Aseptic Prefilled Syringe Vacuum Filling Machine for Bubble-Free Performance

The HIJ PFV-800 is equipped with a high-performance vacuum system capable of achieving -0.08 to -0.095 MPa (-800 to -950 mbar), which is the optimal range for aseptic prefilled syringe applications.

This vacuum level is critical for three key reasons:

• Eliminates air bubbles in viscous products: High-viscosity liquids like hyaluronic acid gels (20,000-30,000 cP) tend to trap air during conventional filling. The vacuum drawn during the fill cycle ensures complete air evacuation, resulting in a perfectly bubble-free product.
• Prevents stopper rebound ("pop-up"): The vacuum is maintained in the syringe headspace during stoppering. This creates negative pressure that holds the stopper firmly on the liquid surface, eliminating the common problem of stopper displacement caused by trapped air expansion.
• Protects oxygen-sensitive biologics: For biopharmaceuticals, vaccines, and other oxygen-labile formulations, removing oxygen from the headspace is essential to prevent degradation and extend shelf life. Our vacuum system reduces headspace oxygen to less than 2%, meeting the strictest stability requirements.

The vacuum pump is an external oil-free rotary vane unit with a dedicated filtration system to maintain cleanroom air quality. It's designed for continuous operation in aseptic environments and complies with cGMP maintenance protocols.

No, changeover is surprisingly simple thanks to our modular tooling system. The HIJ PFV-800 can be reconfigured for different syringe sizes in less than 30 minutes by a single operator, without requiring specialized tools.

The changeover process involves three main steps:

• Replace the format parts: Swap out the syringe nest trays, filling needles, and stopper placement tooling. All parts are color-coded by size (0.5ml, 1ml, 2.25ml, 3ml, 5ml, 10ml, 20ml) and designed for quick-release installation.
• Adjust the star wheel spacing: The turntable star wheel is servo-controlled and can be automatically adjusted via the HMI touchscreen. Simply select the new syringe size from the recipe menu, and the machine recalibrates itself.
• Update the recipe in the PLC: Load the pre-validated recipe for the new size, which automatically adjusts fill volume, vacuum timing, stopper insertion depth, and cycle speed.

Supported syringe formats include:

• Plastic SCF syringes from BD, Gerresheimer, Schott, and DATWYLER
• Glass Type I prefilled syringes (custom tooling available)
• Both luer-lock and luer-slip configurations

For Contract Development and Manufacturing Organizations (CDMOs) that frequently switch between products, we offer a complete changeover kit with all format parts pre-sterilized and ready for installation, minimizing downtime between batches.

Absolutely. The HIJ PFV-800 is specifically designed for aseptic processing environments and can be seamlessly integrated into:

• ISO Class 5 (Class 100) cleanrooms: The machine's compact footprint (808mm x 758mm) and smooth, crevice-free stainless steel construction make it ideal for high-grade cleanroom installation. Optional HEPA-filtered laminar airflow (LAF) hoods can be mounted directly over the filling and stoppering zones to provide Grade A (ISO 5) air quality at critical points.
• RABS (Restricted Access Barrier Systems): The machine can be operated via the external HMI touchscreen through the RABS glove ports. All routine operations (loading syringes, stopper replenishment, product changeover) are designed for execution within the barrier system.
• Isolators (cGMP-compliant aseptic isolators): For the highest level of sterility assurance, we offer an isolator-compatible version of the PFV-800 with specialized features including:
  • Pass-through integration for syringe and stopper transfer
  • Stainless steel panels with large radii (no sharp corners) to facilitate VHP/H₂O₂ sterilization
  • Remote diagnostics and monitoring to minimize interventions inside the isolator
  • Full compliance with ISO 14644 and Annex 1 of EU GMP guidelines

Our engineering team will work with your facility design consultants during the FAT phase to ensure seamless integration, including utilities routing, pressure differentials, and airflow patterns.

We provide a complete validation package that meets FDA, EMA, and WHO GMP requirements. Our documentation is designed to accelerate your validation timeline and ensure audit readiness from day one.

Your documentation package includes:

• Design Qualification (DQ): A comprehensive document explaining how the machine's design features (SS316L contact parts, crevice-free construction, servo-driven precision) support cGMP principles and your User Requirements Specification (URS).
• Factory Acceptance Test (FAT) Protocol & Report: Witnessed testing at our facility to verify that the machine meets all functional and performance specifications before shipment. Includes fill weight accuracy studies, vacuum level verification, and stopper placement consistency tests.
• Installation Qualification (IQ) Protocol: Step-by-step procedures for verifying correct installation, including equipment ID, utility connections, calibration of sensors, and safety system checks. Pre-formatted for easy execution at your site.
• Operational Qualification (OQ) Protocol: Test procedures to confirm that all operational parameters (fill accuracy, cycle speed, alarm functions, vacuum performance) meet specifications across the full operating range.
• Material Certificates & Compliance Documents:
  • AISI 316L material certificates for all product-contact parts
  • CE certification for electrical safety
  • ATEX certification (optional, for explosive atmospheres)
  • FDA Drug Master File (DMF) references for ceramic pump components
• Software Validation Documents (21 CFR Part 11 ready): For the Siemens PLC control system, we provide:
  • Software design specifications
  • Source code review documentation
  • Audit trail configuration guide (user login, batch records, change logs)
  • Data integrity validation report
• Preventive Maintenance (PM) Schedule & SOPs: Detailed maintenance procedures and recommended spare parts lists to ensure long-term compliance.

All documents are provided in editable MS Word format and can be customized to align with your company's validation templates and regulatory requirements.

For the HIJ PFV-800 vacuum syringe filling machine, our standard lead times are:

• Standard configuration: 8-10 weeks from order confirmation and deposit receipt. This includes a single syringe size format (e.g., 1ml or 3ml) and standard voltage (380V/220V, 50Hz/60Hz).
• Custom configuration: 12-14 weeks. Custom projects may include:
  • Integration with automatic syringe denesting machines
  • Isolator-compatible design with pass-through systems
  • Multi-format changeover kits for 2-3 syringe sizes
  • ATEX-certified explosion-proof version for solvent-based products
  • Integration with existing filling lines or downstream inspection systems

What's included in the lead time:

• Engineering review of your URS: We'll schedule a technical kick-off meeting to review your specific product properties (viscosity, pH, temperature sensitivity) and process requirements.
• Manufacturing & in-process quality control: All critical dimensions and performance parameters are verified at multiple stages during assembly.
• Factory Acceptance Test (FAT): You or your representative are invited to witness a full-cycle performance test at our facility. We can also conduct a remote FAT via live video if travel is not feasible.
• Complete documentation package: As outlined in Q4 above, all IQ/OQ protocols, material certificates, and operation manuals.
• Professional packaging & logistics: The machine is securely crated for international shipping, with proper humidity control and shock absorption to ensure it arrives in perfect condition.

We understand that project timelines can be critical. For urgent requirements, we offer an expedited production service with a lead time of 6-7 weeks (surcharge applies). Contact our project management team to discuss your specific deadline.

Post-delivery support: Our global service network can provide on-site installation, IQ/OQ execution, operator training, and ongoing technical support to ensure your project stays on schedule.