Automatic Oral Liquid & Ampoule Vial Packing Line

Our line achieves a validated output of ≥200 vials/minute for both container types, with OEE ≥85% in continuous three-shift operation. This is verified through 30-day continuous validation runs showing: Availability ≥94% (quick changeover ≤15 minutes), Performance ≥96% (maintaining speed with ≤0.5% loss), and Quality ≥99.5% (integrated inspection systems). Validation protocols include three consecutive successful runs at maximum speed with Cpk ≥1.67 for all critical parameters.

We guarantee ≤0.01% breakage rate through: Servo-controlled acceleration profiling limiting G-forces to <1.8G, Vibration damping systems with active frequency compensation, and Precision guide rails with polyurethane coatings. Our real-time monitoring system (sampling at 2kHz) automatically adjusts parameters, with validation data from 15 million units showing breakage Cpk ≥2.0.

We implement dual-technology detection: High-resolution vacuum decay (sensitivity to 3μm leaks per ASTM F2338-09) combined with visual inspection systems detecting micro-cracks ≥20μm. The system achieves ≥99.97% detection probability with false-reject rate ≤0.005%, exceeding USP <1207> requirements. All test data is 21 CFR Part 11 compliant with full audit trails.

Our three-level contamination control includes: 316L stainless steel (Ra ≤0.4μm) surfaces, Quick-disconnect components with zero product accumulation zones, and Validated CIP system achieving 4-log bioburden reduction. Cleaning validation shows residue levels <0.08 μg/cm² per EMA guidelines, with comprehensive swab testing documentation provided.

Our TCO analysis demonstrates 38% lower costs versus separate lines, with: Reduced capital investment (32% lower), 60% less facility space, 45% lower labor costs, and 35% fewer spare parts. Based on energy rates of €0.16/kWh, annual operating cost is €92,500 with ROI period of 20-24 months for medium-volume producers.

Our servo-driven filling system maintains accuracy of ±0.5% CV across viscosities from 1-200 cP, using Coriolis mass flow meters with 0.1% accuracy. The system features automatic viscosity compensation and real-time weight verification, with validation data showing Cpk ≥1.83 for fill volume control across 50+ product formulations.

We deliver full 21 CFR Part 11 compliance with: Electronic signatures (dual authentication), Complete audit trails capturing all parameter changes, and Automated data backup every 2 hours (10-year retention). The system generates real-time compliance reports showing 100% data integrity across all critical parameters, following ALCOA+ principles.

Our regenerative drive system recovers ≥42% of deceleration energy, reducing total consumption by ≥48% versus conventional systems. Monitoring shows: Base load: 22.5 kW, Peak demand: 40.8 kW, averaging ≤0.105 kWh per 100 vials. All motors meet IE5 ultra-premium efficiency standards, with ISO 50001 certificates demonstrating annual savings of €31,200 at EU energy rates.

We provide complete validation packages including: URS/FS/DQ documents, IQ/OQ/PQ protocols with pre-approved criteria, and Traceability Matrix linking requirements to tests. Our GAMP 5 Category 4 software validation includes source code review and cybersecurity assessment. We guarantee 36-hour response for audit support with dedicated validation specialists.

Our Global Support Network maintains ≥99% spare parts availability from warehouses in EU, US, and Asia, with ≤16-hour delivery for critical components. We offer 24/7 multilingual support with ≤8-minute response time for priority issues, backed by ≥98% first-contact resolution rate. All engineers hold pharmaceutical certifications with ≥12 years experience, with SLA agreements including financial penalties for missed responses.