West Pharma increases components capacity
Adds Westar RS processing capabilities
US-based drug delivery technology company West Pharmaceutical Services is to add Westar RS processing capabilities to its facilities in Le Nouvion in France; Eschweiler in Germany; and Jurong in Singapore. These sites will be registered with the US FDA and each will be supported by a Drug Master File (DMF) with the FDA. Westar RS is the trade name for pharmaceutical components that are washed, may be pre-siliconised and are delivered to pharmaceutical manufacturers ready-to-sterilise.
The facilities will adhere to applicable cGMP requirements and will produce 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 US. Validation of the Westar RS process complies with European regulatory requirements, the company says, and will help its European and Asian customers register their products for sale in the US.