DURAN® PURE Glass Bottles & Screw Caps offer 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 bottles & closure provide moisture permeation rates that support botte-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.
Glass bottles are made with USP Type I 3.3 borosilicate glass and conform to USP <660>, Ph. Eur. 3.2.1 and JP 7.01 Method 1. Glass type I is a neutral glass and is practically inert. Their protective dust cover conforms to DIN ISO 3585. Documented log management and traceability can be done using the “Retrace Code” on the front of the bottle.
Comprehensive validation packaging including Certificate of Analysis (CoA), Type III Drug Master File (DMF), and Qualification Documentation
100% traceability of components including the bottle, screw cap, and cap sealing liner
Supply from a single production lot simplifying traceability
All the supplied packaging material meets the specified quality standard, reducing the risk of rejection
cGMP change control management – by mutual agreements, planned product related changes will be communicated