IntegraLab® PLUS

IntegraLab® PLUS your customized turnkey* radiopharmacy solution, seamlessly combining equipment and services tailored to meet your needs. 

Develop your project

Project Conception

IBA team helps you conceive your project depending on your production goals. This phase is critical in order to lay the foundation for a successful project.

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

  • Monte Carlo shielding simulation report
  • Radiation monitoring and radiation protection equipment

Environmental impact

  • Support for radioactive waste management strategy
  • Decommissioning guidelines

Equipment integration

IBA collaborates with you to identify and integrate the appropriate equipment for your center, ensuring a seamless and successful implementation.

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).

Process Validation

IBA offers support with process validation, ensuring that your processes meet the necessary quality and regulatory standard.

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 (documentation only) validation including aseptic filling validation
  • Cleaning validation

FDG Market Authorization (MA)

  • Marketing authorization template

Consultancy

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

Maximize your production uptime

IBA has developed upgrade packages tailored to your configuration and training programs to increase performance and operator efficiency.

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

 

 

*according to the scope of supply