Particle standards play a central role in KNAPP test kits, which are widely utilized in the pharmaceutical industry for training and qualifying visual inspectors in the detection of particulate matter in sterile injectable products. These kits are designed to comply with regulatory guidelines from the USFDA (21 CFR Part 211), USP <790>, USP <1790>, and EMA Annex 1, helping pharmaceutical manufacturers meet global requirements for visual inspection of parenteral products. The KNAPP kit particle sets include a carefully curated range of visible particulate matter—such as glass shards, stainless steel particles, rubber fragments, fibers, plastic chips, metal flakes, and organic particles—that simulate both intrinsic (product- or container-related) and extrinsic (process- or environment-related) contaminants.
These visual inspection particle standards are customized by particle type, size, color, opacity, movement behavior (floating or settled), and container compatibility (vials, ampoules, and cartridges), allowing for a comprehensive training and challenge program. KNAPP test kits also incorporate opaque, translucent, fibrous, colored, and high-contrast particles to mimic real-world inspection challenges under varied lighting and rotation conditions. Used in both manual inspection training and AVI (automatic visual inspection) qualification, these kits ensure inspectors are properly trained to detect critical defects and reduce false acceptance or rejection rates. Pharmaceutical companies use particle challenge sets from KNAPP kits during batch release qualification, regulatory audits, and routine inspector performance evaluations.
Incorporating validated particle defect reference standards into your visual inspection process supports consistent product quality, inspector competency, and full compliance with international sterile drug manufacturing regulations. Mahant Pharma Advances is a leading provider for standard particles for creation of best quality visual inspection kits.