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PACKAGING AND SHIPPING BIOMEDICAL MATERIALS

PACKAGING AND SHIPPING BIOMEDICAL MATERIALS Biomedical Materials Introduction Definitions Packaging of etiologic agents and infectious substances Federal Express minimal requirements Notice of delivery and failure to receive Dangerous Goods Manifests Definitions

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PACKAGING AND SHIPPING BIOMEDICAL MATERIALS

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  1. PACKAGING AND SHIPPING BIOMEDICAL MATERIALS

  2. Biomedical Materials • Introduction • Definitions • Packaging of etiologic agents and infectious substances • Federal Express minimal requirements • Notice of delivery and failure to receive • Dangerous Goods Manifests

  3. Definitions • Etiologic Agents / Infectious Substances • Diagnostic Specimen • Biological Product • Materials containing certain etiologic agents

  4. 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

  5. Packaging of Etiologic Agents and Infectious Substances • Volume exceeding 50 ml • Primary and Secondary Containers as same as volumes less than 50 ml • Absorbent materials in volume as the secondary container • Primary container volume not to exceed 1000ml • Maximum amount in a single outer shipping container shall not exceed 4000 ml

  6. Packaging of Etiologic Agents and Infectious Substances • If dry ice is used as a refrigerant, it must be place outside the secondary container • Dry ice amounts must be reported in pounds(lbs) and kilograms(kg) on shipping manifest

  7. Packaging of Etiologic Agents and Infectious Substances • 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

  8. 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

  9. Containers and Packaging Materials

  10. Primary and Secondary Containers

  11. Markings and Labels

  12. Notice of Delivery and Failure to Receive • Not received within 5 days • Sender must notify CDC

  13. 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

  14. Additional Information • www.saftpak.com/Product • www.cdc.gov • www.usps.gov

  15. QUESTIONS ???

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