Visual Inspection

Challenge Sets

Gillson Sciences has set the standard in manufacturing challenge sets for visual inspection. Our kits are trusted by injectable pharmaceutical manufacturers and professional organizations nationwide to train and qualify:

  • Human inspectors
  • Semi-automated inspection systems
  • Fully automated inspection machines

We bring expertise in every container configuration, supporting feasibility testing, new product designs, and the development of inspection methods tailored to unique requirements.

Custom-Built for Your Products

From new product and container development to cost-effective mimic solutions, Gillson Sciences offers comprehensive configurations and expert guidance to ensure your kits meet all regulatory standards. Our sets are fully customizable for ongoing training, qualification, and requalification of manual, semi-automated, and automated inspection processes.

Introductory / Training Sets

Designed for inspectors new to visual inspection, these sets help build skills and confidence in detecting common contaminants. Begin with larger defect sizes, progressing toward the limit of detection Mostly defect units, plus 1–2 “blank” (no-defect) units Single-defect particles per container, with typical particle sizes: Particles: 100–1000 µm Fibers: 500–2000 µm

Knapp / Threshold Sets

To meet USP <790> and USP <1790> regulatory requirements, many facilities use the Knapp method to establish manual performance baselines and qualify inspection systems. POD sets typically include 10–15% defect units (based on contamination risk analysis) Real-world particle types plus multiple replicates of standard particles.

Certified Challenge Set

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