IntegraLab®
From maze to amazing results
Integralab Gmp Radiopharmacy
The path to setting up a radiopharmacy can appear like a complex maze. IntegraLab® combines equipment and services that allow you to establish your research or radiopharmaceutical production center whilst achieving full regulatory compliance. By letting IBA show you the way with IntegraLab®, your PET center will soon yield amazing results.
Define
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PRODUCTION SOLUTIONS FOR SPECT & PET
- High capacity cyclotron and targetry system
- Full range of chemistry systems for radiopharmaceuticals and radiolabeled compounds.
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FINANCIAL SOLUTIONS
- Supporting investment/financing via our network
Comply
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GMP FACILITY DESIGN
- Customized and optimized facility layout compliant with GMP standards
- Facility, architectural and engineering services such as Heating, Ventilation and Air-Conditioning (HVAC) design.
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SAFETY
- Risk Analysis
- Monte Carlo shielding simulation report
- Radiation monitoring and radiation protection equipment
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ENVIRONMENTAL IMPACT
- Radioactive waste management
- Decommissioning guidelines.
Design
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CLEAN ROOM EXPERTIZE
- Integration of radiopharmaceutical laboratories requirements with special techniques (air classification and ventilation).
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PROCESS EQUIPMENT
- User requirements for specific radiopharmaceuticals process equipment
- Supply of production and quality control equipment compliant with Pharmacopeia.
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VALIDATION MASTER PLAN
- Development of customized validation master plan (VMP).
BUILD
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EQUIPMENT QUALIFICATION
- Protocols for :
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ).
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GMP VALIDATION
- Customized protocols for process validation and product stability studies
- Customized SOP (standard operating procedures and SMF( site master file)
- Standard quality assurance procedures according to GMP requirements.
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FDG MARKET AUTHORIZATION
- Deliverables based on IBA dossier
- Guidance to obtain market authorization.
RUN
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IBA ACADEMY
- Comprehensive training program:
- For equipment operation and maintenance, quality control, quality assurance, site management, ...
- At IBA centers, at your site or internship.
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CONSULTANCY SUPPORT
- Technical support from IBA experts in GMP and/or regulatory affairs
- Center qualification validation.
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ENDLESS INNOVATION
- Participate in the IBA international VIP Collaboration Network
- Delivery of new tracers and automated production systems to cover your R&D needs
- Upgradable path.
