Medical Device Link.

Originally Published PMPN September 2003

Blow-Fill-Seal

For products that are not candidates for BFS technology, Unicep (Sandpoint, ID) offers an alternative for unit-dose packaging. Unlike BFS, in Unicep’s process the container is blow molded, then filled and sealed in stages within a process that does not subject the product filled to the heat characteristic of BFS. This process is not aseptic, so the finished product is not sterile unless it is sent out for terminal sterilization.

Unicep handles volatile products that would pose too great a risk of explosion under BFS conditions. “We do have some limitations. We drew the line at rocket fuel,” laughs Steve Dilts, director of sales and marketing, remembering a request he denied from a manufacturer of small hobby rockets. “But we have packaged 70% ethanol, so we can accommodate relatively volatile products.” 

Even when the danger of explosion is low, the possibility of evaporation of a highly volatile product through the container walls remains. Unicep has for the most part used the same low-density polyethylene (LDPE) that is standard for BFS. The company is now offering polypropylene as an optional resin. 

For a product with a high percentage of alcohol, Unicep found that LDPE was unacceptable. Medium-density polyethylene reduced the weight loss in incubated testing by about half, Dilts reports. “Polypropylene further cuts that weight loss by a significant margin,” he adds. Like BFS manufacturers, Unicep uses foil laminate pouching and nitrogen flooding to compensate for the permeability of the resins.

Unicep is also able to package products too viscous for the BFS process. “We specialize in topical products and dental products, so we have some expertise with filling highly viscous products,” Dilts explains. “We have packaged materials up to 1 million centipoise.”

Manufacturers with small jobs, too small to offset the cost of developing molds for BFS machinery, also may turn to Unicep. “We completed a project in the past few months. It was a new diagnostic test product, and the initial runs were in the tens of thousands,” Dilts says. “But even before that, in the start-up phase we were running only 5000 pieces.” These runs would obviously be too small for BFS manufacturers.

Unicep is completing a $5 million, 34,000-sq-ft facility expansion and plans to eventually offer aseptic processing. 

Copyright ©2003 Pharmaceutical & Medical Packaging News