International Shipping Documentation

The IIDP will provide each center with the supplies necessary for shipments as listed in the materials section. Standard lab supplies will be provided by the IIDP Centers as listed below.

The following SOPs may be implemented for these shipments. This protocol is written to assist the participating islet isolation centers who are part of this program.

• Packaging and Cold Shipping of Human Islets
• Collection, Packaging and Cold Shipping of Fresh Non-Islet Pancreatic (Acinar) Tissue
• Packaging and Shipping of Flash Frozen Non-Islet Pancreatic (Acinar)Tissue
• Collection, Broadcast, Packaging and Shipping of Non-Islet Biospecimens
• Generic Institution Box Label IIDP 2019.pdf

Shipping Supplies provided by the IIDP Centers: * Completed UPS or FedEx Shipping Labels

• Islet Allocation Tissue Shipment Forms for appropriate recipients

The IIDP recommends UPS for most international shipments because UPS is the typical courier outside of the United States. FedEx is not typically used for international shipments but is acceptable for shipping to Canada. Each center may use whichever shipping vendor is most feasible for them. These steps follow the UPS website which is a dynamic website. The FedEx instructions are similar.

Go to the UPS site and log in. If you do not have an account, follow the instructions in 2.1 to create an account.

Create UPS Account

For IIDP shipments of islets or tissues to international investigators, a UPS account must be set up by each IIDP Islet Isolation Center (IIC) in order to access the documentation needed to send an international shipment and to charge the investigator (the payer) for the shipment.

• Review International Shipping Guide for more detailed information.
• Each step below is hyperlinked to the appropriate address of the website (url) within the UPS site, at time of this publication. Since this is a dynamic site, it may have been upgraded or internal links may have changed.

Click on SHIP on the home page. Create a Shipment

♦ 1 WHERE: :

Complete the following information for Shipper and Consignee/Importer

Shipper

Where are you shipping from?

• Fill in Country, Company Name, Address, Email, Phone Number
• Indicate if you would like UPS to send status updates on the shipment
• Must declare ID/EIN: for USA for your institution
• Save the new entry and the default return address for later shipments.

Consignee/Importer

Where is your shipment going?

• Obtain information from the IIDP Investigator Shipping Information from Shipment Confirmation Page.
• Fill in Country, Company Name, Address, Email, Phone Number
• Include EORI/Tax ID from IIDP Investigator. (Note: EORI is the Economic Operator Registration and Identification) This is only needed when shipping to European Union countries. There is not a place on the FedEx form, so notate in the reference area of form.
• All new entries should be saved for later shipments.

♦ 2 WHAT: :

Use the following information for the Type of Packaging:

• My packaging (Islet Shipper (S-7359): 11 L x 9W x 12 H
• Weight (Weight will impact shipping cost): Use 8 lbs .
• Total Package Value (impacts customs taxes): Use $10 USD.
• For UPS: It is easiest to use the UPS Tracking number. Alternatively, the Islet or Biospecimens RRID number could be used (SAMN...).

♦ 3 HOW: ♦ 3 HOW :

Specify the Shipment Preference:

• Drop off or include it in another pickup OR
• Schedule a new Pickup
• Estimated Ship Date (optional)

Delivery Schedule

• When would you like it delivered?
• Recommended: UPS Worldwide Saver

♦ 4 DETAILS: 4 DETAILS:

The following information can be used for documentation.

International Shipping Details

• What best describes this shipment? From drop down list choose: None of these reasons apply.
• What are you shipping? Max 35 characters: Noninfectious human lab material

Commercial Invoice

• Complete with guidance will provide the following questions:
• See "An Easy Guide to International Shipping"
• Required to export anything other than documents (including personal items and goods not for sale).
• Description of Goods: Non-infectious human material for lab testing only. NEGATIVE for COVID-19.
• HS Code: Harmonized Tariff Code Number: : The Harmonized Code is a specific group of numbers that informs customs what is contained in the package. In the case of human islet shipments, the code number is 3002.90.5150 which designates human tissue. It is used on the Certificate of Origin document.
• Unit of Measure (How is this product packaged or sold (dropdown list): Each
• Unit Value 10 USD
• Country of origin? Where was this product made or assembled? United States
• Save Product As* Product Name/Part Number; Product ID (Primary Identifier, sent to Customs, could be tracking number). Alternatively, the Islet or Biospecimens RRID number could be used (SAMN...).
• Number of Units (Quantity): 1

UPS recommends U.S. Certificate of Origin; however, it is included in the Commercial Invoice under "An Easy Guide to International Shipping" in Step 7. 2

• Optional: only for UPS, not needed for FedEx.
• US cert_of_origin.pdf

Complete this form using the following information:

• Non-infectious human material for lab testing only.
• NEGATIVE for COVID-19.
• Valued at 10.00 USD.

Other Available Documents:

• Access International Forms as needed UPS or FedEx shipping label containing bar code.
• 3 copies of the Commercial Invoice, each attached to a smaller version of shipping label (containing bar codes). Take these 3 copies to FedEx for shipping. They will verify that the Commercial Invoice is correct. These will go in a resealable pouch supplied by FedEx.
• Include Tissue Shipment Form (IIDP TSF) in box.
• Standard Goods Permit (for Australian recipients only). Each Australian investigator must provide their own form. An example of a redacted form is attached.

Std Goods Permit 04112022[98]australia redacted.pdf

Tracking Notifications:

• Add or modify email notifications for tracking.

♦ 5 PAYMENT

Choose to Bill Other Account in order to charge the recipient for the shipment

Bill Other Account:

• Your account is required to verify charges to someone else.

• Add an Existing Account

• Create a New Account

Import Charges

• How would you like to pay import charges?
• Dropdown: Charge receiver for duties and taxes

We recommend UPS for most international shipments because UPS is not a typical courier outside of the United States. FedEx is acceptable for shipping to Canada.

Go to the FedEx home and follow instruction which should be similar to UPS.

Please note the special islet shipment parameters listed in Step 7.2 above.

Stage all materials needed for packaging the islets and ensure all ice packs and CryoPak pouches are at the proper temperature. The following is a summary of the steps detailed in the following Packaging and Cold Shipping of Human Islets SOP:* Packaging and Cold Shipping of Human Islets https://www.protocols.io/view/packaging-and-cold-shipping-of-human-islets-ewov18o7ogr2/v2

• The Cold Chain Complete Card is shipped with the WarmMark Indicator attached. Adhere the ColdMark indicator to the card and activate the WarmMark indicator .
• Immediately place the Cold Chain Complete Card along with the islet shipping bottles into a Ziploc bag and seal.
• Line the inner cardboard (S-4434) box with absorbent pad.
• Place the bagged shipping bottle(s) containing the islets in the Ziploc bag into the lined inner cardboard box.
• Surround bottle with six 8ºC cold packs, one on bottom, one on each of the four sides and one on top as directed in the Shipping SOP.
• Mark the direction for upright bottle. Seal the inner box with shipping tape and stand upright.
• Place one 8°C CryoPak pouch and one 8°C cold pack (stored in the refrigerator) in the bottom of the Styrofoam box.
• Place the inner cardboard box containing the islets on top of the pouch and pack, ensuring that the bottle inside is standing upright and centered in the shipping container.
• Place one 8°C CryoPak TCP pouch and one -20°C frozen ice pack on each long side of the inner box. (Packs/pouches are placed in the larger gap between the inner box and the insulated shipping container.)
• Place one 8°C CryoPak TCP pouch and one 8°C cold pack on the top of the inner box . NOTE NOTE-All packs should be placed in an alternating method, to ensure two of the same packs are not next to each other in the configuration.
• Place the Styrofoam lid on top. Place Tissue Shipment Form on top of Styrofoam lid.
• Close the flaps of the shipping box and seal with shipping tape. Add Live Cells box label to the box.
• Attach FedEx or UPS label with recipient FedEx or UPS number to box and ship priority overnight.

The allocation system will enter the IEQ determined to be shipped on the "Confirm Recipient Screen". However, the Center can change the number, based on the recipient profile or additional IEQ requested, for distribution. The final shipment amount must be confirmed and entered, along with the UPS or FedEx tracking numbers.