Knapp Kits – Visual Inspection Qualification Made Easy Certified kits for training, qualification, and performance validation in line with USP <1790>, FDA, and EU GMP guidelines.
Knapp Kits are industry-standard visual inspection challenge sets used to evaluate and qualify manual, semi-automated, and automated visual inspection systems (AVI). Each kit contains a controlled mix of good and defective units, enabling measurement of Probability of Detection (PoD) and control of False Rejection Rates (FRR).
At FTI Incorporation, our Knapp Kits are manufactured under cGMP-compliant conditions, ensuring reproducibility, accuracy, and regulatory acceptance.
Particle Defect Kits
Focused on particle-related defects, these kits include vials, ampoules, or syringes seeded with particles of varying sizes, colors, and materials (glass, metal, fiber, rubber, organic).
Applications:
- Training operators to detect particulate matter
- PoD studies for regulatory compliance
- AVI system sensitivity checks
Cosmetic Defect Kits<1790>
Designed to simulate cosmetic and container-related defects such as cracks, scratches, missing flip-off caps, sealing issues, and fill volume deviations.
Applications:
- Operator training in distinguishing cosmetic from functional defects
- Reducing false rejection rates in AVI systems
- Establishing acceptance criteria for visual inspection
PoD Kits (Probability of Detection Kits)
Structured with statistically significant distributions of defective vs. good units (typically ≤10% defects), PoD kits allow measurement of inspector efficiency and machine performance.
Applications:
- Inspector qualification & requalification
- AVI performance studies
- Regulatory audits requiring quantitative detection data
Defect Library Kits
A comprehensive collection of defects covering particles, cosmetic issues, closure integrity failures, and fill-level anomalies.
Applications:
- Training labs and quality control centers
- Building internal reference libraries
- Long-term inspector education & R&D support
Features & Benefits
- Customizable formats (vials, ampoules, syringes, cartridges)
- Traceable particle standards for regulatory compliance
- cGMP-compliant production
- Reduces inspector bias with mixed good/defective ratios
- Supports FAT, SAT, PQ, and requalification cycles
