IntegraLab® PLUS

IntegraLab® PLUS — полностью укомплектованное решение, сочетающее в себе оборудование и услуги и позволяющее удовлетворить ваши потребности.

Develop your project

Project Conception

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

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

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

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