Sensitive pharmaceuticals and biopharmaceuticals require a high-quality containment and delivery system that will help maintain drug purity and efficacy, and ensure safety for the patient. You need components that meet not only the high-quality standards of patient care, but also the demands of our sensitive drug products.
NovaPure® components are available in elastomer formulations 4023/50 gray and 4432/50 with FluroTec® barrier film to minimize compatibility issues with the drug product.
From start to finish, NovaPure® components have been designed and manufactured through a process using Quality by Design principles to mitigate risk for the patient.
NovaPure® Vial System Solutions meet the increasing market requirements for vial-based packaging systems, West NovaPure® stoppers have been proven to be very clean and optimal in physical properties from filling, through storage to final patient use. Exceptional cleanliness and barrier properties help ensure excellent drug compatibility and drug protection for liquid and lyophilised drug products over their shelf life.
Components manufactured with Quality by Design principles meet Critical Quality Attributes:
- Sub-visible particle specifications
- Tight visible particle specifications
- Minimized exposure to sources of cellulose
- Critical dimensions measured in CpK
NovaPure components for vials help you:
- Reduce quality issues associated with particulate
- Protect sensitive drug products with exceptional cleanliness and barrier properties
- Address patient needs with an in-depth Quality Target Product Profile (QTPP)
- Minimize Total Cost of Ownership
West offers enhanced transparency to NovaPure Customers via:
- 24/7 access to Customer Connection, a comprehensive online library of process and product documents
- Key extractable reporting to monitor material consistency and minimize variability of leachables
- Regulatory support, including a Drug Master File in Common Technical Dossier (CTD) format for US & Canada