Product

Product Brief: Sterile Type IB Borosilicate Glass Tubing Vials for Injections

Product Name: Sterile Type IB Borosilicate Glass Tubing Vials for Injections

DMF Number: 038735

These ready-to-use sterile vials are manufactured from high-quality Type IB borosilicate glass tubing through rigorous processes including forming, washing, and sterilization. They are suitable for high-demand aseptic filling applications such as aqueous injections, lyophilized powders, and biologics, and comply with the requirements for Type I glass as specified in the Chinese Pharmacopoeia, USP, and EP, offering excellent hydrolytic resistance and freeze-thaw tolerance.

Key Advantages

Ready-to-Use Sterility Assurance: Pre-sterilized (SAL 10⁻⁶), eliminating the need for secondary washing or depyrogenation, thus simplifying the filling process.

Excellent Chemical Stability: Made from borosilicate glass with a low coefficient of thermal expansion and high hydrolytic resistance (Hydrolytic Class HC 1), suitable for pH-sensitive or protein-based drugs.

High Dimensional Precision: The tubing process ensures minimal tolerances on both the finish and body dimensions, ensuring compatibility with a wide range of stoppers and automated filling equipment.

Optical Clarity: Facilitates visual inspection of solution clarity and foreign particles, enhancing quality control efficiency.

Regulatory Support: DMF 038735 is available to support drug manufacturers in accelerating ANDA/NDA/BLA submissions.

Typical Applications

Aqueous injections, lyophilized powders, antibody drugs, vaccines, and other sterile injectable products.