West Pharmaceutical Services of the USA is rolling out its Westar RS sterilised component service, formerly only available from its US facilities, at sites in France, Germany and Singapore.
Westar is West Pharma's service for treating serum, lyophilisation and intravenous stoppers and syringe components, which is designed to help customers reduce their manufacturing and production costs and facilitate securing product approvals in the USA. Under the process, manufacturers supply their components to West, which then rinses them, siliconises them (if required) and returns them in Sterilizablebags, ready for the customer to sterilise in-house. In effect, customers transfer portions of their component preparation process to West Pharma.
The company is adding Westar RS processing capabilities to its facilities in Le Nouvion (France), Eschweiler (Germany) and Jurong (Singapore). These sites will all be registered with the US Food and Drug Administration and will adhere to applicable current Good Manufacturing Processes, "producing components meeting the same specifications for bacterial endotoxin, bioburden and particulate levels as for ready-to-sterilise components processed at West's facility in the USA," said the company.
The data from the Westar process is documented for US and Canadian registrations in site-specific Drug Master Files, which have already been submitted to the appropriate regulatory authority.