01TRAIN
Inspector training
Introduce selected defect types and help inspectors practice recognition within your training program.
For QC, validation & visual inspection teams
Custom Defect Test Kits for Pharmaceutical Visual Inspection
Project-specific challenge sets for inspector training, qualification, Knapp comparative studies, and automated visual inspection development and validation support.
- Project-specificBuilt around the agreed scope
- CoC includedCertificate of Conformance
- Images optionalSeeded-particle images on request
Tell us what your study needs. This is a call request, not a meeting booking; we will follow up to arrange a suitable time.
Known scope. Documented preparation.
A defect set and CoC, with unit identification and defect inventory agreed in the project specification.
Start with your studyContainer & fillTarget defectsInspection methodDocumentation needs
Use cases
A challenge set with a purpose.
Begin with the decision your study needs to support, then define the kit around it.
02QUALIFY
Manual qualification
Scope challenge units around your inspection method, qualification protocol, and site-defined criteria.
03COMPARE
Knapp studies
Plan a defect set for comparative studies and probability-of-detection assessments under your study conditions.
04DEVELOP
AVI development
Support automated visual inspection development and validation activities with project-specific challenges.
Your team approves suitability for the intended use, the protocol, and acceptance criteria. A test kit is one input to your inspection program.
Selected defect scope
Particles, containers, and the details that matter.
Discuss the materials and visible attributes you need. Feasibility and the final defect selection are subject to the agreed project scope.
Particulate challenges
Broad material families to discuss
- Glass
- Particles or fragments
- Metal
- Particles or fragments
- Fibers
- Selected strands or fibers
- Elastomer
- Selected rubber or closure materials
- Polymers
- Selected plastic materials
Material, form, size requirements, and quantities are reviewed together—not every material or defect is feasible for every configuration.
Container & fill challenges
Selected visible defects to discuss
- Container surfaceCracks, chips, scratches
- Fill presentationUnderfill, overfill, empty units
- Closure appearanceVisible cap or crimp defects
Visible closure or seal defects do not establish container closure integrity (CCI). Any integrity assessment requires its own suitable method and protocol.
Container & fill
Start with your format.
Vials, syringes, cartridges, ampoules, bags, and bottles can be discussed. Share your container, closure, and fill requirements so feasibility can be reviewed.
Product or surrogate selection and any required appearance or flow characteristics belong in the approved specification.
Explore the defect-kit serviceDocumentation included
A Certificate of Conformance with your defect set.
The CoC documents the preparation—not a claim of regulatory approval or suitability for every study.
Optional images of seeded particles are available. Discuss image needs when defining the scope.
CoC
What the CoC covers
- Instruments used
- Step-by-step preparation process
- Materials used
Define the inventory and answer key
Unit identification and defect inventory are agreed in the project specification. Defect-free units can be discussed per your approved protocol; they are not assumed to be included.
How it works
From study requirements to a defined kit.
Four steps, with scope and timing agreed before preparation begins.
Discuss your study
Start with a free 15-minute scope call about your container, fill, inspection method, and target defects.
Agree the specification
Review feasibility, unit identification, defect inventory, quantities, documentation, pricing, and timing before approval.
Prepare the defect set
The approved scope guides the materials and step-by-step preparation process. Discuss any required changes before proceeding.
Receive kit + CoC
Receive the agreed defect set with its Certificate of Conformance and any optional seeded-particle images you requested.
Common questions
Before you scope a kit.
Practical details to help you prepare your request.
What does the Certificate of Conformance include?
YB supplies a Certificate of Conformance with the defect test set. It records the instruments used, materials used and step-by-step preparation process. The scope call establishes the project specifications and documentation needs. A CoC is not regulatory approval or a substitute for the customer's qualification of the set for its intended use.
Can we request images of the seeded particles?
Yes. Images of the particles seeded in the set are available as an optional addition. Discuss the image scope and format when requesting your quote. The illustrations on this page are not examples of those optional particle images.
Can you configure sets for different container formats and inspection methods?
Discuss your vial, syringe, cartridge, ampoule, bag or bottle presentation and intended manual, semi-automated or automated inspection use. Configuration and feasibility are agreed for the specific product, container, defect population and protocol rather than assuming one set suits every application.
How long does a test set remain suitable for use?
Continued suitability depends on the actual formulation or surrogate, container, seeded defects, storage, handling and use. The customer should establish lifecycle controls and review criteria for the approved intended use. Absence of microbial growth alone does not prove suitability; no blanket shelf-life guarantee is made here.
Is the scope call a booking or a purchase?
No. Submitting this form requests a free 15-minute scope conversation. YB reviews your details and contacts you to arrange a time. It does not book a meeting, place an order or commit you to a purchase. Timing, feasibility and pricing are confirmed after the scope is agreed.
Let’s define your scope
Request a free
15-minute scope call.
A short conversation to review your study requirements and the next steps for a project-specific quote.
- Container, closure, and fill requirements
- Target defects and intended use
- Documentation, feasibility, and timing
Submitting a request does not book a meeting. We will follow up to arrange a suitable time.
Prefer email?
info@ybinspection.comTell us about your project.
A few details help us prepare. Required fields are marked *.