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Suzhou Lingyao IV Bottle Filling-Sealing-Capping-Labeling Line GMP-Compliant Aseptic Processing

Suzhou Lingyao IV Bottle Filling-Sealing-Capping-Labeling Line GMP-Compliant Aseptic Processing

2020-06-05

Pharmaceutical-Grade Precision Meets Scalable Manufacturing Excellence

 Core Technological Advantages
 1.  Zero-Contamination Aseptic Design

  • Achieves Class A/B cleanroom compliance with laminar airflow shielding and double-layer HEPA filtration, ensuring particulate control ≤0.3μm during antibiotic/vitamin IV solution filling .
  • Patented "One-Touch" servo-driven alignment system reduces container breakage rates to <0.01% (vs. industry average 0.15%).

2.  Modular Scalability for Diverse Formats

  • Handles 50-1000ml glass/PET infusion bottles, adaptable to niche biologics (e.g., monoclonal antibody therapies) and high-volume saline solutions.
  • Quick-change toolkits enable <15-minute transitions between rubber stoppers (20mm) and flip-off caps (32mm) .

3.  Smart Traceability & Process Validation

  • Integrated MES system logs critical parameters (fill volume ±0.5-1%, capping torque 6-15N·m) for FDA 21 CFR Part 11/EU Annex 11 compliance.
  • QR-coded batch tracking from raw materials to final labeling (thermal transfer/inkjet options).

GMP Compliance & Certifications

  • Validated per EU GMP Annex 1 and PIC/S PE 009-17 guidelines, certified for cytotoxic drug production.
  • Annual revalidation reports and IQ/OQ/PQ documentation provided.

Post-Sales Service Commitment
      2-Year Comprehensive Warranty

  • Covers mechanical/electrical faults, including servo motors and PLC modules.
  • Priority 48-hour on-site response for APAC clients; 72-hour global remote diagnostics.

      Lifetime Spare Parts Guarantee

  • Maintain 10-year inventory for legacy components (e.g., filling needles).
  • Cost-effective upgrade paths from pneumatic to servo-driven capping heads.

      Predictive Maintenance Integration

  • IoT-enabled vibration/thermal sensors provide real-time wear alerts for critical assemblies (gearboxes, conveyor belts).
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Blog Details
Created with Pixso. Home Created with Pixso. Blog Created with Pixso.

Suzhou Lingyao IV Bottle Filling-Sealing-Capping-Labeling Line GMP-Compliant Aseptic Processing

Suzhou Lingyao IV Bottle Filling-Sealing-Capping-Labeling Line GMP-Compliant Aseptic Processing

2020-06-05

Pharmaceutical-Grade Precision Meets Scalable Manufacturing Excellence

 Core Technological Advantages
 1.  Zero-Contamination Aseptic Design

  • Achieves Class A/B cleanroom compliance with laminar airflow shielding and double-layer HEPA filtration, ensuring particulate control ≤0.3μm during antibiotic/vitamin IV solution filling .
  • Patented "One-Touch" servo-driven alignment system reduces container breakage rates to <0.01% (vs. industry average 0.15%).

2.  Modular Scalability for Diverse Formats

  • Handles 50-1000ml glass/PET infusion bottles, adaptable to niche biologics (e.g., monoclonal antibody therapies) and high-volume saline solutions.
  • Quick-change toolkits enable <15-minute transitions between rubber stoppers (20mm) and flip-off caps (32mm) .

3.  Smart Traceability & Process Validation

  • Integrated MES system logs critical parameters (fill volume ±0.5-1%, capping torque 6-15N·m) for FDA 21 CFR Part 11/EU Annex 11 compliance.
  • QR-coded batch tracking from raw materials to final labeling (thermal transfer/inkjet options).

GMP Compliance & Certifications

  • Validated per EU GMP Annex 1 and PIC/S PE 009-17 guidelines, certified for cytotoxic drug production.
  • Annual revalidation reports and IQ/OQ/PQ documentation provided.

Post-Sales Service Commitment
      2-Year Comprehensive Warranty

  • Covers mechanical/electrical faults, including servo motors and PLC modules.
  • Priority 48-hour on-site response for APAC clients; 72-hour global remote diagnostics.

      Lifetime Spare Parts Guarantee

  • Maintain 10-year inventory for legacy components (e.g., filling needles).
  • Cost-effective upgrade paths from pneumatic to servo-driven capping heads.

      Predictive Maintenance Integration

  • IoT-enabled vibration/thermal sensors provide real-time wear alerts for critical assemblies (gearboxes, conveyor belts).