Regulatory Compliant Shipping – What Sites Need to Know

With so many agencies regulating the medical aspects of a clinical trial it is easy to forget the transport regulations.  USDOT, ICAO, and IATA also have rules and regulations that must be followed when shipping your samples to the lab for testing.

The packaging provided by Covance is fully regulatory compliant if used properly.  Ambient samples classified as Biological Substances Category B must be packed in a triple barrier packaging system that consists of the tube, specimen collection bag, and a rigid outer box.

Frozen samples shipped on dry ice, in addition to the triple barrier requirement, must also be packaged to allow the venting of any gas build up from the sublimation of the dry ice.  Below are some common mistakes that will cause a courier to be unable to transport the shipment.

• A frozen box being used to ship ambient samples but the Class 9 label and dry ice information was not completely obscured

• Weight of dry ice is not on the box

• Shipping document (or Label) placed on top of the dry ice label and information, or the Biological Substance information and marking

The photos below show the incorrect and correct way to ship samples. In the photo on the left there is writing on the box which is not allowed.  The photo on the right has a label over the Class 9 label.

shipping label with writingbad shipping label example

To ensure that a sample arrives at the laboratory within testing stability, pay special attention that the sample is properly packed.