Watch our engineers meticulously assemble and validate the 100-500ml Vial Filling Machine, designed for pharmaceutical and biotech applications requiring GMP-compliant, high-speed liquid filling.
1️⃣ Modular Assembly Process
Engineers calibrate the rotary lobe pump system (accuracy ±0.5%) for viscous solutions like vaccines or monoclonal antibodies.
Installation of 316L stainless steel contact parts to meet FDA-grade corrosion resistance and hygiene standards .
2️⃣ Critical Testing Phases
Leakage Simulation: Pressure testing nitrogen-protected stopper mechanisms to ensure airtight sealing for oxygen-sensitive biologics.
Speed Optimization: Adjusting servo-driven conveyor belts to achieve 50-70 vials/minute while maintaining fill volume consistency.
3️⃣ Quality Assurance Protocols
Engineers execute 3-stage validation:
IQ (Installation Qualification): Verify mechanical alignment.
OQ (Operational Qualification): Test automated capping torque control (5-15 N·m range).
PQ (Performance Qualification): Run 500-vial batches with colored placebo to detect deviations.
Technical Advantages Showcased:
✅ Adaptive Production: Rapid changeover between 100ml IV bags and 500ml infusion bottles via programmable HMI interface.
✅ Traceability Integration: Barcode scanner installation for batch tracking compliance with EU Annex 11 regulations.
Target Industries:
Vaccine Manufacturers: Precision filling of adjuvanted formulations.
Biologics Labs: Small-batch production of gene therapies in sterile vials.