DURAN® PURE Bottle Only, Amber, Borosilicate Glass, GL45, 500 ml, case/10

DURAN® PURE Bottle Only, Amber Borosilicate Glass, GL45, 500mL. Caps Sold Separately. DURAN PURE offers a complete, USP compliant range of bottles from 25mL to 20 Liter. These validation-ready sizes are scalable from pilot projects 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; providing a 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.

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
• USP Type I 3.3 borosilicate glass
• Wide usage temperature range
• Excellent gas barrier
• Low leachable/extractable profile
• Biocompatibility
• Made in Germany

Features

• Supplied from a single production lot
• cGMP change control management
• Bottle Conforms to USP <660>, Ph. Eur. 3.2.1 and JP 7.01 Method 1
  
• Dust cover on bottles conforms to DIN ISO 3585
• Volume graduations with improved accuracy compared to standard bottles
• Documented lot management and Traceability using the "Retrace Code"
• Comprehensive validation package includes:
  • Certificate of Analysis (CoA)
  • Type III Drug Master File (DMF)
  • Qualification documentation
• 100% traceability of components, including:
  • Bottle
  • Screw cap
  • Cap sealing line

Benefits

• Meets official requirements for documented proof of suitability and traceability of primary packaging material
• Meets documentation and production requirements of national and international pharmacopeias for primary packaging materials
• Simplifies traceability
• All the supplied packaging material meets the specified quality standard, reducing the risk of rejection

DURAN PURE bottles and caps meet the requirements of the national and international pharmacopoeias, and are supported by a full range of documents and certifications that meet the detailed requirements of the regulatory authorities. A comprehensive qualification package providing product information and supplier qualification is available for download from duran-group.com.