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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


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


Who are we?

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Starter: You & your challenge

Products


Company overview


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%


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


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


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


The Structure of Seidenader

Seidenader is organized in two business units:

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BUTrack&Trace

BUInspection Machines


How do we work?

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Products


Company overview


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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


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Project Delivery MethodologyOrganization

Our organization matching your organization


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


Products

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Products


Company overview


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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


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


Easy-to-use softwareSettings for cams

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Easy–to-use softwarePM2.0 Manual Bundle Aggregation

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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



Line Network Control all machines & devices of 1 line

Status of all all connecteddevices

Doing the batch work


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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


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!


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!


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Thank you for listening!


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Backup


Brands of Körber Medipak

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International T&T Requirements

not finally specified in progress already in place


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


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