Certified Challenge Set

By Gillson Sciences

A Certified Challenge Set is a fully customizable qualification tool designed for the ongoing training, qualification, and requalification of manual, semi-automated, and fully automated inspectors and machines. Set Design Considerations Sets typically include: - Contain 10–15% defect units, with the remainder being known no defect or “blank” units - Have defect counts determined through a risk analysis of potential extrinsic, intrinsic, and inherent contamination sources - Include 3–4 sizes of each contaminant material, selected to span the full range of probability-of-detection values established during system qualification To ensure your set produces reliable, actionable data, several design factors must be considered: - Container Type & Size: Each container type (vials, ampoules, syringes) requires its own dedicated set - Container Color & Opacity: Factors like amber glass or opaque syringe barrels can impact detection and must be accounted for - Solution Properties: Turbidity, viscosity, and color—especially in hazardous or cytotoxic products—must be matched. Gillson Sciences can formulate a placebo or surrogate solution for accurate simulation - Unknown Particle Identification: If your defect library contains unidentified particles, we can isolate and identify them to ensure accurate representation in your set