THE LUNDBECK SERIALIZATION JOURNEY SO FAR.

Transcription

1 THE LUNDBECK SERIALIZATION JOURNEY SO FAR. DAu Conference, Hilleroed October 2014 Presented by Henrik Broholm, Senior Specialist, Pharmaceutical Engineering

2 Brief Overview in bullets H. Lundbeck, who are we? The beginning of the Journey The beginning The start up & Requirements The Project Our current system The Print file Reading and decoding 3rd Generation Electronic Supervision Codes Initial set-up, Briefly Questions if any?

3 Product Flow with Serialization and Aggregation Internal Packaging Customers Batch with Internal or External Serialization and Aggregation Externals Suppliers Batch with Internal or External Serialization and Aggregation X X X X X Data Handling Complete Batch with Aggregation file Batch Split Warehouse Country A Country B X Reaggregation Aggregation file prepared for Authorities Physical Order X Transport X Full Track & Trace during Transport TBD X Data Files to Authorities

4 LUNDBECK IN BRIEF We are an international pharmaceutical company specializing in central nervous system disorders Founded by Hans Lundbeck in 1915 An integrated company with core competencies in research, development, production, marketing and sales International presence with pharmaceuticals in more than 100 markets Marketed pharmaceuticals include treatments for Alzheimer s disease, depression and anxiety, epilepsy, Huntington s disease, Parkinson s disease and schizophrenia/bipolar disorder and more Headquarters in Copenhagen, Denmark Approximately 6,000 employees in 57 countries 2013 revenue: DKK 15.3 billion (approx. EUR 2.1 billion/usd 2.6 billion) SHINGO Silver medallion awarded in 2012 as the first European company 4

5 Where are we located? Headquarter Packaging facilities 5

6 What or Who started this? Requirement from TR MoH arrived in draft Originally from D matrix code, serial number and GTIN number were a requirement What was the specific demands at that point?

7 Initial requirements 2D matrix code Serial number GTIN number All applied on Single Pack Bundle Shipping box Pallets Data transferred to MoH when shipped

8 Final requirements What the initial requirement ended up with? 2D Matrix Code Serial number GTIN number Applied on single packs only And data transferred upon request

9 Start up How to do it By external partner/warehouse? At Lundbeck owned warehouse? Online on the packing line? Business case including all three options

10 Essentials from business case Installation on all packing lines and CMO s (9 lines) Implementation from Q to Q Investment of Break even after three years

11 Prerequisites One overall IT system in Lundbeck: SAP Master data management already handled in SAP Changes to packing material already handled in SAP Serial number generator already present in SAP Printing technology on Packing lines already linked to SAP In house know how regarding printing technology and programming in SAP

12 Project plan detailed level

13 The beginning of serialization.. HLu Business requirement to introduce serialization on some strategic products was introduced in 2008 Project Team initiated, Supply, Production, IT Only serialization on carton boxes was decided GS1 ECC 200 2D datamatrix coding/system was chosen Internal or external system was evaluated Discussions with different suppliers Turkey s MoH requirement was introduced Change of scope to fulfill Turkish requirement s First set-up decided, (Functionality, interface, equipment etc.) URS written Pilot project initiated incl. 1 Pilot CMO was chosen

14 Our current setup The system

15 How to handle in Production Order released for production Serial numbers for the specific order Generated Automatically in SAP Production order initiated at packing line On line printing system automatically receives serial number including other printable data

16 Operation Packaging line Operator is entering SAP transaction ZPRINT from the desktop PC at the packaging line

17 The printfiles Example of a file with 2D matrix code and serialization: Example of a file with exp., lot and price:

18 Transfer to the printers and vision systems, (The program) We re using a customized interface for the communications with the printer and vision system The program is named Print & Verification The program is installed on a standard HLu desktop PC which is located at the single packaging line This PC is installed with 2 pcs. ethernet connections: One for the HLu network, (to be able to reach the shared folder) One for the internal network between the desktop PC, the printer and the vision system

19 Print & Verification, (In Danish only, sorry...) Start screen: Start print:

20 Continued. Pause: Line Clearence: Finalizing and deleting the file

21 Reading, decoding, grading and score The vision system for controlling the single print:

22 Reading, decoding, grading and score The vision system for controlling the single print:

23 Reading, decoding, grading and score The 2D data matrix code is a GS1 ECC 200 Minimum printed size is 9x9mm Grading according to ISO 15415, min. grade C, (dynamic grading) Static grading according to ISO performed during validation with Axicon 2D verifier.

24 Axicon Test Grade A

25 Axicon Test Grade F

26 The First experiences We did recognized a quite high level of rejects when producing with serialization and 2D data matrix, often >5% Mainly due to poor quality of the 2D code, modulation and contrast Dust in nozzles at the HP cartridge, (coming from the cartons) Alignment of cartons during conveying of cartons Repeated serial numbers occured The access to the database was to easy whenever some problems occured and then it was resetted Foreign PC on the network, no access to registration database etc. CMO Extranet solution was running to slow when generating the print files Purchasing a 2D verifier, (ISO compliant), Axicon

27 2nd Generation

28 The 3rd generation Introducing the 3rd generation we changed the equipment and setup New Inkjet printers, Wolke M600 Advanced and Domino G-series both using the HP cartridge technology Installing both the printer and the vision system inside our carton machines

29 3rd Generation, (Current)

30 Our system as of today Still using SAP as the main generator Using the interface called Print & Verification Everything operated at the Packaging line by operators All data s are automatically loaded into the systems No start/stop on printer requried No teach in of the vision system required Only a few mouse click for ready to go Very low rejection rate, normally less than 1% Still only printing at one level only, (no aggregation) Readback files are stored in our system

31 EU System 31

32 Electronic Supervision Codes, China H. Lundbeck will be affected by the SFDA required E-Codes for one product Regulation says; E-codes applied on this product by the beginning of 2014 Regulations says; Electronic Supervision Code must be applied on all drugs before 2015 First finished goods with e-codes are planned to be shipped by the end of November 2013 One packaging line, (in this case located in France), is being upgraded to secure delivery and to get and gather experience

33 Electronic Supervision Codes, China

34 Electronic Supervision Codes, China Lundbeck EasyShare FTP server Download/ upload from SFDA Download and distribution of files) FTP Server, Carton supplier Site Server (virtual) Future lines (L6, L9, L10) L7 Working station Warehouse Working station send XML files Interface to SAP (optional) QA Connection for batch release before shipment

35 Electronic Supervision Codes, China Three different codes can be used: Type A Type B Type C We have chosen the most simple one, Type A:

36 Questions? Henrik Broholm H. Lundbeck A/S Mobile: