On 4 November, Bram Keymolen, CEO and Co-Founder of eyetec, joins the PDA Aseptic Processing of Biopharmaceuticals Conference in Incheon, Korea.
Bram will speak in the Annex 1 implementation track on a topic that’s reshaping modern sterile manufacturing:
“Automated Visual Inspection: Getting it right from the start.”
Why Annex 1 puts Visual Inspection in the spotlight
The revised EU GMP Annex 1 and recent FDA guidance on visual inspection both underline a growing expectation: manufacturers must demonstrate that their inspection systems are effective, validated, and representative of real conditions.
Annex 1 now dedicates four paragraphs to visual inspection—a major increase from the single paragraph in earlier versions—reflecting how central this process has become to sterile product quality.
As Bram explains:
“When you think about Annex 1 from a high-tech perspective, one thing comes to mind: the increased focus on visual inspection. That’s why it’s so important to get automated visual inspection right from the start.”
Early project definition shapes success
Based on eyetec’s experience from dozens of automated visual inspection (AVI) implementations, most recurring issues later in the project — such as false rejects, unstable detection, or qualification delays can often be traced back to the early project definition phase.
Common missed steps include:
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Defect classification that doesn’t reflect realistic particle types or patient risk
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Feasibility studies at vendors using non-representative samples
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Mechanical integration overlooked in favour of vision system performance
Key takeaway for PDA APAC attendees
The message of Bram’s session is simple yet essential:
The beginning of the project determines its outcome.
By investing the right attention in the early qualification steps—defect classification, feasibility studies, and mechanical design—teams can prevent months of rework and unplanned downtime later.
Bram will share structured best practices that have proven effective in more than 50 real-world AVI implementations under GMP.
Event details
Conference: PDA Aseptic Processing of Biopharmaceuticals (PDA APAC 2025)
Location: Incheon, Korea
Speaker: Bram Keymolen, CEO & Compliance Director, eyetec
Track: Annex 1 Implementation
Topic: Automated Visual Inspection: Getting it right from the start
If your team is planning or reviewing an automated visual inspection project, eyetec can support you with practical, experience-based guidance.
