The use of AI-based visual inspection in the pharmaceutical industry is rapidly expanding. This guide provides a step-by-step process on how to qualify an AI-based visual inspection system to ensure product quality, consistency, safety, and regulatory compliance.
The qualification process consists of three key stages: Installation Qualification, Operational Qualification, and Performance Qualification. These steps provide a structured approach to validating that equipment is properly installed, functions according to its operational specifications, and performs effectively in real production scenarios. In this guide, we will discuss each qualification stage, focusing on the use of AI-based automated visual inspection systems for pharmaceutical inspection.
Step 1: Installation Qualification
The Installation Qualification (IQ) is the first step after acquiring a new inspection system. This stage focuses on ensuring that all components are present and installed correctly. It is a systematic review of all physical, mechanical, and electronic components to validate that the system has been installed per manufacturer specifications and in alignment with predefined regulatory standards.
On-Site Installation of Components
During IQ, the automated visual inspection system is installed on-site in the pharmaceutical facility. This includes mounting the cameras, lighting, computer systems, and any other auxiliary equipment necessary for proper operation. The IQ process also verifies that all parts, including spares, are present.
Verification of Utility Connections
After installation, utilities such as power supplies, air connections, and network connectivity are verified. This ensures that the equipment is ready to proceed with the operational phase. Our AI-based visual inspection system, AVIS, for example, includes a light-tight cabinet to provide optimal imaging conditions, and this installation step verifies that these components are set up as per operational needs.
Documentation
The final aspect of IQ involves documentation to record every detail of the setup process. This documentation helps ensure traceability and is a regulatory requirement. IQ serves as the foundation for the next two stages, verifying the initial setup and functionality of the inspection system.
Step 2: Operational Qualification
The Operational Qualification (OQ) phase tests whether the installed system operates according to the functional specifications. This stage is essential for establishing the equipment’s operational limits and confirming that it meets expected performance criteria under typical conditions.
Basic System Checks
First, the system is powered on, and basic functionality checks are performed. This includes confirming that the cameras, lights, and software interfaces activate as expected. AVIS utilizes three high-definition monochrome cameras, with each camera calibrated to specific regions of interest (ROI) to ensure that every vial is adequately covered during the inspection.
Mechanical and Electrical Verification
Next, the mechanical and electrical operations of the system are tested. This involves confirming that vial feed mechanisms are running smoothly.
Functional Test Recipe Creation for Automated Inspection
Testing the eject system is a critical part of OQ. Prior to formal production qualification of an AVIS recipe, a test recipe is created with 50 pre-inspected vials. This process takes only 10 minutes and acts as a functional test that AVIS is accepting compliant vials and rejecting gross defects. Defective units should appear on the Human Machine Interface (HMI), and the ejection system should segregate compliant from defective units with 100% accuracy.
Knapp Study Comparison
An important component of OQ is comparing the system’s detection capability with that of human inspectors in a Knapp study. This study provides empirical evidence that the system performs equal to or better than human operators. This benchmark comparison ensures that the system meets the quality assurance levels needed for pharmaceutical products.
The Knapp study comparison with AVIS will use a more comprehensive production-ready recipe than was used in the Functional Test Recipe step described above. This production recipe will be created from 500 compliant units and will have complete coverage of all vial surfaces to be inspected.
Step 3: Performance Qualification
Performance Qualification (PQ) involves testing the system in a live production setting, simulating real-world operations to verify that it performs effectively over time and at full production speeds.
Running Live Batches
This part of the qualification ensures that the inspection system can consistently operate under normal production conditions. Three production batches are run through AVIS but are not released until they have passed an elevated Acceptable Quality Limit (AQL) inspection.
Elevated AQL Inspection
The next step is to apply an elevated AQL inspection to each of these batches. The elevated AQL is a stricter version of the standard AQL quality threshold, allowing fewer missed defects in each defect severity level.
Batch Release
If the three batches pass the elevated AQL standards, they can be released, thus marking the successful qualification of the inspection system and the production recipe.
Conclusion
The qualification of an AI-based visual inspection system, like AVIS, follows a similar process used for traditional visual inspection systems. Through the three key stages—Installation Qualification, Operational Qualification, and Performance Qualification—pharmaceutical manufacturers can validate that their inspection systems meet stringent regulatory and quality standards.
