evolution of technology · liquids / parenterals / emulsions •sterile solutions •non-sterile...
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EVOLUTION OF TECHNOLOGYCustomised technology for pharmaceutical and biotechnological plants
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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
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ZETA Subsidiaries
www.zeta.com Page 3 Evolution of Technology
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
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ZETA Sales Partner
www.zeta.com Page 4 Evolution of Technology
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
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Biopharma Process
page 5 Evolution of Technologywww.zeta.com
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Our Core Competences
www.zeta.com Page 6 Evolution of Technology
ZETA is specialised in designing, engineering,
development, manufacture, automation and
maintenance of customised process solutions for
liquid aseptic applications.
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Page 7 Evolution of Technologywww.zeta.com
ZETA Lifecycle
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ZETA – Solution Path
Page 8 Evolution of Technologywww.zeta.com
www.zeta.com/solutionpath/
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Business Lines
www.zeta.com page 9 Evolution of Technology
• 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
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Human Resources
Page 10 Evolution of Technologywww.zeta.com
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
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www.zeta.com Evolution of Technology
ZETA Headquarters at Lieboch
ZETA GmbH, Zetaplatz 1, A-8501 Lieboch/Graz +43 3136 / 9010-0
Page 11
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ZETA Headquarters in Lieboch
www.zeta.com Evolution of TechnologyPage 12
Current territory: 26.000 m2
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ZETA‘s Fab Shop 1
www.zeta.com Page 13 Evolution of Technology
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
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ZETA‘s Fab Shop 2
www.zeta.com Page 14 Evolution of Technology
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
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ZETA‘s Fab Shop 3
www.zeta.com Page 15 Evolution of Technology
KEY FIGURES
• Lebring, Austria
• 1.300 m² (14,000 sq ft)
• Total indoor height: 12 m (475”)
• Offices 250 m² (2,700 sq ft)
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ZETA‘s Fab Shop 4
www.zeta.com Page 16 Evolution of Technology
KEY FIGURES
• Brno, Czech Republic
• 1.200 m² (12,900 sq ft)
• Total indoor height: 6 m (235”)
• Offices 200 m² (2,100 sq ft)
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Range of Equipment
www.zeta.com Page 17 Evolution of Technology
• 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
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Customised Systems
www.zeta.com Page 18 Evolution of Technology
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
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Customised Systems
www.zeta.com Page 19 Evolution of Technology
PREPARATION AND
FORMULATION SYSTEMS
Liquids / Parenterals / Emulsions
• Sterile solutions
• Non-sterile solutions
• Stationary and mobile
preparation vessels
• Sterile filtration
• Integration of isolator
technology
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Customised Systems
www.zeta.com Page 20 Evolution of Technology
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
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Installation & Services
www.zeta.com Page 21 Evolution of Technology
STERILE PLANT
INSTALLATION
• Construction site management
• Plant installation
• Sterile pipe installation
• Supply chain management
• Inspection and documentation
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Engineering & Services
www.zeta.com Page 22 Evolution of Technology
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
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Engineering & Services
www.zeta.com Page 23 Evolution of Technology
ENGINEERING SERVICES
• Scale Up to Industrial
• Concept Design
• Basic Engineering
• Detail Engineering
• Procurement
• Qualification Services
• Validation Services
• Lifecycle Management – Process
Optimization
• Revamping – Plant Enhancement
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Engineering & Services
www.zeta.com Page 24 Evolution of Technology
SERVICES
• Engineering services
• Continuous maintenance and
servicing
• Spare part management
• 24/7 Service-hotline
• Periodical calibration
• Software upgrades
• Cleaning / passivation
• Service and maintenance
documentation
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Automation
www.zeta.com Page 25 Evolution of Technology
AUTOMATION SOLUTIONS
• Distributed Control Systems
• Batch Management Systems
• SCADA Systems
• Freeze Controller
• Single-Use Bioreactor Controls
• Switchgear Cabinets
• Field Instrumentation
• Electrical Mounting & Fitting
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Automation
www.zeta.com Page 26 Evolution of Technology
HARDWARE
ENGINEERING
• Client-/Server- and IT-Hardware
• Automation Hardware
• Field Instrumentation
• Switchgear Cabinets
• Electric and IT Installation
• Hardware- FAT
• Loop Check
• FAT/SAT
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Automation
www.zeta.com Page 27 Evolution of Technology
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
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Automation
www.zeta.com Page 28 Evolution of Technology
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 +
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© B
ELIM
ED
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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)
www.zeta.com Page 29 Evolution of Technology
Autoclave Washing machine Centrifuge
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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)
www.zeta.com Page 30 Evolution of Technology
UltrafiltrationFreeze ControllerSingle-use
bioreactor
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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)
www.zeta.com Page 31 Evolution of Technology
Fruit preparation lineSolution
preparation system
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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)
www.zeta.com Page 32 Evolution of Technology
USP and DSP
system
Cell fermentation line
and solution
preparation system
Single-use
bioreactor
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Products & Components
www.zeta.com Page 33 Evolution of Technology
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%
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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
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ZETA Freeze & Thaw System – Production Scale
Page 35www.zeta.com Evolution of Technology
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www.zeta.com Evolution of TechnologyPage 36
Freeze Container
10 ml & 20 ml
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www.zeta.com Evolution of TechnologyPage 37
Freeze Container
5 l
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Product Range: ZETA Magnetic Agitators
www.zeta.com Page 38 Evolution of Technology
ZETA BMRFBottom-mounted for bioreactors
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Food Systems
www.zeta.com Page 39 Evolution of Technology
FOOD INDUSTRY
SYSTEMS
• Pasteurizing systems for
food applications
• CIP/SIP solutions
• Ingredient adding systems
• Aseptic filling systems
• Sampling devices
• Screening solutions
• Consulting and engineering
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Vertical Integration – One Stop Shop Concept
www.zeta.com Page 40 Evolution of Technology
INTEGRATED RANGE
OF SERVICES
• Process Engineering
• Process Optimization
• Mechanical Engineering
• Automation
• Manufacturing and Installation
• Verification and Validation
• Project Management
• Maintenance
• After-Sales Service
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ZETA – Your Partner for:
www.zeta.com page 41 Evolution of Technology
Process Engineering Equipment & Automation
Service & Maintenance
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Project Management
www.zeta.com Page 42 Evolution of Technology
• 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
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ZETA IT Structure – Fully integrated
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* M
icro
soft
Syste
m 2
013
Construction Software Planning-/Supporting Software
2014
*
*
*
*CRM 2011
NAV 2015
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Customer Values offered by ZETA
www.zeta.com Page 45 Evolution of Technology
• 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
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Advantages for our Customers
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• 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
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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
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Selected Customers
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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