The radiopharmaceutical field is rapidly transforming the treatment of life-threatening diseases, offering new hope to patients.
However, this growing treatment sector, with a projected 12.3% annual Compound Annual Growth Rate (CAGR) between now and 2029, presents unique challenges and stringent requirements in both management and manufacturing.
Radiopharmaceutical production necessitates highly specialised equipment in controlled environments designed to safely store, prepare, fill, and package radioactive materials. These facilities must adhere to complex regulatory standards, ensuring the safety of both workers and the surrounding community.
Designing facilities to accommodate these critical processes demands a meticulous approach to safety, efficiency, and regulatory compliance.
A comprehensive design approach facilitates securing regulatory approvals and reducing time-to-production
Given the highly individualised nature of radiopharmaceutical products, it’s crucial the design team be embedded with the client early in the process. This allows for a deep understanding of specific needs and objectives, as facility requirements vary significantly among clients and processes.
Following are some essential considerations in facility planning to ensure a successful radiopharmaceutical manufacturing facility.
Site selection and facility layout/compartmentalisation
Whether renovating or building new, selecting a suitable site and evaluating any existing structures are critical. Key assessment factors include:
- Access to raw materials and a stable supply chain infrastructure supporting efficient operations
- Adequacy and availability of utility services
- Geological site profiles and structural integrity of existing buildings to support the demands of radiopharmaceutical production, including the weight of shielding materials, mechanical equipment, and specialised production equipment
- For existing buildings, ensuring adequate height from the finish floor to the underside of the roof structure is critical to house and maintain building utility equipment while providing future flexibility to accommodate technology advances
- Operational efficiency and safety are critical when designing radiopharmaceutical facilities. The design should clearly define zones for production, quality control, storage, and supporting services with pathways designed to minimise contamination risks. Additionally, carefully locating office and amenity spaces will ensure safety and employee well-being, strategic placement of zones can facilitate smoother workflows and enhance safety protocols, and columns should be located outside cleanrooms in adjacent chases where possible to provide flexibility to facilitate process advances, new technologies or equipment.
Further, minimising the risk of radioactive contamination is paramount. Strategies include:
- Implementing specialised handling and containment solutions to manage production materials and waste and employing automated systems and remote handling techniques to reduce human interaction with radioactive substances
- Designing dedicated rooms for production procedures requiring hazardous materials exposure to minimise occupant contamination risk; and
- Incorporating robust ventilation and air quality systems to protect staff from potential radiation exposure.
Beyond designing to mitigate radiation exposure risk, creating facilities prioritising user health and wellness of staff yields return in employee attraction, retention, engagement, and productivity.
The use of strategic room “sinks” and “bubbles” is critical to prevent cross-contamination between lab and workplace functions
Additionally, creating dedicated spaces for staff amenities, including break rooms with natural light, ergonomic workstations, and areas for relaxation, can significantly enhance employee well-being and productivity. Incorporating biophilic design elements such as indoor plants and access to outdoor spaces also contribute to a healthier and more comfortable work environment.
Infrastructure
Designing a radiopharmaceutical facility requires a deep understanding of scientific processes and overarching regulations to create facilities meeting today’s stringent standards, ensuring safe and effective production while at the same time being adaptable to accommodate future innovations.
Beyond supporting the complexities of radiopharmaceutical production, a comprehensive design approach facilitates securing regulatory approvals and reducing time-to-production.
Incorporating redundancy in critical systems, including HVAC and power supply, ensures operational continuity and mitigates equipment failure risks. Significant capex investment in a new facility requires the design to maximise long-term viability and future flexibility to accommodate production line or capacity changes and technology advancements. New treatments and production processes are being tested regularly in this fast-growing industry.
The equipment procurement process is a balancing act that weighs factors such as cost, lead times, regulatory standards, maintenance requirements, future integration and adaptability, and operational workflow.
Designers must be well-versed in the standards set by bodies such as the Nuclear Regulatory Commission (NRC) and the International Atomic Energy Agency (IAEA)
Close collaboration between operations, facilities, and procurement professionals and the design team will ensure downstream efficiencies and cost control while meeting project schedules. Equipment ordering schedules should be developed and scrutinised against changing supply chain challenges.
Advanced automated systems and robotics can enhance safety by minimising direct human interaction with radioactive materials.
Security threats, regulations, and measures to safeguard secure environments are constantly evolving.
Protecting people, sensitive materials, technologies, and products are a critical design foundation. While surveillance systems, controlled access, and rigorous inventory management are standard, the design team must understand anticipated visitor and access requirements and restrictions and operational flows to ensure proper levels of equipment sophistication.
Specialised design elements, including production room interior windows, can allow visitor views without penetrating secure spaces.
Environmental considerations
Specialised ventilation systems are critical to prevent the spread of airborne radioactive contaminants.
To achieve this, designers can incorporate high-efficiency particulate air (HEPA) filters, bag-in-bag-out (BIBO) filtration, and maintain negative pressure in critical areas. Strategic airflow management ensures contaminants are effectively captured and filtered, safeguarding the facility's internal environment and the external community.
The use of strategic room “sinks” and “bubbles” is critical to prevent cross-contamination between lab and workplace functions.
Radiopharmaceutical facilities contain dedicated spaces for radioactivity, producing ionising radiation during operation, necessitating a robust shielding strategy
In addition to controlled radioactivity, environmental radioactivity can infiltrate buildings, pose significant health risks, and impact equipment calibration and quality control. The decay of uranium in ground sources, producing radon, is a common example of environmental radioactivity.
Effective radon mitigation strategies are crucial for radiopharmaceutical facilities to ensure quality control. These strategies involve continuously monitoring radon levels to prevent accumulation and exposure in addition to negative ventilation below the slab.
Radiopharmaceutical facilities contain dedicated spaces for radioactivity, producing ionising radiation during operation, necessitating a robust shielding strategy. Facility design must integrate lead, concrete, or steel barriers into walls, floors, and doors. The type and thickness of shielding materials should be tailored based on the specific radioactive materials used, ensuring compliance with safety standards and minimising radiation exposure.
Regulatory compliance
Prior to site selection, the design team must navigate the complex regulatory landscape. Designers must be well-versed in the standards set by bodies such as the Nuclear Regulatory Commission (NRC) and the International Atomic Energy Agency (IAEA). Early engagement with regulatory consultants can facilitate compliance with all applicable guidelines, ensuring that facility operations are both safe and have obtained the appropriate permitting.
The design and development of radiopharmaceutical facilities require a deep integration of specialised knowledge, innovative solutions, and strict adherence to regulatory standards. Collaboration between architects, engineers, regulatory experts, and clients from the earliest stages is essential to ensure that all design aspects are optimised for safety, efficiency, openness and connectivity, and long-term viability.
This strategic approach to facility design will ultimately enable the radiopharmaceutical industry to continue its groundbreaking work in treating life-threatening diseases
As the radiopharmaceutical field continues to evolve, so must the approach to designing these facilities, ensuring they remain adaptable to future advancements and increasing demands. Numerous considerations - from site selection and infrastructure to environmental controls and regulatory compliance - are critical to successfully implementing a facility that meets today's stringent requirements and is poised for tomorrow's challenges and opportunities.
By addressing these key elements, stakeholders can create compliant and operationally efficient facilities and support the overarching goal of advancing medical science and improving patient outcomes.
This strategic approach to facility design will ultimately enable the radiopharmaceutical industry to continue its groundbreaking work in treating life-threatening diseases, ensuring safety and effectiveness at every step of the process.