49
Inspiring Solutions for Clean Technology Applications
Inspiring Solutions for Clean Technology Applications
Outline» Deerns … who we are» International Clean Technology Practice … what we deliver» Why Deerns …» References
Strong History and Reputation
» Privately owned, since 1928» Fully independent» Largest M&E engineering consultancy of Europe» Long-term health has priority over short-term profit
Subject Data
In Business 85 years
Specialists 550 Wordwide
Turnover 2012 €55,000,000
Project Value €10,000,000,000
Repeat Business 70% of customers
Global Focus on Specific Clients
20 Offices Worldwide
Service Portfolio
Concept Development Design Budgeting Contracting Building
Supervision
Maintenance & Retrofit
Planning & Programming
…brings concepts to life by» Focus on client’s business» Combining worldclass technical consultancy and
engineering with innovative solutions and proven technologies
» Delivering lowest TCO design solutions based on realized projects
1) Office and mixed-use buildings, leisure and entertainment
2) Residential buildings
3) Health Care institutions
4) Airports5) Mission-Critical facilities -
Data Centres, Clean Rooms and Research Laboratories
Market Segments
» Regulatory environment of FDA, EU, WHO, PICschemeincl. complete validation services and support
» Process environment and process flow of API, pharmaceutical and biotech biosafety manufacturing and laboratories
» 3D design of process, facilities and utilities» Project management and supervision» Certification and Facility management consulting
Our Services: 5D Design and Integration of
Processes
Pharmaceutical Processes» Bulk Chemicals» Bulk Biotechnology» Solid Dosage Forms » Semi Solid Dosage » Parenterals, Ophthalmica and Freeze Drying» Aerosols and Sprays
Risk Analysis Criteria for Production Processes» Normal Products» High Potent Materials» Radioactive Materials» Steroid Products» DNS/RNS Critical Materials» Cancerogenic Products
Services
Biosafety and Biosecurity Laboratories and Manufacturing» BSL 1 S 1» BSL 2 S 2» BSL 3 S 3» BSL 4 S 4Human, Animal, Aquatic, and Plant Applications
Risk Analysis» Bio Risk» Chemical Risks» Radioactive Risks» DNS/RNS Risk» Cancerogenic RiskBio Risk Manuals, Biosafety Compliance, Training
Life Cycle of a Pharmaceutical Product
F & E - Phase
TIME
Development - Phase Launch - Phase Productions - Phase
Patent Affiliation
Clinical phase I, II und III GalenicEnd of Patent
Concept
Design
Construction Operation
Idea
Life Cycle of a Project100%
Time0%
Definition Phase Pharmacist
Concept Phase Pharmacist and/or Consultant
Construction
Operation / Production
Design Phase Expert/Engineering/Consultant
With CAQ, integrated design and installed facility management and assetmanagement more than 15 % of costs can be cut off.
Development of Costs
Operating Costsafter 3-4 years
Operating Costsafter 8 – 10 years
Investment Costs
ProjectDevelopment
Design Construction Operation
Deg
ree
of In
fluen
ce
Cost of Design
Already after 3 to 4 years the operating costs equal the investments !
Engineering Qualification
Parallel Process of Qualification/Validation and Engineering
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
URS
Concept-Design
Basic Design
Detail Design
Construction
Start Up
Turnover
Qualification-Design
QualificationMaster Plan
DQ
IQ
OQ
PQ
Summary Report
Milestone Approach
Concept DesignFeasibility Study
CostEstimate± 25 %
BasicEngineering
Cost Estimate± 15 %
Governmentaland Regulatory
Aspects
DetailEngineering
CostEstimate± 10 %
ConceptQualification
GMP-Review
FDAPreapproval
Validation Master PlanMaster Qualification PlanDesign Qualification
VMP-MQP
DQ
InstallationQualificationFactory Acceptance TestSite Acceptance Test
FATSAT
IQ
Concept/Development/Site Selction
Milestone Approach
Construction
Readiness
Certification
Certification
After Sales SupportService & MaintenFacilityManagement
OperationalQualification
PerformanceQualification
PQ
End Report
TurnoverProcess
ValidationCleaning
Validation
OQ
Qualification Validation Process
Design Qualification (DQ)
Installation Qualification (IQ)
Operation Qualification (OQ)
Performance Qualification (PQ)
Qualification Plan -
Development
Execution
Approval
Computerized
System
Validation
End Report
Process Validation - Cleaning Validation
Ishikawa Diagram of a Solid Dosage Form Production
Validation Life Cycle
International Clean Technology Practice
Core team members each with more than 25 years’ experience in design, build and realization of cleanroom research, pilot and production lines
» Taiwan : TSMC / Macronix / Winbond / Vanguard / ASML» Germany : NXP / IBM / Siemens / Wacker / Bayer / Shering» China : Hua Hong / ASMC / Motorola » Singapore : Chartered» Netherlands : Philips / ASML / Universities / DSM / MSD» Belgium : IMEC / Upjohn / Janssen» Italy : Texas Instruments / STM / Thales» Ireland : Intel
Clean Technology Task Force
GeorgePollock
HorstWeiβsieker
EricStuiver
BarryWeisscher
SheilahBain
Aad Hofstede
WimButers
Develop and deliver tailor made cleanroom solutions
for professional clients within Clean Technology Applications...
...made by Passion
Integrated solutions for complex technical environments
» Electronics » Life Sciences » Solar » Containment» Health Care » R&D Laboratories
ICTP Mission
Project Samples - Electronics
• ASML Netherlands, Veldhoven
• ASML Taiwan, Linkou
• Space Research Organisation, Utrecht
• Thales Alenia Italy, l’Aquilia
Project Samples - Life Sciences
• Crucell, Leiden
• MSD, Haarlem
• Banner Pharmacaps, Tilburg
• Philips, Molecular Medicine
Project Samples - High Containment
• Spronck lab, Bilthoven
• RIVM Polio, Bilthoven
• ML III Lab, Groningen
• Erasmus Medical Centre,Rotterdam
Project Samples - Health Care
• Martini Hospital, Groningen
• NKI, Amsterdam
• Erasmus Medical Center, Rotterdam
• Reinier de Graaf Hospital, Delft
Project Samples - Laboratories
• Danone, Utrecht
• DSM, Delft
• FOM Institute, Amsterdam
• Philips, High Tech Campus, Eindhoven
Deerns is involved in four out of five facilities of NanoLab NL, an investmentprogram of high-tech, state-of-the-art nanotechnology infrastructure that isaccessible to NanoNed and the Dutch research community as a whole.
Project Samples - Nano Facilities
Key services Feasibility, programming, design, commissioning, supervision and qualification
» Continuously serving clients in state-of-the-art cleanroom facilities
Our Clients
» Extensive expertise and experience in designing and delivering cleanrooms to international standards (ISO, GMP, BSL, FDA) > 45 Specialized Consultants > 150.000 m2 of delivered cleanroom area
» In-depth understanding of all requirements of the latest process equipment, ensuring all performance criteria are met and smooth hook-up and startup is achieved. This is regarding: Cleanroom / particle requirements (ISO, GMP) Chemical contamination (<5 ng/l organic) Electromagnetic contamination (EMC e.g. 10 nT) Vibrations (down to VC-F and VC-G)
» Proven capabilities within all clean technology applications: electronics including semiconductor, aerospace and solar life sciences regulatory including validation barrier technologies for containment (up to BSL4) full range of laboratories (generic <> specific)
» Full integration (design, commissioning) with sustainability requirements including LEED, BREEAM
ICTP Value Proposition
Clean Technology - Top Down <> Bottom Up
Top -down
Bottom - up203020131960
0.1 nm
Biofysica
Self assemblyQuantum computing
Bio-elektronica
10,000 nm
100 nm
10 nm
1 nm
Clean Technology - Trend
Ballroom
Tunnel
Mini-Environment
Clean machine
1970
1980
1990
2000
Nano clean
2010
BioNano clean
2020
ISO 3 - 5
ISO 5 - 8
‘Nano clean’
‘BioNano clean’
» Diversification and reduction in ‘critical’ cleanroom area
» Project Programming Consultancy
» Project Management
» Design and Engineering
» Construction Supervision
» Testing, Qualification and Validation
» Hook-Up
» Operational Support
Services, what we deliver• Definition of the project starting points including process/research equipment
lists, process utilities requirements, conceptual and functional layouts, logistic flow schemes etc.
• Preparation of the Technical Program of Requirements / User Requirements Specifications.
• Preparation, implementation and monitoring of the project plan• Coordination of the parties involved in the design and construction
management• Time control (compliance with target time frame)• Cost control (compliance with target budget)• Quality control (compliance with target specification)• Arrange for progress and review meetings• Reporting to the Client.
• Preparation of complete design documents for general building systems and process critical systems
• In close conjunction with the Architect the development of engineering and tender documents for HVAC & Cleanroom, Electrical & Control, Central & Process Utilities, Environmental & Safety Systems and Sustainability Measures
• Site organization, coordination and direction of contractors/suppliers• Definition, implementation and monitoring of procedures and instructions• Safety management on-site• Time, cost and quality monitoring• Coordination and verification of test & acceptance procedures of
(sub)systems• Coordination and support of hand-over procedures to Client• Arrange for coordination meetings and reporting to project managementX
• Set-up of the Validation Master Plan• Development and support of the execution of the Installation Qualification (IQ)• Development and support of the execution of the Operation Qualification (OQ)
and the Performance Qualification (PQ) of the facility and its installationsXX
• Preparation of detailed design documents for utility requirements, system interconnect and space management
• Preparation of macro and micro layouts for process and support areas• Definition and design of mini-environments and associated construction
documents• Design coordination of floor and wall penetrations and appropriate shop drawings• Coordination and direction of contractors/suppliers• Time, cost and quality monitoring• Coordination and verification of test & acceptance procedures• Coordination of hand-over procedures to Client
Con
tam
inat
ion
Con
trolle
d Fa
cilit
ies
Approach, how we deliver
OPERATION
Quality Assurance
Construction Supervision
Inspection
Field Engineering
Commissioning
Quality Assurance
Basic DesignFinal DesignBid PackagesTender DocumentsBid Evaluation
Feasibility Study
Project Definition
URS - PoR
Cost Estimates
Technical Surveys
Cost Engineering
Assessment Analysis
START-UPPROJECTIMPLEMENTATION
PROJECTDESIGN
PROJECTPREPARATION
PROCESSINGFIT-OUTHOOK-UP
CHANGEMANAGEMENT
FLEXIBILITYCHANGEABILITY
LOGISTICS LAYOUTS
Maintenance Planning
Testing
Validation
Operations Support
Maintenance Planning
PROJECTPLANNING
TECHNOLOGYEQUIPMENTPROGRAM
FACILITIES
PROCESS TECHNOLOGY
» Seamless integration of processes, equipment, buildings & installations
» Focus on added value not volume
» Services based on client / project needs
Organization, with whom we (can) deliver
» Project cost analysis : continuously exchange of international benchmarks and figures
1. Tendering Design & Build Contract2. Budget Control3. Client Hand-Over
Cost Control
€ 1.300.000€ 2.350.000
€ 1.700.000
€ 16.250.000
Buildings & Installations
Hook-Up
Equipment & Furniture
Management & Design Fee
Why Deerns…
» Highly skilled and specialised staff each with more than 25 years’ experience in planning, designing and delivering contamination controlled research/production facilities and laboratories to international standards (ISO, VDI, GMP, BSL, FDA)
» Continuous involvement at the leading-edge of new process and research technologies
» Thorough understanding of client’s critical business & technology processes
» In-depth understanding of all requirements of the latest process equipment, ensuring all performance criteria are met to guarantee that smooth hook-up and startup is achieved
» Independent cost expertise & benchmarking
» Extensive experience in all type of projects including greenfield, brownfield, relocation, extension, modification and live upgrade projects
» World’s most energy efficient, reliable and flexible cleanroom and laboratory concepts for a wide range of applications (physical, chemical, biological, radiological, electromagnetically shielded)
» Full integration (design, commissioning) with sustainability requirements including LEED, BREEAM
» Deerns proprietary TCO, Energy & CFD modelling tools
Why Deerns?
Clean Technology References
Clean Technology References (1)
Client / Project Features Services
TU TwenteCleanroom
RIVM BilthovenLaboratoria
KLM SchipholCatering
Knorr, LoosdrechtFood IndustryConimex, BaarnFood Industry
Bio IntermediairGroningen, Farma
Gist-Brocades, DelftTest Center
Cordis EuropeUpgrade Building 5
1990
Year
R & DMicroelectronics
VaccinsLaboratoria
Preparation andPacking
Preparation andPackingTest en SimulationProduction line
Production LabFarmaceutical
Peniciline
Production and TestMedical equipment
3.800 m2
Class 100-10.000
2.600 m2
Class 100-100.000
25.000 m2
28.000 m2
2.100 m2
Class 1.000-100.000
1.500 m2
Class 1.000
3.000 m2
Class 100.000
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
1992
1993
1994
1995
Clean Technology References (2)
Client / Project Features Services
CPRO-DLO,WageningenClimat cells
Centocor, LeidenFarmaceutical
ASML, VeldhovenAssembly & Test
TU/e, EindhovenCascade building
KU Nijmegen
TU/e, EindhovenTechnology Building
Philips Research, E’hovenBuilding WAG
RIVM, BilthovenMDL
1996
Year
Microbiological
PharmaceuticalsDiagnostics
Steppers, Scanners
Faculty PhysicsLaboratoria
Faculty PhysicsLaboratoria
R & D Fotonics
R & D Semiconductors
BiotechnologyLaboratories
1.800 m2
Class 100-100.000
2.800 m2
Class 100-10.000
7.000 m2
Class 100-100.000
3.500 m2
12.000 m2
2.000 m2
Class 100-10.000
1.600 m2
Class 10.000
1.200 m2
BSL3, BSL4
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Design
1998
2000
2002
Clean Technology References (3)
Client / Project Features Services
Philips ElectronicsBuilding WDX
LouwersGlass and Ceramics
NMiTechnópolis
TU Twente, MESA+
NanoLab
Mead JohnsonNijmegen
SRON, UtrechtUpgrade
TNO, TU DelftNANOSCIENCE
RIVM, BilthovenUpgrade gebouw U4
ASML, VeldhovenWorkcenters
2003
Year
Physical & ChemicalLaboratories, Cleanroom
Micro-mechanicsCleanroom
Physical & ChemicalLabs & Cleanroom
Physical LaboratoriesCleanroom
Microbiological &Chemical Laboratories
Microelectronics Micro-mechanics
Microelectronics,Labs & Cleanroom
BiotechnologyVaccin production
Microelectronics,Steppers, scanners
14.500 m2
200 m2
Class 10.000
3.500 m2
Class 100.000
1.500 m2
Class 10.000
530 m2
ML2, ML3
1.000 m2
Class 10.000-100
8.500 m2
Class 10.000-100
2.000 m2
BSL2, BSL3
3.100 m2Class 10.000
Design, ConstructionCoordination
Design, ConstructionCoordination
Design, ConstructionCoordination
Programming, Design,Supervison
Design, ConstructionCoordination
Programming, Design,Supervison
Design, ConstructionCoordination
Programming, Design
Design, ConstructionCoordination
2004
2005
Clean Technology References (4)
Client / Project Features Services
DBF BiofarmaHelmond
TU DelftFaculty of Sciences
ASML, VeldhovenProduction Phase 1
ASML ACETaiwan
PhotovoltechBelgium
IMECBelgium
ASML, VeldhovenApplication Lab
Philips ElectronicsBuilding WB
2006
Year
CleanroomFacility Upgrade
Physical, Bio LabsCleanroom
MicroelectronicsScanners
Microelectronics Training / Refurb.
Solar CellCleanroom Facility
Microelectronics300mm Cleanroom
Microelectronics,Scanners
Physical & ChemicalLaboratories, Cleanroom
5.000 m2
35.000 m2
Class 100.000
5.000 m2
Class 10.000
20.000 m2
Class 10.000
5.000 m2
5.000 m2
1.500 m2Class 10.000
14.500 m2
Design, ConstructionCoordination
Programming
Programming, DesignConstruction
Programming, DesignConstruction
Design clean utilities
Design clean utilities
Design, ConstructionCoordination
Design, ConstructionCoordination
2007
Clean Technology References (5)
Client / Project Features Services
Erasmus Medical CentreRotterdam
Philips, EindhovenBioresearch
ASML, VeldhovenProduction Phase 2
DBF BiofarmaHelmond
TU EindhovenSpectrum
Philips ResearchEindhoven
BronkhorstRuurlo
Neways, EindhovenWorkcenters
2007
Year
High containmentLaboratories
Bio & ChemicalLabs & Cleanroom
MicroelectronicsScanners
PharmaceuticalsCleanroom
Microelectronics Upgrades
Labs & Cleanroom
Microelectronics Assembly
MicroelectronicsCleanroom
500 m2
12.000 m2
Class 10.000
5.000 m2
Class 10.000
500 m2
Class 10.000
1.000 m2
Class 10.000-100
8.500 m2
Class 10.000
1.000 m2
Class 10.000
1.000 m2Class 10.000
Programming, Design, Coordination
Design, ConstructionCoordination
Programming, Design,Construction
Design, ConstructionCoordination
Design, ConstructionCoordination
Programming
Programming, Design
Programming, Design
2008
Clean Technology References (6)
Client / Project Features Services
SRONUtrecht
ASML, VeldhovenProduction EUV
ASML, VeldhovenExisting Facilities
TNO, DelftNanoScience
VieCurieVenlo
TU EindhovenSpectrum
SRONUtrecht
ASML, VeldhovenProduction EUV
TU EindhovenSpectrum
2009
Year
MicroelectronicsMicromechanics
MicroelectronicsScanners
MicroelectronicsScanners
Nano-electronics
HealthcarePharmacie
Microelectronics Upgrades
MicroelectronicsMicromechanics
MicroelectronicsScanners
Microelectronics
1.000 m2
Class 10.000-100
25.000 m2
Class 10.000
20.000 m2
Class 10.000-100
2.500 m2
Class 10.000-100
500 m2
Class 10.000
1.000 m2
Class 10.000-100
1.000 m2
Class 10.000-100
5.000 m2
Class 10.000-100
1.000 m2
Class 10.000-100
Operational Support
Programming
Masterplan
Hook-up
Validation, Design
Hook-up
URS New Facility
Design
Retrofits
2010
Clean Technology References (7)
Client / Project Features Services
MSDOss
ASML, VeldhovenExisting Facilities
TU EindhovenSpectrum
ASML, VeldhovenFacility Planning
Neways, EindhovenHose Bundles
ASML. VeldhovenExtension
BronkhorstRuurlo
Flexplant
LouwersGlass & Ceramics
2010
Year
Pharmaceutical
MicroelectronicsScanners
MicroelectronicsMOVPE
Microelectronics
Microelectronics
Microelectronics
MicroelectronicsAssembly
PharmaceuticsBiotechnology
Micromechanics
1.000 m2
Class 10.000
25.000 m2
Class 10.000
1.000 m2
Class 1.000
25.000 m2
Class 10.000
MaterialsClass 10.000
7.000 m2
Class 10.000-100
1.000 m2
Class 10.000
Confidential
1.000 m2
Upgrade
Retrofits & Upgrades
Hook-Up
BusinessProgramming
Selection, Qualificationand Training
ConstructionSupervision
Upgrade
Design
Design
2011
Clean Technology References (8)
Client / Project Features Services
FOM DIFFEREindhoven
ASML, VeldhovenExisting Facilities
DSM, DelftGMP Laboratories
RIVM, BilthovenMDL
University UtrechtAnimal Facilities
SRONAmsterdam
IMECLeuven
ASML, Veldhoven450mm EUV
TSC Solar
2012
Year
Solar Fusion
MicroelectronicsGas Yard
Bio/Food research
BiotechnologyLaboratories
Animal ResearchLaboratories
Microelectronics
Microelectronics
Microelectronics
Solar Production
1.000 m2
Class 100.000
2.500 m2
20.000 m2
Class 10.000
1.200 m2
BSL3, BSL4
35.000 m2
Class 10.000
15.000 m2
Class 10.000-100
10.000 m2
Class 10.000-100
10.000 m2
Class 10.000-100
6.000 m2
Design
Design, Supervisionand Commissioning
Design
Validation
Design
PoR
Upgrades
Design, Supervisionand Commissioning
PoR
2013
Clean Technology References (9)
Client / Project Features Services
DERU BerlinHamburg
Metallux LeutenbachStuttgart
University, DelftQuantum Lab
University, E’hovenMagnetic Lab
Banner PharmacapsTilburg
BioLab IzmirTurkey
2013
Year
Metrology Lab
Microelectronics
ResearchLaboratories
ResearchLaboratories
UpgradeLaboratories
New Laboratories
500 m2
5.000 m2
Class 10.000
1.000 m2
800 m2
1.000 m2
Class 100.000
20.000 m2
BSL 2/3
Consultancy, Design
Consultancy, Design
PoR, Design, Supervision
PoR, Design, Supervision
Consultancy, Design
Consultancy, Supervision
Deerns Raadgevende Ingenieurs bvP.P. Box 1211 | NL-2280 CE RijswijkT +31 88 374000 0F +31 88 37400 10E [email protected]
Deerns Deutschland GmbHHelmholtzstraße 2-9 | 10587 BerlinT +49 30 3980192 0F +49 30 3980192 9E [email protected]
Deerns Deutschland GmbH | NL KölnGraeffstraße 5 | 50823 KölnT +49 221 5741 0F +49 221 5741 206E [email protected]
Deerns Deutschland GmbH | NL StuttgartWiddumhofstraße 12 | 70499 StuttgartT +49 711 13983 0F +49 711 13983 99E [email protected]
Contact – Deerns Group
