February Seidenader Maschinenbau GmbH Christian Frenz, Product Manager T&T

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2 Track&Trace Seidenader Maschinenbau GmbH

3 Why serialization? 3

4 Why serialization? Some facts on the counterfeit drug market (based on WHO information) Global Drug Market (billion US-$) 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 people die every year due to treatment with counterfeit drugs 100 Pharmaceutical Market 400 Counterfeit Drug Market 4

5 Existing and Upcoming Regulations USA Serialization: Aggregation: GS1 Datamatrix Europe Serialization*: Aggregation: Not req. GS1 Datamatrix India Serialization: Aggregation: Serial on tert. pack GS1 Datamatrix, Code 128 Brazil Serialization: Aggregation: GS1 Datamatrix Turkey Serialization: Aggregation: GS1 Datamatrix China Serialization: (all) Aggregation: (all) Code 128 Argentina Serialization: Aggregation: Not req. GS1 Datamatrix Saudi Arabia Serialization: Aggregation: Not req. GS1 Datamatrix South Korea Serialization: Aggregation: GS1 Datamatrix, RFID, Code 128 * incl. Tamper Evident feature 5

6 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 6

7 Seidenader Track&Trace Solutions Integration of Seidenader Track&Trace Solutions into existing and new packaging lines Integrated solutions Flexible marking and verification 7

8 Seidenader Track&Trace Solutions 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 8

9 Seidenader Track&Trace Solutions 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. Customer Project Standard Products Standard Jobs Manual configuration and adaption Standard 9

10 Seidenader Track&Trace Solutions Customer Project Customer A Customer A Customer A B Customer B Customer B Customer B Customer C Manual configuration and adaption Multi Line Manager Standard Products Line Controller Standard Item Expert Bundle Expert Case Expert Pallet Expert Standard Jobs Serialization Aggregation Rework Data Transfer Data Capture 12

11 Seidenader Track&Trace Solutions 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 China (Code 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

12 Seidenader Track&Trace Solutions Integration into 3 rd 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 3 rd party machines. References 14

13 Global Installed Base Europe ItemUnits: 233 Aggregation: 21 North America ItemUnits: 13 Aggregation: 8 Latin America ItemUnits: 3 Aggregation: 1 Asia ItemUnits: 7 Aggregation: 4 Middle East ItemUnits: 44 Aggregation: 20 15

14 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 16

15 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) 17

16 Seidenader Track&Trace Solutions 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 18

17 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 3 rd party machines Sites: Kundl, Austria Unterach, Austria Tagu Mures, Romania Rudolstadt, Germany Holzkirchen, Germany Boucherville, Canada 19

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