Our radiopharmaceutical manufacturing cleanroom and lead-lined hot cell integration delivers turnkey facility engineering for the production of diagnostic and therapeutic radiopharmaceuticals. This specialised solution merges cGMP cleanroom classification with radiation shielding architecture, addressing the dual constraints of aseptic product control and ionising radiation containment. Designed for radiotracer synthesis, radiolabelling, formulation and dispensing workflows, the integrated layout segregates radioactive zones from non-radioactive clean areas while maintaining uncompromised protection for operators, product sterility and regulatory compliance for nuclear medicine facilities.
The engineering scope encompasses cleanroom zoning design, lead or high-density composite shielding calculation, hot cell structural integration, remote handling mechanism layout, HVAC cascade design, radioactive waste routing and dedicated utility systems. We perform radiation shielding simulation to validate dose-rate attenuation, paired with airflow and pressure differential modelling to uphold ISO 14644 cleanliness grades within aseptic processing areas. Full deliverables include shielding design drawings, hot cell interface schematics, P&IDs, radioactive drain networks, material/personnel airlock planning and URS documentation aligned with IAEA safety standards and global cGMP requirements for radiopharma production.
Seamless integration of shielded hot cells within the cleanroom envelope eliminates design conflicts between radiation safety and aseptic manufacturing. Robust lead shielding construction maintains low occupational radiation exposure, while optimised airflow and zoning reduce cross-contamination between active and cold areas. Remote manipulator interfaces minimise human entry into high-radiation zones, lowering operational risk and simplifying batch traceability. The modular design approach supports phased capacity expansion and flexible reconfiguration for multiple isotope and radiolabelling campaigns.
This integrated facility solution serves radiopharma CDMOs, nuclear medicine centres and biotech firms developing PET tracers, targeted radionuclide therapies and radiodiagnostic agents. Beyond design and integration, our service portfolio includes design validation, installation supervision, commissioning, radiation survey support and GMP qualification consultancy. We enable clients to build inspection-ready manufacturing infrastructure that balances radiation safety, product sterility and operational efficiency, accelerating clinical and commercial radiopharmaceutical production deployment.
