April 2010 | Case Studies | Casebook

Just Chill: Moving Live Tissue

Tags: Temperature-Sensitive Goods, Health Care Logistics

A precise temperature-controlled packing and shipping procedure helps Advanced BioHealing ensure its biomedical product's safety and integrity.

With only a 15-second window to transfer a costly and extremely temperature-sensitive biomedical product from freezer to specialized shipping package, technicians at Advanced BioHealing Inc.'s La Jolla, Calif., distribution center must perform the company's packing and shipping procedure with precise planning and execution.

The product, Dermagraft, is a cryopreserved bioengineered skin substitute that assists in restoring damaged tissue and supports the body's natural healing process.

To allow long-term maintenance of tissue integrity and cellular viability, the product—a two-inch by three-inch, three-dimensional piece of living human skin tissue—must be stored between -103°F and 14°F. If the product is exposed to room temperature for more than 15 seconds, it must be discarded.

Given such critical temperature restrictions, Advanced BioHealing requires strict adherence to regulations specifying the shipping packages it uses, how technicians handle the product, and how long the storage freezer can remain open. Only by following these rules can the shipper ensure the product's viability and avoid costly destruction.

Advanced BioHealing designed a custom packing and shipping process to ensure Dermagraft's integrity from the manufacturing facility to the doctor's office. Technicians select one of four validated shipping containers that keep Dermagraft below -85°F for between 96 and 104 hours, depending on the size and type of insulation within the container.

Each package consists of an outer container insulated with dry ice, using either special blown foam or six vacuum-insulated panels. The technician must measure and record the dry ice's weight, because the Federal Aviation Administration limits how much dry ice can be loaded on an aircraft. The specialized containers require between 11 and 33 pounds of dry ice, depending on the size of the package and the number of Dermagraft pieces inside.

The containers are pre-labeled with packing slips and return addresses. Workers add dry ice to the package and wait at least 10 minutes for the packing material to reach the proper temperature.

With a limited number of time-sensitive windows to move the product from storage freezer to shipping container, technicians, who wear special gloves to prevent the product from thawing if it touches bare hands, must work quickly to minimize transfer time.

Precise rules apply to this phase of the materials handling. The freezer may not be open for more than two minutes at a time to maintain its temperature at -103°F. It must recover for at least five minutes before being reopened, and it may only be opened three times within one hour. If opened three times in an hour, the freezer must be allowed to recover for at least two hours before reopening or the contents are considered compromised. Any mistakes can cause costly shipment delays.

HANDLED WITH CARE

After the time-sensitive transfer of Dermagraft from storage freezer to shipping container is complete, the technician seals the container, stamps it with an expiration date, and prepares it for shipping to its designated location. Eighty percent of Dermagraft shipments leave the company's manufacturing facility by next-day air to the East Coast, while about 20 percent remain on the West Coast.

The receiving physicians must use or unpack and store the Dermagraft order in a freezer, which is typically provided by Advanced BioHealing, within four days. If they do not, the Dermagraft product must be discarded or sent back to the La Jolla facility for return to the controlled -103°F freezers.

Because Advanced BioHealing pays $50 to $80 per specialized shipping container, it developed a package recycling process. Physicians flip over the lid on the container to reveal a pre-addressed return label. The used containers are shipped to Advanced BioHealing's packaging supplier for re-assembly.

Advanced BioHealing employees have performed this precise shipping procedure daily since the company restarted manufacturing Dermagraft in 2007, following a 2006 acquisition of the product and its 70,000-square-foot manufacturing facility from Smith & Nephew Wound Management. Using this custom manufacturing, packing, and shipping method, approximately 1,500 pieces of Dermagraft move weekly, accelerating the healing process for more than 50,000 patients each year.