Machine Qualification Kits – Assuring AVI System Performance Certified kits for validation, calibration, and functional testing of Automated Visual Inspection (AVI) systems, aligned with FDA, USP <1790>, and EU GMP.
Machine Qualification Kits from FTI Incorporation are engineered to test and validate the accuracy, reproducibility, and compliance of Automated Visual Inspection systems (AVI). These kits provide standardized defect samples and good units to challenge machine performance during Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Performance Qualification (PQ), and routine requalification.
Our kits ensure that AVI systems meet Probability of Detection (PoD) requirements while minimizing False Rejection Rates (FRR), supporting full GMP compliance
Performance Qualification Kits (PQ Kits)
Designed to validate AVI system performance against regulatory acceptance criteria, PQ Kits include calibrated defects across particles, cosmetic flaws, and closure integrity issues.
Applications:
- FAT & SAT during equipment commissioning
- Routine PoD and FRR studies
Machine Calibration Kits
Calibration kits allow fine-tuning of cameras, lighting systems, and software sensitivity in AVI systems. They include standardized particle defects and cosmetic units to establish reliable detection thresholds.
Applications:
- Routine calibration of AVI systems
- Aligning detection sensitivity with regulatory expectations
- Preventing drift in machine performance over time
Functional Kits
Functional Kits confirm the correct installation and setup of format parts, conveyors, and inspection stations. They feature easy-to-detect defects that verify system readiness before performance testing.
Applications:
- Post-installation verification of AVI equipment
- Quick checks during format or line changeovers
- Preventing downtime due to misconfiguration
Features & Benefits
- ✅ Custom defect types across container formats (vials, ampoules, syringes, cartridges)
- ✅ Supports full validation lifecycle (FAT, SAT, PQ, and requalification)
- ✅ Traceable and reproducible defect standards
- ✅ GMP-compliant manufacturing & QA documentation
- ✅ Optimized to balance PoD with low FRR
Why Choose FTI Machine Qualification Kits?
- Trusted by leading global pharma & biotech companies
- Built under cGMP conditions for regulatory compliance
- Available in standard sets or customized solutions
- Full technical support and training included