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 Committee of Experts ICAO – Technical Instructions I.A.T.A D G C A.

International Regulations

Indian Regulations

Dangerous 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. 3. Category A: Highly infectious material and cultures 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 Classification
Category A

Proper Shipping  Name
Infectious Substance affecting humans

UN #  
UN 2814

    Packaging      Instruction
602

Category A

Infectious Substance affecting animals

UN 2900

602

Category B

Diagnostic Specimens/ Clinical Specimens

UN 3373

650

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. 2. 3. 4. 5. 6. 7. 8. 9. Leak proof primary receptacle/s Leak proof secondary packaging Absorbent material, sufficient material to absorb the entire content Pressure test required, 95 kPa for Primary or secondary packaging  Outer packaging must not contain more than 4L  Itemized list of contents between secondary & outer packaging Outer package must have minimum dimensions of 100mm x 100mm Must successfully pass drop test to 1.2 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 (VRI Code) Manufacturer Year of 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 Shipper_________________ ________________________ Consignee_______________ _______________________ Responsible person Mr. Son – Tel.123456789

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 Net Quantity 20kg Shipper______________ ____________________ Consignee____________ ____________________

UN3373

Responsible 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 Department of Gstroentrology Raining Drive, Mumbai 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

123-456-789 1 1

XXXXXXXX XXXXXXXX XXXXXXXX

Mumbai Los Angeles
XXXXXX

UN2814

INFECTIOUS SUBSTANCE, AFFECTING HUMANS (LASSA VIRUS) (LIQUID)

6.2

45 mL PACKED IN 1 FIBREBOARD BOX

602

UN1845

CARBON DIOXIDE, SOLID (DRY ICE)

9

III

9 kg NET

904

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

© World Courier Management Inc. 2004. All Rights Reserved.Use, Duplication or Sale of this product except as authorized in writing by World Courier Management Inc. is strictly prohibited. This product contains propriety information of World Courier Management Inc.

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