Description
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 can fulfill your requirement matrix. DURAN PURE offers a complete, USP compliant range of bottles from 25 mL 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 (sold separately) provide moisture permeation rates that support bottle-closure integrity for process biologics; its 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 delivers raw material purity with the following features:
• Chemically inert
• Wide usage temperature range
• Excellent gas barrier
• Low leachable/extractable profile
• Biocompatibility
DURAN® PURE Glass Bottles (Caps are sold separately):
• Documented lot management and traceability using the retrace Code
• Volume graduations with improved accuracy compared to standard bottles
• Conforms to USP <660>, Ph. Eur. 3.2.1 and JP 7.01 Method 1
• USP Type I 3.3 borosilicate glass is a neutral glass and practically inert
• Protective dust cover conforms to DIN ISO 3585
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