Particle Validation Standards

Confidence® Particle Validation Standards provides certified and customized sets for visual inspection training programs performed at Fill & Finish process.

Item No.: 
Particle-Validation-Standards

*Custom/bulk order quotes are provided within 72 hours of request.

Our Particle Validation Standards comprise a broad range of custom-manufactured standards designed to validate the visual inspection process.

Visible particulates in injectable products can jeopardize patient safety. Therefore, reliable control of particulate contamination in fill and finish process steps is essential. Control measures include visual inspection of the final drug product to ensure it is "essentially free" or "practically free" of particles.

Benefits:

  • In-house knowledge: reliability secured over 40 years’ experience and global coverage
  • High quality: fabrication, processing and inspection are performed under ISO 9001 QMS
  • Cost-efficiency: customized kits are ready-to-use for visual inspection training

Applications:

  • Final filling

Offering:

  • Certified Customized Defect Kits
  • Loose Particles