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DURAN ® PURE From R&D through Phase III trials, the task of selecting and validating biologic intermediate packaging is a complex matrix of requirements. The inherent properties of DURAN PURE 3.3 borosilicate glass bottles and fluoropolymer screw caps can fulfill your requirement matrix. DURAN PURE delivers raw material purity with the following features: • Chemically inert • Wide usage temperature range • Excellent gas barrier • Low leachable/extractable profile • Biocompatibility DURAN PURE offers a complete, USP compliant range of bottles from 25mL to 20L. These validation ready sizes are scalable from pilot to production volumes, with the added durability to go from hot “sterile” fills to cold storage. The DURAN PURE bottle and closure provide moisture permeation rates that support bottle-closure integrity for process biologics; it’s the protective environment for long-term stability assurance. DURAN PURE Process Bottle System is supported by a comprehensive, easy to access online validation document package and support services.
DURAN PURE Features
Benefits
Comprehensive validation package • Certificate of Analysis (CoA) • Type III Drug Master File (DMF) • Qualification documentation 100% traceability of components • Bottle • Screw cap • Cap sealing liner
DURAN PURE meets the official requirements for documented proof of suitability and traceability of primary packaging material
DURAN PURE meets the documentation and production requirements of national and international pharmacopeias for primary packaging materials
Supply from a single production lot
Simplifies traceability
All the supplied packaging material meets the specified quality standard, reducing the risk of rejection By mutual agreement, planned product related changes will be communicated
100% visual control of the DURAN PURE Bottles and Premium Screw Caps
cGMP change control management
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