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Essential Guide to UN3373 Compliant Packaging for Biological Samples

2025-09-29

最新の企業ニュース Essential Guide to UN3373 Compliant Packaging for Biological Samples

In the field of medical diagnostics, research, and public health, the safe transportation of biological samples is paramount. Whether it's blood, tissue, or other specimens, ensuring they reach their destination without compromising safety or integrity is regulated by international standards. Central to this is the UN3373 designation, which governs the shipping of infectious substances classified as Category B. This article explores key components of UN3373-compliant packaging, focusing on biological sample bags, UN3373 transport boxes, UN3373 sample bags, and specimen transport boxes. These elements form the backbone of secure sample transport, preventing leaks, contamination, and exposure risks during transit.

Understanding UN3373: The Regulatory Framework

UN3373 refers to the United Nations' classification for "Biological Substance, Category B," which includes diagnostic specimens that may contain infectious agents but are not expected to cause permanent disability or fatal disease in healthy humans or animals. These are distinct from Category A substances, which pose higher risks. The packaging requirements fall under Packing Instruction P650 of the International Air Transport Association (IATA) and similar guidelines from organizations like the World Health Organization (WHO) and the U.S. Department of Transportation (DOT).

The primary goal of UN3373 regulations is to ensure triple-layered packaging that withstands normal transport conditions, including pressure changes, vibrations, and temperature fluctuations. This typically involves:

  • Primary Receptacle: The innermost container holding the sample, such as a leakproof tube or vial.
  • Secondary Packaging: A watertight or siftproof layer that contains any leaks from the primary.
  • Outer Packaging: A rigid exterior that protects the entire assembly.

Non-compliance can lead to delays, fines, or health hazards, making it essential for laboratories, hospitals, and shipping companies to adhere strictly to these standards.

Key Components of UN3373 Packaging

UN3373-compliant systems rely on specialized bags and boxes designed to meet durability, absorbency, and labeling criteria. Below, we break down the keywords in the context of these requirements.

Biological Sample Bags

Biological sample bags are typically used as secondary packaging to enclose primary receptacles like test tubes or vials. These bags are made from durable, leakproof materials such as polyethylene or similar plastics, often with biohazard symbols for easy identification. They must be sealed securely—via zip-lock, heat-sealing, or adhesive—to prevent any escape of liquids or solids.

For liquid samples, these bags include absorbent materials (e.g., super-absorbent polymers or cotton pads) capable of soaking up the entire volume in case of breakage. This layer is crucial for containing spills and protecting handlers. Biological sample bags are versatile, used in clinical settings for transporting blood, urine, or swab samples, and must comply with pressure differential tests (e.g., 95 kPa resistance from -40°C to 55°C).

UN3373 Sample Bags

Similar to biological sample bags, UN3373 sample bags are specifically marked with the UN3373 diamond-shaped label, indicating compliance for Category B substances. These are often secondary or intermediate packaging options, pre-printed with the required "Biological Substance, Category B" text and designed for single-use to avoid cross-contamination.

These bags are ideal for smaller shipments and can be used in combination with outer boxes. They emphasize traceability, often including spaces for shipper and recipient details. In practice, UN3373 sample bags help streamline airport or courier inspections, as the marking signals low-risk infectious material. Capacities are limited—e.g., no more than 1L per primary receptacle inside—to align with overall package limits.

Specimen Transport Boxes

Specimen transport boxes serve as the outer packaging in UN3373 systems, providing rigidity and impact resistance. Constructed from corrugated fiberboard, plastic, or metal, these boxes must be strong enough to survive a 1.2-meter drop test without contents escaping. They are essential for protecting fragile inner layers during ground, air, or sea transport.

These boxes often come with foam inserts or cushioning to immobilize contents, preventing movement that could cause damage. Minimum dimensions ensure visibility of labels (at least 100mm x 100mm on one side), and they must include an itemized content list between the secondary and outer layers. Specimen transport boxes are widely used in pathology labs for shipping biopsies or cultures.

UN3373 Transport Boxes

UN3373 transport boxes are specialized versions of specimen transport boxes, explicitly certified and labeled for Category B shipments. They feature the mandatory UN3373 mark—a black diamond on white background with "UN3373" inside—and adjacent text stating "Biological Substance, Category B."

These boxes are rigid and reusable in some cases, with options for temperature control (e.g., insulated for cold chain samples using dry ice, limited to quantities that don't exceed cooling needs). Total limits include 4L for liquids or 4kg for solids per box. They are favored by couriers like FedEx or UPS for their pre-compliance features, reducing preparation time.

Comparison of Packaging Elements

To illustrate the roles and specifications, here's a table comparing the key components:

 
Component Primary Role Material Examples Key Requirements Capacity Limits
Biological Sample Bag Secondary packaging Polyethylene, sealed plastic Leakproof, absorbent inclusion for liquids Up to 1L per primary inside
UN3373 Sample Bag Secondary/Intermediate Plastic with UN3373 marking Pressure-tested (95 kPa), labeled Aligns with outer limits (4L/4kg)
Specimen Transport Box Outer packaging Corrugated fiberboard, plastic Rigid, drop-tested (1.2m) 4L liquids or 4kg solids total
UN3373 Transport Box Outer packaging (certified) Fiberboard with markings UN3373 label, contact info required Same as above

 

This table highlights how bags focus on containment while boxes emphasize protection.

Importance and Best Practices

The use of these packaging solutions is critical in preventing the spread of pathogens, especially during outbreaks like COVID-19, where rapid sample transport enabled testing and research. Proper packaging minimizes risks to transport workers, the public, and the environment.

Best practices include:

  1. Always verify manufacturer certification for UN3373 compliance.
  2. Include sufficient absorbents and cushioning to handle worst-case scenarios.
  3. Label clearly with responsible person's contact details.
  4. Train staff on assembly to avoid errors.
  5. For international shipments, check carrier-specific rules (e.g., FedEx requires no use of their standard envelopes or paks as outer containers).

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