SHIPMENT OF BIOLOGICAL MATERIALS
There are specific requirements for the packaging and labeling of biological materials. Biological materials include infectious substances (etiologic agents), diagnostic (clinical) specimens, and biological products. (See definitions below)
Proper shipping papers, "Shipper's Declaration for Dangerous Goods," must be completed for shipment of infectious substances, but not for biological products, or diagnostic specimens. However, all three groups of materials require proper packaging. DHL Worldwide Express may be used for non-infectious substances ONLY. Federal Express and other carriers will transport infectious substances.
Definitions
| Infectious substances or etiologic agents: |
| Substances known to contain, or reasonably expected to contain, pathogens. Pathogens are microorganisms or recombinant microorganisms that are known or reasonably expected to cause disease in humans or animals. (Unacceptable for carriage by DHL) |
| Diagnostic Specimens: |
| Any human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluids, being transported for diagnostic or investigational purposes, but excluding live infected animals. (Acceptable for carriage by DHL) |
| Biological Product: |
| Those products derived from living organisms, that are manufactured and distributed in accordance with the requirements of national governmental authorities which may have special licensing requirements, and are used either for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto. They include, but are not limited to, finished or unfinished products such as vaccines and diagnostic products. (Acceptable for carriage by DHL) |
Classification of Shipments
Human blood, blood by-products, tissues, etc. always require "Universal or Standard Precautions" and may be considered a diagnostic specimen and shipped without the dangerous goods paperwork. (Use packaging instructions for non-infectious substances) However, a biohazard sticker must be present when shipping human blood etc., according to the OSHA Bloodborne Pathogens Standard. If the human blood, etc. is known to be infected with an infectious substance, or if it is being transported for the purpose of initial confirmatory testing for the presence of a pathogen, it must be packaged and shipped as such and requires the dangerous goods paperwork. (Use packaging instructions for infectious substances)
Substances Shipped Refrigerated or Frozen
If dry ice accompanies a shipment, these materials must be declared, and packages must be properly labeled with a DOT Class 9 dry ice label. DHL Worldwide Express will only accept packages with less than 5 pounds of dry ice. Dry ice shall then be placed in a styrofoam box along with the secondary specimen container(s) (i.e., ziplock bags), and then the styrofoam box is placed in the outer packaging. Interior support (i.e., styrofoam pieces or paper stuffing) must be provided to secure the secondary packaging(s) in the original position after the dry ice has been dissipated. The outer packaging must permit the release of carbon dioxide gas.
If wet ice is used, the packaging must be leak-proof. (Insulated shipping boxes with blue ice are available from the stockroom for use in DHL shipments.)
Packaging Instructions for Non-Infectious Substances
(Non-hazardous diagnostic specimens and biological products and a low
probability exists that infectious substances are present)
Contact the Safety Department (X8843, X8925) for guidance on compliance with these regulations.
| 1. | Water tight primary receptacle(s) with screw-on, snap-on or push-on lids - i.e., glass/plastic vials, jars, canisters. Lids must be taped closed. (i.e., adhesive tape) Use proper internal labeling for identification of samples. (maximum quantity 500 ml) | |
| 2. | Water tight secondary packaging - i.e., sealed plastic ziplock bag, screw-cap container. (maximum quantity per outer packaging 4L) (The primary receptacle or the secondary packaging must be capable of withstanding a 95 kPa pressure differential) | |
| 3. | Absorbent material must be placed between the primary receptacle and the secondary receptacle. If multiple primary receptacles are placed in the same secondary receptacle, they must be individually wrapped to prevent contact between them. Enough absorbent material must be used to absorb the entire contents of all the primary receptacles - i.e, paper towels, cotton balls, wool. | |
| 4. | An itemized list of contents must be enclosed between the secondary packaging and the outer packaging. | |
| 5. | A sturdy outer packaging constructed of corrugated fiberboard, wood, metal or rigid plastic. (Styrofoam, plastic bags and paper envelopes are NOT acceptable outer packaging) Reinforce corrugated cardboard boxes with packaging tape. (Outer packaging must meet certain drop test criteria) | |
| 6. | Any shipment of non-infectious blood samples, blood by-products, tissues, etc. requires a "BIOHAZARD" label in a prominent position on the outer packaging. (Shipments sent by DHL must also have "Perishable" designated on the outer packaging.) | |
| 7. | Each package and the "Nature and Quantity of Goods" box of the air waybill must show the text "Diagnostic Specimen packed in compliance with IATA packing instructions 650." | |
| 8. | If shipment contains dry ice, refer to the previous section on shipping refrigerated or frozen substances. In addition, a Class 9 dry ice label must be placed on the outer packaging. | |
| 9. | A Shipper's Declaration for Dangerous Goods is not required. |
Packaging Instructions for Infectious Substances
(Including hazardous diagnostic specimens)
Please contact the Safety Department (X8925) for specific shipping, packing, marking and labeling requirements regarding Infectious Substances. (IATA packing instructions 602)
A Shipper's Declaration for Dangerous Goods is required.
Click here for information on shipping radioactive materials.
| University of the Sciences in Philadelphia • 600 South Forty-third Street • Philadelphia, PA 19104-4495 • phone: 215-596-8800 • email: safety@usp.edu |