Calibrated Particles for Inhouse Seeding of Defect Kits

Scientifically characterized reference materials for visual inspection system validation:

50μm – 5,000μm
USP 790 Compliant
NIST Traceable

Trusted by
90+ Drug Manufacturers Globally

Precise Engineered Particles

Our calibrated particles enable accurate qualification of visual inspection systems and personnel, with individual particle characterization for reliable defect detection studies.

Key Advantages:

Individual particle certification with microscopy images
Anti-adhesion technology prevents sticking to containers 
USP 790/1790 compliant defect library

Technical Specifications

Particle Specifications

Size Range

50μm – 5000μm

Size Tolerance

±5μm (≤100μm)
±5% (>100μm)

Materials Available

Glass, SS, Rubber, Fibers, plastics and other particles arising from any contacts parts in a pharma production environment

Certification

NIST-traceable measurements

Characterization Methods

Digital microscopy (100x-1000x)

ASTM-certified sieve analysis

3D laser scanning for irregular particles

Regulatory Compliance

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Applications of Calibrated Particles

AVI System Validation

Challenge automated inspection machines during FAT/SAT and routine performance checks.

Inspector Qualification

Train and evaluate manual inspectors per USP 1790 requirements.

In-House Kit Preparation

Create custom qualification kits with technical support from our experts.

Kit Documentation

Included with every Package:

Certificate of Analysis

Detailed size distribution and microscopy data

Particle Images

High-resolution digital microscopy photos

USP Compliance Report

Alignment with USP 790/1790 requirements

Packaging Options:

Individual Slides

Mounted particles for zero handling loss

Bulk Vials

Pre-cleaned, ready for in-house seeding

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Supported Container Types

Glass Vials-Clear & Amber

Pre-Filled Syringes

Lyophilized Vials

Ampoules

BFS/Bottles

Cartridges

Frequently Asked Questions

What sizes and types of calibrated particles does SSI supply?

SSI supplies calibrated particles across an approximate 50 – 5,000-micron range, with particle type, size and quantity defined against the customer’s URS and intended application.

How do I determine the appropriate particle size for visual inspection qualification?

The qualification range is generally set around the probability-of-detection threshold. You can refer to our short article on this topic.

When would we need very small particles such as 50 microns?

Very small particles are mainly relevant to AVI feasibility and POD studies. Regulatory guidance references approximately 95% detection at 200 microns, 70% at 150 microns, 40% at 100 microns and 10% at 50 microns.

Can SSI supply calibrated particles separately from a defect kit?

Yes. SSI can supply particles alone or provide particles with onsite kit preparation. A URS describing particle types, sizes and quantities is typically required.

What documentation and traceability are provided with calibrated particles?

A typical kit includes a master certificate, individual certificates with high-resolution photographs for each particle, source of material certificate, recommended kit-handling SOP and inspection technique.

Order Process

Select Your Particle Type

Specify Your Range

Choose from standard sizes (50 to 500 microns)

Receive with CoA

All particles ship with a Master Certificate, Source of Particle Certificate, and Individual certificates for every particle with high-resolution photographs