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
Choose your Confidence® Validation Services
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
Questions & Answers (8)
Glassware, sealing, and fill solution defects are all common defect types. Contact us for our F-908 document which state the standard defect types we offer.
The expiration date varies by fill solution and particle type.
100µm is the smallest and 10,000µm is the largest available particle size we offered. Human inspectors can see 100-200µm depending on particle type and color. Fiber and hair tend to start at 500µm.
Ideally, automatic inspection machines and human inspectors should be tested using separate Particle Validation Standards for each potential type of contaminant in the manufacturing process.
Sartorius can work with 50mL vials, recommending particles start at 150µm for molded glass. 100mL tubular vials can be filled up to 50mL, requiring extra inspection time of 1-2 weeks.
Blank or single particle standards are typical. Two or three particles per container can be certified upon request. More than three particles are evaluated case-by-case and not certified.
Customers must supply containers and components in the same quality and cleanliness as used in manufacturing. If impractical, send them unopened in original packaging from the supplier.
Yes, every order includes a Certificate of Compliance and Traceability, confirming NIST-traceable sizing, ISO 9001 standards adherence, and an Inventory Summary.