Antero Abrunhosa
Director at ICNAS, University of Coimbra
Quality Control
GMP control room
Production hotlab & packaging
Airlock
R&D Hotlab
Cyclone KIUBE
Control room
Technical room
Develop your project
Maximize your performances
Build you future
Develop your project
Project Conception 01
-
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
IBA & YouUser's voice
