Bram Keymolen
Co-Founder | Compliance Director
Bram Keymolen, a pharmacist with a master’s degree in Industrial Pharmacy from the University of Antwerp, brings over 20 years of GMP experience in roles spanning qualification, validation, QA, and QP. His extensive background includes key positions in biotech companies, startups, corporations, and university hospitals, with a strong focus on sterile production.
In 2011, Bram founded eyetec, specializing in Visual Inspection (VI) and Container Closure Integrity Testing (CCIT) under GMP standards. Together with Gunther Coenen, his co-founder at eyetec, who has a strong background in pharmaceutical manufacturing, they offer a unique blend of production, engineering, and compliance expertise.
A key differentiator of eyetec is its expertise in developing specialized Visual Inspection Test Sets, including Particle Test Samples (PTS) and container defects, designed to validate both manual and automated inspection systems. Furthermore, eyetec offers CCIT samples, known as Leak Test Samples (LTS), which serve as certified positive controls with precisely calibrated leak defects. eyetec also sells GMP and lab equipment and provides critical after-sales support, including maintenance, and calibration for GMP and lab equipment.
DAY 2: June 6th, 2025
SESSION: Defect Classifications: Categorizing Defects and Nonconformities
◆ Classification of defects (cosmetic, functional, critical).
◆ Categorization schemes used in visual inspection (minor, major, critical).
◆ Standardization of defect classifications to maintain consistency.
◆ Particle Source Risk Assessment as the first step toward USP1790 and Annex 1 compliance.
