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Core considerations for radiopharmaceutical facility design and construction

Designing and constructing a radiopharmaceutical facility is a complex process that requires meticulous planning and expertise. Success in such a project hinges on several core considerations that lay the foundation for seamless integration, operations, compliance, and optimal functionality. In this article, we explore these essential factors that must be evaluated before embarking on a radiopharmaceutical design and build project.

Crystal clear production objectives

Defining clear and realistic production objectives is crucial. This includes considerations such as the start up and licensing schedule, selection of radioisotopes and molecules, batch size and scheduling, commercial scale-up plans, and adherence to regulatory and licensing frameworks. The maturity of process development, availability of funding, and equipment lead times are all factors to be taken into account.

The inclusion of an accelerator, typically a cyclotron, is a pivotal decision. This choice influences the facility’s configuration, structural design, and production capabilities. Factors like radioisotope selection, targetry choices, beamline configuration, target transfers, and shielding requirements must be carefully considered. Deciding between a self-shielded or unshielded accelerator requires a thorough evaluation.

Spatial dynamics: facility layout and controlled spaces

Efficient facility layout is essential to ensure operational efficiency, regulatory compliance, equipment integration, and potential future scale-up or equipment replacement. The strategic placement of major equipment within the facility is critical, and controlled spaces and specialised rooms must be incorporated to create a seamless journey from production to dispatch.

Radiopharmaceutical facility design must blend radiation-classified areas with conventional, non-radiological spaces. This integration includes secure receptions, storage areas, material and personnel transfer zones, laboratories, waste management, and administrative sectors. The goal is to create a holistic environment where radiological and non-radiological elements coexist harmoniously.

Treading the regulatory path: GMP and compliance

Adhering to medical regulatory standards and Good Manufacturing Practice (GMP) is paramount in radiopharmaceutical design, whether for clinical or commercial-scale manufacturing. Integrating GMP requirements with radiological controls ensures that the facility operates efficiently and complies with quality and safety standards. This includes carefully integrating ventilation systems, air handling plants, discharge abatement, and environmental monitoring into the overall design.

Collaborative synergy: leveraging shared services

Designing and building a radiopharmaceutical facility requires a balance of technical expertise, meticulous planning, delivery experience, and a deep understanding of technical, radiological, and regulatory intricacies. This complex undertaking is a testament to the fusion of knowledge and experience that shapes radiopharmaceutical project delivery excellence.

With a commitment to innovation, meticulous attention to detail, and a proven portfolio of successful projects, Scitech offers guidance to bring these core considerations together into a harmonious and effective radiopharmaceutical facility design and construction.

For more information, contact us to learn how we can support your project.

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