Roman Mathaes
Chief Executive Officer
Roman Mathaes is CEO of Clear Solutions Laboratories and a recognized expert in visual inspection and particle contamination control for injectable medicines. Previously, he held leadership roles at Roche/Genentech and served as Head of Pharmaceutical Services at Lonza, supporting global pharmaceutical development and manufacturing.
DAY 1: September 28th, 2026
SESSION: A Roadmap for Implementation of Automated Visual Inspection for Parenteral Drug Products
Automated Visual Inspection (AVI) is increasingly adopted for sterile injectable drug products, but practical implementation guidance remains limited. This presentation proposes a pragmatic roadmap from equipment selection to inspection process performance qualification (iPPQ), with a focus on visual inspection (VI) test set requirements.
◆ Demonstrating AVI equivalence to Manual Visual Inspection (MVI) per USP <1790> and EU GMP Annex 1.
◆ Defining fit-for-purpose VI test sets throughout the AVI lifecycle.
◆ Common implementation pitfalls and mitigation strategies.
◆ Optimization of false reject rates (FRR) during vision engineering.
◆ Product bracketing considerations for AVI systems.
◆ Opportunities and limitations of artificial intelligence in AVI.
Special emphasis is placed on the critical role of VI test sets in qualification, performance verification, and lifecycle management to enable robust, compliant, and efficient AVI implementation.
