Our Services

End-to-End Visual Inspection Solutions

From defect test kit manufacturing to surrogate solution development, automated inspection support, and regulatory consulting — we deliver the tools and expertise your visual inspection program demands.

Core Product

Particulate & Cosmetic Defect Test Kits

Our defect test kits are precision-manufactured to contain characterized, traceable particulate and cosmetic defects. Each kit is designed for use in visual inspection training, inspector qualification, Knapp studies, and equipment recipe development — all in compliance with FDA, USP, and EU GMP requirements.

Particulate defects: fibers, glass, metal, rubber, and custom materials
Cosmetic defects: cracks, chips, scratches, seal integrity issues
Fully characterized with size, type, and location documentation
Available for vials, syringes, cartridges, ampoules, bags, and bottles
Knapp study-ready with statistical sampling support
Manufactured under a comprehensive QMS with full traceability
Visual inspection testing in a pharmaceutical laboratory
Range of pharmaceutical containers for surrogate solutions
Custom Formulations

Surrogate Solutions

When your actual product is unavailable — whether due to controlled substance restrictions, high dollar value, special storage requirements, or limited supply — our surrogate solutions provide a scientifically matched alternative for visual inspection validation.

Index of Refraction

Matched to your product's optical properties

Density & Viscosity

Precise physical property matching

Automated Filling

Solutions compatible with filling equipment

We have developed surrogate solutions for CGT products, CDMOs, compounding pharmacies, biologics, and therapeutics across all major container formats.

Equipment Support

Automated & Semi-Automated Visual Inspection Support

Transitioning from manual to automated inspection requires careful planning, validated recipes, and qualified test sets. We provide end-to-end support for AVI and SAVI implementations.

Equipment recipe development and optimization
Equipment design consultation for automated visual inspection
Validation protocol development and execution support
Performance qualification using characterized defect test kits
Statistical analysis and reject limit establishment
Ongoing monitoring and requalification support
Automated visual inspection equipment
Expert Consulting

Visual Inspection Consulting & Engineering

Our team brings deep expertise in pharmaceutical visual inspection, process validation, and regulatory compliance. We support your organization through every phase of your inspection program — from initial design through ongoing qualification.

Process Validation

End-to-end validation support for manual, semi-automated, and automated visual inspection processes.

Regulatory Strategy

Guidance on FDA, EU GMP Annex 1, USP <790>/<1790> compliance for your visual inspection program.

Project Support

Dedicated project management for visual inspection equipment installations, upgrades, and technology transfers.

Training Programs

Inspector qualification programs, Knapp study design, and probability of detection (PoD) study support.

Risk Assessment

Comprehensive risk-based approaches to defect classification, reject limit establishment, and process control.

Site Audit Readiness

Preparation and support for regulatory inspections and customer audits of your visual inspection operations.

Need a Custom Solution?

Every visual inspection challenge is unique. Tell us about your requirements and we will develop a tailored solution for your program.