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Serialization Technology -Seidenader: Integral Solution Provider
SindusfarmaAugust, 28th 2013
Dr. Stefan Loelkes
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Agenda
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Your challenge
Products
Integral solution provider
Company overview
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Your challenge
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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
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013 8/29/2013
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But you are not alone ...
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Seidenader Serialization:
since 2008 / 2009
worldwide > 380 machines
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Who are we?
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Starter: You & your challenge
Products
Integral solution provider
Company overview
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
The Structure of the Körber Group
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Hauni Maschinenbau AG
Tobacco
Körber Schleifring AG
Machine tools
Körber AG
PharmaceuticalPackagingSystems
Körber Medipak GmbH
Körber ProcessSolutions GmbH
Tissue, Automation,
Intralogistics, Mailing
sales: EUR 2 bn / employees: 9,600 / equity capital: 67% / return on sales: 11.4%
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Körber Medipak
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•Körber Medipak stands for integrated Packaging and Inspection Solutions, Technologies and Services for the Healthcare Industry.
•Pharma Technology•Packaging and
Inspection Machines
•Pharma Materials•Packaging Development
and Materials
•Pharma Services•Contract Manufacturing,
Packaging, Full-Service
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
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
Markets 95% pharmaceutical industry
– worldwide
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•Headquarters Markt Schwaben / Germany
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
KMNA / USATechnical center for service
and maintenance
Seidenader Headquarters: Markt Schwaben / Germany
Germany
IndiaLocal staff for service and
maintenance
Turkey1 service technician
Global Service
Support through factory trained Seidenader employees in key markets.
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Brazil / MaquidrexLocal support, service and
maintenance
Rieckermann / China / Thailand / VietnamSeidenader trained
technicians
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
The Structure of Seidenader
Seidenader is organized in two business units:
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BUTrack&Trace
BUInspection Machines
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
How do we work?
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Starter: You & your challenge
Products
Integral solution provider
Company overview
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013 8/29/2013
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Seidenader Industry Position
Comprehensive track and trace solutions from one single source
Project engineering Software
Hardware incl. machine building
Service
Documentation/ validation
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
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Project Delivery MethodologyOrganization
Our organization matching your organization
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Seidenader PDM (Project Delivery Methodology)
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Elements of Project Delivery Methodology
Sales Project Initiation Specification andDesign Implementation Integration on
Site Support
Processes andactivities
Documents
Quality Gates
Sta-tus
Sta-tus
Sta-tus
Sta-tus
Compliant with GAMP5
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Products
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Starter: You & your challenge
Products
Integral solution provider
Company overview
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013 8/29/2013
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Seidenader Single Unit
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 3rd party
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Integration in Bundler / Case packer / Palletizer
End off line solutions based on Manual work stations Integrated solutions (automatic)
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Main work: Clarification with3rd party equipment
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Easy-to-use softwareSettings for cams
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Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Easy–to-use softwarePM2.0 Manual Bundle Aggregation
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Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
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Seidenader Line Server LS
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Line ServerSerial Number Management
User InterfaceState Line
Line StartupProcess Handling
Process Unit 1Process Handling
Process Unit 2Process Handling
Devices- Printer- Scanner- Camera
Devices- Printer- Scanner- Camera
Devices- Printer- Scanner- Camera
Line Network Control all machines & devices of 1 line
Status of all all connecteddevices
Doing the batch work
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013 8/29/2013
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Seidenader Multi Line Server MLS
Interface to upper IT systems(ERP, MES, ...)
Centralized site administration
Central serial number serverfor all lines
Connect up to 15 lines
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Seidenader as Solution Provider
Product to project: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
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A Seidenader solution is more thanonly equipment or software!
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
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
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Thank you for listening!
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
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Thank you for listening!
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
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Backup
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Brands of Körber Medipak
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Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
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International T&T Requirements
not finally specified in progress already in place
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Customer solution
Seidenader T&TNew ePedigree Architecture
80% - Standard software
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ProcessManager Platform
*optional
20% - Custom
Standard Modules
• 15% Configuration• 5% Customization
• Re-usable standard modules• Robust process automation platform
M.. M.. Mn
M.. M.. M..
M4 M.. M..
M1 M2 M3
C1 C2 Cn
Configuration
Sindusfarma Convention, Sao Paulo Brazil – Dr. Stefan Loelkes © Seidenader Pharma Technology Solutions, 2013
Process Manager Extension Unit Example
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Cartoner
Case Packer
Palletizer
Process ManagerMain Station
Multi-Line Server
PM ExtensionItem
PM ExtensionEnd-of-line
PM ExtensionRework / QA