Serialization Technology - Seidenader: Integral Solution Provider

Transcription

1 Serialization Technology - Seidenader: Integral Solution Provider Sindusfarma August, 28th 2013 Dr. Stefan Loelkes

2 Agenda 1 2 Your challenge Company overview 3 4 Integral solution provider Products 2

3 Your challenge Comply with a partially unknown regulation Implement new serialization equipment and/or Change existing equipment / lines with limited space Interface with existing IT systems You need a solution, not only equipment 3

4 But you are not alone... Seidenader Serialization: since 2008 / 2009 worldwide > 380 machines 4 4

5 Who are we? 1 2 Starter: You & your challenge Company overview 3 4 Integral solution provider Products 5

6 The Structure of the Körber Group Körber AG sales: EUR 2 bn / employees: 9,600 / equity capital: 67% / return on sales: 11.4% Tobacco Tissue, Automation, Intralogistics, Mailing Machine tools Pharmaceutical Packaging Systems Hauni Maschinenbau AG Körber Process Solutions GmbH Körber Schleifring AG Körber Medipak GmbH 6

7 Körber Medipak Körber Medipak stands for integrated Packaging and Inspection Solutions, Technologies and Services for the Healthcare Industry. Pharma Technology Packaging and Inspection Machines 7 Pharma Materials Packaging Development and Materials Pharma Services Contract Manufacturing, Packaging, Full-Service

8 Company Profile - Seidenader Founded 1895 Employees 350 Products Inspection machines for injectables and tablets Vision systems in pharma packaging lines Track and trace solutions Operator interface and data management systems Headquarters Markt Schwaben / Germany Markets 95% pharmaceutical industry worldwide 8

9 Global Service Support through factory trained Seidenader employees in key markets. Seidenader Headquarters: Markt Schwaben / Germany Turkey 1 service technician Germany KMNA / USA Technical center for service and maintenance Rieckermann / China / Thailand / Vietnam Seidenader trained technicians 9 Brazil / Maquidrex Local support, service and maintenance India Local staff for service and maintenance

10 Seidenader is organized in two business units: The Structure of Seidenader BU Inspection Machines BU Track&Trace 10

11 How do we work? 1 2 Starter: You & your challenge Company overview 3 4 Integral solution provider Products 11

12 Comprehensive track and trace solutions from one single source Seidenader Industry Position Project engineering Software Hardware incl. machine building Service Documentation / validation 12

13 Project Delivery Methodology Organization 13 Our organization matching your organization

14 Seidenader PDM (Project Delivery Methodology) Elements of Project Delivery Methodology Sales Project Initiation Specification and Design Implementation Integration on Site Processes and activities Documents Quality Gates Status 14 Status Status Status Compliant with GAMP5 Support

15 Products 1 2 Starter: You & your challenge Company overview 3 4 Integral solution provider Products 15

16 Seidenader T&T Single Unit Printing and verification (serialization) With label applicator (e. g. Bollini) - option tamper evidence (product security) also integration of printer & cams in 3 rd party Seidenader Single Unit 16

17 Integration in Bundler / Case packer / Palletizer End off line solutions based on Manual work stations Integrated solutions (automatic) Main work: Clarification with 3rd party equipment 17

18 Easy-to-use software Settings for cams 18

19 Easy to-use software PM2.0 Manual Bundle Aggregation 19

20 Seidenader Line Server LS Line Server Serial Number Management User Interface State Line Line Startup Process Handling Line Network Control all machines & devices of 1 line Status of all all connected devices Process Unit 1 Process Handling Process Unit 2 Process Handling Doing the batch work - Printer - Scanner - Camera Devices - Printer - Scanner - Camera Devices - Printer - Scanner - Camera Devices 20

21 Interface to upper IT systems (ERP, MES,...) Seidenader Multi Line Server MLS Centralized site administration Central serial number server for all lines Connect up to 15 lines 21

22 Product to project: Seidenader as Solution Provider Standard design => modular setup => configured & customized Comprehensive track and trace solutions from one single source Project engineering & management Own hard- and software Servers & interfaces to other IT systems Own maintenance & service Documentation Validation support A Seidenader solution is more than only equipment or software! 22

23 References Global Partners (multiple applications) Novartis Bayer Schering Plough Boehringer Ingelheim Roche DHL Sanofi Teva GlaxoSmithKline Merck Sharp & Dohme Sanofi Pasteur Acino Pharma AG Bristol-Myers Squibb Sandoz Ferring 23 Thank you for listening!

24 Thank you for listening! 24

25 Backup 25

26 Brands of Körber Medipak 26

27 International T&T Requirements not finally specified in progress already in place 27 27

28 Seidenader T&T New epedigree Architecture Customer solution Configuration C1 C2 20% - Custom Cn 15% Configuration 5% Customization Standard Modules M1 M2 M3 M4 M.. M.. M.. M.. M.. M.. M.. Mn 80% - Standard software Re-usable standard modules Robust process automation platform ProcessManager Platform 28 *optional

29 Process Manager Extension Unit Example Multi-Line Server PM Extension End-of-line PM Extension Item Palletizer Case Packer Cartoner PM Extension Rework / QA Process Manager Main Station 29