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LyoTec® and FluroTec® is a are registered trademarks of West Pharmaceutical Services, In., in the United States and other jurisdictions.
FluroTec® technology is licensed from Daikyo Seiko, Ltd.
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
Containment/delivery systems for sensitive biologic drugs must provide the chemical, physical, and performance properties required to ensure product quality through shelf life. Further, they must be compatible with fill/finish operations, and enable functional performance during administration. Legacy rubber components may no longer meet the increasing technical and regulatory requirements of current and future biologic drug products.
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
Containment/delivery systems for sensitive biologic drugs must provide the chemical, physical, and performance properties required to ensure product quality through shelf life. Further, they must be compatible with fill/finish operations, and enable functional performance during administration. Legacy rubber components may no longer meet the increasing technical and regulatory requirements of current and future biologic drug products.
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