Product

Product Brief: Sterile Cartridge Systems for Pen-Injectors

Product Name: Cartridge Systems for Pen-injectors

DMF Number: 041500

This product is a prefillable cartridge system specifically designed for sterile pen-injectors, suitable for multi-dose administration (e.g., insulin, GLP-1 analogs, growth hormones). The system consists of a glass or COP barrel, a piston, an aluminum cap, and a rubber septum. It is pre-sterilized and ready for direct filling.

Key Advantages

Ready-to-use Sterility Assurance – Pre-sterilized packaging (SAL 10⁻⁶), eliminating the need for washing and sterilization, simplifying the filling line.

Accurate and Consistent Dosing – High-precision inner diameter tolerance enables continuous, micro-volume, and repeatable dosing with pen-injectors.

Low Compatibility Risk – Materials comply with pharmacopoeia standards, with low extractables and leachables, suitable for sensitive biologics.

Convenient and Safe Operation – Snap-lock structure facilitates easy assembly into the pen holder, with anti-disengagement design to prevent accidental needle withdrawal.

Regulatory Compliance – DMF 041500 supports ANDA/NDA/BLA submissions for drug manufacturers.

Typical Applications

Multi-dose injectable therapies for diabetes, obesity, autoimmune diseases, and other chronic conditions.