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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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Presentation Transcript
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
Definitions
  • Etiologic Agents / Infectious Substances
  • Diagnostic Specimen
  • Biological Product
  • Materials containing certain etiologic agents
packaging of etiologic agents and infectious substances
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
packaging of etiologic agents and infectious substances5
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
packaging of etiologic agents and infectious substances6
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
packaging of etiologic agents and infectious substances7
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
federal express minimal requirements for shipping
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
notice of delivery and failure to receive
Notice of Delivery and Failure to Receive
  • Not received within 5 days
  • Sender must notify CDC
shipping manifest
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
additional information
Additional Information
  • www.saftpak.com/Product
  • www.cdc.gov
  • www.usps.gov