IntegraLab^®

Introduction - Integralab

Integralab is a global solution combining products and services for the production of radiopharmaceuticals.

Integralab includes among others, building design according to cGMP and the selection, integration, supply and installation of suitable equipment to match customer's radioisotopes production goals.

Define

18F Capacity and new Radiotracers

Production solutions for SPECT & PET

• High capacity cyclotron and targetry system
• Full range of chemistry systems for radiopharmaceuticals and radiolabeled compounds

Financial solutions

Providing investment/financing via our network of financial partners

Comply

Regulations and Safety

GMP Facility design

• Customised and optimised facility layout, compliant with GMP standards
• Facility, architectural and engineering services such as HVAC design

Radiation Safety For discussion

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

Environmental impact For discussion

• Radioactive waste management
• Decommissioning guidelines

Design

Select and Integrate

Clean Room Expertise

Integration of radiopharmaceutical laboratories requirements with special techniques ( air classification and ventilation)

Process Equipment

• User requirements for specialised radiopharmaceuticals production process equipment
• Supply of production and quality control equipment compliant with Pharmacopeia

GMP Certification

Standard required GMP procedures in terms of quality assurance and regulatory aspects

Validation Master Plan For discussion

Development of customised validation master plan (VMP)

Build

On Time and On Budget

Material qualification

Protocols for :

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

Process Validation

• Customised standard operating procedures (SOPs) for quality system elaboration and site master file (SMF)
• Elaboration of calibration, validation and preventive maintenance programs

FDG Market authorization

• Guidance to obtain global market authorisation
• Deliverables based on IBA dossier

Run

Training and Support

Technical consulting support

• On-site technical support from IBA experts in GMP or/and regulatory affairs

Training

• Extensive training programs for equipment operation and maintenance
• GMP training on site or/and at IBA production centers

Endless innovation

• Participate in the IBA international VIP Collaboration Network
• Delivery of new tracers and automated production systems to cover your R&D needs