Aseptic Vial Filling Equipment
12-Head In-Line Filler with 10-Head Crimper: High-Speed Integrated Solution for Sterile Vial Packaging
Introducing our 12-Head In-Line Filler with 10-Head Crimper, a fully integrated production system engineered as premier aseptic vial filling equipment for the high-throughput packaging of sterile injectables, vaccines, and lyophilized pharmaceuticals. This advanced line combines the precision of a 12-station in-line filler with the secure closure of a 10-head crimping station, delivering a complete automatic vial filling and stoppering machine solution in a streamlined linear layout. Designed for optimal visibility, accessibility, and speed, it provides a reliable foundation for automatic vial filling within Grade A/B cleanroom environments, ensuring uncompromising sterility assurance and container-closure integrity.
Integrated Linear Design for Aseptic Efficiency
This system is configured in a clean and efficient in-line (linear) layout, offering superior operator visibility and easier maintenance access compared to rotary systems. The process begins with the 12-head filling station, which utilizes servo-driven peristaltic or piston pump technology to deliver precise, non-contact liquid dispensing into vials. Immediately following filling, vials are transferred to the integrated 10-head crimping station, where sterile rubber stoppers are precisely seated and aluminum overseals are crimped uniformly. This seamless, synchronized flow within a single machine envelope makes it a robust automatic vial filling and stoppering machine, eliminating transfer points that pose contamination risks and optimizing production speed for critical sterile products.
Engineered for Critical Aseptic Processing
Built to meet the most stringent cGMP guidelines and the enhanced sterility requirements of EU Annex 1, this system qualifies as true aseptic vial filling equipment. Key features include:
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Hygienic Design: Constructed with 316L electropolished stainless steel, CIP/SIP capabilities, and smooth, crevice-free surfaces.
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Grade A Environment Integration: Designed for installation within isolators or Restricted Access Barrier Systems (RABS), with laminar airflow (LAF) protection over critical zones.
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Closed System Filling: Utilizes peristaltic pump technology with single-use tubing sets, ensuring absolute product isolation and preventing cross-contamination—a critical aspect of reliable automatic vial filling for potent or multi-product facilities.
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Precision Stoppering & Crimping: The crimping heads provide consistent, calibrated force to ensure every vial achieves validated container-closure integrity (CCI), which is mandatory for sterile injectables.
Core Features & Technical Advantages
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High-Speed, Linear Throughput: The 12-head filler paired with a 10-head crimper delivers high output speeds suitable for medium to large batch production, all within a compact, accessible linear footprint.
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Exceptional Filling Accuracy: Servo-controlled pumps achieve filling accuracy within ±0.5% for volumes from 0.5mL to 100mL, ensuring precise dosing.
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Automatic Stoppering & Sealing: Functions as a complete automatic vial filling and stoppering machine, automatically placing stoppers and applying tamper-evident aluminum seals in one continuous cycle.
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Rapid Changeover & Easy Maintenance: The in-line design and tool-less adjustments facilitate faster format changes and easier cleaning, reducing downtime.
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Data Integrity & Control: 21 CFR Part 11-compliant PLC with HMI provides full recipe management, electronic batch records, and comprehensive audit trails for both filling and crimping operations.
Ideal Applications
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Sterile Liquid Injectables: Vaccines, monoclonal antibodies, antibiotics, and parenteral solutions.
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Lyophilized (Freeze-Dried) Products: Integration with freeze-dryers for automated stoppering and crimping post-lyophilization.
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Ophthalmic Solutions: Sterile eye drop formulations requiring precise, aseptic packaging.
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Diagnostic Reagents: Sterile buffers, calibrators, and controls.
Your Partner in Sterile Manufacturing Excellence
We provide an end-to-end partnership for your aseptic packaging needs. Our support includes feasibility analysis, machine customization for your container-closure system, factory acceptance testing (FAT), and comprehensive on-site validation support (IQ/OQ/PQ). We ensure this aseptic vial filling equipment is fully optimized and validated for your specific product and regulatory requirements.
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