How to Select the Right Vial Filling Machine for Pharmaceutical Production

1. Functionality & Application Scope
   • Core Process Integration: Prioritize machines with integrated washing-drying-filling-stoppering capabilities (e.g., LYKGF model) to minimize contamination risks and streamline workflows.
   • Material Compatibility: Ensure compatibility with 2-30ml vials (common for injectables like vaccines, biologics, and insulin).
2. Technical Specifications
   • Filling Accuracy: Opt for systems with ±0.5% volumetric precision, critical for high-value APIs (Active Pharmaceutical Ingredients).
   • Sterility Assurance:
     • Class 100 cleanroom compatibility (HEPA filtration).
     • Dry heat sterilization up to 300°C for endotoxin-free production.
3. Machine Configuration
   • Automation Level:
     • PLC control systems (e.g., Siemens SIMATIC S7-200) for programmable batch adjustments.
     • Touchscreen HMIs (e.g., SMART 700 IE V3) for real-time monitoring.
   • Critical Components:
     • Peristaltic pumps (easy cleaning, low cross-contamination).
     • Stainless-steel contact surfaces (GMP-compliant, corrosion-resistant).
4. Capacity & Scalability
   • Output Range: Machines handling 6,000-26,000 vials/hour (adjustable via frequency converters like SINAMICS V20).
   • Modular Design: Support for rapid changeover between vial sizes (e.g., 2ml to 30ml) to accommodate multi-product facilities.

Cleanroom & Facility Layout Considerations

1. Workspace Optimization
   • Zoning: Separate personnel/equipment flow paths to minimize particulate contamination.
   • Equipment Placement:
     • Position filling lines in ISO Class 5/7 areas with unidirectional airflow.
     • Dedicate adjacent zones for vial sterilization (ultrasonic cleaning) and post-filling QC.
2. Regulatory Compliance
   • GMP Alignment: Validate systems per 21 CFR Part 11 (electronic records) and Annex 1 guidelines.
   • Traceability: Integrate QR code/barcode tracking from raw materials to finished vials.

Recommended Configuration (Case Study)

Model: LYKXGF2-30 Vial Washing-Drying-Filling-Stoppering Line

• Components:
  • Siemens PLC & HMI for automated batch control.
  • Dry heat tunnel (300°C) + ultrasonic washer for vial prep.
  • Peristaltic pumps with 316L stainless-steel fittings.
• Performance:
  • 98% uptime in 24/7 biologic production.
  • Validated for viral clearance (SAL ≤10⁻⁶).