Vial Packing-Cartoner Solutions for Pharmaceuticals

Our global network maintains ≥99% spare parts availability from warehouses in EU, US, and Asia, with ≤18-hour delivery for critical components. We provide 24/7 multilingual support with ≤10-minute response time, backed by ≥97% first-contact resolution rate. All engineers hold pharmaceutical certifications with ≥15 years experience, supported by SLA agreements with performance guarantees.

We deliver complete validation packages including: URS/FS/DQ documentation, IQ/OQ/PQ protocols with pre-approved criteria, and traceability matrices. Our GAMP 5 Category 4 software validation includes source code review and cybersecurity assessment. We guarantee 48-hour audit support and provide dedicated validation specialists throughout your qualification process.

Our multi-camera inspection system utilizes 5MP cameras with strobe illumination (500fps) detecting particles ≥25μm. Validated per USP <788> requirements, achieving ≥99.98% detection accuracy with false-reject rate ≤0.01%. The system performs 100% inspection for particles, container defects, and fill level verification, with all data recorded in 21 CFR Part 11 compliant format.

Our TCO analysis shows 35-40% lower costs over 7 years through: Energy savings ≥45% (regenerative drives), Reduced maintenance (30% fewer spare parts), and Labor optimization (50% reduction). Based on €0.18/kWh, annual operating cost is €68,500 with ROI period of 18-22 months. We provide customized TCO calculators incorporating your specific utility rates and production volumes.

Our systems deliver full regulatory compliance through: Electronic signatures with dual authentication, immutable audit trails capturing all parameter changes, and automated data archiving (10-year retention). The ALCOA+ compliant platform demonstrates 100% data integrity across all critical parameters, with real-time compliance reporting and cybersecurity protection per GAMP 5 guidelines.

We guarantee breakage rate ≤0.008% through: Servo-controlled motion profiling (limiting G-forces to <1.8G), vibration damping systems with active compensation, and polymer-coated guide rails. Validated using high-speed camera analysis (1000fps) and data from 20 million vials showing Cpk ≥2.0. Integrated glass fragment detection using 5MP vision systems provides additional quality assurance.

Our RFID-enabled Quick Changeover System achieves complete format transitions in ≤18 minutes using standard tools. This covers: container handling adjustment (6 mins), inspection system recalibration (7 mins), and packaging format change (5 mins). Validated through 500+ change cycles showing ±0.2mm repeatability, with digital work instructions and recipe management ensuring operator-independent consistency across all GMP operations.

Our dual-technology detection system combines high-resolution vacuum decay (ASTM F2338-09, detecting ≥3μm leaks) with laser-based headspace analysis. Validated to achieve ≥99.97% detection probability with false-reject rate ≤0.005%, exceeding USP <1207> requirements. Each system includes auto-calibration verification and provides 21 CFR Part 11 compliant data recording for complete audit trails and regulatory compliance.

Our validated vial packaging lines achieve OEE ≥88% through: Availability ≥95% (quick changeover ≤15 mins), Performance ≥97% (maintaining 400 vials/min), and Quality ≥99.5% (vision inspection accuracy ≥99.98%). This is verified through 30-day continuous runs showing Cpk ≥1.67 for all critical parameters, with real-time OEE monitoring via SCADA systems that track and optimize performance metrics continuously.