FLEXLINE RF-ST is a sterile robotic filling machine for RTU containers, powered by SuperTrak™ magnetic conveyance, designed to simplify validation and accelerate sterile production.
The solution integrates robotics, advanced magnetic transport, and Grade A containment (oRABS or isolator) into a single, compact filling line, ensuring high sterility assurance, process repeatability, and production flexibility for liquid sterile products.
FLEXLINE RF-ST is designed to support modern aseptic manufacturing with a strong focus on flexibility, sterility assurance and rapid validation. The line is capable of handling RTU vials (tubs or trays), syringes and cartridges, managing plungers, serum or lyo stoppers and push-fit caps within the same configuration.
Thanks to SuperTrak™ magnetic conveyance, containers are transported without glass-to-glass contact, reducing the risk of particulate generation and mechanical stress. A fully robotic architecture, combined with fast format changeover and a unified SCADA/HMI for filler and isolator, simplifies operation and significantly shortens project timelines.
The solution combines a sterile robotic filling machine with a Class A containment system (oRABS or modular isolator), ensuring laminar airflow across the entire critical process. This integrated architecture minimizes operator intervention, enhances process repeatability and significantly reduces the risk of human-related contamination.
At the core of FLEXLINE RF-ST is SuperTrak™ Conveyance, a magnetic transport platform based on linear servo motor technology. This solution enables independent shuttle control with fast and precise motion, allowing compact layouts, high productivity and reduced mechanical complexity. By eliminating traditional transfer mechanisms, SuperTrak™ improves reliability while lowering maintenance and contamination risks.
Sterility assurance is further enhanced by an isolator designed in accordance with strict cGMP and pharmaceutical standards. Grade A chambers are manufactured in AISI 316L stainless steel with mirror-bright finish, ensuring optimal cleanability and long-term integrity.
The containment system guarantees ISO Class 5 (ISO 14644-1) conditions, airtightness according to ISO 10648-2, and controlled airflow through UDAF H14 HEPA filters. Hinged tempered glass doors, inflatable gasket systems with interlocks, glove ports, integrated pressure monitoring and a layout optimized for cleaning and sterilization complete the design. The package can be equipped with state-of-the-art VPHP generators and dedicated distribution systems for effective biodecontamination.
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