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 Qualification Documents