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Quality by Design Components
NovaPure

NovaPure® Components: The New Definition of High-Quality

Pharmaceutical companies are challenged to find consistent, reliable, high-quality components that are manufactured with the goal of meeting their needs and the needs of patients.

Through a product development process that incorporates Quality by Design principles, West has developed NovaPure components to help ensure the efficacy and purity of a drug product. The NovaPure product offering includes serum and lyophilization stoppers and syringe plungers.

Patient safety influenced the design process for NovaPure components from start to finish. West 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.

NovaPure components:

  • Help pharmaceutical companies lower total cost of ownership through
    • Reduced compliance risk
    • Reduced filling rejection rate
    • Reduced process costs
  • Will improve transparency between West and its pharmaceutical customers
  • Ensure quality is driven by patients’ needs
  • Are manufactured with unprecedented product and process understanding

For the NovaPure components, 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.

Features and processes that help 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.

 
 
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NovaPure components
offer unrivaled quality…by design
 
 

 

NovaPure and FluroTec are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

FluroTec® technology is licensed from Daikyo Seiko, Ltd.