Tulane University

Tulane University - Office of Environmental Health & Safety (OEHS)

PACKAGING AND SHIPPING BIOMEDICAL MATERIALS

Tulane University Employees who are responsible for packaging and shipping

infectious materials and substances

Objectives

• To know the definition of an infectious substance

• To know how to properly package etiologic agents and infectious substances

• To know Federal Express minimal requirements for shipping infectious substances

Objectives

• To know how to properly label and package diagnostic and/or clinical specimens

• To know how to properly notify CDC if a package has failed to deliver or failed to receive

• To know how to properly fill out a Dangerous Goods Manifest for infectious substances

Definitions

• Etiologic Agents / Infectious Substances are viable microorganisms or their toxin that causes or may cause disease in humans or animals.

• Diagnostic Specimens are defined as any human or animal material being shipped for purposes of diagnosis

• Biological Products are products that are prepared and manufactured in accordance with the Department of Agriculture or Health and Human Services

Packaging of Etiologic Agents and Infectious Substances

• Volume not exceeding 50 ml– Primary container, water tight and secured– Secondary container, durable water tight– Absorbent materials in spaces between the

primary and secondary container– Outer shipping container constructed of

corrugated fiberboard, cardboard or wood

• Volume exceeding 50 ml– Primary and Secondary Containers must be water tight

and secured

– Absorbent materials must be able to absorb the total volume of the secondary container

– Primary container volume not to exceed 1000ml

– Maximum amount in a single outer shipping container shall not exceed 4000 ml

• If dry ice is used as a refrigerant, it must be placed outside the secondary container

• Dry ice amounts must be reported in pounds(lbs) and kilograms(kg) on shipping manifest

• Outer Shipping container must be labeled properly• DOT Infectious Substance label must be used and

DOT Hazard Class label 9 must be used when shipping in dry ice

• Outer Shipping container must bear the following markers:– United Nations symbol

– Code designating the type of packaging

– The text “Class 6”

– The last two digits of the year of manufacture of the packaging

– State authorizing the allocation of the mark

– Name of the manufacture

Federal Express Minimal Requirements for Shipping

• Watertight Primary Receptacle

• Watertight Secondary Packaging

• Absorbent Material between primary and secondary packaging

• Sturdy Outside Packaging – Styrofoam, plastic bags and paper envelopes are unacceptable, minimum size 7”x 4”x2

Containers and Packaging Materials

Primary and Secondary Containers

Markings and Labels

Diagnostic and Clinical Specimens

• As of January 1st 2005 all diagnostic samples must have the UN 3373 label adjacent to Diagnostic or Clinical Specimen label on the external secondary packaging.

Shipping of Diagnostic Samples

With no known serious human or animal diseases

UN3373

Diagnostic Samples

1. Assemble required components Water-tight primary Water-tight secondary Sufficient absorbent material

for liquids Itemized Packing List Outer shipping container box

bearing the appropriate UN markings

Diagnostic Specimens sticker

• The primary container may not contain more than 500 ml or 500g.

Diagnostic Samples

2. Place sufficient absorbent material into the secondary container that can absorb the entire contents of the liquid shipment.

Diagnostic Samples3. Place tubes into bubble-

wrap sleeves. Tubes must be individually wrapped and not in contact with each other so only one tube per compartment.

4. Roll the sleeve containing the tubes and secure it with a piece of tape.

Diagnostic Samples

5. Place the

bubble-wrapped

primary containers

into a suitable

secondary container

with sufficient

absorbent material.

6. Close and tighten the cover on the secondary container.

Diagnostic Samples

7. Place secondary container into the outer shipping container.

8. Place itemized list of contents between the secondary and outer containers.

Diagnostic Samples9. Label the shipping container with:

Shipper / Consignee / Name

and Number of Person Shipping

and Person Receiving 24 Hour emergency number to

call in case if damage or leakage

to the package (for US shipments) UN Number Diagnostic Specimens Sticker Orientation arrows (usually pre-printed on the box)

10. Place labels on the box by following patterns outlined on the shipping container.

Notice of Delivery and Failure to Receive

• Not received within 5 days

• Sender must notify CDC

Shipping Manifest

• Must be filled out properly

• Must have a 24 hour contact number of sender

• Must be signed by sender

• Must have proper shipping name and hazard class

Shipping Manifest

Packaging and Shipping Information Websites

• www.saftpak.com/Product

• www.cdc.gov

• www.usps.gov

Summary

• To know the definition of an infectious substance• To know how to properly package etiologic agents

and infectious substances• To know how to properly label and package

diagnostic and/or clinical specimens• To know how to properly notify CDC if a package

has failed to deliver or failed to receive• To know how to properly fill out a Dangerous

Goods Manifest for infectious substances

Tulane UniversityOffice of Environmental Health & Safety (OEHS)

www.som.tulane.edu/oehs Bruce McClue, Hazardous Waste Supervisor

(504) 988-2865 / bmcclue@tulane.edu

If unable to proceed to quiz, type the link below into your browserhttp://aurora.tcs.tulane.edu/ehs/enterssn.cfm?testnum=22

Proceed to Quiz

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