Key points for quality control in the one-time forming of liquid bag welding and cutting

Through a single-step forming process, pharmaceutical manufacturers can upgrade liquid bag production from "pass rate control" to "zero-defect manufacturing," providing more reliable packaging assurance for drug safety and clinical efficacy.

Key Quality Control Points

1. Online Inspection Systems

   • Weld Strength Monitoring:
     Integrated laser rangefinders perform real-time weld width measurements. Abnormal readings trigger automatic alarms and shutdowns.
   • Leak Testing:
     100% leak detection per product using negative pressure methods (e.g., -80 kPa for 30 seconds) or tracer gas methods.
   • Cutting Dimension Verification:
     Machine vision systems compare actual cut lines with preset templates. Out-of-tolerance deviations trigger automatic marking and isolation.

2. Process Validation

   • Accelerated Aging Tests:
     Simulate 3-year storage conditions (40°C ±2°C, 75% ±5% humidity) to ensure weld strength attenuation ≤15%.
   • Transport Vibration Testing:
     Conduct vibration and impact testing per ISTA 3A standards to ensure weld integrity under simulated transportation shocks.

Case Studies

• A Multinational Pharmaceutical Company:
  Adopted the single-step forming process for insulin liquid bags, reducing weld leakage rates from 0.3% to 0.005%, enabling compliance with EU and US regulatory requirements.
• A Domestic Blood Products Manufacturer:
  Optimized welding frequency and pressure parameters to enhance albumin liquid bag weld pressure resistance to 0.5 MPa (vs. 0.3 MPa for traditional processes), meeting high-pressure clinical infusion demands.