Page

Serialization
Track & Trace eBook
by
1
As presented live at the
2013
Serialization Track & Trace
Page 2
The following eBook content has been
originally presented during a workshop at
Pharmapack 2013, in Paris. This very
informative and interactive session was
conducted by Mr. Jean-Pierre Allard. The
slides in dark blue are the actual content
presented at the conference while the
slides in white were specifically added for
the eBook.
Also, if you would like to have more
information on serialization, Optel Vision
offers free webinar sessions. Divided into 3
different parts, these webinars will allow
you not just to become familiar with the
cur r ent and evol vi ng ser i al i zat i on
requi rements, but al so revi ew and
understand real use cases of Track &
Trace. You will also be able to understand
the different perspectives for line and IT
implementations.

About this eBook
Serialization Track & Trace
Page 3
Mr. Jean-Pierre Allard, Optel Visions,
Serialization Product Manager, has 12
years of experience in the vision industry.
Mr . Al l ar d began hi s car eer i n
Spectrometer Design and R&D project
management. Mr. Allard is the Serialization
Solution Manager for Optel Vision and is
working on the design and road map for
vision and software solutions to address the
serialization needs for numerous countries
and products. Working closely with various
global implementations projects as an
active member in GS1 US Healthcare, Mr.
Al l ard i s recogni zed as one of the
serialization subject matter experts.
Jean-Pierre Allard Workshop
Presenter
Page
4
Introduction
Serialization Track & Trace
Page 5
Table of Contents
Worldwide
Regulations
Standards Overview
General Solution
Architecture
Bottle Association
Bottle or Carton
Aggregation
Carton Case Packer
Aggregation
Label Artwork
IT Implementation

Page
6
Worldwide Regulations
Serialization Track & Trace
Page 7
In terms of worldwide regulations, there are
several countries where serialization was
applied. In 2012, Turkey was one of the first
countries to fully implement Track & Trace,
they only required serialization at the item
level. Complete aggregation will be enforced
this year. They are aligned on the GS1
standards and the carrier of the serial number
must be the 2D code.
In India, they are only doing serialization
without aggregation, but it is applied at every
pack agi ng l evel and pr ogr es s i vel y
implemented this year at the blister or bottle
level. They are also aligned on GS1 standards
and the carrier of the serial number must be
the 2D code. This only applies to production
shipped outside of India.
In China they have established their own
custom serialization system. With a list of 267
drugs that require a 1D barcode, the serial
numbers are supplied by the government and
contain a security encryption within the
number.
In the United States, the state of California is
currently enforcing its upcoming regulations as
i t i s t he onl y s t at e t hat has begun
implementation with full blown aggregation
Track & Trace. Pharmaceutical manufacturers
needs to be ready in 2015 otherwise they will
face a penalty. By then, 50% of the products
will need to be serialized. There are three ways
to validate the 50%. It could be 50% of the
SKUs, 50% of the volume or 50% of the product
type.
In Europe, there are currently no active
regulations in place. It could be GS1 standard
and the carrier of the serial number has not
been identified. In the current timeline it will
be mandatory to serializes by 2017.

Latest Legislation Summary
Serialization Track & Trace
Page 8
Latest Legislations Summary
Country
Item Level
Serialization
Serialization and
Aggregation
Standard Carrier
Turkey 2010 2013
2D
barcode
India
2011
to 2013
-
2D
barcode
China - 2012
Custom
System
1D
barcode
California
(USA)
- 2015 Any
Europe 2017 -
Possibly
TBD
Page
9
Standards Overview
Serialization Track & Trace
Page 10
When serializing, each bottle or carton has
their own serial number but the bundle
created afterward has a top label with its
own unique serial number through the
aggregation. The aggregation records the
association of each bottle to its bundle
parent pack.
With serialization and Track & Trace, you
know where the product has been at all
times through each and every step. Think of
it as parcel tracking. But along with seeing
where it has been the last time, you have
the total history. On a packaging line this
means you will know when the product has
been packed, when it has been transferred
to the warehouse and when it has been
shipped to a distributor or a hospital, etc


What is Serialization?
Serialization Track & Trace
Page 11
What is Serialization?
Serialization is the assignment and
application of a unique, verifiable
product identifier to an individual
pack of drug products.
Simply put, it is the
application of a
serial number to any
item.
Serialization Track & Trace
Page 12
Different Mediums are
Available for Serialization
1D bar code

2D bar code

Human readable

RFID tag
GTIN 10534890157010
SN 12345678901
(01)10534890157010(21)00001208639
Serialization Track & Trace
Page 13
In a bundle of bottles or cartons,
each unit has its own serial number
but the bundle itself has a top label
including a unique serial number. In
total this bundle has 13 different serial
numbers.

Aggregation records the association
of each bottle to its bundle parent
pack.
What is Aggregation?
Serialization Track & Trace
Page 14
What is Aggregation?
Aggregation is the association of
uniquely serialized packs to a higher
packaging level also having an
unique serial number.
Example:
6 bottles are packed in the same
bundle, in serialization words it
means t hat 6 chi l dr en wer e
aggregated to a parent.
Serialization Track & Trace
Page 15
What is Track & Trace?
Track: Concerns a
process of determining
the current and past
locations (and other
information) of a unique
item or property
Trace: Past history of
the item or property


Serialization Track & Trace
Page
Serialization vs. Track & Trace
16
In terms of business operation, if you are putting a serial
number on a product, then you are doing serialization. If
you are doing Track & Trace then it is mandatory to
capture and record the association and aggregation.
This needs to be repeated each time shipping and
receiving occurs and when the product is dispensed to
the patient.
Depending on the country, some are only doing
serialization others are doing full Track & Trace. For
fighting against counterfeit products, both methods are
efficient. But this is not the case for stolen goods. For
example, in the United States, they are not affected
greatly by counterfeiting, but they are seeing the
number of stolen trucks increasing. In 2009, 12 cargo
trucks were stolen and this number has increased to 54.
Since this type of crime is growing, there is an urgent
need to prevent the theft of precious medicines. This
hurts the most when these medications are reintroduced
into the normal supply chain. Thieves do not monitor
the products temperature and the integrity is not always
maintained. This has even resulted with the death of
some patients. It took a full year of investigation to
determined that the defective product was coming from
a batch that was stolen and re-introduce into the supply
chain. With Track & Trace, since you scan your pallet
serial number, and since it has been aggregated, you will
know every bottle that is contained on this pallet. If the
truck was stolen, you can immediately change the status
in the database to stolen goods. Since the product is
tagged as stolen, if it reaches the pharmacies, they will
be able to easily identify and discard them.
For recalls, the current method is to send an email, fax or
make a phone call to all pharmacies, most pharmacies
do not have the product on hand. They receive several
recall sheets per week and most are irrelevant. This is
why most recalls are usually only returning 20% of the
product.
With Track & Trace, you will be able to tell who has your
product and make targeted recalls for 100% returns.
Track & Trace gives the greatest visibility to all the supply
chain.
Serialization Track & Trace
Page 17
Serialization vs. Track & Trace
Business Operations Serialization Track & Trace
Product Serialization ! !
Aggregation Captured !
Serial Number Captured when shipped !
Serial Number Captured when received !
Verification at Point of Dispense ! !
Problem to Solve Serialization Track & Trace
Counterfeit Products ! !
Reimbursement Fraud ! !
Stolen Products !
Ineffective Recalls !
No Inventory Visibility Through Supply Chain !
Serialization Track & Trace
Page 18
GTIN, is a Product Identifier
Valid and Unique Globally
In the United States, the NDC (National
Drug Code), gives a unique number to
each given product sold in the US. On the
other hand the GTIN (Global Trade Item
Number), gives a unique number to each
given product sold everywhere in the
world. This is used for shipping between
various countries.
GTIN has been created by GS1, a non-
profit organizations in order to convince
countries to adopt a new standard. The
first digit, not part of the NDC, is used to
identify the packaging level.
For example a bottle GTIN can start with a
0 and a case with a 2, etc. There are no
real standards for what the number
means. You can have the same GTIN for a
case except for the first digit which will be
different for each packaging level. The
resul ti ng barcode wi l l be di fferent
depending on the package level and can
be used to set different prices depending
on the quantity enclosed.
The country prefix 03 is currently reserved
for the FDA numbering system. Basically,
numbers from 01 to 17 are reserved for
companies in the US. The very last digit is a
check di gi t used as a veri fi cati on
mechanism. It comes from an algorithm
that sums up all the first 13 digits and
provides a number.
The algorithm is public, please visit
http://www.gs1.org/barcodes/support/
check_digit_calculator to learn more
about the algorithm. This kind of
verification is very useful and can help
prevent operator error since the last digit
does not match with the preceding digits.

Serialization Track & Trace
Page 19
GTIN, is a Product Identifier
Valid and Unique Globally
NDC:
Labeler
Code
Product
Code
Package
Code
Indicator
Digit
Company
Prefix
Product
Code
Check
Digit
61414-1234-1
00361414123411
GTIN:
US regional
standards
Serialization Track & Trace
Page 20
NTIN is a National Product Identifier
using the Same 14-Digit Format
German PZN to NTIN Conversion
Serialization Track & Trace
Page 21
In order to uniquely identify a product, it is truly
the combination of a GTIN and a serial number
which makes it unique. For example, if you start
packaging product (A) on packaging line #1,
all bottles will have the same GTIN but they will
also have a different serial number.
I f you start packi ng product (B) onto
packaging line #2, this product can have the
same serial number as product (A) since the
uniqueness is coming from the combination of
the serial number and the GTIN.

GTIN and a Serial Number are
the True Unique Item Identifiers
Serialization Track & Trace
Page 22
GTIN number is static for a given
product

Serial Number changes for every
individual item produced
Same GTIN
Different Serial Number
GTIN and a Serial Number are
the True Unique Item Identifiers
Serialization Track & Trace
Page 23
GS1 has Defined a Clear
Structure
GS1 standard code is made of Application Identifiers (AI)
Code can be formatted in 2D or 1D bar code
(01)10534890157010(21)12237203824
(01)10534890157010(21)12237203825
(01)10534890157010(21)12237203826

GTIN AI GTIN-14 S/N AI S/N
Serialization Track & Trace
Page 24
GS1 has Defined More than
90 Application Identifiers
In the following example, the (01) and
t he ( 21) ar e cal l ed t he GS 1
application identifiers, the purpose of
these numbers is to identify what is
inside a 2D data matrix or linear bar
code. Usually a function character
code is inserted just before the
number string (FNC1). The parenthesis
are only shown in the human readable
form to help spot each application
identifier. When a camera reads a
FNC1, it knows the following string is a
GS1 compliant code.
Serialization Track & Trace
Page 25
GS1 has Defined More than
90 Application Identifiers
AI Description Data Format
00 Serial Shipping Container Code(SSCC-18) 18 digits - numeric
01 Shipping Container Code (SSC) 14 digits - numeric
02 Number of containers 14 digits - numeric
10 Batch Number 1-20 alphanumeric
11 Production Date 6 digits: YYMMDD
13 Packaging Date 6 digits: YYMMDD
15 Sell by Date (Quality Control) 6 digits: YYMMDD
17 Expiration Date 6 digits: YYMMDD
20 Product Variant 2 digits
21 Serial Number 1-20 alphanumeric
22 HIBCC Quantity, Date, Batch and Link 1-29 alphanumeric
23x Lot Number 1-19 alphanumeric
240 Additional Product Identification 1-30 alphanumeric
250 Second Serial Number 1-30 alphanumeric
30 Quantity Each -
310y Product Net Weight in kg 6 digits
311y Product Length/1st Dimension, in meters 6 digits
312y
Product Width/Diameter/2nd Dimension, in
meters
6 digits
313y
Product Depth/Thickness/3rd Dimension, in
meters
6 digits
Several Application Identifiers are available.
Using this standard, and there is no need to
communicate to other partners how to read
your code.

Serialization Track & Trace
Page 26
Global Acceptability of
Standards
Source
Page
27
General Solution
Architecture
Serialization Track & Trace
Page 28
Packaging Line Ready for
Track & Trace
On the following packaging lines, the bottles
or cartons are bundled together. This set-up is
aligned with the California requirements
which means the bottles or cartons not only
need to be serialized but the aggregation
needs to be recorded.
On a carton line, it is difficult to print on the
cartons and have a good print quality. The
first module contains a unit that prints the
serial number on the cartons or bottles, then
they are bundled together and so on. Until
the bundles are manually packed in a case.
The dotted line represent the separation
bet ween pr e- aggr egat i on and post -
aggregation. Basically there are two ways to
record aggregation. You can use the pre-
aggregation method, which means you have
to know what cartons are in each bundle.
Simply assumed that the first 12 cartons
inspected will end in the first bundle and so
on.
This method relies on the order of the
products that are inspected. But this is risky
since if you remove a carton, the order is now
off and the aggregation will not be correct
for all the remaining bundles.
Even if the risk of this event happening is low,
the result can be disastrous and you can
have hours of products not aggregated
accurately. The other method, is post-
aggregation. This records what is inside the
bundle only after they have been packaged
together. This means each individual cartons
code will need to be visible.
In this example, there is a camera that reads
all the codes from each carton after they are
bundled together. The Post-aggregation
inspection is always preferred against pre-
aggregation inspection.


Serialization Track & Trace
Page 29
Carton Packaging Line
Ready for Track & Trace
Carton Print
& Inspection
Bundle
Content
Inspection
Bundle Label
Print &
Inspection
Manual
Aggregation
Station
Pre-Aggregation Post-Aggregation
Serialization Track & Trace
Page 30
Bottle Packaging Line Ready
for Track & Trace
Bottle Inspection
and Association
Bundle
Content
Inspection
Bundle Label
Print &
Inspection
Manual
Aggregation
Station
Pre-Aggregation Post-Aggregation
Page
31
Bottle Association
Serialization Track & Trace
Page 32
Bottle Association Station
Prior to the association, the coder must print a unique
serial number on the label, then a camera will inspect
the information. The inspection will validate that the 2D
code is a match with the human readable, along with
the serial number, lot number and expiry date validity.
Then there is a 5 camera station (4 around + 1 one at the
top or bottom) that will inspect 360 around the bottle to
make the association since the orientation of the label is
not predictable.
This system is used to associate the serial number applied
on the bottle with another unique serial number printed
at the top or bottom. The principle is when the bundle
will be assembled together one must find a way to make
sure what is the identity of each bottle. In the industry, as
di scussed earl i er there are two ways of doi ng
aggregation.
In example, the first 12 bottles will end up in the first
bundle and so on. As you can imagine this is a risky
approach. If there is any disruption on the packaging
line (bottle removed, dropped, inserted) there will be
errors introduced in all the following bundles.
In post-aggregation inspection, it is sometimes difficult to
see all the labels inside a bundle, this is why a secondary
unique code can be applied on the top or bottom of
the bottles so it is possible to capture all bottles that are
in the bundle. The top code can be directly applied on
the cap, on a top cert or on the bottom of the bottle. In
the case of square bottle, you would not need a 5
camera system since the label inspection will always be
at the same place.
The LineMaster is where all the events are reported. It will
also record what serial numbers have been printed,
which serial numbers have been inspected and which
ones failed the inspection and association.
Serialization Track & Trace
Page 33
Bottle Association Station
360 Station +
Top Code
Inspection
Label
Inspection
HMI
Serialization Track & Trace
Page 34
What is a Tracking Code?
Temporary unique number
Associated with the label serial
number
Read after aggregation
Not an official serial number
Can be a simple incremental code
Does not need to have a wide
range (can be from 0 to 999 999)
Tracking Code
Tracking
Code
Serial Number
Serial Number
Serialization Track & Trace
Page 35
Bottle Post-Aggregation Inspection
Requires an Accessible Tracking Code
A Tracking Code to
Capture all bottles once
packed in bundle or case
Stay away from risky FIFO (First
In First Out) methods
Allow any operator
intervention prior or inside the
packing station
Serialization Track & Trace
Page 36
How and Where to Apply a
Tracking Code on a Bottle?
Pre-printed on
topsert
(UV or visible)
On-line printing
on cap
(visible)
On-line printing
on cap
(UV - invisible)
Serialization Track & Trace
Page 37
Bottle Association and
Commissioning Station
360Station +
Top Code
Inspection
Serialization Track & Trace
Page 38
CartonTracker Inspection
Station
Typical unit ensure:
Carton Stabilization
Increase Print Quality
Minimum line changes
Benefits from:
Reduced reject due to
poor print
Increase quality
Mobility
Cost saving
Simplified validation
Page
39
Bottle or Carton
Aggregation
Serialization Track & Trace
Page 40
Bottle or Carton Bundle
Aggregation
Aggregation
Inspection
Station
When the bundle comes out
of t he s hr i nk wr apper,
cameras can inspect the top
code. The cameras are
taking several picture of the
different rows as the bundle is
passing by to identify the
chi l dr en i n t he speci f i c
bundle.
Serialization Track & Trace
Page 41
Bundle Inspection
In the next step, if all the
bottl es are successful l y
read, a Pri nt & Appl y
machine will add a bundle
label on top. If any of the
child bottles was not read
correctly or their status is
not as expected, then no
label will be applied. The
camera will then inspect
the newly applied label to
validate the serial number
o f t h e b u n d l e a n d
associate it with the bottles.

Bundle Label
Print &
Inspection
Serialization Track & Trace
Page 42
Manual Packing
Aggregation
Here the bundles are manually
packed in a case and the cases are
manually packed onto a pallet. Of
course the packaging line can be
fully automatized. But most of the
time this operation is done manually.
The scanner used for aggregating
the cases can be a fixed mount type
as show here or can be handheld.
Each bundle must be scanned prior
to being packed into a case. When
the case is completed, a case label
prints automatically with a unique
serial number.
Then the operator needs to scan the
label to associate the containing
bundl e to the case. The same
principle applies to the pallet once
completed. Most vendors offer a
mode which if the last case is partial
or the last pallet is partial, it is possible
to ask the system to print a label
anyway even if the case or pallet is
not completed.

Page
43
Carton Case Packer
Aggregation
Serialization Track & Trace
Page 44
Case Packer Aggregation
There are several ways to do aggregation
at the case packer level.
The first option (A), is to add the cameras
within the pushing plates and each time it
pushes a layer the codes are read. The
serial numbers must always be on the
same side to work. This option has a low
risk since they are inside the case packer
and there is often room to install the
cameras. On the other hand if one carton
is misread the full case will need to be
rejected.
Option (B), can inspect the carton row by
r ow on ei t her si de. Thi s opt i on i s
independent of the pushing plate, size
and artwork does not need to be
changed. On the other hand it is harder
to find room for the cameras.
Option (C), is a carton per carton
i ns pect i on. You need t o have a
mechanism to space each of them. The
case packer will need to communicate
with the camera to maintain the first in first
out order. This option only requires one
camera and allows the serial number to
be pre-printed anywhere on the box. You
need to make sure there is enough room
to fit the required hardware.
Serialization Track & Trace
Page 45
Option A: Layer by Layer
Inspection (1/2)
Concept
Cameras mounted on
pushing plate
Acquisition after each layer
push
Serial Number must be on
visible side of the carton
Serialization Track & Trace
Page 46
Option A: Layer by Layer
Inspection (2/2)
Pros
Lowest Risk
Easier to fit cameras
No impact on speed
Cons
More cameras
Valid only if one plate for all
products
Full case is ejected if one
carton is not read
Serialization Track & Trace
Page 47
Option B: Row by Row
Inspection (1/2)
Concept
Cameras mounted
to inspect full row
prior to be piled up
Acquisition of each
row
Useful if Serial
Number is located
toward case bottom
Option to eject full
row avoids whole
case ejection
Serialization Track & Trace
Page 48
Option B: Row by Row
Inspection (2/2)
Pros
Independent from
pushing plate size
S/N on front or rear
carton face
Less cameras than full
layer
Cons
Harder to find room for
cameras
Full row ejection is
complex
Serialization Track & Trace
Page 49
Option C: Carton by Carton
Inspection (1/2)
Concept
One Camera at entrance
Mechanism to space the
incoming cartons
Only the cartons in the
current row gets in
Ejection right after camera
Serialization Track & Trace
Page 50
Option C: Carton by Carton
Inspection (2/2)
Pros
Only one camera
Allows S/N on top,
front, rear
Not a FIFO, cartons
are inspected once
inside
Cons
Spacing mechanism
required
Enlarges the machine
size
Page
51
Label Artwork
Serialization Track & Trace
Page 52
The following pages are examples of
serialized labels which include all the
necessary information. On the right it
contains the lot number, the expiry date
and the serial number.
The 2D code contains the GTIN and the
serial number, optionally it may carry the lot
and expiry date. In Turkey, for example, the
2D codes need to have the lot and expiry
date embedded as well.
Label Layout Consideration
Serialization Track & Trace
Page 53
Label Layout Consideration
Label for serialized products need to be modified to
accommodate new information
Serialization Track & Trace
Page 54
Various Configurations are
Possible
In the following example, the blank area may
need to be enlarged to fit more information.
Sometimes changing the artwork can take a
long time because of the validation. It is a
good idea to start looking at this now and
make sure there is enough room to fit all the
required information.
In this option 13 mm x 22 mm is enough to
contain all the information. You reduce to 10
mm x 28 mm assuming you have the lot and
expiry date printed somewhere else on the
carton.

Serialization Track & Trace
Page 55
Minimal Blank Area Size for
California
Data Matrix 18x18 (0.4mm/module) with the following code:
<fnc1>01106141410001322112345678901
7.2mm
LOT 12345678
8
m
m
1.6mm
EXP 150228
SN 12345678901
26.5mm
Zone for Print Instability
??mm
(Application Related)
FONT: OCR B (Size 6)
Serialization Track & Trace
Page 56
Minimal Blank Area Size for
Europe, Turkey, India
Data Matrix 22x22 (0.4mm/module)
<fnc1>01106141410001321012345678<fnc1>171502282112345678901
LOT 12345678
9
.
6
m
m
1.6mm
EXP 150228
SN 12345678901
35mm
Zone for Print Instability
??mm
(Application Related)
FONT: OCR B (Size 6)
GTIN 10614141000132
8.8mm
Serialization Track & Trace
Page 57
Minimal Blank Area Size for
Europe, Turkey, India
Data Matrix 22x22 (0.4mm/module)
<fnc1>01106141410001321012345678<fnc1>171502282112345678901
LOT 12345678
1
2
m
m
1.6mm
EXP 150228
SN 12345678901
29mm
FONT: OCR B (Size 6)
GTIN 10614141000132
Zone for Print Instability
??mm
(Application Related)
8.8mm
Serialization Track & Trace
Page 58
In terms of bundles, cases and pallet labels.
T he HDMA ( Heal t hcar e Di s t r i but i on
Management Association) has established a
gui dance t o hel p phar maceut i cal
companies with their artwork. They suggest 3
bar codes on each label.
The first 1D code carries the AI(17) which is
the expiry date, the AI(10) which is the lot
number and the AI(30) which is the quantity.
The bottom 1D code carries the GTIN (01)
which is the shipping container code and the
serial number AI(21).
Finally the 2D code on the right hand side will
contain all the above information (expiry
date, lot number, quantity, GTIN and serial
number).
For the pallet, the standards have not
changed. You still need to carry a unique
SSCC and a linear 1D bar code will be
sufficient.

Case Labels
Recommendations by HDMA
Serialization Track & Trace
Page 59
Case Labels
Recommendations by HDMA
Page
60
IT Implementation
Serialization Track & Trace
Page 61
In serialization the packaging line needs to connect
with the local IT interface. In this product flow, the
product goes from packaging, then transfers to the
warehouse or DC and eventually to the customer
or distribution partners. You will need a centralized
server to record what was done at the packaging
line, the warehouse and up to the point where it will
be shipped. With some regulations, you also need
to send an ePedigree which contains all the history
of the product.

This ePedigree needs to be populated through the
remainder of the supply chain. Eventually you will
need to connect to a government agency and tell
them which serial numbers will be shipped to which
country.

In the three main modules, you will always find on a
centralized server for a serialized line, providing
serial numbers to the packaging line as well as the
warehouse in case there is rework occurring, i.e.
splitting a pallet in two or new serial numbers
needed. The server needs a serialization data
capture module into an EPCIS repository and finally
a connection to the warehouse and DC.

Serialization Plant Server
Serialization Track & Trace
Page 62
Serialization Plant Server Role
Serial Number Provider
Serialization Data (EPCIS
Repository)
Warehouse and DC
Serialization Track & Trace
Page 63
EPCIS Allows Serialization Data Transfer
Between Different IT Platforms
Serialization Track & Trace
Page 64
European Centralized Database Model
Serialization Track & Trace
Page 65
EPCIS Event Recorded
Information
WHO
Ship-From, Ship-To
WHAT
Products, Units,
Disposition, Relationships
WHERE
Locations, Warehouses,
Rooms
WHEN
Time, Date
WHY
Commissioned, Packed,
Shipped, Received
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At the packaging line level there are
different events that need to be recorded.
While the following graphic may look
complex, it is actually simple. Lets look at
scenario (B) as it is the most common
scenario. Imagine that you have a bottle
line with a labeler, that a 2D is applied on
the web prior to being applied on the
bottle.
Each square represents an event recorded
in the database with that status. When a
serial number is printed we record a status
as encoded, then on the web they get the
status inspected and finally, the label is
applied to the bottle and commissioned
becoming active.
Listed below are 3 steps which are the most
of ten f ound f or a bottl e l i ne l abel
application, there is also a timestamp to
record the aggregation. You can also have
other events, such as destroyed, when the
product is no good and not to be sold this
status i s per manent and cannot be
changed. Inactive, which is similar to
destroyed will not allow a product to be
packaged but can be re-activated if
needed.
Finally, you have custom disposition to
manage real operation on the line. For
example, QA Sample, to record the specific
serial number used for quality purposes and
the same can applied for label sampling.
EPC Disposition Flow
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Typical IT Architecture
For a company that has several plants, the
first layer, at the corporate level, is the serial
number provider for the packaging lines or
opti onal l y thr ough a mi ddl e war e,
TrackSafe Server, that could have its own
serial number manager. The purpose of this
middleware will be to cache serial numbers
if the corporate server is down, then the
line can keep producing and serializing
products.
At the line level, you need to have at least
one system, here the LineMaster, which
communicates to get serial numbers and
to send back a serialization report. This
system will also connect with all the printers
so you will not need to configure each
printer separately as the settings are
coming directly from the master system
and they provide the correct serial number
to the proper products. You will need a
vision controller to control the cameras and
the ejection station.

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Typical IT Architecture
with a Contract Packer
Another scenario that can happen is when a
contract packer is packaging for several
customers and each customer is working
with numerous contract packers. This will
enable the same product to be packed by
different contract packers.
At the contract packers level you will need
to have a plant server that will change to the
right customer when its time to retrieve serial
numbers and send the final report to the
repository.

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Serial Number Management
When we spoke about seri al number
management, we introduced the possibility to
have a serial number cache. Lets take for
example a product that has never been
serialized.
The first thing that happens is to request from
the serial number provider 100,000 serial
number. This number is fully configurable.
Since this product has never been serialized,
we are getting numbers from 000001 to
100,000. Then the printer starts printing the
label with these serial numbers. Lets say that
the first batch, Line 1 is packaging 40,000
products.
This means all numbers from 000001 to 40,000
have been printed. The cache has now
60,000 serial numbers left. The next time this
product will be packaged, the first serial
number to be used will 40,001.

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Serial Number Management
Remember that each product has its own
cache. Lets pretend that the same product
is now packaged on a different line. Similar
to what happen on Line1, there will be a
request to fill the cache with a range of serial
numbers.

Now the next range available is between
100,001 to 200,000. The labels will be printed
on this line and serial numbers will be used.
Now in the warehouse you will have the same
product with two different ranges of serial
numbers, meaning you cannot utilized the
serial numbers to see how old a product is.
You will need to scan the product to find all
the information related.

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Serial Number Management
Now if Line 1 continues to use its serial
numbers, it will eventually reach the minimal
threshold. The system will automatically refill
the serial number cache up the desired
level, 100,000 in this case.
Since the serial number range has already
been allocated to Line 2, the new range will
be from 200,001 to 250,000. This means that
one day, on your conveyor, you will have
one bottle or carton with the serial number
100,000 and the next one will be 200,001. This
is fine, but serial numbers should not be
utilized to do reconciliation. Normally a good
solution will give a true reconciliation report.

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Serialization allows you to have
the capability to provide very
accurate reports. With all the
s t e p s , t i me s t a mp s a n d
i nf or mat i on, r epor t i ng i s
si mpl i fi ed. Reconci l i ati on,
performance and inspection
reports are available for each
product.

Timestamps Lead the Way to
Various Batch Production Reports
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Timestamps Leads the Way to
Various Batch Production Reports
Reconciliation Reports
Performance Reports
Statistical Analysis
Page
75
Conclusion

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What Makes a Serialization
Project Successful?
Validation and Integration length
Line Setup Time
Maintain the Line Efficiency
Rework Operations
Aggregation Inspection Risk
Plan Ahead of Time
Plan Label or Carton Artwork
Plan Topsert Modifications
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Bring the Right Team
Together, from the Beginning

Project manager (internal)
Validation
Packaging line engineer
Line Operator
IT
Label control
Logistics (warehouse)
Page
78
About Optel Vision

Serialization Track & Trace
Page 79
For over t wo decades , hundr eds of
pharmaceutical companies around the globe
have trusted Optel Visions highly reliable
automated vision systems to significantly
reduce health risks associated with mislabeled
products, dosage errors and product mix-ups.
With Optel Vision, the industry not only benefits
from our extensive experience in packaging
line inspection and serialization systems, but
al so wi th our unmatched passi on for
innovation. Optel Visions dedicated teams
have developed a unique online serialization
application to improve the pharmaceutical
man u f ac t u r e r s abi l i t y t o r e du c e
counterfeiting and further enhance patient
safety.
Optel Visions continuous investment in
researching new cutting edge technologies
guarantees that our customers receive the
most innovative solutions to meet their
challenging needs.

Who is
Serialization Track & Trace
Page
Who is
Worldwide Supplier in the Pharmaceutical Industry
23 years of expertise in turnkey solutions for Software, Optics,
Mechanics and IT Solutions
Over 140 employees
80
Major global
provider of
Track & Trace
with complete
EPCIS repository
server
Serialization Track & Trace
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Pharmaceutical Inspections Portfolios
PharmaProof
BlisterSafe
VialSafe
CountSafe for
Slat Counter
CountSafe for
Electronic Counter
TabletProof 360
TrackSafe
Serialization Track & Trace
Page 82
www.optelvision.com