The FSC FLEX30 is a desktop, fully automated aseptic filling and capping platform designed for biotechnology and pharmaceutical R&D, cell and gene therapy (CGT), ADC, clinical trial batches (Phase I/II/III), and high-value small-batch production. Addressing the needs for small-volume, diverse, and multi-dosage flexible filling, the FLEX30 features a modular, quick-release design, completing the three main processes of "fully automated filling, capping, and sealing" on a single, compact platform. It can be seamlessly integrated into aseptic isolators, biosafety cabinets (BSCs), or aseptic laminar flow systems.

I. Three-dosage compatibility and integrated operation compatibility: RTU vials (2–10 mL), pre-filled syringes (0.5–10 mL) and cartridges (1.5–3 mL) can complete the entire process of filling, capping and sealing in a single machine.

II. High-precision metering and bottom-lift injection: optional disposable peristaltic pump or ceramic/SUS316L piston pump (accuracy ±0.5%), with synchronous bottom-lift injection and anti-drip and anti-foaming design.

III. Multifunctional stopper and servo capping supports full stopper insertion for vials, freeze-dried half stoppers, and syringe piston insertion; servo control precisely monitors cap torque and height, eliminating the generation of metal aluminum shavings.

IV. Production efficiency and quick changeover: Production capacity up to 16 pcs/min (12 pcs/min for cartridges); modular snap-on quick-release design enables tool-free quick specification switching and cleaning.

V. The streamlined, dead-angle-free body integrates sterile protection and isolators, is compatible with ISO Class 5 / Grade A vertical unidirectional flow, and can be directly integrated into Isolators / RABS / BSCs. The entire machine is resistant to VHP and IPA sterilization.

VI. Computerized compliance and complete validation include audit tracking and electronic signatures, comply with FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5, and provide complete DQ/IQ/OQ/PQ validation documentation.

Equipment Introduction

• 3-in-1 RTU Multi-Container Compatibility

  • A single device can accommodate three commonly used sterile container types: RTU (ready-to-use) vials (2-10 mL), pre-filled and pre-sealed syringes (0.5-10 mL), and cartridges/pen refills (1.5-3 mL).

  • Designed specifically for laboratories to upgrade from R&D to more efficient small-batch manufacturing processes, it can quickly switch between different specification modules to meet the needs of multi-pipeline R&D and flexible production.

• Integrated Automated Filling, Stoppering & Capping

  • The integrated system continuously completes the entire process of "fully automated filling → automatic plugging/insertion → automatic sealing/capping", significantly reducing the risk of human intervention.

  • High production capacity: up to 16 pcs/min for Vials, up to 16 pcs/min for Syringes, and up to 12 pcs/min for Cartridges.

• High-precision dosing and standard anti-drip nozzle filling system

  • Supports high-precision peristaltic pumps or piston pumps (ceramic or stainless steel optional), with filling accuracy up to ±0.5% (based on 1 mL of water for injection WFI).

  • Equipped with a precision anti-drip nozzle, it effectively prevents residual liquid from dripping from the needle tip and contamination of the bottle mouth sealing area.

• Quick-Change Capping Rollers

  • It adopts a quick-change cap roller design, which can quickly adapt to different cap types and specifications.

  • It features a stable and precise capping mechanism that effectively suppresses the generation of particles during the capping process, ensuring excellent aseptic seal integrity.

• Built-in Grade A laminar flow protection and high compatibility with sterile environments.

  • The fuselage structure has built-in Grade A laminar flow protection, which effectively maintains the cleanliness of key operating areas.

  • Flexible configuration: It can be used independently in general operating environments or seamlessly integrated into biosafety cabinets (BSCs), clean benches, or dedicated ISO-100 isolators (Grade A / ISO Class 5 chambers, compatible with VHP sterilization systems).

• Pharmacopeia-Grade Sanitary Materials with Corrosion-Resistant Design

  • The materials of the pharmaceutical contact parts strictly comply with SUS316L stainless steel and fully comply with USP Class VI specifications.

  • The sanitary-grade structural design allows the entire unit to withstand VHP (vaporized hydrogen peroxide) sterilization and high-concentration IPA wiping disinfection.

• Computerized System Compliance & Validation Support

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

  • The system complies with FDA 21 CFR Part 11 and GAMP 5 regulations, and supports formula management, multi-level access control and complete audit trail.

  • Provides a complete DQ, IQ, OQ validation document system and professional PQ support that conforms to cGMP standards.