bactiguard clean room site visit - caverion · pdf filebactiguard clean room site visit...

Bactiguard clean room Site visit

Capital Markets Day

September 10, 2014

Caverion

About Bactiguard

Capital Markets Day, September 2014 2

° 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

Caverion

Turnkey delivery – Design & Build


° Total clean room area of 550 m2

° Technical installations include:

o Clean room envelope

o Ventilation

o Automation

o Piping

o Electrical

o Cooling

Caverion

Complex delivery driven by GMP regulation


The pharmaceutical industry has the toughest requirements on microbiological control according to GMP (Good Manufacturing Practice) in the EU and USA.

Caverion

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


Caverion

Our clean room offering – Turnkey delivery

7 Capital Markets Day, September 2014

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

Caverion

Design principle GMP clean room


Caverion

Clean room delivered by our own products CleanPlus® and KrantzTM

9

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

Caverion

Modular system with short installation time

Monoblock wall system


CleanWall™

Caverion 11 Capital Markets Day, September 2014

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

Caverion 12 Capital Markets Day, September 2014

Unique

dust free

steel door

Hygienically

integrated

windows

Secure passage

CleanDoor™ Self lifting hinges –

Ease to clean

Caverion

CleanLock guarantees correct function according to GMP

Control system for air locks

code locks/card readers

Safe control system for entering clean room

CleanLock™


Caverion

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.


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®


Caverion


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



° Scope: clean room envelope, HVAC,

MICRONOVA at VTT, Finland



° Scope: clean room envelope, HVAC, Electrical, Mechanical, Process cooling water, CDA, Process gases, Pure water system, Gas monitoring system


Caverion


17

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


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.


bactiguard clean room site visit - caverion · pdf filebactiguard clean room site visit...

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