Implementation and production readiness
Preparing processes, equipment and operators for qualified and reliable production.
We support the transition of developed radionuclide and radiopharmaceutical production processes into fully operational routine production.
Our implementation support covers installation, commissioning, qualification, validation, documentation, technology transfer, operator training and maintenance.
Capabilities
Where we can contribute.
01
Production-site integration
Equipment integration in hot cells and cleanrooms, interfacing with site infrastructure, waste handling and adaptation to production workflows.
02
Production scale-up
Adaptation and testing of process conditions, equipment setup and operating procedures for higher radiation exposure and material throughput.
03
Process validation
Engineering runs, reproducibility studies, performance verification, validation studies and supporting documentation.
04
Installation and commissioning
Installation planning and preparation, equipment installation, system adjustments and site acceptance testing (SAT)
05
Equipment qualification
IQ/OQ protocol development, execution and reporting
06
Technology transfer and training
Site-readiness assessment, transfer planning, hands-on operator training, supervised production runs and transition to routine operation.
07
Supply-chain resilience
Identification of critical materials and components, selection of alternatives, supplier qualification support and obsolescence risk assessment
08
Maintenance and lifecycle support
Preventive maintenance, spare-parts strategy, and planned equipment modifications and upgrades.
09
GMP documentation
Drafting of SOPs, work instructions and batch records.
10
Troubleshooting
Investigation and resolution of process deviations, equipment malfunctions and other production issues.
Typical customer questions
Questions we can help answer
Can our radiochemical process be reliably scaled up to the intended activity and throughput?
What can we do to minimise downtime during maintenance or equipment upgrades?
How can we prepare our operators to run the process independently after handover?
Why are we experiencing recurring yield losses or batch failures, and how can we prevent them?
OUTPUT
Typical project deliverables
Site readiness and gap analysis
Qualification protocols and reports
SOPs and batch records
Operator training programme
Scope
FutureChemistry supports the transition to routine radiochemical production through site integration, commissioning, qualification, validation, GMP documentation and operator training. Formal responsibility for regulatory approvals, facility licensing and the customer’s quality system is outside our scope.
LET'S TALK
Moving a radiochemical process into routine production?
Share where things stand and we can explore what is still needed.