Automatic Double Head
Prefilled Syringe Vacuum Filling Machine

Our dual-stage vacuum filling system is specifically engineered to eliminate air entrapment, which is critical for viscous products like hyaluronic acid, dermal fillers, and biological injectables.

Stage 1 - Pre-Vacuum: Before filling begins, the system creates a vacuum inside the syringe barrel, removing residual air and creating negative pressure.

Stage 2 - Bottom-Up Filling: The ceramic plunger pumps deliver liquid from the bottom of the syringe upward at a controlled rate. This allows the liquid to slowly displace the vacuum space without turbulence.

• No foaming: Eliminates the agitation that causes bubbles in traditional top-down filling.
• Prevents oxidation: Oxygen-sensitive biologics maintain potency and stability.
• Consistent dosing: Bubble-free filling ensures accurate volume measurement and uniform product quality.

This process is validated to achieve less than 0.1% air content in filled syringes, meeting the strictest pharmaceutical standards for injectable products.

Yes, our machine is universally compatible with both plastic and glass prefilled syringes from major global manufacturers. However, dedicated change parts are required for optimal performance and to prevent cross-contamination.

• Plastic syringes: BD, Gerresheimer, SCHOTT TopPac, and other COC/COP syringes (0.5ml to 20ml).
• Glass syringes: SCHOTT syriQ, BD Hypak, Gerresheimer Gx RTF syringes (0.5ml to 10ml).
• Custom formats: Non-standard syringe dimensions can be accommodated with engineered change parts.

Quick changeover design: Our modular turntable system allows format changeover in approximately 30-45 minutes with minimal tools. Each format set includes:

• Syringe nest plates (custom-fitted for each syringe geometry)
• Filling needles (optimized length and gauge for each volume)
• Stopper insertion tooling (matched to stopper specifications)
• Guide rails and positioning blocks

This versatility makes it ideal for contract manufacturers and facilities producing multiple product lines with different packaging formats.

Our modular quick-change system is designed for maximum production efficiency. Typical changeover times are:

• Same syringe brand, different volume (e.g., 1ml to 3ml): 20-30 minutes
• Different syringe brand or material (e.g., BD plastic to SCHOTT glass): 30-45 minutes
• Major format change (e.g., 1ml to 20ml): 45-60 minutes

The changeover process includes:

• Mechanical changeover: Swap nest plates, filling needles, and stopper tooling (15-20 minutes)
• HMI recipe selection: Load pre-programmed parameters for new format (2-3 minutes)
• Test run and adjustment: Verify positioning and dosing accuracy (10-15 minutes)
• Cleaning validation: CIP cycle if required for product changeover (additional 20-30 minutes)

All change parts are clearly labeled and color-coded to prevent mix-ups, and our HMI system stores unlimited format recipes with foolproof parameter recall. Training documentation is provided for your operators to achieve these changeover times consistently.

Absolutely. We specialize in turnkey syringe filling line integration, providing seamless connectivity with both upstream preparation and downstream finishing equipment.

Upstream Integration (Pre-Filling):

• Syringe denesting systems: Compatible with Bausch+Ströbel, Stevanato, and other major denester brands
• Washing/sterilization stations: Can integrate with ultrasonic cleaners or steam sterilizers
• Inspection systems: Pre-fill cosmetic and dimensional inspection integration
• Conveyor systems: Continuous or indexing conveyor interface with accumulation buffers

Downstream Integration (Post-Filling):

• Plunger rod insertion: Automatic rod feeding and pressing systems
• Tip cap application: Safety needle cap or Luer cap placement
• Inspection systems: Fill level, bubble detection, cosmetic inspection cameras
• Labeling and packaging: Integration with labelers, cartoners, and case packers

Communication & Control: All integrated equipment communicates through a central SCADA system with unified HMI control, batch tracking, and coordinated startup/shutdown sequences. This eliminates the complexity of managing multiple supplier interfaces.

Our engineering team works closely with your preferred suppliers or can recommend proven integration partners based on your specific requirements and budget.

We provide comprehensive validation support that meets the most stringent regulatory requirements for aseptic pharmaceutical manufacturing. Our documentation package is designed to expedite your regulatory submission and audit processes.

Design & Engineering Documentation:

• Design Qualification (DQ): Complete design rationale demonstrating cGMP compliance
• Risk Assessment (RA): FMEA analysis for all critical control points and failure modes
• Material traceability: Certificates for all AISI 316L contact parts and elastomer components
• Software validation: 21 CFR Part 11 compliant PLC and HMI documentation

Installation & Commissioning Support:

• Installation Qualification (IQ): Complete protocols and execution support
• Operational Qualification (OQ): Functional testing of all systems and safety interlocks
• Performance Qualification (PQ): Process capability studies with your actual product
• Cleaning validation: CIP/SIP cycle development and bacterial challenge testing

Ongoing Compliance Support:

• Training materials: GMP-compliant operator and maintenance training programs
• Change control procedures: Documentation templates for future modifications
• Audit support: Our validation specialists can participate in regulatory inspections
• Annual reviews: Periodic system assessments to maintain validation status

All documentation follows ICH Q7, FDA Guidance for Industry, and EMA guidelines. Our validation team has successfully supported over 50 regulatory inspections worldwide, with zero major observations related to equipment validation.