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 itÃ–.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 firstname.lastname@example.org.
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.
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).
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.
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.
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.
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.
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.
To Order, Call Toll Free
International orders and general inquiries, call 1-919-933-9569
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)
The course meets the requirements for training as specified in 49 CFR 172 Subpart H, including testing of participants. This course does not cover driver training as required for each hazmat employee who will operate a motor vehicle.
Course Fee: $ 175
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:
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
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
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.