Achieving Quality Liquid Filling Operations: Closed Loop Manufacturing

Concentration control is essential because even minor variations in active ingredient potency or excipient levels can impact drug efficacy, safety, and regulatory compliance. Maintaining accurate concentration levels ensures each filled vial delivers the intended therapeutic effect while minimizing the risk of batch failures, recalls, and production delays.

Connect™ CPV improves quality by using AI-driven predictive models, UV-Vis spectrometry data, and automated pump controls to monitor and adjust manufacturing processes in real time. The system detects deviations in concentration and particle size distribution, automatically corrects process variables, and prevents non-compliant products from progressing through production.

Adaptive manufacturing enables pharmaceutical companies to achieve greater product consistency, reduce waste, accelerate production timelines, improve operational efficiency, and strengthen regulatory compliance. By responding to process variations in real time, manufacturers can maintain high-quality standards while minimizing manual interventions and costly rework.

Connect™ CPV uses a software-based soft sensor that analyzes UV-Vis spectrometry data and process variables to estimate particle size distribution indirectly. This predictive approach enables real-time monitoring and detection of particle size anomalies, eliminating the need for frequent manual sampling and reducing production delays.

Closed-loop manufacturing supports compliance by continuously documenting process performance, automating quality verification, and maintaining operations within predefined quality thresholds. Connect™ CPV’s validated architecture and automated data collection capabilities help manufacturers meet regulatory requirements, including 21 CFR Part 11 standards, while improving audit readiness and reducing compliance-related workloads.