With production bottlenecks costing life sciences manufacturers millions in lost productivity, Catalyx unveiled OpenLine LineClearance Assistant™ 3.0, a breakthrough AI-powered solution addressing this issue. The new solution transforms line clearance into a fully automated digital process, accelerating product changeover time, minimizing downtime, and maximizing operational efficiency.

"With our new solution, Catalyx removes line clearance as a manufacturing obstacle, providing faster line turnover, improved accuracy, and a compliance-enabled solution for modern life sciences environments," said Mario L. Rocci, Jr., CEO, Catalyx. "We designed the system with intelligence that learns, adapts, and improves every day through guided operator feedback and review."

Breakthrough Technology
OpenLine LineClearance Assistant™ 3.0 introduces advanced AI training and machine vision technology, combining automated intelligence with structured human oversight to make digital processes easier to deploy and operate during line clearance, an essential quality assurance process that ensures production equipment is properly cleaned and configured between product runs. Key innovations include:

• Revolutionary self-healing inspection intelligence that automatically creates and proposes performance adjustments based on real world outcomes, with changes guided, reviewed, and approved by qualified personnel to continuously improve inspection accuracy
• Advanced AI-powered machine vision to verify production lines are free of residual materials and rogue components between production runs, completing inspections in milliseconds with a complete digital inspection record
• Streamlined in-application model training and enhanced image management that enable faster inspection review and improved handling of complex production environments

Addressing Industrywide Pain Points
The launch comes following Catalyx's 2025 Life Sciences Line Clearance Benchmark Report revealing that 70% of life sciences organizations experienced at least one clearance failure in the past 12 months. Nearly a third (30%) reported six or more failure annually. With more than half of respondents (63%) still relying on traditional paper-based processes for critical production line changeovers, Catalyx's new solution provides manufacturers with the ability to smoothly transition to a fully digital approach.

OpenLine LineClearance Assistant™ 3.0 is available immediately for global deployment. The solution supports GMP and global regulatory requirements and emerging EU AI Act requirements. Every inspection and system update is automatically documented to support traceability, transparency, and explainability.