Ensuring the quality of liquid pharmaceuticals requires strict control across the packaging process. As vials and syringes move through sterile filling lines, their integrity and compliance must be fully verified. While AI‑driven inspection seems ideal, most algorithms fail to meet GMP Annex 22, highlighting the need for compliant AI technologies.
Current Challenges in quality inspection in aseptic filling
- High‑speed pharma lines exceed the limits of rule‑based inspection.
- Subtle, variable, or rare defects often go undetected.
- Rising data‑management and traceability demands (e.g., FDA 21 CFR Part 11).
- Limited flexibility for new formats or evolving inspection needs.
- Disconnected data sources block real‑time insights and process optimization.
The Solution: GMP Annex 22 compliant AI-based inspection with OMRON pharma dedicated solution
- Static, Annex‑22‑Ready AI: A fixed, non‑evolving AI model engineered for controlled, traceable, and fully GMP‑compliant visual inspection.
- Deterministic, Repeatable Results: The model always delivers identical outputs for identical inputs—supporting regulatory expectations for consistency and validation in GMP environments.
- Full Traceability via Checksum: Each trained model is assigned a unique checksum “digital fingerprint,” automatically recorded in the Audit Trail for secure version control, transparent traceability, and simplified qualification.
Enabling Technologies
Faster machine operation, cameras for every application
Experience Unmatched Precision and Efficiency with the Omron FH Vision System: Revolutionizing Quality Control and Automation in Manufacturing
Fibre heads
Discover a versatile range of compact, high accuracy fibre optic heads for any application: From standard solutions to advanced designs resistant to vacuum, chemicals or extreme temperatures, our portfolio combines precision, durability, and small-size performance for even the most demanding environments
Amplifiers
Our Smart Fiber Amplifier delivers ultra-stable, high-precision detection, making it ideal for applications where accuracy and consistency are essential. It offers easy setup with patented Smart Tuning and Smart Verification, along with a wide light adjustment range to ensure reliable performance across different materials. With built-in IO-Link connectivity, it enables seamless integration, real-time monitoring, and dependable, error-free operation.
