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.

Scitech to attend SNMMI Annual Meeting in Toronto

We are excited to attend the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Toronto from June 8-11. Recognised as the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging, this meeting provides a unique platform to showcase Scitech’s expertise in the field.

Leading radiopharmaceutical expertise

Our subject matter experts are skilled at working with companies to develop or expand their nuclear medicine facilities, leveraging two decades of experience to manage the varied complexities of these projects. Our teams provide consultancy services and deliver full lifecycle projects for clients worldwide, with experience covering all stages of design and engineering services, from early strategic and technical advice to construction, qualification and validation, and regulatory compliance.

Over the course of four days, the SNMMI Annual Conference will offer attendees, including physicians, technologists, pharmacists, laboratory professionals, and scientists, a comprehensive exploration of the latest research and developments in nuclear medicine and molecular imaging. Moreover, it will delve into practical applications tailored for clinical settings, ensuring a well-rounded understanding of the industry’s advancements.

Showcasing radiopharmaceutical facility design

Representing Scitech at the event will be Dave Grant, Managing Director of Scitech Ltd; Marlous van der Hooft, Managing Director of Scitech GmbH; and Mark Randle, Scitech Sales Manager. They will showcase Scitech’s 20 years of continuous experience delivering a wide range of radiopharmaceutical projects.

Dave Grant commented: “The advancements in nuclear medicine and molecular imaging hold immense promise. These current strides are laying the foundation for improved diagnostics and more precisely targeted therapies, offering a brighter outlook for patient well-being. As we look to the future, we anticipate even more innovative applications and breakthroughs that will transform how we understand and treat various medical conditions. It is an exciting time to be part of this field, and we are committed to contributing to its growth and development.”

For more information about Scitech’s radiopharmaceutical services or to schedule a meeting with our experts at the SNMMI Annual Meeting, please visit our website or contact Dave, Marlous, or Mark. You can find us at booth 1930.