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The transport of radiopharmaceuticals is one of the most critical activities in the pharmaceutical supply chain. Used in diagnostics and therapy in nuclear medicine, radiopharmaceuticals combine the regulatory complexity governing radioactive materials (DG Class 7) with the stringent quality, traceability, and temperature control requirements of the pharmaceutical sector. In this context, choosing a qualified logistics operator for the transport of radiopharmaceuticals is not only an operational decision, but also a choice of governance and regulatory responsibility. Here are the main aspects to be aware of and consider when choosing a supplier.
What regulations govern the transport of radiopharmaceuticals?
Full compliance for the transport of radiopharmaceuticals requires structured integration between radiological regulations and pharmaceutical quality requirements, with provisions at international and national level.
The IAEA Regulations for the Safe Transport of Radioactive Material (SSR-6) constitute the primary international reference for the transport of Class 7 radioactive materials, establishing requirements for packaging, labeling, documentation, personnel training, and operational controls. Depending on the mode of transport, additional modal regulations apply, including:
- ADR for road transport in its contracting countries
- the IATA Dangerous Goods Regulations (DGR) for air transport
As for provisions related to the pharmaceutical sector, the main reference is the EMA’s Good Distribution Practice (GDP), which imposes stringent standards on quality, traceability, deviation management, and temperature control.
Who can transport radiopharmaceuticals?
The transport of radiopharmaceuticals may only be carried out by operators authorized and qualified for DG Class 7. Specifically, a compliant operator must guarantee:
- Dangerous Goods-trained and certified personnel, specific to radioactive materials (Class 7)
- Documented operating procedures implemented within a management system compliant with IAEA SSR-6 requirements and Good Distribution Practice (GDP)
- Vehicles and packaging approved in accordance with international regulations
This means being able to demonstrate, during operations and audits, that the logistics provider is qualified on the basis of objective and verifiable criteria.
How are radiopharmaceuticals transported?
Radiopharmaceuticals are shipped in approved packages compliant with the IAEA Regulations for the Safe Transport of Radioactive Material (SSR-6) and applicable modal transport regulations, such as ADR for road transport and the IATA Dangerous Goods Regulations (DGR) for air transport.
In most cases, the following are used:
- Type A packages, for activities not exceeding the A1/A2 limits
- Packages incorporating shielding using high-density materials, such as lead
- Packages designed to provide certified shock and impact protection.
How is the cold chain guaranteed during the transport of radiopharmaceuticals?
Packaging design is an integral part of the product safety and quality assurance system, on a par with operating procedures and analytical controls.
Good Distribution Practices (GDP) precisely define the minimum requirements applicable to cold chain management in the transport of medicines, including radiopharmaceuticals. In particular, they require:
- Continuous temperature monitoring during all stages of transport
- Recording and storage of data (audit trail)
- Formalized procedures for managing deviations
- Assessment of the impact of any temperature excursions
However, an effective cold chain system is not limited to the technical control of transport conditions. It requires a systemic approach that includes risk analysis related to the specific type of radiopharmaceutical, validation of packaging and distribution processes, and the preparation of business continuity plans capable of managing critical scenarios without compromising product quality and safety.
What are the main risks involved in transporting radiopharmaceuticals?
The risks associated with the transport of radiopharmaceuticals must be analyzed using a structured risk management approach and include:
- Accidental exposure to radiation
- Damage to packaging with potential dispersion
- Theft or illicit use of radioactive material
- Temperature fluctuations that compromise quality, safety, and clinical efficacy
Non-compliant management can lead not only to safety risks, but also to regulatory impacts, supply blockages, and reputational damage. For this reason, preventive measures include specialized training, real-time traceability, emergency protocols, and rigorous document checks.
In some cases, enhanced measures may be required in proportion to the category and level of activity of the material being transported, in accordance with IAEA guidelines and national nuclear safety and security regulations.
The advantages of choosing a specialist radiopharmaceutical logistics operator
When transporting radiopharmaceuticals, compliance is not just a matter of formally complying with Dangerous Goods Class 7 and Good Distribution Practice (GDP) requirements, but also requires the ability to clearly and comprehensively demonstrate that each stage of distribution has been managed according to verifiable standards.
During audits and inspections, pharmaceutical companies and healthcare facilities must be able to quickly access items such as temperature monitoring reports, DG documentation, staff qualifications and training, updated standard operating procedures (SOPs), and records relating to the management of deviations.
For this reason, relying on a highly specialized logistics operator such as PHSE, a world leader in radiopharmaceutical logistics, is a strategic factor as well as an added value. It means being able to rely on validated processes, continuous tracking and monitoring systems, structured cold chain management, and full integration between radiological safety requirements and pharmaceutical quality standards.
PHSE provides its customers with dedicated expertise, authorized infrastructure, and logistics solutions specifically designed for the safe and compliant transport of radiopharmaceuticals throughout the healthcare supply chain.
Discover all the advantages of PHSE’s radiopharmaceutical transport services and request a personalized consultation.
Regulatory references
- ADR – Agreement concerning the International Carriage of Dangerous Goods by Road (UNECE)
- IAEA – Regulations for the Safe Transport of Radioactive Material (SSR-6)
- EU Guidelines on Good Distribution Practice (2013/C 343/01)
- IATA Dangerous Goods Regulations
