The FS-V features a highly compact body structure and top-tier pharmacopoeia-grade hygienic design, allowing for seamless installation within sterile isolators (such as TOSEI ISO-100), biosafety cabinets (BSCs), or laminar flow hoods. The device integrates a highly sensitive servo peristaltic pump system and a programmable needle lifting and dispensing mechanism, ensuring precise micro-volume filling (accuracy up to ±0.5%) while completely eliminating foaming during dispensing and needle residue issues, fully meeting the stringent requirements of GMP Grade A cleanrooms for particle control and aseptic assurance.

I. High-precision servo metering and anti-drip backflow support 2–20 mL (2R–20R), filling accuracy up to ±0.5%, automatic micro-backflow after injection, eliminating needle dripping and contamination.

II. Programmable bottom-up injection: The needle rises smoothly and synchronously with the liquid level, precisely controlling the shear force and completely eliminating foaming and splashing.

III. Dual operating modes and error-proof sensing provide single manual and automatic cycle modes (up to 10 bottles per cycle), and have a "no bottle, no filling" photoelectric error-proof mechanism.

IV. Pharmacopoeia-grade materials and sterilization-resistant design: The contact surfaces are made of SUS316L and USP Class VI silicone tubing. The body is resistant to VHP vaporized hydrogen peroxide sterilization and IPA wiping, meeting Grade A cleanliness requirements.

V. Computerized Compliance and Validation Support: The industrial-grade PLC touch interface supports multiple formulation management, complies with FDA 21 CFR Part 11 and GAMP 5, and provides complete IQ/OQ validation documentation.

Equipment Introduction

• High-Precision Servo Peristaltic Dosing System

  • It adopts a high-performance servo-driven precision peristaltic pump, with a filling accuracy of up to ±0.5% (based on 1 mL of water for injection WFI), ensuring high consistency between micro-volume and expensive drug solutions.

  • Designed specifically for 2–20 mL (2R–20R) standard vials, the flow path features a disposable/single-use tubing configuration, completely eliminating the risk of cross-contamination and significantly simplifying the cleaning and confirmation process.

• Intelligent Bottom-Up Diving Nozzle & Suck-Back Anti-Drip Mechanism

  • During the filling process, the injection needle can move synchronously up and down with the liquid level, effectively suppressing foaming and droplet splashing in prescriptions containing high-protein, antibody, or surfactant ingredients.

  • It features a precise micro-suck-back function that instantly cuts off the liquid column and eliminates any drips upon completion of the injection, ensuring a clean sealing surface at the vial neck and preventing any impact on the quality of subsequent capping and sealing.

• Flexible Dual-Mode Operation & Container Detection

  • It supports both "single manual mode" and "single automatic cycle mode" (up to 10 bottles can be filled continuously per cycle), taking into account the flexibility of small-batch R&D and the needs of semi-automatic continuous production.

  • It comes standard with a high-sensitivity photocapacitor detection system and features a "No Vial, No Fill" safety interlock mechanism to prevent accidental triggering that could lead to waste of the medication or contamination of the machine.

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

  • All pharmaceutical contact parts comply with SUS316L, pharmaceutical grade silicone rubber, UHPE and PTFE standards, and are fully compliant with USP Class VI specifications.

  • The structure and appearance feature a hygienic design with no blind spots, fully resistant to VHP (vaporized hydrogen peroxide) sterilization and high-concentration IPA wiping; the compact body (L483 × W810 × H675 mm) can be directly integrated into ISO-100 (Grade A) isolators, biosafety cabinets (BSC) or clean benches for operation.

• Industrial-grade control systems and regulatory compliance architecture (Industrial PLC Control & Data Integrity Compliance)

  • The control core complies with IEC 61131-3 and PLCopen international program standards, and is stable, reliable, and easy to maintain.

  • The computerized system complies with FDA 21 CFR Part 11, GAMP 5 and ALCOA+ data integrity requirements, and supports complete formula management and multi-level access control.

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