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Bactiguard clean room Site visit
Capital Markets Day
September 10, 2014
Caverion
About Bactiguard
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° A Swedish medical technology company with the primary goal of preventing healthcare associated infections.
° All the expertise, in the form of the development, manufacture and staff functions have been gathered under one roof in this new life science facility.
° With this establishment, the company creates a closely linked presence to the research units at KI and KTH care and the care facilities at Karolinska University Hospital in Huddinge.
° Bactiguard is undergoing a strong expansion phase with a focus on new markets in Europe, the Middle East, Asia and South America.
° The company headquartered is in Stockholm, with production facilities in Sweden and Malaysia.
° Listed on the Nasdaq OMX Stockholm in June 2014.
Complete solutions for clean room
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Turnkey delivery – Design & Build
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° Total clean room area of 550 m2
° Technical installations include:
o Clean room envelope
o Ventilation
o Automation
o Piping
o Electrical
o Cooling
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Complex delivery driven by GMP regulation
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The pharmaceutical industry has the toughest requirements on microbiological control according to GMP (Good Manufacturing Practice) in the EU and USA.
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Responsible for GMP requirements & validation Validation activities DQ – Design qualification
IQ – Installation qualification
OQ – Operational qualification
EU GMP C
EU GMP D
CNC /
EU GMP D
Personal Airlock
Material Airlock
Material Airlock
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Caverion
Our clean room offering – Turnkey delivery
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Operation Conceptual
Design
Basic
Design
Detailed
Design
Construction and
installations
Start up
Utility requirement
System Design
Procurement
Working doc.
Clean room & Systems
Commissioning
Qualifications
Design and Engineering, Project Management and Execution
Advisory Services
Technical
Maintenance
SLA
Early involvement shortens lead-time for the entire project
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Design principle GMP clean room
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Caverion
Clean room delivered by our own products CleanPlus® and KrantzTM
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1. CleanCeiling™ – ceiling
2. CleanWall™ – walls
3. CleanDoor™ – door
4. CleanVision™ windows
5. CleanLock™ – interlocking
system
6. CleanLight™ – light fittings
7. Krantz™ – HEPA inlets
8. CleanPass™ – wall cabinets
9. CleanExtract™ – air extract
10.CleanSeal™ – hygienic tube
sealing
11.CleanFittings™ – fittings
Capital Markets Day, September 2014
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Modular system with short installation time
Monoblock wall system
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CleanWall™
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Innovative solutions
CleanLight™ Flush mounted light fittings
with hygienic access.
HEPA filter air inlets for clean rooms with pull down outlet
element and modular design.
Krantz™ Prui Clean HEPA
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Unique
dust free
steel door
Hygienically
integrated
windows
Secure passage
CleanDoor™ Self lifting hinges –
Ease to clean
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CleanLock guarantees correct function according to GMP
Control system for air locks
code locks/card readers
Safe control system for entering clean room
CleanLock™
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Validation process
Operation Conceptual
Design
Basic
Design
Detailed
Design
Construction and
installations
Regulatory requirements & quality assessment
DQ Execution
IQ/OQ Protocol Development
IQ Execution
OQ Execution
IQ/OQ Reports
Change Control In Place
User Requirement
Specification - URS
Start up
Validation process Requirements SLA
Re-qualifac.
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Caverion
References - examples
Cepheid – Sweden
° Turnkey contract including design, installation and validation
° Scope: Complete delivery of clean room classification C according EU GMP with Cleanplus® & Krantz system for GMP applications including, HVAC engineering and electrical engineering.
Karolinska University Hospital, Sweden
° Turnkey contract including design, installation and validation
° Scope: Complete delivery of clean room classification D according to EU GMP with Cleanplus® system for GMP applications including, HVAC engineering and electrical engineering.
Astra Zeneca, Sweden
° Turnkey contract including design and installation.
° Scope: Complete delivery of clean room classification C & D according to EU GMP, envelope Caverion Cleanplus® system for GMP applications including, ceiling, walls, windows, doors with Caverion interlock system CleanLock®
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Caverion
References - examples
Nanolab at NTNU, Norway
° Turnkey contract including design and installation
° Clean room classification ISO 5-7 “in-operation”
° Scope: clean room envelope, HVAC, Electrical, Mechanical, Process cooling water, CDA, Process gases, Pure water system, Gas monitoring system
DANCHIP at DTU, Denmark
° Turnkey contract including design and installation
° Clean room classification ISO 4-7 “in-operation”
° Scope: clean room envelope, HVAC,
MICRONOVA at VTT, Finland
° Turnkey contract including design and installation
° Clean room classification ISO 5-7 “in-operation”
° Scope: clean room envelope, HVAC, Electrical, Mechanical, Process cooling water, CDA, Process gases, Pure water system, Gas monitoring system
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Caverion
References - examples
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Friedrich Loeffler Institute, Germany
° High-end clean room HVAC system for the facility.
° BSL-4 laboratory
° Scope: Developed a solution at the own R&D center and installed extinguishing systems with Halon substitutes.
Bernhard-Nocht-Institute, Germany
° Design and installation
° BSL-4 laboratory
° Scope: HVAC, electricity, automation, gaseous extinguishing system, maintenance
Fraunhofer IPA, Germany
° Design and installation of HVAC system for the “cleanest room in the world“
° Clean room classification ISO 1 (150 m²)
° Scope: HVAC including ULPA filter technique, automation, electricity
° -70 % primary energy consumption after renovation with Caverion
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Caverion
Turnkey clean room deliveries – One partner
Caverion has long track record and experience of clean room contracts and have understanding of the applications requiring controlled process environments
We have the ability in early project stages to transfer customers requirements into system and building solution and develop basic designs for high tech & pharmaceutical clean rooms including HVAC, piping and electrical systems.
We have profound experience with regulatory demands required for building and validating clean rooms and pharmaceutical projects and the competence to conduct qualification activities required.
We have developed proprietary clean room systems where highest demands on quality, flexibility and modularity is achieve in the production facilities.
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