Product Details
The DURAN® Pure bottle is made of clear borosilicate glass, featuring a GL45 neck and a capacity of 250ml, with caps sold separately. This product is part of a complete, USP compliant range of bottles that spans from 25ml to 20 liters, providing validation-ready sizes suited for both pilot projects and production volumes. The bottles are designed to handle a wide temperature range, allowing for hot "sterile" fills to cold storage, while maintaining moisture permeation rates that ensure bottle-closure integrity for process biologics, thereby offering long-term stability assurance. The DURAN Pure process bottle system is backed by a comprehensive online validation document package for easy access. Key attributes include the use of chemically inert USP Type I 3.3 borosilicate glass, an excellent gas barrier, a low leachable/extractable profile, and biocompatibility, with products manufactured in Germany. Additional features include compliance with cGMP change control management, adherence to USP, Ph. Eur. 3.2.1, and JP 7.01 method 1, a dust cover conforming to DIN ISO 3585, and volume graduations with improved accuracy over standard bottles. The comprehensive validation package consists of a certificate of analysis (COA), Type III drug master file (DMF), and qualification documentation, ensuring 100% traceability of components, including the bottle and screw cap, and covers cap sealing line benefits. The product meets official requirements for documented proof of suitability and traceability of primary packaging materials and complies with the documentation and production requirements of national and international pharmacopoeias for primary packaging materials, thus simplifying traceability.
