Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published November 1999
CASE HISTORY
Protecting Artificial Skin
A flexible bag uses air chambers to protect a delicate biotech product from shipping hazards.
Grown in the laboratory and comprised of living human skin cells, Apligraf is a synthetic live skin product designed as a substitute for conventional skin grafts. The skin substitute, manufactured by Organogenesis Inc. (Canton, MA), has been approved for use on venous leg ulcers and is currently well into testing for numerous other applications. Because it is fragile and sensitive to extreme temperatures, it is grown and shipped in a custom vacuum-formed tray on an Agarose gel medium until it is placed on an open wound. If an air bubble forms between the product and the medium or if the tray is damaged during transit or storage, there is a high probability that the skin will not survive.
Charged with the task of designing a shipping package for Apligraf, Source Packaging N.E. (Warwick, RI) needed to create a package that would maintain a stable temperature range for up to five days while at the same time comply with strict drop and vibration requirements. "This particular package, besides needing to protect a very fragile item, also needed to be stabilized between 20 and 31 degrees centigrade for an extended period of time," said Rick Ferris, president of Source Packaging N.E.
When Ferris and his colleagues figured out how to maintain the desired temperature range and stability, they incorporated traditional soft urethane foam products into the packaging in different configurations along with corrugated materials. However, the configurations were not providing the necessary cushion to protect the primary container and the product. "The problem came when we started applying standard ISTA (International Safe Transit Association) criteria to our validation protocols and testing regimen. We began seeing product damage even though we had never seen any real damage in the field," said Alex Tschumakow, manager of process engineering for Organogenesis.
In addition, the materials necessary to maintain temperature stability brought the shipping weight to about 20 lb. "The issue was how to control the fragility of the product when encircled by heavy thermal barriers—much like trying to protect a thin sheet of glass from breaking while surrounding it with bricks," stated Source's Ferris.
"Even after many attempts with different cushioning configurations, we continued to have damage to the primary package and the product," said Ferris. "That's when we came across Air Packaging Technologies's (Valencia, CA) Air Box design."
Air Box is a four-layer nylon-polyethylene bag with inflatable air chambers that will hold up to three primary packages, in this case with Apligraf. The packages are slid into the bag, and then the bag is inflated. The air chambers completely encapsulate the product in the middle so the primary packages become suspended in the center. An inner corrugated shell holds the thermal barrier in place, which is then surrounded by the outer corrugated package.
Once the Air Box was accepted as the shipping package, the next step was to test it according to ISTA standards for vibration and drop, as well as to compare the temperature to predetermined levels. After three to four months of testing and adjustments, Tschumakow found no damage to the primary package or the product.
Currently, Organogenesis and Source Packaging N.E. are designing a second-generation Air Box package for Apligraf. The goal is to reduce size and improve the primary package in which Apligraf is grown and shipped in order to make it more resistant to damage and physical shock. "It was a very unique approach to packaging and helped solve our problem," said Tschumakow, who feels they have reached the end of package improvements given the current state of materials and technology, but they will continue to use this package design with its current configuration and future Organogenesis products.
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