2D Barcode Simbology Evaluation Chart
25
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
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26
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
PDF417
Code 128
1 error in 37 million
Code 39
UPC
1 error in 394 thousand
1 error in 800 thousand
5. Practical Application
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27
Applications
....
.... So??
Application
Batch
Wireless
Fixed Station
Bill of Lading
Material Tracking
28
Application
29
... So??
30

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....
6. SWOT Analysis
(Technologies Comparison using SWOT
Techniques)
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31
2D Data Matrix v/s RFID
SWOT Analysis (rough)
Applied to Serialization
Aggregation??
Conclusions
2D Data Matrix V/S RFID
Printed Symbologies
 Economic Printing/Coding Support (Label,
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32
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
RF ID
 More Expensive Support (Special Label)
 Dedicated Device
 Multiple Reading, WITHOUT the possibility to
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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
SWOT Analysis
Weackness
Strength Points
2D
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RFID
Economic Printing
Multiple reading
Possibility to identify
physical position
Reading Accuracy
Easy to Produce

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2D
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Multiple reading
Integration with other
sensors
Doesn’t need
Physical/Direct Contact
2D
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RFID
2D Reader are standard
product
Standard Connection
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TAG’s CODE could be
modified/integrated with
additional information
(physical e-Pedegree)
More flexible in time
RFID
Print only once
Need Line Reading
Line
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
2D

RFID
Less flexible in
Time
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Opportunity
33
More Expensive Support
Dedicated Device
Multiple Reading, WITHOUT
the possibility to identify
SINGLE code position
NOT 100% affordable with
many simultaneous object
Higher Impact on
Environment
COMPATIBILITY WITH BIO
PRODUCT (to be
investigated)
Disturbs on other Instrument
Threats
Applied to Serialization
Weackness
Strength Points
2D
 Economic Printing
 Multiple reading
 Possibility to identify
physical position
 Reading Accuracy
 Easy to Produce
RFID
 Multiple reading
 Integration with
standard
product
 Standard
Connection
RFID

TAG’s CODE
could be
modified/integrate
d with additional
information
RFID
Need Line Reading
Line
 More Expensive
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
2D
Support
Dedicated Device
Multiple Reading,
WITHOUT the
possibility to identify
SINGLE code position
RFID
 Higher Impact on


Opportunity
34

other sensors
 Doesn’t need
Direct Linear
Contact
2D
 2D Reader are
2D
Environment
COMPATIBILITY WITH
BIO PRODUCT (to be
investigated)
Disturbs on other
Instrument
Threats
Aggregation??
2D Data Matrix Readers
(camera/s)
The system reads all codes layer by
layer when the case is being filled
35
Aggregation??
2D Data Matrix Readers
(camera/s

Can read up to 150 datamatrix
codes in one case with dimension
500x300 mm.
o
o
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Reading modes:
o
o
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36
Multiple GigE Camera Module
configurable in order to reach the
required resolution
Vision Box Analyser
single shot
scanning
Polarized lighting system to
maximize recognition even under
overwrapping film
Aggregation??
2D Data Matrix Readers (camera/s
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37
Every Datamatrix is recognized and geometrically identified in
its position in the case, for proper handling.
Logical status are managed
Aggregation??
…they HAVE A
“GOOD AUDITORY
SYSTEM, but do not
see!
38
Aggregation??
Why not a combination,
were applicable ??
39
7. Conclusion

40
Conclusion
Conclusion 1
41

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 2
42

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
www.ctpsystem.com
www.comex.mde.buenosaires.gov.ar
Myriam Tevez
www.latconsultores.com.ar
[email protected]
(005411) 4126 2950
Gilberto Rossi
[email protected]
0039.348.7216946
0054.911.50608387
Thanks for the Attention!
Para bajar la presentacion conectarse a la pagina
www.latconsultores.com.ar/novedades.asp
43

Trazabilidad de los Productos Farmacéuticos medidas contra la

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