Pointers on Shipping Clinical Samples, Biological Substance ...

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At FedEx Express, we understand the importance ofensuring the safe shipping of clinical samples such ashuman or animal materials, including excreta, secreta,blood (including FDA-approved pharmaceuticals thatare blood products), tissue and tissue fluids, as wellas environmental test samples of soil and water. Ourobjective is to deliver these special shipments safelyto their destinations in the same good condition aswe receive them from you.This brochure provides essential pointers to help youmeet FedEx Express requirements on the properpackaging of these materials. In addition, all shipmentsmust comply with all applicable local, state and federallaws governing packing, marking and labeling. Blood,urine, fluids and other specimens containing orsuspected of containing infectious substances mustbe shipped according to applicable governmentand International Air Transport Association (IATA)regulations. For more information, call 1.800.GoFedEx1.800.463.3339 and press “81” to reach the DangerousGoods/Hazardous Materials Hotline.The illustrations depict sample packaging that isacceptable for shipping clinical samples such ashuman or animal materials, including excreta, secreta,blood (including FDA-approved pharmaceuticals thatare blood products), tissue and tissue fluids, as wellas environmental test samples of soil and water. Allof the packaging illustrated here are acceptable andmay be used in any combination as long as the fourbasic requirements for acceptable packaging are met.NOTE: Specific requirements for BiologicalSubstance Category B (UN 3373) are highlightedand underlined below.*GENERAL ACCEPTABLE PACKAGINGProper packaging of clinical samples and environmentaltest samples includes four basic requirements:1. Watertight Primary Receptacles2. Watertight Secondary Receptacles3. Absorbent Material4. Sturdy Outer Packaging1. Watertight Primary ReceptaclesAll primary receptacles must have positive closures(such as screw-on, snap-on or push-on lids) that mustbe taped.For Biological Substance Category B (UN 3373),primary receptacles may be glass, metal or plastic.Positive means of ensuring a leak-proof seal, skirtedstopper or metal crimp seal must be provided.Reinforce screw caps with adhesive tape.For liquid specimens, the primary receptacle(s) mustbe leak-proof and must not contain more than 1 L.The primary or secondary receptacle(s) must be ableto withstand, without leakage, an internal pressureproducing a pressure differential of not less than 95 kPain the range of -40 C to 55 C (-40 F to 130 F).For solid specimens, the primary receptacle(s) mustbe siftproof and must not exceed the outerpackaging weight limit.Plastic Canister Glass/Plastic Jar Glass/Plastic Vial2. Watertight Secondary ReceptaclesTo prevent contact between multiple fragile primaryreceptacles, individually wrap or separate each andplace inside a leak-proof secondary receptacle.For Biological Substance Category B (UN 3373),enclose an itemized list of contents between thesecondary packaging and the outer packaging. Forliquids, the secondary packaging must be leakproof;for solids, the secondary packaging must be siftproof.These illustrations below are not intended to representsecondary containers for Biological SubstanceCategory B (UN 3373). Secondary containers forBiological Substance Category B (UN 3373)must be certified by the manufacturerprior to use.NOTE: Internal filler or cushioning is recommendedto protect fragile contents and limit movement.For Biological Substance Category B (UN 3373) forboth liquids and solids, cushioning material is required.Sealed Styrofoam ® Container(1-inch-thick minimum)SealedPlastic BagPlasticCanisterScrew-CapCan*Dangerous-goods regulations can be reviewed in the IATA Packing Instruction 650.
3. Absorbent MaterialPlace absorbent material betweenthe primary and secondary receptacle,making sure that multiple primaryreceptacles are individually wrappedto prevent contact. Use enoughabsorbent material to absorb theentire contents of allprimary receptacles.Paper TowelsMARKINGS: Patient specimens for which thereis minimal likelihood that pathogens are presentare marked by the shipper “Exempt human specimen”or “Exempt animal specimen” as appropriate to complywith current IATA regulations.However, each UN 3373 shipment must show the text:“BIOLOGICAL SUBSTANCE CATEGORY B,” at least6 mm high, marked on the outer package adjacent tothe following diamond-shaped mark.Cellulose WaddingCotton BallsSuper-Absorbent PacketFor Biological Substance Category B (UN 3373)containing liquids, absorbent material is requiredbetween the primary and secondary receptacles.4. Sturdy Outer PackagingSturdy outer packaging must be rigid, consisting ofcorrugated fiberboard, wood, metal or rigid plasticand be appropriately sized for content.For liquids, the outer packaging must not containmore than 4 L.For solids, the outer packaging must not contain morethan 4 kg.When using an airbill pouch on outer packaging, theminimum package size that FedEx Express will accept is7" x 4" x 2". For outer packaging smaller than thesedimensions, use a plastic FedEx ® Clinical Pak as anoverwrap. As long as the final package meets the fourbasic packaging requirements, you may insert yourpackage into the FedEx Clinical Pak to comply with theminimum acceptable size. (See “FedEx Clinical Pak”on the following page.)For Biological Substance Category B (UN 3373),the minimum outer-container size inthe smallest overall externaldimension is 4 inches.Each completed package must becapable of withstanding a 4-foot(1.2-meter) drop test outlined inIATA 6.6.1. The outer packagemust be rigid.Corrugated FiberboardRigid Plastic Container Wood Rigid CoolerUN3373The UN mark must be in the form of a square set at anangle of 45 degrees with each side having a length ofat least 50 mm (2 inches). The width of the line must beat least 2 mm and the letters and numbers must be atleast 6 mm high.The name and telephone number of a responsibleperson must be marked on the package OR providedon the airbill.The name and address of the shipper and the consigneemust be marked on the package. When the shipper orconsignee is also the “person responsible,” the nameand address need only be marked once in order tosatisfy the name and address provisions.Finally, if more than one properly prepared BiologicalSubstance Category B (UN 3373) shipment is placedinto another outer package, this constitutes anoverpack. The word “OVERPACK” must be markedon the outer package and all other required packagemarkings must be reproduced on the outside of theoverpack.Specific requirements:Please consult the current ICAO/IATA regulationsfor specific requirements for the following:a. Biological Substance Category B (UN 3373) shippedrefrigerated or frozen.b. Biological Substance Category B (UN 3373) shippedin liquid nitrogen.AIRBILL ENTRIESIf a paper airbill is used, the following text mustbe included: “Biological Substance Category B”and “UN 3373”. If not marked on the outer package, thename, address and telephone number of a responsibleperson must be marked on the airbill.
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