Cartridge Combination Device for Pen-Injectors

Product Details

Product Features:

• 100% In-line Optical Inspection: Ensures excellent visual appearance.

• Steam Sterilization: More environmentally friendly and safer compared to ethylene oxide (EtO) sterilization, with a Sterility Assurance Level (SAL) of 10⁻⁶.

• Advanced Automated Washing & Assembly Line: Manufactured in a local Grade A (ISO Class 5) cleanroom environment, resulting in low particulate burden and full regulatory compliance.

• Nest-Packaged Cartridges: Prevents glass-to-glass contact and reduces the risk of container breakage, enhancing product safety.

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Manufacturing Process:

• Incoming Material: Uses imported Type I borosilicate glass, offering excellent chemical stability to ensure drug integrity.

• Washing: Containers are cleaned using Water for Injection (WFI).

• Silicone Coating & Depyrogenation: A proprietary silicone coating process ensures uniform treatment of the cartridge’s inner surface. An advanced baking process cures the silicone oil coating while simultaneously achieving depyrogenation.

• Pre-capping: A fully automatic capping system ensures perfect compatibility with the cartridges.

• Nest Packaging: Optimal nest spacing effectively prevents glass-to-glass contact and container breakage, improving product safety.

• Sealing & Sterile Pouch Packaging: Sealed using Tyvek® to maximize sterility and cleanliness assurance.

• Sterilization: Utilizes steam sterilization, a more environmentally friendly and safe method.

Packaging: trays are packaged in breathable bags. Each tray holds 100 cartridges, and each carton contains 15 trays.

• Pre-sterilized, Ready-to-Use Option Available: From molding to final packaging, cartridges are manufactured in GMP-managed cleanrooms.

• Compatible with Multiple Sterilization Methods: Suitable for both Ethylene Oxide (EtO) and Steam sterilization.