Description
The system is designed for high-performance aseptic filling applications, featuring quick, tool-free format changeovers to minimize downtime. Each unit is equipped with verified leak-tight sealing and validated VPHP sterilization capability, achieving up to 10⁶ spore log reduction for robust decontamination assurance.
Its modular filling head design (2–10 nozzles) allows scalable production capacity depending on batch requirements. All product-contact and critical components are CIP/SIP compatible, supporting sterile and contamination-controlled batch-to-batch transitions.
Built in alignment with FDA 21 CFR Part 11 requirements, the platform supports optional PAT (Process Analytical Technology) integration, enabling in-process weight verification and full production traceability. The system is particularly suited for the manufacture of oncology injectables, mRNA-based therapeutics, and autoinjector drug delivery systems that require fully closed and highly contained processing environments.
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