PACKAGING AND SHIPPING BIOMEDICAL MATERIALS

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PACKAGING AND SHIPPING BIOMEDICAL MATERIALS
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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

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Definitions

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

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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

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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

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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

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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

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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 7x 4x2

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Containers and Packaging Materials
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Primary and Secondary Containers
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Markings and Labels
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Notice of Delivery and Failure to Receive

• Not received within 5 days
• Sender must notify CDC

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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

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Additional Information

• www.saftpak.com/Product
• www.cdc.gov
• www.usps.gov

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