Category B biological substances are a dangerous good, specifically pathogens that present a non-fatal risk in the event of a release and therefore are not considered Category A. If you need a refresher on which category your substance falls under, see our companion article. Here, we’ll review requirements for packaging, labeling, marking and documentation.
Follow and save any instructions provided with boxes and validated thermal shippers you purchase, so you always have something to reference. Triple packaging is the best practice for all classifications of biological shipments.
Here are the four elements you need for your packaging:
1. Leak-proof Primary Receptacle
2. Leak-proof Secondary Packaging
This is your inner container. Ensure the primary or secondary receptacle can withstand:
3. Cushioning and Absorbent Material
4. Rigid Outer Packaging
Note: This does not include Styrofoam layer, if using wet/dry ice. Express carriers such as FedEx and UPS do not accept packages with a Styrofoam container as the outside packaging so add rigid outer packaging such as a cardboard box or validated thermal shipper.
Maximum Permissible Quantities
Driving courier, FedEx Ground and UPS Ground services: No restrictions
Air including FedEx Express, UPS Air and Specialty Cold Chain:
|Per primary receptacle |
|Per outer container||4L or 4x1L bottles||4kg|
Example of the triple packaging system for the packing and labeling of Category B, UN 3373 infectious substances:
Disposing of or Repurposing Rigid Outer Packaging
Before empty packaging is returned to the consignor, or sent elsewhere, it must be disinfected or sterilized to nullify any hazard and any label or mark indicating that it contained an infectious substance must be removed.
When shipping blood samples
A biohazard symbol is required on any sample that contains human blood and other potentially infectious materials (OPIM). This label must be affixed to the primary receptacle or secondary packaging.
An overpack is an extra outside packaging used when shipping multiple boxes to the same address or used to refrigerate materials being shipped in a smaller box. All markings and labels must be on the outside of the box along with the word “OVERPACK”. Since your inside package is the “triple package” you need all markings and labels on that package as well.
Standardized labeling must be affixed to the outside. When the package dimensions are adequate, labels must be located on the same surface of the package near the Proper Shipping Name mark.
Except for the orientation arrows, mount all labels and markings on the front side of the box — all on one surface area. “Cargo Aircraft Only” labels are required when applicable.
Orientation Arrows Label
If you are shipping a liquid, orientation arrows are required. Label must be affixed on 2 opposite sides and perpendicular to the front of the package. Orientation arrows should be red or black on a contrasting background.
Overpack labels have a height Requirement of 12mm (~0.5 inch). Either of these styles is acceptable:
The markings on a package are the words and numbers that must be present. Generally, markings include:
Tip: Don’t include any abbreviations other than mL, L, G, KG.
All Shipments must include:
Contact the Receivers
Make sure you contact the receivers prior to shipping. Keep in mind that some labs only receive Monday to Thursday. If you ship on Friday, it might sit over the weekend, or arrive on Saturday and nobody's there. If they are open on Saturday, make sure you label for Saturday delivery so the carrier knows they can deliver on Saturday and not hold the package over the weekend.
Know the stability of your sample and how long it can last, roughly 6% of Express Carrier shipments are not delivered on the requested date for a variety of reasons. Think carefully of the day you’re shipping and the stability of the shipment to avoid a potential re-draw from the patient.
Other FedEx and UPS Requirements
Before you ship any material abroad, you should answer the following questions:
Penalties and Fines
Shipping biological substances is a tightly regulated activity. If you need more reasons to get it right, here is a list of violations and the minimum assessments for each:
Need more assistance? Consider working with a company like Mercury Business Services. Mercury offers a comprehensive shipping solution that allows you to focus on your work, and leave the shipping and logistics to the professionals.
Request a quote today.