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NovaPure® Stoppers
The highest standards in risk mitigation
The NovaPure™ brand is West’s premium line of stoppers, offering the tightest particulate specification available for West elastomer products. NovaPure stoppers combine the protection of FluroTec® barrier film, West Envision® automated vision inspection and lot-to-lot extractables testing with the assurance that comes from deep process understanding and manufacturing controls based on Quality by Design (QbD) principles. The result is a consistent product that has shown itself capable of meeting the challenges of today’s sensitive, high-value biologics and small molecules.
Overview
NovaPure stoppers are offered in two leading West formulations, a bromobutyl and a chlorobutyl. Special handling and testing ensures compliance with the tightest particulate specification offered in each of these formulations. This specification, stated in parts per million (ppm), comprises visible and sub-visible measurements.
NovaPure stoppers are available in a range of familiar global designs selected for proven machinability and functionality and further enhanced through QbD-based principles of continuous improvement. Data gather, statistical analysis and knowledge management is an essential part of the NovaPure stopper quality process. In addition to the production feedback loop used to document critical processes and drive their improvement, all NovaPure stopper products undergo formal annual review.
NovaPure stopper business continuity is supported through West’s continuing investment in plants across our global network.
product attributes
NovaPure components can be supplied washed (ready to sterilize) or sterilized (ready to use) in standard STERIlizableBAG™ packaging or in ported bags depending on your need. To find out more about our sterile small quantity offerings, you can also refer to West Ready Pack® brand offering.
Packaging Options
Downloadable Resources
West NovaPure® Information Sheet
West NovaPure® 1-3mL Plungers Information Sheet
Gene Therapy Information Sheet
Compounding Pharmacies Information Sheet
Video - Manufacturing - Receipt and Inspection of Novapure Plungers and Stoppers
Video - Manufacturing - Receipt and Entry of Novapure Plungers and Stoppers
Related Products
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is a registered trademark of Daikyo Seiko, Ltd.
NovaPure®, FlurtoTec® and Ready Pack® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec technology is licensed from Daikyo Seiko, Ltd.
