Introducing NovaPure® Components
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In April, West introduced a new line of high-quality components under its NovaPure brand. Through a product development process that incorporates Quality by Design principles, NovaPure components, including serum and lyophilization stoppers as well as syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products.
“Patient safety influenced the design process for NovaPure components from start to finish,” said Donald E. Morel, Jr., Ph.D., West's Chairman and CEO. “We incorporated a variety of high-quality processes and features designed to ensure not only component reliability, but also provide an unrivaled level of quality for our customers, which ultimately can aid in the safety and efficacy of their drug product for the patient.”
Help pharmaceutical companies lower total cost of ownership
Will improve transparency between component and pharmaceutical manufacturers
Ensure quality driven by patients’ needs
Are manufactured with the deepest product and process understanding
For the NovaPure component line, West developed a comprehensive quality target product profile (QTPP) based on the needs of its customers and the end users. Critical quality attributes (CQAs), determined with the patient in mind, have been built into the development process to help ensure quality, safety and efficacy throughout a drug product’s lifecycle. Features and processes that help to ensure reliability include:
FluroTec® barrier film – a proven, effective barrier against extractables that provides lubricity without the need for silicone oil
Validated wash and sterilization processes that help ensure consistency of stopper preparation
100 percent vision verification to assure low particles
Lot-to-lot extractable profile to assure material consistency
NovaPure components are globally available with reduced lead time and are provided in optimized packaging that helps ease transition through manufacturing environments. NovaPure components are supported by a series of unique service features that help assure the latest compliance and customer satisfaction requirements are met.
For more information about NovaPure components, contact your account manager today or visit www.WestNovaPure.com.
FluroTec® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec® technology is licensed from Daikyo Seiko, Ltd.