Radioactive material refers to any substance containing radionuclides where both the activity concentration and total activity exceed established regulatory limits. Proper classification is essential, as it determines the necessary packaging, labelling, and documentation to ensure safe transportation.

Pharmaceutical Shipment Classifications

UN2910 – Excepted Packages

Designed for materials with extremely low radioactivity, these packages have minimal regulatory requirements and do not require extensive shielding.

Examples: Diagnostic radiopharmaceuticals with minimal radiation levels.

Requirements:

• Packaging: Must meet general safety standards but does not require UN specification packaging; UN3373 packaging is appropriate for UN2910 when properly labeled.
• Radiation Limits: Surface dose rate of packaging must not exceed 0.5 mrem/hr as measured by a radiation survey instrument.
• Documentation: No Dangerous Goods Declaration (DGD) needed.
• Labelling & Marking: Must display “UN2910” on the exterior; no hazard labels are required.

UN2915 – Type A Packages

Used for higher radioactivity materials, these packages must meet stringent performance and containment standards to prevent leakage or exposure under normal transport conditions.

Examples: Radiopharmaceuticals for cancer therapy, radioactive waste, and industrial radioactive source.

Requirements:

• Packaging:
  • Requires a robust outer shell composed of steel, wood, or fibreboard, along with an inner containment vessel made of glass, plastic, or metal.
  • Protective materials such as polyethylene or vermiculite should be employed.
  • Minimum external dimension must be 10 cm (4 inches).
  • Must maintain integrity within temperatures ranging from -40°C (-40°F) to 70°C (158°F).
  • The containment system must be secured with a fastening device to prevent accidental opening.
  • Must withstand pressure reductions down to 60 kPa (8.7 psia).
• Documentation: A DGD is required.
• Labelling & Marking: According to radiation levels:
  • Yellow II: Surface radiation between 0.5 mrem/hr. and 50 mrem/hr.
  • Yellow III: Surface radiation between 50 mrem/hr. and 200 mrem/hr.

Best Practices for Compliance

To ensure compliance and safety, please adhere to the following best practices:

1. Identify the Correct UN Classification: Evaluate activity levels and determine appropriate packaging requirements.
2. Use Compliant Packaging: Select packaging that adheres to containment and shielding standards.
3. Ensure Proper Labelling & Marking: Apply the correct labels in accordance with radiation levels.
4. Maintain Accurate Documentation: Include all required shipping documents, especially for UN2915 shipments.
5. Train Personnel: Ensure that staff handling radioactive shipments receive training on 49 CFR, IATA, and ADR regulations.
6. Stay Informed on Regulatory Changes: Regularly monitor updates to transport regulations.

Whether shipping low-risk materials under UN2910 or higher-activity shipments classified as UN2915, adherence to IATA and country-specific regulations is essential. Proper classification, packaging, labelling, and documentation are necessary to mitigate risks and ensure efficient logistics operations.

Marken stays committed to supporting clients in navigating the regulatory and trade landscape of the global clinical supply chain. For more information or if you have any questions, contact our team at TradeCompliance@marken.com.