Medical Device Link.

Originally Published EMDM September 2003

INDUSTRY NEWS

In the wake of heightened US FDA requirements, West Pharmaceutical Services (Lionville, PA, USA) has announced that it will add presterilization capabilities to its facilities in Le Nouvion, France; Eschweiler, Germany; and Jurong, Singapore. These sites are registered with US FDA. A Drug Master File supports each.

The company’s Westar RS programme will provide OEMs with ready-to-sterilize drug-delivery components. The parts are washed, and may be presiliconized, at the West Pharmaceutical facilities prior to shipment. The process has been in use in the United States for more than five years.
“In Europe, we’ve been providing products to customers for internal washing processes,” says Graham Reynolds, European division director of marketing. Treatment wash, rinse, and siliconization can be a problematic process for OEMs, however. By outsourcing these services to West Pharmaceutical, customers can save time and money, according to the firm. The upgraded facilities also allow the firm to offer regional sourcing to OEMs who are registering their products for sale in the United States.

West Pharmaceutical’s EU and Singapore sites will meet the same specifications for bacterial endotoxin, bioburden, and particulate levels as its US facilities. Processing also complies with European regulatory requirements. Water serum, lyophilization, and IV stoppers, as well as syringe components, routinely undergo Westar RS processing. 

For more information, contact West Pharmaceutical Services,101 Gordon Dr., Lionville, PA 19341, USA; phone: +1 610 5942900; fax: +1 610 5943000; Internet: www.westpharma.com. 

Laura Angela Bagnetto

Copyright ©2003 European Medical Device Manufacturer