Specialized Requirements for Transportation of Diagnostic & Infectious

Substances by Air

Dhananjay AchudanDhananjay AchudanCountry ManagerCountry Manager

World Courier India Private LimitedWorld Courier India Private Limiteddhananjay@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

The UN Committee of

Experts

ICAO – Technical

Instructions

International Regulations

I.A.T.AD G C A.

Indian Regulations

Dangerous Goods

Regulations

Associated Governing OrganizationsAssociated Governing Organizations

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

DIVISIONSome 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)(IATA DGR Section 3 – Classification)Class 1Class 1 ExplosivesExplosivesClass 2Class 2 GasesGasesClass 3Class 3 Flammable LiquidsFlammable LiquidsClass 4 Class 4 Flammable SolidsFlammable SolidsClass 5 Class 5 Oxidizing Substances and Organic Oxidizing Substances and Organic

PeroxidesPeroxidesClass 6 Class 6 Toxic andToxic and Infectious Substances Infectious Substances

Division 6.1 – Toxic substancesDivision 6.1 – Toxic substances

- - Division 6.2 – Infectious SubstancesDivision 6.2 – Infectious SubstancesClass 7Class 7 Radioactive MaterialsRadioactive MaterialsClass 8Class 8 CorrosivesCorrosivesClass 9Class 9 Miscellaneous Dangerous GoodsMiscellaneous Dangerous Goods

INFECTIOUS SUBSTANCES

Infectious substances are those which are known or are reasonably expected to contain pathogens.

Pathogens are defined as micro-organisms 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

1. Category A: Highly infectious material and cultures

2. 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/s2. Leak proof secondary packaging3. Absorbent material, sufficient material to absorb the entire content4. 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 packaging7. Outer package must have minimum dimensions of 100mm x 100mm8. Must successfully pass drop test to 1.29. A diamond shape label with “UN3373” and the words Diagnostic specimens must

appear on the outer package10. Dangerous goods shippers declaration not required and no specification markings are

required11. 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 Diagnostic Specimens/Clinical Specimens, category B

For infectious substances, category A

For shipments on dry ice

Handling label for infectious substancesIn liquid form of more than 50 ML in One package & are required on two oppositeSides of the package

UN Specified Box

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

PackagingType Code Material Code Specific Marking

State(VRI Code)

Manufacturer Year ofManufacturer

UN2814 Infectious substance,affecting humans (Human Immunodeficiency Virus)Net Quantity 40ml

Shipper_________________________________________Consignee______________________________________

Responsible personMr. Son – Tel.123456789

4G/CLASS 6.2/02NZ/CAA 435

UN1845 Dry iceNet Quantity 20kg

Example of Infectious substance, Category A packed with dry ice

UN2814 Infectious substance,affecting humans (Hepatitis B Virus)Net Quantity 50 ml

Shipper_______________________________________Consignee____________________________________

Responsible personMr. Son – Tel.123456789

4G/CLASS 6.2/02NZ/CAA 435

Example of Infectious substance, Category A packed without dry ice

UN3373 DIAGNOSTIC SPECIMENS

Shipper__________________________________

Consignee________________________________

UN1845 Dry iceNet Quantity 20kg

Responsible personMr. Son ChongAddress. ABCTel.123456789

UN3373

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

UN3373 DIAGNOSTIC SPECIMENS

Shipper__________________________________

Consignee________________________________

Responsible personMr. Son ChongAddress. ABCTel.123456789

Example of Infectious substance in Category B, (known as Diagnostic Specimens or Clinical Specimens) packed without

dry ice

Air Waybill Shipper’s Declaration

DOCUMENTATION

THE ALL SAINTS HOSPITALDepartment of GstroentrologyRaining Drive, MumbaiINDIA TEL: + 91 22 5676 6501CONT: Clinical Research Team

1 1

THE ALL SAINTS HOSPITALDEPARTMENT OF GASTROENTEROLOGY21 FORTUNE DRIVELOS ANGELES, 90210 CALIFORNIA, U.S.A.TEL: + 1 500 900 1200 MRS GABBY BURNS

XXXXXXXXXXXXXXXXXXXXXXXX

XXXXXX

Mumbai

Los Angeles

123-456-789

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   OVERPACK USED X 1

  

904

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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