Testset Manufacturing
This project focused on the GMP-compliant design and manufacturing of customized test sets used for visual inspection system qualification. The test sets simulate realistic defect scenarios in syringes, vials, and ampoules to support Manual, Semi-Automated, and Automated Visual Inspection (MVI, SAVI, AVI) processes.
QPS Engineering managed the full process from defect design and feasibility studies to controlled manufacturing, documentation, and delivery. The defects included particle contamination, glass cracks, cosmetic flaws, fill level deviations, and stopper issues—produced under validated and traceable conditions.
The test sets are now being used in operator training, system qualification, and requalification campaigns across various sterile manufacturing facilities in Europe.
Scope of Services
-
Design and simulation of real-life defect scenarios
-
GMP-compliant manufacturing of test containers (vials, syringes, ampoules)
-
Documentation of defect type, location, and severity per item
-
Labeling, packaging, and transport validation
-
Custom defect libraries tailored to customer-specific inspection needs
-
Ongoing support for test set lifecycle management and traceability
