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Longer life for life-saving blood product

SiOX-coated film delivers the barrier properties required for this human blood substitute product. Film clarity lets clinicians perform important visual inspection.

Currently the packaging operation at Hemosol is done manually, but plans call for more automation once Hemolink goes commercial
Currently the packaging operation at Hemosol is done manually, but plans call for more automation once Hemolink goes commercial

A soon-to-be-commercialized human blood substitute product called Hemolink(TM) is so sensitive to oxygen that its Toronto-based maker, Hemosol, used to keep it frozen once it was packaged in IV infusion bags and nylon overpouches. Neither primary nor secondary packaging materials were able to keep oxygen away from the sensitive product, and only by freezing it could its stability and efficacy be protected.

But costly and inconvenient freezing became a thing of the past once Hemosol began using an overpouch made of a ClearFoil® film from Rollprint (Addison, IL). The high-barrier property of this multilayer lamination gives Hemolink a projected shelf life of at least two years at refrigerated temperatures of 4°C, and at least one year at room temperature.

"We haven't finalized our data yet, but the shelf life looks promising," says Dirk Alkema, vice president of manufacturing at Hemosol. "This film meets our specifications for high oxygen and moisture barrier properties while the clarity of the material maintains our product's visibility."

The clarity issue is important, says Alkema. "Clinicians are used to seeing blood in an IV bag. They visually inspect the blood for quality." The clarity of the ClearFoil pouch allows them to do this, says Alkema.

The pouch is made by Rollprint from a three-layer adhesive lamination of 75-ga oriented polypropylene/ClearFoil SiOx-F/2.5-mil sealant layer. The SiOx-F is an unnamed substrate coated with silicon oxide to Rollprint's specifications. It has the highest barrier of all the films in Rollprint's ClearFoil family. It provides an oxygen transmission rate of 0.003 cc/100 sq"/24 hr at ambient temperature under normal atmospheric pressure.

Moisture barrier properties are important as well, says Sam Teleki, special projects manager at Hemosol. The ClearFoil laminate delivers. MVTR is 0.02 g/100 sq"/24 hr.

"Minimizing water vapor loss protects product concentration," Teleki explains. "For example, if we produce a product with a 10 percent concentration of hemoglobin, fill one hundred milliliters into an IV bag and then we lose three milliliters of moisture during the shelf life of the product, we've just increased the product concentration to 10.3 percent."

Adds Alkema: "As we designed our overpouch, we looked for the highest level of oxygen and water vapor barrier in a clear film so that we could protect the stability of the product. The improved shelf life we get as a result is an added value."

Flex-crack resistance is another characteristic of the overpouch material that is greatly appreciated, especially since these pouches are kept under refrigeration.

"Flex-crack resistance becomes more difficult at cold temperatures because some plastics become very brittle," says Teleki. "The flex-crack characteristics of the ClearFoil laminate are good, even at very low temperatures."

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