Specialized Requirements for

Transportation of Diagnostic & Infectious

Substances by Air

Dhananjay Achudan
Country Manager
World Courier India Private Limited
dhananjay@worldcourier.co.in
 Clinical Trial Logistics
• How is Clinical Research Associated
with Logistics?

• Why is CTL Important?

• What is the role of a courier company in

CTL?
 Clinical Trial Logistics
• Investigational Drugs to reach in safe &
proper condition.

• Specimens to reach in proper condition for

Testing.

• Meeting timelines of CT.

• Adhering to Rules and Regulation

 Overview
Associated Governing Organizations

Dangerous Goods Regulations

Definition & Classification 

Packing, Marking & Labeling

Documentation 

Potential Problems

Solutions

Shipper Responsibilities
 Associated Governing Organizations
The UN ICAO –
Committee of Technical I.A.T.A
D G C A.
Experts Instructions

International Indian Dangerous

Regulations Regulations Goods
Regulations
Defining Dangerous
Goods
“Dangerous goods are articles or substances, which 
are capable of posing a risk to health, safety, 
property or the environment and which are shown 
in the list of dangerous goods in the dangerous 
goods regulations or which are classified according 
to the dangerous goods regulations.”
 Classifications
CLASS
  The nine classes relate to the TYPE of hazard

DIVISION
Some of the nine classes are broken down into divisions

PACKING GROUP  
The packing groups relate to the applicable DEGREE 
OF DANGER within the class. 
 Classification of Dangerous
Goods
(IATA DGR Section 3 – Classification)
Class 1 Explosives
Class 2 Gases
Class 3 Flammable Liquids
Class 4  Flammable Solids
Class 5  Oxidizing Substances and Organic 
Peroxides
Class 6  Toxic and Infectious Substances
Division 6.1 – Toxic substances
  ­ Division 6.2 – Infectious Substances
Class 7 Radioactive Materials
Class 8 Corrosives
Class 9 Miscellaneous Dangerous Goods
 INFECTIOUS SUBSTANCES

Infectious substances are those which are known or are 
reasonably expected to contain pathogens. 
Pathogens are defined as micro­organisms including 
bacteria, viruses, rickettsiae, parasites, fungi and other 
agents as such as prions, which can cause disease in humans 
or animals.
 DIVISION 6.2
Infectious Substances
2. Category A: Highly infectious material and cultures
3. Category B: Diagnostic substances/UN 3373
(UN 3373 now has two acceptable proper shipping names: 
Diagnostic Specimens or Clinical Specimens)
3. Exemptions:
• Material that does not contain pathogens
• Substances unlikely to cause disease
• Blood/blood components prepared for transfusion of blood 
products
• Tissue or organs intended for transplant
 UN Identification

Substance Proper Shipping  UN #     Packaging 

Classification Name       Instruction

Category A Infectious Substance UN 2814 602

affecting humans

Category A Infectious Substance UN 2900 602

affecting animals

Category B Diagnostic Specimens/ UN 3373 650

Clinical Specimens
 Packaging Instruction
602
•Watertight primary receptacle/s (vial)

•Watertight secondary packaging (Bio bottle)

•Absorbent material

•Itemized list of contents between secondary & outer packaging

•Rigid outer packaging of adequate strength 

•Outer packaging bearing UN specification markings

•Name & telephone number for person responsible for the shipment

•Requires Shippers declaration known as DGD
 Packaging Instruction
650
1. Leak proof primary receptacle/s
2. Leak proof secondary packaging
3. Absorbent material, sufficient material to absorb the entire content
4. Pressure test required, 95 kPa for Primary or secondary packaging 
5. Outer packaging must not contain more than 4L 
6. Itemized list of contents between secondary & outer packaging
7. Outer package must have minimum dimensions of 100mm x 100mm
8. Must successfully pass drop test to 1.2
9. A diamond shape label with “UN3373” and the words Diagnostic specimens must 
appear on the outer package
10. Dangerous goods shippers declaration not required and no specification markings are 
required
11. Does not require a shippers DGD
 Additional Listed Dangerous
Good Used Regularly

Is Dry Ice or Carbon Dioxide, Solid
Used as a refrigerant
Has a listed identity in Dangerous Goods as UN 1845
Packaging instruction is 904
Is covered under Class 9 of Miscellaneous Dangerous Good
 Packaging Instruction
904
• Packaging must be able to permit the release of carbon dioxide gas

• DGD is only required when dry ice is used as a refrigerant for a DG

• No UN specification packaging required (A48 Page 300 DGR)

• Package must be marked with:

∙        Proper shipping name (Dry Ice or Carbon Dioxide, solid)
∙        UN1845
∙        Class 9
∙        The number of packages; and
∙        The net quantity of dry ice in each package
LABELS REQUIRED
For infectious substances, category A

For Diagnostic Specimens/Clinical Specimens, 
category B

For shipments on dry ice

Handling label for infectious substances
In liquid form of more than 50 ML in 
One package & are required on two opposite
Sides of the package
UN Specified Box

Packaging
Type Code Material Code Specific Marking

4G / CLASS 6.2 / 05
IND / 2-98-18-99

State Manufacturer Year of

(VRI Code) Manufacturer
Example of Infectious substance, Category A packed with 
dry ice

UN2814 Infectious substance,

affecting humans (Human
Immunodeficiency Virus)
Net Quantity 40ml
UN1845 Dry ice
Net Quantity 20kg
Responsible person
Shipper_________________ Mr. Son – Tel.123456789
________________________
Consignee_______________
_______________________
4G/CLASS 6.2/02NZ/CAA 435
Example of Infectious substance, Category A packed without 
dry ice

UN2814 Infectious substance,

affecting humans (Hepatitis B Virus)
Net Quantity 50 ml

Shipper________________
_______________________
Consignee_____________
_______________________

Responsible person
Mr. Son – Tel.123456789

4G/CLASS 6.2/02NZ/CAA 435

 Example of Infectious substance in Category B, (known as 
Diagnostic Specimens or Clinical Specimens) packed with dry ice

UN3373 DIAGNOSTIC SPECIMENS

UN1845 Dry ice UN3373

Net Quantity 20kg

Shipper______________
____________________ Responsible
Consignee____________ person
____________________ Mr. Son Chong
Address. ABC
Tel.123456789
 Example of Infectious substance in Category B, (known as 
Diagnostic Specimens or Clinical Specimens) packed without 
dry ice

UN3373 DIAGNOSTIC SPECIMENS

Shipper______________
____________________
Consignee____________ Responsible
____________________ person
Mr. Son Chong
Address. ABC
Tel.123456789
DOCUMENTATION

Air Waybill Shipper’s Declaration

THE ALL SAINTS HOSPITAL 123-456-789
Department of Gstroentrology
Raining Drive, Mumbai 1 1
INDIA TEL: + 91 22 5676 6501
CONT: Clinical Research Team

THE ALL SAINTS HOSPITAL

DEPARTMENT OF GASTROENTEROLOGY
21 FORTUNE DRIVE
LOS ANGELES, 90210 CALIFORNIA, U.S.A.
TEL: + 1 500 900 1200 MRS GABBY BURNS

XXXXXXXX Mumbai
XXXXXXXX
XXXXXXXX
Los Angeles XXXXXX
UN2814 INFECTIOUS SUBSTANCE, 45 mL PACKED IN
6.2 602
AFFECTING HUMANS 1 FIBREBOARD BOX
(LASSA VIRUS)
(LIQUID)

UN1845 CARBON DIOXIDE, SOLID 9 III 9 kg NET 904

(DRY ICE)

OVERPACK USED X 1

24 HOUR EMERGENCY CONTACT: Dr. Head PH: + 91 22 5676 6501

Dr. Head, H C O

Bangalore, 04th March 2006

Know It All
 AIR WAYBILLS

Dangerous Goods as per attached Shipper’s Declaration

Infectious Substance
 Potential Problems
• Regulations
– vary from region to region
• Permit Requirements
– differ from country to country
• Customs
– paperwork discrepancies
 Solutions
• Training
– Through Locally endorsed training provider
• Partnership
– Choosing the courier company that matches
your needs:
• Knowledge of specialized requirements
• Dedicated personnel on hand 24 hours a day
• Global network
 Shipper Responsibilities
• What are your responsibilities as the shipper?

As the shipper, you are responsible for:

• Classifying a shipment, that is determining if the shipment is dangerous
or not.
• Pack the shipment correctly, according to the appropriate packing
instruction, and in UN specification packaging
• Label the shipment according to the regulations
• Mark the shipment according to the regulations
• Provide original documentation for the shipment, according to the
regulations
• Make necessary arrangements with the consignee or recipient to
ensure the necessary import permits are in place.
• Make advanced arrangements with the carrier to ensure the shipment
will be accepted for transport and that the most direct/fastest route is
utilized.
 THANK
YOU

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