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February 2016
Seidenader Maschinenbau GmbH – Christian Frenz, Product Manager T&T
1
Track&Trace
Seidenader Maschinenbau GmbH
Why serialization?
February 2016
3
Why serialization?
Some facts on the counterfeit drug
market
(based on WHO information)
 Total market volume expected to
exceed 100 billion dollars
 30% of all sold drugs in Asia,
Africa and Latin America are
counterfeits
 About 1% in the western world
 Up to 100.000 people die every
year due to treatment with
counterfeit drugs
February 2016
Global Drug Market
(billion US-$)
100
400
Pharmaceutical Market
Counterfeit Drug Market
4
Existing and Upcoming Regulations
USA
Serialization:11.2017
Aggregation: 11.2023
GS1 Datamatrix
Europe
Serialization*:02.2019
Aggregation: Not req.
GS1 Datamatrix
India
Aggregation: Serial on tert. pack
GS1 Datamatrix, Code 128
Brazil
GS1 Datamatrix
Turkey
GS1 Datamatrix
China
Serialization: 12.2015 (all)
Aggregation: 12.2015 (all)
Code 128
Argentina
GS1 Datamatrix
Saudi Arabia
Serialization: 03.2016
GS1 Datamatrix
South Korea
Serialization: 01.2015
GS1 Datamatrix, RFID, Code 128
* incl. Tamper Evident feature
February 2016
5
Seidenader Track&Trace Solutions
Comprehensive Track&Trace
Solutions from one single source
for the whole packaging line
 Consulting/Feasibility
 Software
 Hardware incl. machine
building for item level
 Project engineering
 Service
 Documentation
 Training
 Life Cycle Management
February 2016
6
 Integration of Seidenader
Track&Trace Solutions into
existing and new packaging
lines
 Integrated solutions
 Flexible marking and
verification
February 2016
7
Serialization/aggregation on each packaging level!
Seidenader has been implementing for more than six years Track&Trace
Solutions and provides this experience in a reliable modular software
solution to realize serialization and aggregation on each packaging level.
Focus
 Reduce integration effort
 Use Seidenader Track&Trace Solutions know-how
 Adapt flexibly to customer needs
February 2016
8
Reduction of project
implementation effort leads to
significant reduction of downtime
 Standard jobs are solved with
standard products
 Standard functionality covers
approximately 80% of all
customer requirements
 Customer specific project
requirements can be easily
realized through configuration by
adapting templates and manual
adaption.
February 2016
Customer
Project
Manual configuration
and adaption
Standard
Products
Standard
Standard
Jobs
9
Customer
Project
CustomerBB
Customer
Customer
B
CustomerAA
Customer
Customer
A
CustomerBB
Customer
Customer
C
Manual configuration
and adaption
Multi Line Manager
Standard
Products
Line Controller
Standard
Item Expert
Standard
Jobs
February 2016
Bundle Expert
Case Expert
Aggregation
Serialization
Rework
Data
Transfer
Pallet Expert
Data
Capture
12
Requirements of different target markets
(e.g. Turkish Coding, French Coding, China SFDA eCode)
Seidenader offers flexible hard and software solutions for country specific
coding requirements.
Turkey (DMC + 4 lines text)
• GS1-DataMatrix Code
• GTIN
• Serial Number
• Expiration Date
• Lot number
February 2016
China (Code-128 + SFDA eCode)
• 128C barcode
• 20 digit serial number
• 9 digit government issued
serialized number
France (DMC + 3 lines text)
• GS1-DataMatrix Code
• CIP-13
• Expiration Date
• Lot number
13
Integration into 3rd party machines
Seidenader work with global and local packaging solution providers and
integrate hard and software solutions with the full feature set and proven
stability into 3rd party machines.
References
February 2016
14
Global Installed Base
Europe
ItemUnits: 233
Aggregation: 21
North America
ItemUnits: 13
Aggregation: 8
Asia
ItemUnits: 7
Aggregation: 4
Latin America
ItemUnits: 3
Aggregation: 1
Middle East
ItemUnits: 44
Aggregation: 20
February 2016
15
ItemUnit
Seidenader ItemUnit features
 Print and verification at secondary packaging
 Serialization
 Batch information
 Check weighing
 Leaflet presence check
 Foreign objects check
 Label application and verification
(content, presence, position)
 Tamper evidence
February 2016
16
AggregationUnit
Seidenader AggregationUnit features
 Seidenader Event-Based Aggregation Process Configuration
 Event-Modules for flexibility
 Configuration based aggregation
 Reduced delivery time
 Print and verification at each
packaging level
 Serialization
 Batch information
 Label application and verification
(content, presence, position)
February 2016
17
Manage multiple lines and centralized data management!
With Seidenader Multi Line Manager it is possible to control and to
manage multiple lines from one terminal – also as web application
Manage all production relevant data from one web based central access
point
 Serial number management
 Central interface to MES/ERP/SMS
 Recipe management
 Batch management and information
 User management
 Report management
 Line administration and information
February 2016
18
Success Story Sandoz
Global Sandoz Track&Trace Core Program by Seidenader




Over 40 Track&Trace lines in the next three years
Installations with Multi Line Manager, Serialization and Aggregation
Many integrations into 3rd party machines
Sites:
 Kundl, Austria
 Unterach, Austria
 Tagu Mures, Romania
 Rudolstadt, Germany
 Holzkirchen, Germany
 Boucherville, Canada
February 2016
19
February 2016
20

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