BY MARK A. DeSORBO
SALT LAKE CITY, Utah—Interaction between parenteral drug products and the packaging continues to be a critical issue, especially since validation and risk-based approaches are top priorities on the Food and Drug Administration's agenda for current good manufacturing practices (cGMPs).
Contamination—leachables, extractables and particulates—from the packaging can get into drug products, while pharmaceuticals can absorb into the packaging, altering the efficacy and endangering patients.
West Pharmaceuticals says its FluroTech film and WestarRS process significantly minimizes parenteral drug contamination.
With the rapid increase in the development of high-performance, bio-engineered drugs, there is an even greater need to minimize this type of interaction, says Don McMillan, vice president of marketing for West Pharmaceutical Services Inc., which has developed an advanced barrier film for pharmaceutical closures.
“It is a barrier film that is placed on the area of the stopper where there is likely to be contact,” he says. “Most of today's high-end biotech drugs, whether they are proteins or peptides, require this barrier to the package component, and it greatly reduces the interaction between the stopper and the drug product, where there are extractables and leachables—finer terms for contamination.”
West's FluroTec, a fluorocarbon film, is made from a modified ethylene-tetrafluoroethylene (ETFE) copolymer. The film helps maintain the full strength and shelf life of packaged drugs by reducing absorption and adsorption of the drug product, and by providing an effective barrier against organic and inorganic contamination. The film can be applied to complex-shaped closures, which are typically required for dry-powder and lyophilized (freeze-dried) applications.
Donald E. Morel, Jr., West's chief executive and president, says FluroTech is a closure system “for drug manufacturers who face the potential risk of losing millions of dollars that could result from a contaminated drug.
Once FluroTech is applied, such closures as stoppers are then fed through the company's cGMP-validated WestarRS process, which involves a wash in purified water to achieve a minimum 3-log bacteria endotoxin reduction. From there, components are transferred to an ISO Class 5 cleanroom for packaging under continuous environmental monitoring.