Shipping Infectious Substances & Diagnostic Specimens

The past few years have seen many changes to the regulations in the US involving the shipment of infectious substances and diagnostic specimens. Due to the potential hazards associated with these types of samples, the regulations concerning both air and ground transportation are very specific and involved. Two of the most common violations for shipments of infectious substances and diagnostic specimens are improper packaging and inadequately trained personnel. The information provided on this page is to serve as a resource for the necessary training required for shipment and packaging and provide some guidance to those who must ship these types of samples.

We carry a line of packaging products designed specifically to meet the regulatory requirement for the shipment of infectious substances and diagnostic specimens including the shipment of these samples using dry ice. Following the proper packaging requirements, will ensure your packages arrive safely at their destination and eliminate the potential of costly fines for use of improper packaging. [view our bioship packaging solutions]

Our online training course for the shipment of infectious substances is truly unique. The course is ideally suited to those who do not ship any other type hazardous materials. It is tailored specifically to cover the fundamental information needed to ship infectious substances (including shipments on dry ice) and meets the requirements for training as specified in 49 CFR 172 Subpart H, including testing of participants. The online format gives you the flexibility to get the training when you need itÖ.immediately or at your leisure, whenever is most convenient for your schedule. [view our online training solutions]

Bioship Packaging Solutions

All packaging shown below are compliant UN regulated hazardous material packaging for all levels of pathogens. There are options for both ambient and temperature controlled situations. If you have a specific need for a package that you don't see listed, please give us a call at 877-504-0956 or email us at sales@keikaventures.com.

Packaging: Infectious Substance Shipper - Bioship 602SS FX11 Ambient Temperatures SKU: 602SS FX11 Economical and easy to use kit that is 100% compliant for all modes of international and domestic transportation (air and ground). Meets FedEx Operator Variation FX-11 size requirements. Complete Description $101.10 case (12)

Packaging: Diagnostic Specimen Cooler Kit - Bioship 602SS DCK Temperature Control SKU: 602SS DCK Economical and easy to use kit to ship temperature sensitive diagnostic specimens that is 100% compliant for all modes of international and domestic transportation (air and ground). Complete Description $128.30 case (12)

Packaging: Diagnostic Specimen Dry Ice Cooler Kit - Bioship 602SS DTCK Temperature Control SKU: 602SS DTCK Economical kit to ship temperature sensitive diagnostic specimens that is 100% compliant for all modes of international and domestic transportation (air and ground). ˜ 10 lbs of dry ice. Complete Description $18.50 each

Packaging: Diagnostic Specimen Bag Kit - Bioship 602 DTCK Temperature Control SKU: 602 DTCK Economical kit to ship temperature sensistive multiple bags (primary receptacles)of diagnostic specimens that is 100% compliant for all modes of international and domestic transportation (air and ground). ˜ 2-5 lbs of dry ice. Complete Description $14.00 each

Packaging: Infectious Substance Dry Ice Shipper - Bioship 602SS ITCK Temperature Control SKU: 602SS ITCK Economical kit to ship temperature sensitive infectious substances that is 100% compliant for all modes of international and domestic transportation (air and ground). Holds about 10lbs of dry ice. Complete Description $21.00 each

Packaging: Diagnostic Specimen Bag Shipper - Bioship 602 DBK Ambient Temperatures SKU: 602 DBK Economical kit with an airtight pressue biohazard bag for shipping diagnostic specimens. Meets postal mail requirements, DOT 40CFR and air requirements for shipping. Complete Description $93.30 case (24)

Packaging: Bioship 650SS Small Air/Ground Kit SKU: 650SS K Small (6" x 4 3/8" x 3") and economical diagnostic specimen kit that's compliant for all modes of transportation. Complete Description $165.90 case (40)

Shipping Infectious Substances Online Training

This course covers the fundamentals of shipping infectious substances and diagnostic specimens. Our 7 step approach encompasses all of the activities which must be addressed when preparing a hazardous material for shipment. This course has been updated to include recent changes to the regulations, including HM-215D. The course also covers shipments containing dry ice.

• Infectious Substances, Category A (UN 2814 and UN 2900),
• Biological Substances, Category B (UN 3373),
• Patient Specimens, and
• Carbon dioxide, solid (dry ice), Class 9 (UN 1845)

If you ship other hazardous materials in addition to infectious substances, you will need training which cover the shipment of all hazardous materials (or Dangerous Goods) and, quite possibly, other supplemental training. A few of our other related courses:

Shipping Infectious Substances This course covers the fundamentals of shipping hazardous materials, with an emphasis on infectious substances.

IATA Dangerous Goods Training Covers the fundamentals of shipping dangerous goods by air according to the IATA regulations.

RCRA & DOT Refresher This unique "hybrid" course reviews the fundamentals of hazardous waste management and shipping hazardous materials.

Hazard Communication Course focuses on the responsibilities of the employer in establishing and implementing an effective hazard communication program.

Frequently Asked Questions

What’s the difference between an infectious substance and a diagnostic specimen?
A diagnostic specimen is any human or animal material, including but not limited to excreta, secreta, blood and its components, tissue and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected humans or animals.

An infectious substance is defined as materials known to contain or suspected of containing a pathogen. A pathogen is a virus or micro-organism (including viruses, plasmids or other genetic elements, if any) or a proteinaceous infectious particle that has the potential to cause disease in humans or animals.

Will the online training course certify me to ship infectious substances?
Yes, it can. The regulations place the onus on the company to ensure ("certify") that their employees are adequately trained. The Shipping Infectious Substances (IATA and DOT) course meets the requirements for training as specified in 49 CFR 172 Subpart H, including testing of participants. If you have questions about whether one of our courses is appropriate for your situation, feel free to contact us and we'll do our best to answer your questions.

How often is training required?
IATA regulations specify that training occur every 24 months (IATA DGR Section 1.5). DOT specifies that training occur every 3 years (49 CFR 172.700). However, it is important to note that this is the minimum amount of training that is required. If there are changes in the regulations that affect the shipment of hazardous materials then you are responsible to follow the new requirements even if your training is still current.

Do the regulation changes affect air shipments?
Yes! IATA’s Dangerous Good Regulations provide the proper procedures for shippers to safely transport materials with hazardous properties by air on all US commercial air transport. These regulations are updated every year and are effective January 1 of each year. Changes were made effective January 1, 2003 to reflect changes to the United Nations Recommendations on the Transport of Dangerous Goods and the ICAO (International Civil Aviation Organization) Technical Instructions for the Safe Transport of Dangerous Goods by Air.

Examples of some of the changes include: assigning a UN Number to diagnostic specimens and the risk groups removed in relation to the classification of diagnostic specimens.

Do the regulation changes affect ground shipments?
Yes! Ground shipments in the US are governed by DOT regulations in Part 49 of the Code of Federal Regulations (CFR). On August 14, 2002 the CFR published HM-226 which went into effect on February 14, 2003. Both changes within DOT and the U.S. Postal Service were made to bring the regulations in line with international regulations and defining criteria established by the World Health Organization (WHO), the United Nations, and ICAO.

Examples of some of the changes include: elimination of the current exception form requirements in the HMR (Hazardous Materials Regulations) for diagnostic specimens, revision of current packaging requirements for Division 6.2 materials, modification of the current exception from requirements in the HMR for biological products, and new bulk packaging options for the transportation of regulated medical waste.

Do the regulation changes affect US Postal mailings?
Yes! Effective June 12, 2003, the US Postal Service (USPS) adopted changes in the mailing standards for the packaging and classification of infectious substances. These changes align the USPS standards with the current international standard for the transport of hazardous materials. The initial phase-in period was through January 1, 2004 so now all USPS mailings must conform to the new mailing standards.

Examples of some of the changes include: new classification criteria for Division 6.2 infectious substances, regulation of diagnostic specimens in Risk Groups 2, 3, or 4 as hazardous materials, and regulation of certain Risk Group 1 materials (including diagnostic specimens) as hazardous materials.