Aseptic Double Head
Prefilled Syringe Vacuum Filling Machine
(cGMP Compliant)

The HIJ-PFS-2 is specifically engineered to handle high-viscosity injectables (up to 500 cP) that challenge conventional filling systems. Our solution combines three critical technologies:

• Ceramic plunger pumps: Unlike stainless steel pistons, our ceramic pumps eliminate scoring and wear even with abrasive or sticky formulations. They maintain accuracy over millions of cycles.
• Vacuum-assisted filling: The filling chamber is evacuated to 6×10⁻² Pa before product entry. This vacuum eliminates air resistance, allowing viscous liquids to flow freely into the syringe barrel without cavitation or foaming.
• "Bottom-up" nozzle design: The fill nozzle enters from the bottom of the syringe and rises with the liquid level. This prevents splashing and ensures complete air displacement, critical for bubble-free hyaluronic acid or PRP formulations.

During your Factory Acceptance Test (FAT), we'll run your actual product formulation to validate performance before shipment. We can also adjust pump stroke length and vacuum duration to optimize for your specific viscosity profile.

Format changeover is completed in under 20 minutes by a single operator, thanks to our tool-free modular design. Here's what the process involves:

• Nest holders and guides (5 minutes): Quick-release clamps allow you to swap the syringe nest holder and positioning guides without any tools. Each format has color-coded parts for foolproof identification.
• Fill nozzle set (3 minutes): Bayonet-mount nozzles are removed and replaced in seconds. We provide dedicated nozzle sets for each syringe diameter to ensure precise centering.
• Stopper placement tooling (5 minutes): The vacuum stoppering head is adjusted via calibrated hand wheels. No disassembly required.
• Recipe selection on HMI (2 minutes): Load the pre-saved recipe for the new format from the Siemens touchscreen. All parameters (fill volume, vacuum duration, servo speeds) are automatically recalled.
• Test run and adjustment (5 minutes): Run 10-20 test units to verify accuracy and make minor pneumatic pressure tweaks if needed.

We provide a complete Change Parts Kit for each additional syringe size you specify. During installation training, our engineer will walk your team through the entire changeover procedure to ensure they're confident and efficient.

Yes, the HIJ-PFS-2 is RABS-ready and isolator-compatible by design. We've worked with clients to integrate our filler into Grade A/B aseptic environments globally. Here's how we support your containment strategy:

• Compact footprint (1020mm × 840mm): The machine's small size allows it to fit inside standard isolator enclosures or RABS housings.
• Side-access control panel: All HMI touchscreen controls and electrical interfaces are positioned for external access, so operators don't breach the barrier during production.
• Sealed servo motors: All drive motors are IP65-rated and sealed against H₂O₂ or other sterilants used in isolator decontamination cycles.
• Integrated glove ports: We can add custom glove port flanges for manual interventions (e.g., jam clearance) without breaking isolator integrity.
• Optional VHP-resistant coatings: For isolators using vaporized hydrogen peroxide, we apply specialized coatings to prevent material degradation.

If you're planning RABS/isolator integration, please share your containment system specifications during the URS phase. Our engineering team will provide a detailed integration drawing and coordinate with your isolator supplier to ensure seamless compatibility.

For the HIJ-PFS-2, our standard project timeline from order to commissioning is 12-14 weeks. Here's a detailed breakdown:

• Weeks 1-2 (URS finalization): After deposit, we review your User Requirements Specification and finalize the technical configuration (syringe formats, voltage, optional features like laminar flow hood).
• Weeks 3-8 (Manufacturing): Precision machining, assembly, and integration of electrical/pneumatic systems. We provide weekly photo updates of production progress.
• Week 9 (FAT preparation): Internal testing and calibration. We run performance qualification with reference materials.
• Week 10 (Factory Acceptance Test): You or your representative witness the FAT at our facility (or via live video link). We test with your actual product if you ship samples in advance.
• Week 11 (Documentation & Packaging): Finalize IQ/OQ/PQ protocols, user manuals, and spare parts inventory. Professional export packaging with anti-vibration crating.
• Week 12 (Shipping): Air or sea freight depending on your urgency. Average sea freight to EU/US East Coast is 4-5 weeks; air freight is 5-7 days.
• Weeks 13-14 (Installation & SAT): Our service engineer travels to your site for installation, training, and Site Acceptance Test.

We handle all export compliance (CE certification, customs documentation, fumigation certificates). You'll receive tracking updates at every milestone. Your project manager is available 24/7 via WhatsApp during the critical shipping and installation phases.

The HIJ-PFS-2 features semi-automated nest loading, which is the optimal balance between aseptic safety and capital investment for mid-scale production. Here's how it works:

• Manual nest preparation (outside the barrier): An operator removes the protective film from the pre-sterilized syringe nest (tub) and places it on the loading conveyor. This step occurs in the Grade B/C environment, minimizing exposure to the critical Grade A zone.
• Automated denesting and feeding: Once the nest enters the machine, servo-driven pick-and-place mechanisms automatically extract individual syringes and load them onto the filling turntable. No human hands touch the syringes after they enter the Grade A zone.
• Vision inspection (optional): We can integrate a camera system that rejects improperly oriented syringes or detects contamination before filling.
• "No syringe, no fill" sensor: If a position on the turntable is empty (due to denesting failure), the filling nozzle will not dispense, preventing product waste.

This semi-automated approach reduces operator intervention by 80% compared to manual loading, while keeping the system accessible and cost-effective. During your site visit or FAT, we'll demonstrate the entire loading sequence and discuss automation upgrades based on your production scale.