CRU 4-06 Specimens Shipment (Biological and Non-biological)

SOP: Specimens Shipment (Biological and Non-biological)
Number:
CRU-4-06		 Date:
Version 6.0,
06/Mar/2026		 Supersedes:
Version
5.0, 19/Jul/2023		 Responsible Authority:
CRU Director		 Page 1 of 4

  1. PURPOSE

    The purpose of this SOP is to describe the procedures related to packing and shipping biological exempt human specimens and non-biological specimens.

  2. REVISIONS FROM PREVIOUS VERSION

    2.1Version 4.0, 01/Mar/2021, updated the date and version number.

    2.2Version 6.0, 06/Mar/2026: reviewed the SOP, updated version number and date, removed Assistant Director from the SOP, corrected minor errors.

  3. POLICY

    3.1Potentially hazardous materials must be packaged to withstand leakage of contents, shocks, temperature and pressure changes and other conditions that may occur during transportation procedures. Biological materials must be packed with the triple packaging principle to include primary receptacle, leak proof secondary container with absorbent material and durable outer container. The packages must comply with the package instructions from IATA such as PI 602 for infectious substances. Buying certified packages from suppliers that are specific to the materials you want to ship will ensure compliance with the packing requirements. The proper shipping name, labels and UN markings must also be on the package before sending out for shipment. If using dry ice or liquid nitrogen with your shipment, these materials must be declared, and packages properly labeled. Dry ice should never be placed in a sealed container, or the package may be at risk of exploding.

    3.2All study staff shipping specimens must complete Shipping Hazardous Materials training prior to first shipment.

    3.3Handling of all samples must adhere to the OSHA Bloodborne Pathogen Standard using Universal precautions (i.e. PPE).

    3.4Frozen specimens must be transported in insulated containers surrounded by an ample amount of dry ice to keep the specimen frozen until it reaches the laboratory.

  4. RESPONSIBILITIES

    4.1Principal Investigator (PI)

    1. 4.1.1Ensure all study team members who will pack, and ship specimens complete the required FAU EH&S trainings (prior to first shipment) as per the FAU EH&S policy and procedures (i.e. Bloodborne pathogens, Shipping Hazardous Materials, etc.).
    2. 4.1.2Ensure all study team members have access to required shipping supplies.
    3. 4.1.3Ensure all biological specimen shipments comply with IATA Dangerous Goods Regulations and/or 49 CFR 100-185.
    4. 4.1.4Provide specific instructions if packing or shipment differs from this SOP.

    4.2CRU Director and Clinical Research Professional (CRP)

    1. 4.3.1Confirm all study team members who will pack, and ship specimens have completed initial Shipping Hazardous Materials training (prior to first shipment) and annual renewal conducted by FAU EH&S, Florida DOH or CITI (renewals).
    2. 4.3.2Confirm all study team members have access to required packing and shipping supplies.
    3. 4.3.3Confirm shipping carrier arrangements (i.e. account number, shipping forms).
    4. 4.3.4Confirm documentation of all specimen shipment(s).

  5. PROCEDURE

    5.1Review and confirm the sample packaging requirements and transportation instructions as indicated in the protocol or this SOP.

    5.2Determine if the samples being shipped are Biological or non-Biological (i.e. pathology slides). Non-Biological samples do not require special shipping precautions.

    5.3Determine if any special form, permits, or custom processes are required for shipment of biological specimens and complete as required.

    5.4Determine the proper timing for shipments and the anticipated turnaround time for results if applicable.

    5.5Ensure the receiving lab/facility will be open to receive the shipment on the anticipated delivery date/time.

    5.6Order or obtain appropriate amount of dry ice, if applicable and as determined by protocol.

    5.7Complete all required shipping documentation.

    5.8Confirm all specimens are labeled with identifiable bar code or study information (i.e. PI name, IRB #, participant ID, sample #, visit #, sample type, collection date/time).

    5.9Package the samples as indicated in the protocol if the instructions are different from the instructions provided in this SOP. If different, verify they are compliant with FAU, Federal, and IATA regulations.

    5.10For liquid specimens (i.e., blood, urine) use watertight containers with a positive closure such as a screw-on, snap-on or push-on lid, taped for an additional seal. When packing fragile primary receptacles in a single secondary receptacle, they must be individually wrapped or separated to prevent contact between them. Ensure that all specimen container caps and lids are properly tightened to prevent leakage.

    5.11For multiple tubes/specimens, use a tube rack to hold the samples.

    5.12Make sure all fields on the study information form are filled out, folded with information showing and placed inside the front pocket of the specimen bag.

    5.13Place absorbent material between the primary and secondary receptacles, using enough material to absorb the entire contents of all primary receptacles. Acceptable absorbent materials include cellulose wadding, cotton balls, super-absorbent packets, and paper towels.

    5.14Place specimen (s) in biohazard bag and seal the bag.

    5.15Place the specimen upright in the Styrofoam container.

    5.16Place 2 freezer ice packs on the outside of each of the refrigerated ice packs. (Note: freezer ice packs should not contact the specimen).

    5.17Stuff the remaining spaces with paper and close the lid. Add scotch tape if needed.

    5.18Add a biohazard sticker on the top of the Styrofoam box.

    5.19Place the Styrofoam container inside the shipping box and tape the box.

    5.20Place 3 biohazard stickers on the shipping box. (One on the top and one on each side).

    5.21Weigh the container and write it on the given space on the shipping label. Place prefilled shipping label inside protective sleeve and stick it on the box (Be sure to keep the senders copy for our records).

    5.22If dry ice is needed, use the proper dry ice handling technique.

    5.23Record the specimens included in shipment.

    5.24Close and tape the container. If dry ice is used, make sure not to seal all box edges to allow CO2 released from the dry ice to escape.

    5.25Confirm all required labels are affixed to shipping container (i.e. Shipping label, Biological Specimens Category B label, Dry Ice label, etc.).

    5.26Contact pre-arranged carrier (i.e. UPS, FedEx) to schedule pick-up and record confirmation number.

    5.27Document the shipment using lab requisition form or the CRU Specimen Shipping log. When courier comes to pick up the package, be sure to get representative name, confirmation number, and the time it was picked up.

    5.28Retain a copy of the shipping receipt (or courier waybill) and/or commercial invoice.

    5.29Send an e-mail to the recipient to inform the package was mailed and to confirm once they have received it.

    5.30Documentation

    1. 5.30.1Shipping Hazardous Materials training certificate(s).
    2. 5.30.2Lab requisition or specimen shipping log.
    3. 5.30.3Copy of shipping receipt (or courier waybill) and/or commercial invoice.
    4. 5.30.4E-mail to inform shipment.

  6. MATERIALS

    6.1  -CRU Specimen Shipping Log

    -Styrofoam secondary container

    -4G type fiberboard outer box minimum dimensions of at least 4" x 4

    -Human Exempt Specimen label

    -Frozen Gel Packs (Frozen at -20°C)

    -Leak-proof primary – NUNC vials, Sarstedt Tubes, etc.

    -Leak-proof secondary (not subject to pressure test) – Ziploc Bags

    -Absorbent material to contain all liquid in package

    -Biohazard Labels

    -If applicable Dry Ice labels (Dangerous Goods, Category 9, UN1845, White with Black)

  7. REFERENCES

    7.1FAU Environmental Health & Safety policies and procedures

    7.2The OSHA Lab Standard (29 CFR§1910.1450)

    7.3IATA Dangerous Goods Regulations

    7.449 CFR 100-185

SIGNATURES

Prepared by: Judyta A. Kociolek, MSN, RN
Director of CRU Operations
Date: 10 Mar 2026

Approved by: Peter J. Holland, MD
CRU Medical Director
Date: 10 Mar 2026

Executed signature pages are available in the Initiating Authority Office