Qualification of AVI Syringes and Vials
This project involved the GMP-compliant qualification of an Automated Visual Inspection (AVI) system for prefilled syringes and vials. The objective was to enhance the detection accuracy for particulate and cosmetic defects while ensuring full compliance with regulatory requirements.
QPS Engineering was responsible for the complete qualification strategy, including risk assessments, IQ/OQ planning and execution, and the validation of the image processing system. A key focus was the integration of modern AI-based defect recognition algorithms, implemented seamlessly into the existing production line without modifying its structure.
Scope of Services:
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GMP-compliant qualification (IQ/OQ) of AVI systems for syringes and vials
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Design and execution of a comprehensive reference defect program
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Integration of AI-driven image processing to improve detection capabilities
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Support during regulatory inspections and audit preparation
