Precision-manufactured particulate and cosmetic defect test kits for pharmaceutical visual inspection training, qualification, Knapp studies, and automated inspection system validation.
Start with the question
Product, package, defect population, inspection method, and intended decision all affect the right study design. These short answers lead to deeper, source-informed guidance.
A controlled set of acceptable and intentionally defective units prepared for a defined training, qualification, development, or comparison study. Suitability depends on intended use and representativeness—not the label on the box.
Explore defect test kitsA surrogate may help when the actual product is unavailable, hazardous, controlled, scarce, or unsuitable for repeated studies. The relevant target attributes, verification, and limitations must be defined for the study.
Review surrogate optionsAVI automates image capture and the accept/reject decision. SAVI uses equipment to present or manipulate the unit while a person makes the decision. Actual configurations and validation strategies vary.
Compare AVI and SAVI supportContainer and closure, fill volume, formulation appearance and viscosity, inspection method, target defect families, intended study, quantity, documentation needs, and timeline.
Start a technical inquiryOur Capabilities
From custom defect test kits to surrogate feasibility and focused consulting, we support defined stages of visual inspection program development and lifecycle management.
Who We Support
Contract Development & Manufacturing
503A & 503B Facilities
Advanced Therapy Manufacturers
Biopharmaceutical Companies
Global Pharmaceutical Firms
Injectable Drug Manufacturers
Container-Specific Study Design
We scope particulate and cosmetic defect test kits around the actual container presentation and intended inspection study. When a surrogate is appropriate, selected optical and physical target attributes, verification methods, and limitations are defined with the customer.
Why YB Inspection
YB Inspection develops test sets and technical support around the actual product, container, inspection method, intended use, and approved site procedure. Scope, documentation, characterization, and acceptance criteria are defined for each project rather than implied by a generic compliance claim.
Knowledge Hub
We publish source-linked technical guides on visual inspection program design, regulatory expectations, qualification, investigations, and equipment studies. Download our latest publications below.
A practical framework covering risk assessment, equipment qualification, operator training, and regulatory-source considerations for SAVI transitions.
A framework for developing and monitoring risk-based AVI reject limits using detection capability, process knowledge, site-approved criteria, and applicable FDA and ICH sources.
Ask about USP, FDA, EU GMP, Knapp testing, AVI validation, and defect classification. Aydın can point you to relevant sources; check any response against current primary references and your approved site procedures.
Whether you need custom defect test kits, surrogate solutions, or expert consulting, we are here to support your quality objectives. Reach out today for a consultation.