Clinical Trial Logistics Tips: How to efficiently prepare biological commodities shipments

28 Sep, 2010 by  Michael Gotz

Your biological commodities are valuable, often irreplaceable, and when shipped must get to their destination in a very timely manner.

Here is what you, the shipper, can do to create the circumstances that will result in efficient shipping:

Obtain training on the transport regulations

The shipping staff must be trained to be able to comply with the rules and regulations governing the transport of biological commodities. Essentially this means the Dangerous Goods regulations: air transport – the IATA DGR, ground transport – in the USA 49 CFR, in Europe the ADR.

Training is required by law, and violators are in fact prosecuted. Professional training classes are widely available, including those offered by Quick. The internet is the place to start your search for appropriate training organizations.

Purchase authorized packaging

Biological commodities must be “triple packed.” This means a leakproof primary receptacle, a leakproof secondary containment, and a sturdy outer packaging. In practical terms: a test tube, vial, or slide inside of a biobag or plastic receptacle, inside of a fibreboard box. The bags and boxes are easily obtained from a number of reliable retailers. Again, the internet can lead you to them.

Mark and label the outer packaging in accordance with the regulations

In the case of nonhazardous, non-infectious commodities, this is generally a shipping label with the name and address of both the shipper and consignee. Infectious substances require marking and labeling in accordance with their classification category, to wit:

Category A: 4G package markings, Class 6.2 label, proper shipping name, UN number, name/phone of a responsible person, shipping label

Category B: UN 3373 label, proper shipping name, name/phone of a responsible person, shipping label.

In both cases when dry ice is used - Class 9 label, proper shipping name, UN number, quantity of dry ice that was placed in the package (in kg). This is not an appropriate space to go into details; rather, a training program will clarify all of this.

Prepare the Shipper’s Declaration for Dangerous Goods in the authorized manner

This is the hard part, but the good news is that in the case of infectious substances a Shipper’s Declaration is only required for Category A commodities (you can learn more about the category classification by downloading QuickSTAT White Paper "How to Classify Biological Commodities for Transport"). Completely error-free completion of this form is a legal requirement, enforced by national government policing agencies (i.e., FAA, CAA, etc.) and the airlines. It is required for Category A commodities shipped by any means, air, rail or truck. Customer Service Representatives at premium courier companies, such as QuickSTAT, are available to assist in this task.

Provide your carrier (airline, freight forwarder, courier) with complete and correct details of your shipment

Confusion and delay are often caused by the lack of complete details provided over the phone or email, which results in mistakes or omissions on the part of the courier/forwarder when relating to the airlines. An example is the non-disclosure of the presence of dry ice, so that when the airlines discover the dry ice in unlabeled boxes sometimes the authorities are called in. The result is that the airline refuses to accept the shipment, causing long delays while the situation is resolved.


Looking at the transport of biologicals from the standpoint of transport staff who are not health industry professionals, these commodities can by a bit scary. That is to say, people sometimes believe they will get sick from close proximity to packages carrying human blood and tissue samples or lab cultures of infectious substances. Therefore, we must be particularly vigilant about complying with all rules, regulations, and practices so as to reassure them that we are concerned about their safety and have done due diligence to ensure the highest level of safe shipping.

To the extent that we fall down in our responsibilities with respect to this, transport staff can and do hold up our shipments for even a hint of what they perceive of as danger to themselves and others. The result is delay of shipment, and in extreme cases, spoilage. By following the guidelines set out above, we can present to the carriers, whether they be air or ground, shipments meeting all of the legal and safety standards. This will both satisfy the concerns of transport staff and result in timely and efficient transportation of our commodities. There will be no delays, no spoilage, and the world of biological transport will be bright and cheery.

About Michael Gotz
HAZMAT Training & Compliance

Michael Gotz has developed IATA-certified Dangerous Goods training programs and has been a panelist in numerous IATA Dangerous Goods international conferences. He is the author of published journal articles on the subject of... Read more.

Recent Blog Posts: