High-Precision Pre-filled Syringe Filling Machines

A pre-filled syringe (PFS) filling machine is automated fill-finish equipment that doses a precise liquid or viscous drug directly into ready-to-use glass or plastic syringes, then inserts the plunger stopper. HIJ builds cGMP-ready PFS systems from 1,800 to 7,200 syringes per hour, using servo-pump dosing for high-viscosity biologics or vacuum stoppering for bubble-free, oxygen-sensitive products, with ±1% dosing accuracy and Grade A / ISO 5 laminar-flow protection.

Servo-pump filling uses direct liquid displacement with high-precision peristaltic or rotary-piston pumps, making it best for high-viscosity products such as hyaluronic acid, sensitive biologics, and larger volumes. Vacuum piston-stoppering evacuates the syringe barrel so liquid is drawn in and the stopper is placed under vacuum, which eliminates air bubbles and is ideal for oxygen-sensitive, low-viscosity aqueous solutions. For maximum flexibility, especially in R&D, we often recommend servo-pump systems; for high-speed dedicated production of low-viscosity products, vacuum filling is highly efficient.

Sterility assurance is built into our designs to a cGMP-ready standard. The filling and stoppering area is protected by Grade A (ISO 5) unidirectional HEPA-filtered laminar air flow. Machines are designed for integration with Restricted Access Barrier Systems (RABS) and full isolators. All product-contact parts are 316L stainless steel, electropolished for a crevice-free finish, and optional automated CIP/SIP systems clean the fluid path. Because the process is fully automated from nest loading to syringe discharge, human intervention — the primary source of contamination — is eliminated.

Yes. Our systems are engineered for rapid, tool-free changeover between different syringe types and sizes. Quick-change format parts — nest holders and gripper heads — can be swapped in under 30 minutes without special tools, and all movements are recipe-controlled via the HMI, so switching from a 1 ml glass syringe to a 5 ml COP syringe means loading the correct saved recipe. Optional universal grippers handle a range of syringe diameters with minimal adjustment. Provide datasheets for every format you plan to run and we deliver a qualified set of change parts with the machine.

Single-head HIJ syringe filling lines run up to 3,600 syringes per hour, while double-head (dual-lane) systems reach up to 7,200 syringes per hour. Vacuum filling and plugging systems run up to 2,400 pcs/hr for sensitive biologics. Actual throughput depends on syringe size, fill volume, and product viscosity; all models hold a filling accuracy of ≤ ±1% across a 0.5–50 ml range.

A standard single-machine pre-filled syringe filling system typically ships in 60–90 days after design sign-off. A complete integrated turnkey line — denesting, filling, stoppering, plunger-rod insertion, and labeling — generally runs 120–180 days depending on configuration, format parts, and validation documentation scope. We confirm an exact schedule against your URS before the order is placed.

HIJ provides a full documentation package to support qualification, including Design Qualification (DQ) drawings, Installation Qualification (IQ) and Operational Qualification (OQ) protocols and templates, material and component certificates, and Factory Acceptance Test (FAT) support. Execution of IQ/OQ/PQ and overall process validation on your site remains your responsibility per GMP, and our engineers support you remotely or on-site throughout.

HIJ pre-filled syringe filling machines are engineered to a cGMP-ready standard and are CE-marked, built under an ISO 9001 manufacturing standard. Sterility protection follows Grade A / ISO 5 laminar-flow principles aligned with EU GMP Annex 1, and product-contact surfaces are 316L stainless steel. HIJ supplies the documentation needed to support your GMP qualification; final validation and certification of the installed line remain the customer's responsibility.