Visual Inspection Qualification Kits
Precision Engineering defect kits for end to end visual inspection needs
- AUDIT READY
- 3 YEAR SHELF LIFE
- ISO 9001 CERTIFIED
Precision Defect Kits for Reliable Inspections
Our Visual Inspection Qualification Kits combine particle defects, cosmetic defects, and good containers to train personnel and validate inspection systems against global regulatory standards.
Key Benefits
- 10x Probability of Detection (PoD) data for each defect
- Particles remain viable for up to 3 years
- Complete documentation package for audits
- Custom configurations for difficult-to-inspect products
Technical Specifications
- Particle Specifications
Size Range
50μm - 5000μm
Materials
Glass, SS, Rubber, Fibers
Sizing Accuracy
5%
Characterization
±5μm (NIST2D/3D microscopy with images traceable)
- Performance Data
Probability of Detection
10x PoD for each defect
Shelf Life
2 years and Extendable up to total 3 years, upon revalidation via visual inspection after every 6 months
Temperature Range
2 to 25
Regulatory Compliance
US FDA, EU GMP, JP, MHRA, TGA etc.
Applications
AVI System Validation
Qualify and challenge automated visual inspection machines during:
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Ongoing performance monitoring
Inspector Training
Develop and maintain manual inspection competency:
- New inspector onboarding
- Semi-annual requalification
- Fatigue management studies
Regulatory Compliance
Meet global pharmacopeia requirements:
- USP 1790 visual inspection validation
- EU GMP Annex 1 particulate monitoring
- FDA 483 observation remediation
Documentation
- Included With Every Kit
Master Certificate
Summary of all defects with acceptance criteria
Particle Characterization
Microscopy images with size measurements
Defect Library Catalog
Complete list of critical/major/minor defects
- Additional Resources
USP 1790 Compliance Guide
How to align your inspection process with USP requirements
Kit Handling Videos
Proper storage and usage instructions
Inspection SOP Template
Ready-to-customize standard operating procedure
Supported Container Types
Custom kits available for all common parenteral packaging formats
Glass Vials
Clear and amber options
Pre-Filled Syringes
Including needle shield defects
Lyophilized Vials
Cake defects & melt back
Ampoules
Seal and particle defects
BFS Containers
Bottles and ophthalmic
Kit Types
Tailored solutions for every inspection need
POD Kit (Probability of Detection)
Establishes baseline inspection accuracy with 20% defect containers and 80% good containers.
- Includes all defect types from library
- USP 1790 compliant
- For manual inspector qualification
PQ Kit (Performance Qualification)
Validates manual or automated systems under real operating conditions.
- Used during validation phase
- Meets predefined acceptance criteria
- Includes critical/major/minor defects
ER Kit (Error Rate)
Evaluates false positives/negatives as required by USP 1790.
- Mandatory for regulatory compliance
- Documents inspector performance
- Used for requalification
Comprehensive Defect Library
18+ years of industry expertise in particulate defect preparation
Critical Defects
- Extrinsic particles (glass, metal)
- Cracks and leaks
- Incorrect container/product
- Discolored solutions
Major Defects
- Rubber particles/stains
- Fill volume variations
- Seal defects
- Fibers (color & white)
Minor Defects
- Outer scratches/stains
- Mold marks
- Airline defects
- Cosmetic imperfections
Frequently Asked Questions
A: For custom kits, the typical lead time is 4–6 weeks from order confirmation to delivery. This includes:
R&D Consultation (1 week)
Technical calls to align on defect types, particle sizes, and container specifications.
Regulatory review (e.g., USP/EMA compliance for your product category).
Kit Development & Validation (2–3 weeks)
Precision particle insertion under laminar flow.
3D particle characterization and documentation.
Stability testing (if required for lyophilized/color-sensitive products).
Quality Release & Shipping (1 week)
Final QA approval with Master Certificate of Analysis.
Global express shipping options available.
Expedited Options:
3 weeks for semi-custom kits (modifications to existing designs).
2 weeks for urgent pilot batches (additional fees apply).
A: Our proprietary Particle Stabilization Technology combines:
Material Science
Particles are pre-cleaned, sterilized, and UV-coded to prevent degradation.
Glass/metal particles undergo surface charge neutralization to avoid adhesion.
Advanced Packaging
Airtight containers with nitrogen blanketing to prevent oxidation.
Anti-static vials for rubber/fiber particles.
Validation Process
Accelerated aging studies (per ICH Q1A guidelines).
Quarterly viability checks via high-resolution microscopy.
Real-World Proof:
98% of particles remain detectable after 3 years in client-reported data.
A: Our proprietary Particle Stabilization Technology combines:
Material Science
Particles are pre-cleaned, sterilized, and UV-coded to prevent degradation.
Glass/metal particles undergo surface charge neutralization to avoid adhesion.
Advanced Packaging
Airtight containers with nitrogen blanketing to prevent oxidation.
Anti-static vials for rubber/fiber particles.
Validation Process
Accelerated aging studies (per ICH Q1A guidelines).
Quarterly viability checks via high-resolution microscopy.
Real-World Proof:
98% of particles remain detectable after 3 years in client-reported data.
A: Per USP <1790> and global GMP guidelines, inspectors must undergo requalification every 6–12 months, or more frequently if:
Process changes occur (e.g., new defect types, container formats).
Performance issues arise (e.g., high false negatives in routine monitoring).
Regulatory audits mandate it (e.g., FDA 483 observations).
SSI’s Requalification Support
We streamline compliance with:
Requalification Kits
Pre-configured with 20% defects + 80% good units (mimics production batches).
Includes critical/major/minor defects per your product profile.
Documentation Templates
Ready-to-use reports for POD (Probability of Detection) and error rates.
Alignment with USP <1790> acceptance criteria (e.g., ≥90% detection for critical defects).
Training Workshops
On-site or virtual sessions to address inspection fatigue, new defect trends, or AVI transitions.
Example:
*”A Top-10 Pharma client reduced requalification failures by 40% using our annual refresher kits.”*
Some of our Esteemed Clientele
Let’s Make Your Visual Inspection Audit-Ready
Whether you need custom kits, inspector training, or system validation—we’ve got you covered.