The TOSEI FS-X from Japan is a multi-functional benchtop aseptic filling device designed for biotechnology and pharmaceutical R&D, cell and gene therapy (CGT), ADC, and preclinical and clinical Phase I/II sample production. Addressing the diverse dosage form requirements at each development stage, the FS-X features a modular, tool-free, quick-release design, achieving high flexibility by being compatible with three types of containers in one device. It can also be seamlessly integrated into isolators, biosafety cabinets (BSCs), or aseptic laminar flow systems.

I. Three-container compatibility and high-precision anti-drip metering support switching between three container types: Vial (2–20 mL), Syringe (0.5–3 mL), and Cartridge (1.5–3 mL), with filling accuracy up to ±0.5%. Automatic micro-absorption after filling prevents needle leakage and contamination.

II. During programmable bottom-up filling, the filling needle can move up and down smoothly and synchronously with the liquid level, precisely controlling the shear force and completely eliminating foaming and splashing.

III. Single manual operation and error prevention detection: Provides a single manual operation mode and has a photoelectric error prevention mechanism of "no filling without container" to prevent loss of precious medicine.

IV. 100% IPC Online Dynamic Checkweighing (Optional) Optional 100% IPC dynamic weighing system to realize real-time differential checkweighing before and after filling and real-time data monitoring and compensation.

VI. Computerized Compliance and Validation Support: The industrial-grade PLC touch interface complies with IEC 61131-3 and PLCopen specifications, FDA 21 CFR Part 11 and GAMP 5, and provides complete DQ/IQ/OQ validation documentation and PQ support.

Equipment Introduction

• 3-in-1 Multi-Container Compatibility and Quick Module Replacement

  • A single device can accommodate three commonly used sterile container types: Vial (2–20 mL), Syringe (0.5–3 mL), and Cartridge (1.5–3 mL).

  • The tool-less/quick-release modular fixture design allows for rapid changeover of different container specifications in a very short time, making it particularly suitable for multi-pipeline R&D and small-batch process switching.

• High-precision servo-driven dosing and suck-back anti-drip technology.

  • It adopts a high-performance precision servo peristaltic pump, with a filling accuracy of up to ±0.5% (based on 1 mL of water for injection WFI).

  • It features a precise micro-suck-back function, which cleanly cuts off the liquid column at the moment of filling, preventing residual liquid dripping from the needle and contamination of the bottle mouth sealing area.

  • The flow path uses a single-use piping configuration to completely eliminate batch cross-contamination and simplify cleaning verification.

• Programmable Bottom-Up Diving Nozzle

  • During the injection process, the filling needle can rise steadily and synchronously with the liquid level, precisely controlling the shear force and completely eliminating foaming and droplet splashing phenomena during the dispensing of high-protein, antibody, or highly active drug solutions.

• Single Manual Operation & "No Container, No Fill" Automatic Error Prevention Sensor

  • Intuitive, one-time manual operation mode designed specifically for small-batch, high-value sample packaging and testing.

  • It comes standard with a high-sensitivity photocapacitor detection system and features a "No Container, No Fill" safety interlock mechanism to prevent the waste of precious medications due to misoperation.

• Optional 100% In-Process Control Weighing online dynamic checkweighing system

  • Optional high-precision IPC dynamic electronic weighing module enables 100% real-time differential weighing before and after repackaging and real-time data feedback compensation, ensuring that the filling volume of each container meets the specifications.

• Pharmacopeia-grade sanitary materials are highly compatible with sterile environments.

  • The materials used for pharmaceutical contact surfaces strictly comply with SUS316L, pharmaceutical-grade silicone rubber, UHPE, and PTFE standards, and fully comply with USP Class VI specifications.

  • The hygienic, no-dead-angle structural design allows the entire machine to withstand VHP (vaporized hydrogen peroxide) sterilization and high-concentration IPA wiping; the compact body (L490 × W810 × H675 mm, 62 kg) is perfectly compatible with Grade A isolators and laminar flow cabinets.

• Computerized System Compliance & Validation Support

  • The control core complies with IEC 61131-3 and PLCopen international program standards.

  • It supports multi-formula memory storage and multi-level access control, and complies with FDA 21 CFR Part 11, GAMP 5 and ALCOA+ data integrity requirements.

  • The manufacturer provides a complete suite of DQ, IQ, and OQ verification documents and PQ on-site verification technology support.