High-Barrier Transparent Packaging Right Rx for Hemolink Blood Substitute

When Hemosol, Inc. of Toronto designed the packaging for its new Hemolink blood substitute product, high barrier properties were crucial to protect product quality and maximize shelf life. "We searched for the highest levels of oxygen and moisture barrier properties available in a clear laminate film," says Dr. Dirk Alkema, VP manufacturing at Hemosol. "Ultra-high barrier protection maintains the stability of the product while the clarity of the material maintains the product's visibility."

Currently in phase II of clinical trials, Hemolink is made from highly purified hemoglobin taken from outdated blood at the Red Cross blood bank. After investigating the permeability of a variety of flexible films, Hemosol selected the new ClearFoil SiOX-F flexible laminate from Rollprint Packaging Products, an Addison, IL-based supplier of heat-sealable, peelable rollstock and pouch technology to the healthcare, industrial and food industries. ClearFoil SiOX-F is a transparent packaging film that keeps gas exchange and moisture loss to a minimum. "The level of protection we get with the ClearFoil film also increases the shelf life of the product at higher storage temperatures," comments Alkema.

Rollprint's newest laminate in the ClearFoil family of films, developed specifically for Hemosol, uses ClearFoil SiOX-F sandwiched between a 2.5-mil sealant layer and a 75-gauge oriented polypropylene (OPP) outer layer. ClearFoil SiOX-F, Rollprint's highest barrier ClearFoil laminate, offers oxygen permeability of only 0.003 cc and water vapor permeability of just 0.02 grams per 100 sq in. per day at ambient temperatures under normal atmospheric pressure.

"The level of oxygen barrier we get with the ClearFoil film represents 130 times more protection than the next-best laminate we found, and that offered 0.04 permeability," notes Sam Teleki, special projects manager at Hemosol.

Clarity Allows Visual Monitoring
Hemosol packages its Hemolink product in an IV infusion bag that resembles those used for donated allogeneic blood and packs the Hemolink-filled IV bags into overpouches made of Rollprint's ClearFoil SiOX-F material. "The clarity of the ClearFoil overpouch enables the clinicians to easily see the IV bag and the blood product inside," explained Dr. Peter Wojciechowski, manager of process development at Hemosol. "This allows for the visual monitoring of the product as an indication of product quality and increases product acceptance."

"Before we chose the ClearFoil film, we analyzed the permeability of a variety of flexible films," says Teleki. "We were looking for maximum barrier levels primarily to maintain product quality, but we recognized that with higher barrier properties, we could also increase the product shelf life at higher product storage temperatures."

Compared to donated allogeneic blood that has a shelf life of less than 42 days, Hemolink packaged in the ClearFoil SiOX-F overpouch offers far greater product stability. "Although our data isn't finalized, the shelf life of our product looks very good," Alkema notes. "Our target is at least a two-year shelf life for Hemolink stored at 4°C and a one-year shelf life for product stored at ambient temperatures. The ClearFoil overpouch will help us achieve that target."

For more information: Karen Berger, Rollprint Packaging Products, 320 Stewart Ave., Addison, IL 60101. Tel: 630-628-1700, Fax: 630-628-8510, e-mail: kberger@rollprint.com