Specialist in testing kit assembly and fulfilment, We are ISO 13485 accredited
We Supply UN3373 Packaging
Nexus biolink, supplies a wide range of UN3373 packaging solutions, designed to comply with both ADR and IATA regulations. Whether you need packaging for road or air transport, we offer products that meet strict safety standards for shipping biological substances.
Difference between Category a & CateGORY b
Category A
UN3373 Category A substances refer to infectious substances that are capable of causing disease in humans or animals. These substances pose a significant risk to health and safety and require special precautions for packaging, handling, and transportation.
Category A Substances (Infectious Substances):
- Definition: Category A substances are infectious substances that are known or reasonably expected to contain pathogens capable of causing disease in humans or animals. These substances pose a significant risk to health and safety.
- Examples: Specimens or samples of infectious material, cultures of pathogenic microorganisms, diagnostic specimens containing infectious agents.
- Packaging Requirements: Packaging for Category A substances must meet stringent criteria to ensure containment and prevent exposure to hazards. This typically involves using leak-proof primary receptacles, secondary packaging, absorbent material (if applicable), and outer packaging that meets regulatory standards.
- Labeling: Packages containing Category A substances must be clearly marked and labeled to indicate the presence of infectious substances. This includes affixing the UN3373 diamond-shaped label and any additional required labels or markings for Category A infectious substances.
- Transportation: Transport of Category A substances is subject to strict regulations to ensure the safety of handlers, transporters, and the public. This may include specific handling requirements, training for personnel involved in transportation, and compliance with international standards for the transport of dangerous goods.
- Safety Precautions: Handling and transportation of Category A substances require appropriate safety precautions to minimize the risk of exposure to infectious agents.
Category B
UN3373 Category B substances refer to biological substances that do not meet the criteria for Category A substances but still pose a potential risk to health and safety during transportation.
Category B Substances (Biological Substances):
- Definition: Category B substances are biological materials that do not meet the criteria for Category A substances but still contain pathogens or have the potential to cause disease in humans or animals. These substances pose a lower risk compared to Category A substances.
- Examples: Specimens or samples of non-infectious microorganisms, tissues, cells, blood, body fluids, or other biological materials that may contain pathogens or genetic material.
- Packaging Requirements: Packaging for Category B substances must provide containment and prevent exposure to hazards during transportation. This typically involves using leak-proof primary receptacles, secondary packaging, absorbent material (if applicable), and outer packaging that meets regulatory standards.
- Labeling: Packages containing Category B substances must be clearly marked and labeled to indicate the presence of biological substances. This includes affixing the UN3373 diamond-shaped label and any additional required labels or markings for Category B substances.
- Transportation: Transport of Category B substances is subject to regulations to ensure the safety of handlers, transporters, and the public. While still regulated, the requirements are generally less stringent compared to Category A substances.
- Safety Precautions: Handling and transportation of Category B substances require appropriate safety precautions to minimize the risk of exposure to pathogens or other hazards, but the level of precautions may be lower compared to Category A substances.
3 Stage packing Process
Primary Receptacle
- Primary Receptacle Requirements:
- Must be leakproof and securely closed.
- For liquids, the receptacle should be able to withstand an internal pressure differential without leaking.
- For solids, the receptacle should be leakproof.
- Labelling:
- The primary receptacle should be clearly labelled with the contents and any necessary biohazard symbols.
Secondary Packaging
Secondary Requirements:
- Must also be leakproof.
- Multiple primary receptacles can be placed in one secondary packaging as long as the combined volume does not exceed the limits and cushioned to prevent breakage.
- Second packaging needs to withstand internal pressure without leaking.
- Absorbent Material:
- Place sufficient absorbent material between the primary and secondary containers to absorb all liquid content in case of leakage.
- Sealing:
- The secondary container should be securely sealed to prevent any leakage.
Rigid Outer Box
Outer Container Requirements:
- Must be rigid and durable enough to protect the contents during transit.
- Should comply with the drop test requirements for packages containing biological substances.
- The outer packaging must be clearly labelled with the UN3373 diamond label and the words "Biological Substance, Category B".
- Ensure the package can withstand typical transportation stresses without compromising the integrity of the inner contents.
- Documentation:
- Include necessary shipping documents and a list of contents between the secondary and outer packaging.
- Ensure that the outer packaging has the sender's and recipient's contact information.
By following these steps, you ensure that the biological substances are packaged in compliance with the regulations, minimizing the risk of leakage or contamination during transport.
Further information can be found by the following sites:
UK Gov website: Packaging and transport requirements for patient samples – UN3373 - GOV.UK (www.gov.uk)
IATA Website: dgr-64-en-pi650.pdf (iata.org)
Royal mail: Guidance-Document-Infectious-Substances-171012.pdf (royalmail.com)