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IntegraLab® PLUS

Quality Control

GMP control room

Production hotlab & packaging

Airlock

R&D Hotlab

Cyclone KIUBE

Control room

Technical room

Develop your project

IBA works with you and supports you right through the whole process, from our first meeting through design, setting-up and operation

Maximize your performances

When your new production facility is up and running, IBA continues to offer you support and expertise, to optimize uptime and maximize your return on investment

Build you future

We will work with you and help you secure your future by offering improvements that lead to higher performance and productivity, enabling you to produce new radioisotopes and radiopharmaceuticals.

Project Conception 01

ALT
  • Business plan

    • Define the radiopharmaceuticals production scope
    • Build your business plan
    • Supporting investment/financing, via our network of financial partners
  • GMP facility design

    • Customized and optimized facility layout, compliant with GMP standards
    • Facility architectural design and engineering services
    • Integration of radiopharmaceutical laboratories requirements
  • Safety

    • Risk Analysis
    • Monte Carlo shielding simulation report
    • Radiation monitoring and radiation protection equipment
  • Environmental impact

    • Support for radioactive waste management strategy
    • Decommissioning guidelines

Equipment integration 02

Production solutions for PET & SPECT

  • High capacity cyclotron and targetry system, chemistry equipment, quality control equipment, hotcell & dispensing system environmental monitoring, radiation monitoring, small laboratory equipment,...

Process Equipment

  • User requirements for specific radiopharmaceutical processes premises and equipment.
  • Supply of production and quality control equipment for Pharmacopeial testing.

Project Management

  • One Single point of contact for the project.
  • Set-up your PET center in time and on Budget.

Equipment Qualification

  • Installation qualification (IQ).
  • Operational Qualification (OQ).
  • Performance Qualification (PQ).

Process Validation 03

GMP documentation

  • Framework covering all the GMP activities on site from sourcing up to the release of the final product
  • Associated set of standard GMP template or customized documents
  • Support to build GMP quality risk management document

Process Validation 

  • QC Method validations
  • Production Process validation including aseptic filling validation
  • Cleaning validation

FDG Market Authorization (MA)

  • Marketing authorization template
  • Additional consultancy to customize or to complete the MA dossier

Consultancy

  • Technical support from IBA experts in GMP and/or regulatory affairs
  • Process validation support

Maximize your production uptime 04

Highest production capacity equipment

  • Set-up your PET center on time and on budget
  • One single point of contact

IBA Academy comprehensive training program

  • For equipment operation and maintenance, quality control, quality assurance, ...
  • At IBA centers or at your site

Specialist advice

  • Regulatory affairs changes
  • Changes to GMP guidance
  • Impact assessment of changing technology
  • Delivery of new tracers and automated production systems to cover your R&D needs

Maintenance services

  • Technical support 24/7
  • Online access to spare parts services
  • System upgrades

Antero Abrunhosa

Antero Abrunhosa

Director at ICNAS, University of Coimbra

Other success stories

Antero Abrunhosa

Antero Abrunhosa

Director at ICNAS, University of Coimbra

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Al Khalidi

Walid I. Al Khalidi

Managing Director Al Khalidi Medical Center Amman, Jordan

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Dr Adrie P

Dr Adrie P. de Jong,

Head of Radiopharmacy Medisch Centrum Alkmaar, The Netherlands

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