EVOLUTION OF TECHNOLOGY · Liquids / Parenterals / Emulsions •Sterile solutions •Non-sterile solutions •Stationary and mobile preparation vessels •Sterile filtration •Integration

EVOLUTION OF TECHNOLOGYCustomised technology for pharmaceutical and biotechnological plants

www.zeta.com Evolution of TechnologyPage 2

ZETA Group

• Key supplier of biotechnological and pharmaceutical process equipment and services

• Established in 1989, more than 25 years of experience

• Headquarters in Lieboch/Graz, Austria, Europe

• Worldwide presence through branches and partners

• More than 515 employees, whereof 300 are engineers

ZETA Subsidiaries

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ZETA GmbHMünchner Straße 8, D-85354 Freising

Im Thal 8, D-82377 Penzberg

ZETA Alro AGMoosweg 36, CH-5606 Dintikon

OOO ZETA RussiaProspekt Mira, 104, Bld. 2, Office 30

RUS-129626 Moscow

ZETA GmbHZetaplatz 1, A-8501 Lieboch/Graz

Römerstraße 42, A-8403 Lebring/Graz

Graumanngasse 7/B4-2, A-1150 Vienna

ZETA CZ s.r.o.Modřická 66, CZ-664 48 Moravany

OOO ZETA UkraineKievskaya Str. 2, Office 28

UA-21009 Vinnica Ukraine

ZETA Sales Partner


PharmAseptic, USA

Robert Miotke, USA

Nordic Engineering ApS, Denmark

IGE Ingenieros sl., Spain

QS Group, Italy

Pharmasep, France

IDL Technological Materials & Sytems, Turkey

ZETA India, India

Xact Engineering, Singapure / Malaysia

Andgel Industrial (Shanghai) Co., Ltd., China

JID Corp, South-Korea

ITOCHU MACHIE-TECHNOS CORP., Japan

Attra Giand Industrial Co. Ltd, Taiwan

Biopharma Process

page 5 Evolution of Technologywww.zeta.com

Our Core Competences


ZETA is specialised in designing, engineering,

development, manufacture, automation and

maintenance of customised process solutions for

liquid aseptic applications.

Page 7 Evolution of Technologywww.zeta.com

ZETA Lifecycle

ZETA – Solution Path


www.zeta.com/solutionpath/

http://www.zeta.com/solutionpath/

http://www.zeta.com/solutionpath/

Business Lines

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• USP Systems:

Fermentation,

Media/Buffer

Preparation

Harvest

• DSP Systems:

Filtration,

Chromatography,

Buffer Preparation

• Solution

Preparation

Systems

• Clean Media

Systems

• CIP/SIP Systems

Customised

Systems

• Engineering:

Conceptual,

Basic, Detail

• Process

Development and

Optimisation

• Verification /

Validation

• Maintenance

• Customer Care

Service

• 24/7 Service

Hotline

Engineering &

Services

• Magnetic Agitators

• Freeze & Thaw

Systems

• Dedustingrings

Products &

Components

• Conceptual,

Basic, Detail

Engineering for

Automation of

Liquid Processes

• Engineering and

Installation of

Electrical

Switchgears

• Software

Engineering and

Commissioning

• Verification

Automation

• Pasteurising

Systems for Food

Applications

• CIP/SIP Solutions

• Ingredient Adding

Systems

• Aseptic Filling

Systems

• Sampling Devices

• Screening

Solutions

• Consulting &

Engineering

Food Systems

Human Resources


62 Engineering

43 Process Engineering

40 Qualification

54 Project Management

70 Automation & E-Installation

130 Fabrication / Installation

26 Maintenance

40 Supply Chain Management

51 Management, Sales &

Administration

∑ 516 Employees

www.zeta.com Evolution of Technology

ZETA Headquarters at Lieboch

ZETA GmbH, Zetaplatz 1, A-8501 Lieboch/Graz +43 3136 / 9010-0

Page 11

ZETA Headquarters in Lieboch


Current territory: 26.000 m2

ZETA‘s Fab Shop 1


KEY FIGURES

• At HQ Lieboch, Austria

• 1.700 m² (18,300 sq ft)

• Total indoor height: 8,5 m (335”)

• Crane hook height: 7 m (275”)

• Crane load: 2 x 8 metric tons

• Door height: 7,5 m (295”)

• Door width: 4,5 m (180”)

• Connection to clean media

distribution center

ZETA‘s Fab Shop 2


KEY FIGURES

• At HQ Lieboch, Austria

• 430 m² (4,600 sq ft)

• Total indoor height: 14 m (550”)

• Crane hook height: 12 m (475”)

• Crane load: 1 x 15 metric tons

• Door height: 7 m (275”)

• Door width: 4,8 m (190”)

• Connection to clean media

distribution center

ZETA‘s Fab Shop 3


KEY FIGURES

• Lebring, Austria

• 1.300 m² (14,000 sq ft)


• Offices 250 m² (2,700 sq ft)

ZETA‘s Fab Shop 4


KEY FIGURES

• Brno, Czech Republic

• 1.200 m² (12,900 sq ft)


• Offices 200 m² (2,100 sq ft)

Range of Equipment


• Biopharmaceutical systems

• Preparation and formulation

systems

• CIP/SIP- and media systems

• Sterile plant installation

• Services

• Process equipment

• Automation systems

• Processing plants for food &

beverage industries

Customised Systems


BIOPHARMACEUTICAL

SYSTEMS

Systems for the upstream

process

• Fermentation systems for bacteria

• Bioreactor systems for cell culture

• Media and buffer preparation

Systems for the downstream

process

• Microfiltration, ultrafiltration and

nanofiltration skids

• Chromatography skids

• Inactivation systems

• Buffer preparation

Customised Systems


PREPARATION AND

FORMULATION SYSTEMS

Liquids / Parenterals / Emulsions

• Sterile solutions

• Non-sterile solutions

• Stationary and mobile

preparation vessels

• Sterile filtration

• Integration of isolator

technology

Customised Systems


CIP/SIP- AND MEDIA

SYSTEMS

• CIP/SIP-solutions

• Distribution/Storage systems for:

Aqua Purificata, HPW and WFI

Ultrapure steam

Sterile compressed air and

technical gases

Installation & Services


STERILE PLANT

INSTALLATION

• Construction site management

• Plant installation

• Sterile pipe installation

• Supply chain management

• Inspection and documentation

Engineering & Services


ENGINEERING SERVICES

• Process Analyses

• Process Optimization

• Due Diligence Support for CMC

Aspects

• QbD/Soft Sensoring

• GMP Assessment

• QM Support

• Scale up for Pilot Plant

• Automation Strategy

• Pilot Plant Setup and Operation

• Qualification Services

• Deviation Management

• Project Management Support



ENGINEERING SERVICES

• Scale Up to Industrial

• Concept Design

• Basic Engineering

• Detail Engineering

• Procurement

• Qualification Services

• Validation Services

• Lifecycle Management – Process

Optimization

• Revamping – Plant Enhancement



SERVICES

• Engineering services

• Continuous maintenance and

servicing

• Spare part management

• 24/7 Service-hotline

• Periodical calibration

• Software upgrades

• Cleaning / passivation

• Service and maintenance

documentation

Automation


AUTOMATION SOLUTIONS

• Distributed Control Systems

• Batch Management Systems

• SCADA Systems

• Freeze Controller

• Single-Use Bioreactor Controls

• Switchgear Cabinets

• Field Instrumentation

• Electrical Mounting & Fitting

Automation


HARDWARE

ENGINEERING

• Client-/Server- and IT-Hardware

• Automation Hardware

• Field Instrumentation

• Switchgear Cabinets

• Electric and IT Installation

• Hardware- FAT

• Loop Check

• FAT/SAT

Automation


SOFTWARE

ENGINEERINGACCORDING TO GAMP5

• Project & Quality Management

• Design (FS/HDS/SDS)

• Software Engineering

• In-house Tests

• Software FAT

• Documentation

• Commissioning

• Operational Qualification (OQ)

• Training

• 24/7 Service and Maintenance

Automation


AUTOMATIONS

HIERARCHYS

FROM SKID AUTOMATION TO

PROCESS CONTROL SYSTEMS

• TIA Portal Siemens

• WinCC Siemens

• PCS 7 Siemens

• Delta V Emerson

• PlantPAx Rockwell

• ControlLogix Rockwell

• Experion PKS Honeywell

• IAS / InTouch Wonderware

- Number of system components / complexity +

© B

ELIM

ED

© B

ELIM

ED

© A

lfa L

aval

Simple, panel-based automation solutions

Local data recording

(only for stand-alone solutions)

Examples: Autoclaves, generators, washing machines,

centrifuges, homogenizers, extruder, …

Systems: TIA Portal (Siemens), ControlLogix (Rockwell)


Autoclave Washing machine Centrifuge

PC-based single-user solutions (stand-alone)

Stand-alone solutions with extended data recording

For simple, fixed and flexible recepies (ISA S-88)

Example: Micro-/ultrafiltration, single-use bioreactors, WFI loop,

Freeze Controller, chromatography systems,…

Systems: TIA Portal (Siemens), ControlLogix (Rockwell)


UltrafiltrationFreeze ControllerSingle-use

bioreactor

PC-based multi-user systems

Several controllers and operator panels

(without batch functionality)

Examples: Solution preparation systems, simple bioreactor systems,

fruit preparation lines (CIP, Cooker/Cooler), …

Systems: TIA Portal (Siemens), WinCC (Siemens), ControlLogix (Rockwell)


Fruit preparation lineSolution

preparation system

Process control systems / distributed control systems

(PLS / DCS)

Automation of batch-oriented production lines

For flexible, modular, hierarchical recipes

Examples: Complex USP and DSP systems,

solution preparation systems, multi-product production lines, …

Systems: PCS 7 (Siemens), Delta V (Emerson),

PlantPAx (Rockwell), Experion PKS (Honeywell)


USP and DSP

system

Cell fermentation line

and solution

preparation system

Single-use

bioreactor

Products & Components


PROCESS EQUIPMENT

• Freeze & thaw systems – from

lab to full scale production unit

• State-of-the-art magnetic

agitators

• Transfer panels – sophisticated

design for small space

• Dedusting rings – eliminating dust

issues in cleanrooms more than

99%

Product Range: ZETA Freeze & Thaw Systems

Page 34

Enhanced process knowledge of freezing and thawing processes:

Integrated system for optimum freezing, transport / storage and thawing of proteins

www.zeta.com Evolution of Technology

From initial lab experiment through pilot scale to full production volume>>> >>>

200 ml – Lab scale 700 ml – Pilot scale 300 l – Production scale

ZETA Freeze & Thaw System – Production Scale

Page 35www.zeta.com Evolution of Technology


Freeze Container

10 ml & 20 ml


Freeze Container

5 l

Product Range: ZETA Magnetic Agitators


ZETA BMRFBottom-mounted for bioreactors

Food Systems


FOOD INDUSTRY

SYSTEMS

• Pasteurizing systems for

food applications

• CIP/SIP solutions

• Ingredient adding systems

• Aseptic filling systems

• Sampling devices

• Screening solutions

• Consulting and engineering

Vertical Integration – One Stop Shop Concept


INTEGRATED RANGE

OF SERVICES

• Process Engineering

• Process Optimization

• Mechanical Engineering

• Automation

• Manufacturing and Installation

• Verification and Validation

• Project Management

• Maintenance

• After-Sales Service

ZETA – Your Partner for:

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Process Engineering Equipment & Automation

Service & Maintenance

Project Management


• Adherence of budget

• Adherence of schedules

• Interface management

• Continuous reporting

• Transparent project

communication

• Web-based project platform

• Approved project structures

• Change management

• Project documentation

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All relevant tests are executed

once completely

at the right time

by suitable and trained personnel

and are documented

correctly on the

right (approved) document.

The ZETA Qualification Concept of integrated

Verification*

* The ZETA concept of integrated verification is following the ASTM E 2500- Standard Guide for Specification, Design and

Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

http://www.astm.org/Standards/E2500.htm

ZETA IT Structure – Fully integrated


* M

icro

soft

Syste

m 2

013

Construction Software Planning-/Supporting Software

2014

*

*

*

*CRM 2011

NAV 2015

Customer Values offered by ZETA


• Time to market

Short project execution time secured by a perfect project management

• Plug & Play

Fast system availability after delivery

Start-up and acceptance at the manufacturers site means reduced

installation services on site

• Lifecycle services

Continuous maintenance and servicing

Detailed service and maintenance documentation

Spare part management

24/7 Service hotline

Advantages for our Customers


• Tailor made systems considering specific customer requirements

• Long-standing experience in designing, manufacturing and automation of

bioreactors

• Long-standing experience in skid and super skid manufacturing

• Professional project management

• User-friendly plant and automation design

• Safe and trouble-free operation of the plant

• Short response time in case of trouble shooting

• Convincing cost/performance ratio

• Reliable service quality

Active collaboration with many well-known scientific institutions

Human Technology Styria (HTS)

Research Center Pharmaceutical Engineering (RCPE)

Joanneum Research

University of Technology Graz

University of Technology Vienna

University of Life Science Vienna

Technical University of Munich / Weihenstephan (Germany)

Technical University Hamburg-Harburg

Cooperations


http://www.human.technology.at/

http://www.rcpe.at/

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Selected Customers


Boehringer

B.Braun GSK

Johnson & Johnson

Fresenius

Merck & Co Tetra Pak

PetrovaxRentschler

Hengrui

Lonza

UCB

Genentech

Bayer

Novo Nordisk

Baxter

Biomarin

GE Healthcare

Schülke + Mayr

Tiantan

Roche

Alexion

CSL Behring

Novartis

Takeda

SanofiSamsung

TEVA

R-Pharm

CTTQ

Biotest

Shire

Octapharma

Pfizer

MSD

Genzyme

Sandoz

Endocrine

Pharmstandard

Pall

Documents

EVOLUTION OF TECHNOLOGY · Liquids / Parenterals / Emulsions •Sterile solutions •Non-sterile solutions •Stationary and mobile preparation vessels •Sterile filtration •Integration