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Small things sometimes come in large packages. When it comes to pharmaceutical components, small items like stoppers and plungers are often sold in quantities large enough to supply drug products to the world. But sometimes, and in particular during the early stages of drug development, large quantities are just too much of a good thing.
In addition, different drug products require different formulations and configurations to help ensure safe and effective delivery to patients. A stopper designed to work with a vial with an American blow-back ring simply won’t work on a European ISO straight wall glass vial. As more companies make the switch to ISO-standard glass vials, obtaining compatible ready-to-sterilize components from a convenient source has been difficult.
To provide easy sourcing and convenient access for its customers, West is pleased to announce that we now offer small quantities of bromobutyl, ready-to-sterilize NovaPure® components from a local distribution center in North America. NovaPure 4023/50 RS stoppers are compatible with ISO-standard glass vials and coated with FluroTec® film to further safeguard drug products from issues such as extractables and leachables.
West NovaPure components offer an unrivaled level of quality for elastomeric closures. Offered in clean, modern formulations, NovaPure components are protected with FluroTec barrier film and are fully visually-inspected. NovaPure component’s tight particle specification is made possible by an advanced level of process understanding and control. NovaPure stoppers in rubber formulation 4023/50 gray are available in ready for sterilization (RS)formats. When customers are ready to transition products into prefilled syringes, NovaPure plungers using identical elastomer and film materials are available to help ensure that the drug products are packaged in a safe and effective system.
Contact your West Account Manager or the West Technical Customer Service team for more details about NovaPure components.
NovaPure and FluroTec are registered trademarks of West Pharmaceutical Serivces, Inc., in the U.S. and other jurisdictions.
FluroTec technology is licensed from Daikyo Seiko, Ltd.
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
As drug development continues to evolve, further advances in delivery technologies will help to refine the overall drug delivery system, from improvements to safety and performance of delivery devices, to primary containers with consistent and higher-quality components.<br />
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
There is no doubt biologics and biosimilars will remain one of the hot topics in 2021. This is due to the pandemic period of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed. Several questions can arise regarding selection of the proper primary package system for a biologic/biosimilar.
<p><em>Component manufacturing process designed with Quality by Design principles meets the high-quality needs of pharmaceutical manufacturers and patients </em></p><p>West has introduced a new line of high-quality components under its NovaPure brand at the PDA Annual Meeting. Through a product development process that incorporates Quality by Design principles, NovaPure components, including serum and lyophilization stoppers and syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products.</p>
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