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  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
  • Pre-filled Syringe Vacuum Filling & Stoppering Production Line
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Pre-filled Syringe Vacuum Filling & Stoppering Production Line

Leggenda specializes in pre-filled syringe vacuum filling technology, presenting this series of high-end Pre-filled Syringe Vacuum Filling & Stoppering Machines for small-volume injectables. Engineered for high-value and high-viscosity formulations, this series is suitable for​ biologics, vaccines, and a wide range of aesthetic injectables—including Hyaluronic Acid, Collagen, PLLA microspheres, cross-linked gels, skin boosters, Calcium Hydroxylapatite, and PDRN (salmon DNA) solutions. Accommodating syringe sizes from 1 mL (slender type) to 20 mL, the machines support diverse clinical and commercial manufacturing requirements.

Integrating precision metering, automated stoppering, and synchronized transfer, the equipment is designed to help maintain container closure integrity throughout the process. Utilizing full servo-drive systems with high-precision ceramic piston pumps, the machines deliver consistent performance under defined operating conditions. Product-contact parts are constructed from SUS316L stainless steel, with material selection and finishing referenced against recognized standards for Extractables and Leachables (E&L) evaluations.

The line is compatible with pre-filled syringes, cartridges, and vials. The design aligns with GMP guidelines, and relevant control strategies take into account​ expectations related to FDA regulations. Drawing on proven process expertise, We provides tailored solutions based on specific production scales, product rheology, container formats, and facility layouts.

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Description

During manufacture of high-value biologics and aesthetic injectables, entrapped microbubbles degrade dosing precision and may induce protein denaturation, posing safety risks for injectable administration. To overcome this filling difficulties, Leggenda Technology has developed the Pre-Filled Syringe Vacuum Filling & Stoppering Line. Utilizing precision vacuum filling processes, this system delivers safe, controllable and automated manufacturing solutions for high-value pharmaceuticals.

The Pre-Filled Syringe Vacuum Filling & Stoppering Line features an integrated filling and stoppering design. A negative-pressure atmosphere within the filling chamber enables bubble-free filling. Equipped with fully servo-driven ceramic metering pumps, the system delivers stable volumetric filling. Its wear-resistant construction accommodates materials ranging from low-viscosity aqueous solutions to high-viscosity cross-linked gels, and is compatible with pre-filled syringes, cartridges and vials.

The overall equipment layout is engineered in accordance with cGMP requirements. it supports customized standalone units or full turnkey production lines.

1. Bubble-free Filling

Implementation of a controlled vacuum environment during the filling process evacuates microbubbles and realize bubble-free filling.

2. Precision Dosing

Fully servo-driven ceramic pumps to support continuous production covering low-viscosity aqueous solutions through high-viscosity cross-linked gels. It maintains stable volumetric metering under preset operating conditions, delivering filling precision up to ±0.5%.

3. Strict aseptic process control

All phases-from process design and wetted components to material feeding, filling and finished product discharging-adopt full aseptic control to keep a clean & contamination-free production environment, complying with pharmacopoeia specifications.

4. Broad Container Compatibility

The platform supports multiple primary packaging formats—including pre-filled syringes (PFS), cartridges, and vials—with quick-change capabilities covering volumes from 0.2 mL to 20 mL. The incorporation of Nest & Tub infeed systems significantly reduces the frequency of operator handling, mitigating contamination risks during aseptic processing.

5. Compliance-Oriented Design

Engineered in accordance with cGMP principles, the system utilizes SUS316L stainless steel and medical-grade polymeric materials for all product-contact surfaces. Design and material qualification align with stringent Extractables and Leachables (E&L) assessment protocols, supporting seamless regulatory compliance and inspection preparedness.

6. Tailored Solutions

Drawing upon deep process know-how, customized solutions are engineered to address specific client needs, encompassing material rheology, capacity planning, and facility layout. Proposals span from individual equipment configuration to comprehensive turnkey line integration, ensuring alignment with both technical and regulatory expectations.




FAQ

  • What products are your filling lines designed for?

    We offer two dedicated lines: Vacuum Filling Lines for small-volume sterile injectables (0.2–20 mL), including biologics, vaccines, and aesthetic formulations (HA series, PDRN, collagen, Gel, PLLA, Hydroxyapatite, Cross‑linked products, Mesotherapy injectable series, etc.), and Catheter Flush Syringe Lines for high-throughput production of saline and heparin flush syringes. For specific formulation compatibility.

  • Are your machines GMP and FDA compliant?

    All equipment is designed in compliance with GMP specifications and can be implemented with reference to relevant FDA general standards. Our quality management system is certified to ISO 9001 and CE. We provide complete documentation support to assist customers in completing the validation procedures.

  • Can you customize lines for our facility?

    Yes. Our modular lines support adjustable head counts, multiple container formats (PFS, cartridges, vials), and flexible layouts (linear, L-shape, U-shape) to fit your cleanroom.

  • What is the typical lead time?

    Standard lead time ranges from 16 to 28 weeks depending on configuration and current order backlog. Expedited options may be discussed for urgent projects.

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About Us
Leggenda (Shanghai) Technology Co., Ltd.

Leggenda (Shanghai) Technology Co., Ltd. was founded in 2019 and is headquartered in Shanghai. It is a supplier of automated pharmaceutical equipment systems and related services, serving pharmaceutical enterprises with products including small-volume pre-filled water syringes.

With a mission to deliver professional services for the pharmaceutical industry, Leggenda Technology prioritizes quality-driven development. Through continuous innovation, it safeguards pharmaceutical production with safer, greener and more advanced professional technologies.

The company consistently upholds the product philosophy of technological innovation and quality first, and attaches great importance to talent training and development. It keeps increasing R&D investment for new products. Within just a few years, the company has filed for and obtained multiple patents. It has finished the product development of high-speed production lines for pre-filled flush syringes, delivering high-speed and turnkey solutions for numerous clients. We are a pioneer in the technical field of vacuum filling and vacuum stoppering for high-viscosity products.

In response to the rapid growth of the pharmaceutical industry and the complex, unique features of production processes, the company vigorously develops core products and concentrates on the R&D of syringe filling equipment. At present, technical staff account for approximately 80% of its total workforce. Most are design and technical engineers with over 10 years of hands-on experience in the pharmaceutical equipment sector.

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