IBA Integralab Brochure

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IntegraLab速 Radiopharmacy HELPS YOU FIND YOUR WAY.


INTEGRALAB® RADIOPHARMACY.

FROM MAZE TO AMAZING RESULTS. At first glance, radiopharmacy resembles a maze. A complicated structure without an exit. But just like all mazes, this one has an exit. You just need to know where to find it.

By letting IBA show you the way with IntegraLab®, your maze will soon yield amazing results.

DEFINE F CAPACITY AND NEW RADIOTRACERS 18

COMPLY REGULATIONS AND SAFETY


our determination to deliver personalized care for all has allowed us to “AtmakeIBA,amazing strides in nuclear medicine. An important development when you consider the implications: nuclear medicine allows hospitals and clinics to make an accurate diagnosis and administer effective treatments to cancer patients. IntegraLabŽ makes this complex process possible, giving you more time and energy to concentrate on patients. A service we’re very proud to provide.

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DELPHINE BLAMPAIN MANAGer FAcIlItY AND proceSS eNGINeerING IBA MOLECULAR

DESIGN SELECT AND INTEGRATE

BUILD ON TIME AND ON BUDGET

RUN TRAINING AND SUPPORT


YOUR GMP CENTER ADAPTED TO YOUR NEEDS COMPLY – Customized and optimized facility layout compliant with GMP standards

– Risk Analysis

– Facility, architectural and engineering services such as HVAC design.

– Radiation monitoring and radiation protection equipment.

DEFINE – High capacity cyclotron and targetry system – Full range of chemistry systems for radiopharmaceuticals and radiolabeled compounds.

FINANCIAL SOLUTIONS – Providing investment/ financing via our network of financial partners.

DE F

PRODUCTION SOLUTIONS FOR SPECT & PET

SAFETY – Monte Carlo shielding simulation report

INE

GMP FACILITY DESIGN

RUN

RUN

IBA ACADEMY

CONSULTANCY SUPPORT

ENDLESS INNOVATION

– Extensive training programs for equipment operation and maintenance

– On-site technical support from IBA experts in GMP or/and regulatory affairs

– Participate in the IBA international VIP Collaboration Network

– GMP training on site or/and at IBA production centers.

– Center qualification validation.

– Delivery of new tracers and automated production systems to cover your R&D needs – Upgradable path.

COMPLY


ENVIRONMENTAL IMPACT – Decommissionning guidelines.

DESIGN CLEAN ROOM EXPERTISE

PROCESS EQUIPMENT

– Integration of radiopharmaceutical laboratories requirements with special techniques (air classiďŹ cation and ventilation).

– User requirements for specialized radiopharmaceuticals production process equipment

DE S

– Supply of production and quality control equipment compliant with Pharmacopeia.

GMP CERTIFICATION

IGN

– Standard required GMP procedures in terms of quality assurance and regulatory aspects.

VALIDATION MASTER PLAN – Development of customized validation master plan (VMP).

IL U B

D

– Radioactive waste management

BUILD MATERIAL QUALIFICATION Protocols for : – Installation QualiďŹ cation (IQ) – Operational QualiďŹ cation (OQ) – Performance QualiďŹ cation (PQ).

FDG MARKET AUTHORIZATION – Deliverables based on IBA dossier. – Guidance to obtain global market authorization.

PROCESS VALIDATION – Customized standard operating procedures (SOPs) for quality system elaboration and site master ďŹ le (SMF) – Elaboration of calibration, validation and preventive maintenance programs.


IBA

PROVEN EXPERTISE THE ULTIMATE PET SOLUTION. With a global network of more than 50 PET centers and years of experience to rely upon, IBA has become the world leader in producing PET radiopharmaceuticals. We do so with only one goal in mind: providing safer and better patient care for all. Which is why we continue to innovate. And why IntegraLab® is the ultimate solution when providing PET radiopharmaceuticals.

DEFINE BEST SCIENCE “ For our new PET Centre,

Herlev Hospital has chosen IBA because of its expertise in equipment integration and advanced solid target technology, notably allowing us to produce124I.”

DR. INGE-LIS KANSTRUP

COMPLY BEST CAPACITY “ Medikol constructs the

first Croatian fully GMP compliant PET Centre. Relying on IBA Molecular’s engineering services and the capacity to produce more than 15Ci of 18F per 2 hours, it is possible to supply our nationwide network of PET imaging facilities from a single FDG production site.”

heAD oF clINIcAl phYSIoloGYNucMeD herleV hoSpItAl DENMARK

IVAN RAJKOVIC DIrector polIKlINIKA MeDIKol CROATIA


DESIGN BEST EFFICIENCY “ Since the beginning of our cyclotron project, thanks to IBA engineering team, we were able to complete the design of a state-ofthe-art facility in a record time and be able to initiate the permitting process effectively.�

JEAN M HEUSCHEN coNSultANt FDI + cAre INDIA

BUILD BEST SUPPORT “ IBA, the winner of the

international tender organized by the Brazilian Nuclear Energy Commission, surpassed our expectations in terms of quality of equipment offered and price. The construction and installation are rigorously on time and on budget. For sure, we will have the most complete and modern radiopharmaceuticals production facility in our country.�

SÉRGIO CHAVES CABRAL proJect MANAGer ceNtro reGIoNAl De cIÊNcIAS NucleAreS BRAZIL

RUN BEST SUCCESS “ Our hospital has selected

IBA technology and know-how based on its worldwide leadership and its ability to understand and tailor a custom-made, comprehensive solution to meet our country’s needs, including personnel training. We are enthusiastic about this ongoing collaboration meeting the interest of the Vietnamese people for medical treatment and technology development.�

DOCTOR DINH NGOC DUY DIrector trAN huNG DAo hoSpItAl VIETNAM

ď Ž IBA EXTENDED DISTRIBUTION NETWORK

YOUR CENTER WILL BENEFIT FROM IBA’S KNOW-HOW GAINED AT ITS OWN PRODUCTION CENTERS.

NortherN AMerIcA

13 pet SIteS ALBANY (NY),

CLEVELAND (OH), DALLAS (TX), GILROY (CA), HAVERHILL (MA), KANSAS CITY (KA), MONTREAL (CA), MORGANTOWN (WV), RICHMOND (VI), ROMEOVILLE (IL), SOMERSET (OH), STERLING (VA), TOTOWA (NJ)

ď Ž INTEGRALABÂŽ ACHIEVEMENTS

IBA HAS ACCOMPLISHED A LARGE NUMBER OF INTEGRALABÂŽ PROJECTS WORLDWIDE.

27 SIteS ALKMAAR, ALMATY,

ANKARA, ASTANA, BANGALORE, BERN, CAMPERDOWN (SYDNEY), CARACAS, COIMBRA, DAMMAM, GLIWICE, HANOI, HERLEV, JAKARTA, KIEN GIANG, KUALA LUMPUR, LAHORE, MOSCOU, PORTO ALLEGRE, RABAT, RIYAD, RECIFE, SANTIAGO, TENERIFE, TRIPOLI, TUNIS, YEREVAN, ZAGREB.

europe

26 pet SIteS

AMSTERDAM, BAD OEYNHAUSEN, BARCELONA, BERN, BORDEAUX, BRUSSELS, CASABLANCA, COIMBRA, FLEURUS, GHENT, GUILDFORD, LYON, MADRID, MALAGA, MONZA, NANCY, NIMES, ORSAY, PARIS AP-HP, RENNES, ROME, SAN SEBASTIAN, SANTANDER, SARCELLES, SEVILLA, UDINE

13

ASIA pet SIteS ADANA, ANKARA, DAEJUN, DAEGU, DELHI, ISTANBUL, IZMIR, KUALA LUMPUR, PUSAN, PYEONGCHON, SEOUL(2), SUNCHEON


IBA Group | 2011 | IntegraLab 2011

IBA Molecular, Europe Chemin du Cyclotron, 3 1348 Louvain-la-Neuve, Belgium Tel.: + 32 10 47 58 58 Fax: + 32 10 47 59 58 Info-cyclo@iba-group.com

IBA Molecular, North America 100 Executive Drive, Suite 100 Sterling, VA 20166 Tel.: + 1 703 787 7900 Fax: + 1 703 787 4079

IBA Molecular, China No 258-1 Caochangdi P.O. Box 100015-92 Chaoyang District Beijing (P.R. China) Tel.: + 86 10 64 34 46 40 Fax: + 86 10 84 56 02 25 IBA delivers solutions of unprecedented precision in the fields of cancer diagnosis and therapy. The company also offers sterilization and ionization solutions to improve the hygiene and safety of everyday life. Published by IBA S.A., Chemin du Cyclotron, 3 1348 Louvain-la-Neuve, Belgium. This brochure is printed on ECF wood-free coated paper. It was produced with plants that comply with ISO 14001, the environmental management standard.


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