The company claims that stoppers equipped with West Fluro Tec film have barrier properties that can significantly reduce leachables, extractables and particulates that result from stopper-drug interaction. It says that this capability maintains seal integrity and reduces the potential of drug contamination that could harm patients and result in product recalls.
West Pharmaceutical Services believes that the fluorocarbon film, which is made from a modified ethylene-tetrafluoroethylene (ETFE) copolymer, can maintain the full strength and shelf life of packaged drugs by reducing absorption of the product. It also provides an effective barrier against organic and inorganic extractables, says the company.
The development of bioengineered drugs which often require lyophilisation (freeze-drying) has seen a rapid increase recently, and West Pharma claims that its barrier film can be applied to the complex-shaped closures, that are typically required for dry powder and lyophilised applications.
The company's president, Donald Morel, said: "with this introduction of Fluro Tec laminated closures, West Pharmaceutical Services is delivering a state-of-the-art closure system for drug manufacturers who face the potential risk of losing millions of dollars that could result from a contaminated drug".
West Fluro Tec has been licensed from Daikyo Seiko, the company's partner and a leading stoppers manufacturer based in Japan. All of the company's components will undergo Westar RS processing, says the company. It claims this will allow drug manufacturers to eliminate processes such as washing and rinsing on their production lines.
West Pharmaceutical Services made the announcement at the American Association of Pharmaceutical Scientists (AAPS) annual meeting yesterday. Morel believes that the barrier film, "will gain rapid market acceptance due to its ability to minimise possible risks while allowing the drug to maintain its therapeutic properties."