Integrated handling of sterile HPAPI through advanced containment and liquid transfer technologies.
Managing sterile processes involving high-potency active pharmaceutical ingredients (HPAPIs) requires uncompromising attention to detail and safety and we found a brilliant solution via a liquid transfer station. Every phase, from containment to transfer, must be meticulously controlled to protect both product integrity and operator safety.
Synergic collaboration within CSV Life Science Group.
This project showcases the consolidated expertise of Pharma Hub and CSV Containment, both part of the CSV Life Science Group, with mechanical integration provided by Officine Galesso, also belonging to the same group. The result is an inline liquid transfer system that seamlessly connect containment technology with process engineering.
Powder-to-liquid transfer starts with secure containment.
The starting point is a glove box engineered by CSV Containment, specifically designed for the initial handling of HPAPI powders. The product enters the process via DIT®, a patented manual or pneumatic double iris system, which ensures drum containment at an OEB5 level. Different drum sizes are managed effortlessly thanks to the integrated drum lifter and adaptable chamber configuration.
Pharma Hub enables continuous transfer and mixing.
Once the product is enclosed in the containment system, Pharma Hub enables the inline transfer through a Venturi-effect-based mechanism, which uses a water stream to move the active material directly into the preparation tank. The system initiates mixing immediately, ensuring homogeneous dispersion of the powder in Water for Injection (WFI).
The tank—custom-built by Officine Galesso—features a thermostatically controlled jacket, insulation, and mirror-polished surfaces, ensuring compliance with sterile manufacturing standards. A magnetic agitator guarantees efficient and controlled mixing throughout the process.
Liquid Transfer Tank
HMI
Smart automation and regulatory compliance.
Process operations are managed via a fully automated control system, configurable according to specific production needs, including client-defined formulation parameters. Compliance with FDA 21 CFR Part 11 ensures traceability, data integrity, and full electronic record management.
Flexible design for dynamic production needs.
The system operates as a “closed-loop process”, ensuring both sterility and containment. Yet, it remains highly adaptable: the glove box can be repositioned in relation to the tank, thanks to the flexible transfer line length. Moreover, it can be repurposed as a “standalone unit for powder handling”outside the liquid transfer flow. This modularity provides manufacturers with the flexibility to tailor the setup to evolving production strategies.
Discover the ideal solutions to optimise your production and overcome the limitations of traditional processing by visiting our LinkedIn page or writing to us at: info@pharma-hub.it.
