Skip to main content

Laboratory Operations

Packaging & Transportation

So far, all our safety discussions have happened within the controlled environment of our own facility. But what happens when a specimen needs to travel? What if a small clinic needs to send a patient’s blood sample to our reference lab, or we need to send a rare bacterial isolate to the CDC for identification? The moment a specimen leaves our building, its journey becomes part of a much larger, public system. It enters the world of couriers, cargo holds, and postal workers. Our responsibility for safety now extends beyond our walls to protect the public

Think of it this way: we are now shipping a precious and perilous package. It’s precious because a patient’s diagnosis and treatment depend on it arriving safely and intact. It’s perilous because, if mishandled, it could leak and expose an unsuspecting person to a potential pathogen. Therefore, the regulations around packaging and transport are incredibly strict and internationally standardized. This isn’t just about putting a tube in a box; it’s a science of containment

Guiding Principle: The Triple Packaging System

The foundation for safely shipping any biological specimen is the universal Triple Packaging System. This multi-layered approach creates redundant barriers to ensure that even if the outer box is dropped or crushed, the specimen inside remains secure and contained. Every shipment you prepare must follow this structure

  • Primary Receptacle: This is the container that is in direct contact with the specimen. It must be leak-proof and securely sealed. This would be your screw-cap tube of blood, your vial of transport media containing a swab, or a sealed petri dish. For liquids, the cap must be reinforced with tape or Parafilm to prevent it from vibrating loose during transit
  • Secondary Container: The primary receptacle is placed inside a second, durable, leak-proof container. This secondary container serves two critical functions:
    1. Containment If the primary container were to break or leak, this secondary layer will contain the spill
    2. Cushioning It must contain sufficient absorbent material (like a paper towel or absorbent pad) to absorb the entire contents of the primary receptacle in case of a leak. The primary container should be cushioned within the secondary so it can’t rattle around
  • Outer Packaging: The secondary container is then placed into a strong, rigid outer shipping container, such as a sturdy cardboard box or a hard-sided cooler. This outer layer protects the inner contents from physical damage during shipping. The outside of this box is where all the required shipping labels and addresses will be placed. A complete, itemized list of the contents must be included between the secondary and outer packaging

Who Writes the Rules? DOT and IATA

You don’t get to make up the rules for this. Two major regulatory bodies dictate every aspect of shipping dangerous goods, including biological specimens

  • DOT (U.S. Department of Transportation): The DOT’s Hazardous Materials Regulations (HMR) govern the shipment of materials by ground transport (courier, truck, mail) within the United States
  • IATA (International Air Transport Association): IATA’s Dangerous Goods Regulations (DGR) are the global standard for shipping materials by air, both domestically and internationally. Because their rules are so comprehensive, IATA standards are often adopted as the default for many labs, even for ground shipping

Categorizing the Danger: The Two Tiers of Infectious Substances

The most important step in preparing a shipment is correctly classifying the material you are sending. This classification determines the level of packaging, labeling, and documentation required

Category A Infectious Substance: High Risk

A Category A substance is an infectious substance in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening disease, or fatal disease in otherwise healthy humans or animals. This is the highest risk category

  • What it is: This is not your routine patient specimen. This is typically reserved for pure cultures of the world’s most dangerous pathogens. For example, a culture of Bacillus anthracis (anthrax), Yersinia pestis (plague), or Ebola virus would be Category A
  • Shipping Name and Labeling: These are shipped as UN 2814, “Infectious substance, affecting humans.” They require extremely robust, performance-tested packaging and are covered in highly visible, specialized warning labels. Shipping Category A substances is a highly specialized process

Category B Biological Substance: The Standard

A Category B substance is an infectious substance which does not meet the criteria for inclusion in Category A. This category covers the overwhelming majority of what we ship in the clinical world

  • What it is: This includes most routine patient specimens—blood, urine, tissues, swabs—sent for diagnostic testing. Even if the patient is known to have HIV or Hepatitis, the specimen itself is considered Category B
  • Shipping Name and Labeling: These are shipped as UN 3373, “Biological Substance, Category B.” The package must bear a distinctive diamond-shaped label with the UN 3373 marking on it. While the packaging is still the robust triple-pack system, it is less stringent than that required for Category A

Training Is Not Optional

You cannot simply read a manual and start packing specimens for shipment. Both DOT and IATA regulations mandate that anyone involved in the shipping process—from classifying the material to packing the box to signing the shipping documents—must undergo formal, certified training. This training must be documented, and you must be re-certified at regular intervals (every 2 years for IATA, every 3 years for DOT). This ensures you are always up-to-date on the complex and ever-changing regulations

This process might seem complicated, but it’s a perfect example of a safety program at work. By following these strict protocols, we ensure the integrity of the sample for the patient while guaranteeing the safety of every person who will handle that precious, perilous package on its journey

Key Terms

  • Triple Packaging System: The required three-layer system for shipping biological materials, consisting of a primary receptacle, a secondary container with absorbent material, and a rigid outer packaging
  • IATA (International Air Transport Association): The global trade association for the airline industry that sets the international standards (Dangerous Goods Regulations) for shipping hazardous materials, including specimens, by air
  • DOT (Department of Transportation): The U.S. government agency that regulates the transportation of hazardous materials by all means (ground, air, sea) within the country
  • Category A Infectious Substance (UN 2814): A substance known or reasonably expected to contain a pathogen capable of causing permanent disability or life-threatening/fatal disease upon exposure (e.g., a culture of Ebola virus)
  • Category B Biological Substance (UN 3373): An infectious substance that does not meet the criteria for Category A. This includes most patient specimens sent for routine diagnostic testing
  • Primary Receptacle: The innermost, leak-proof container that is in direct contact with the biological specimen (e.g., a blood tube)
  • Secondary Container: The leak-proof container that encloses and protects the primary receptacle and contains absorbent material sufficient to soak up the entire contents of the primary container