Particle Size Standards

Dry Microsphere Size Standards

by Particle Technology

View Particle Technology on TEKEN44

Calibrate air particle counters for pharma, healthcare, biotech and electronics Thermo Scientific 4D Series Duke Standards™ Dry Microsphere Size Standards are designed with a calibration uncertainty that is less than or equal to 2.5% of the mean diameter, enabling them to be used to calibrate airborne optical particle counters (OPC) in compliance with ISO 21501-4. These beads come with a Certificate of Calibration and Traceability to the National Institute of Standards and Technology (NIST), providing the documentation needed for QC/regulatory programs and audits. Available in 3 µm, 5 µm, 7 µm and 10 µm diameters, these dry polymer beads are ideal for OPC instrument manufacturers and service providers working to the ISO standard, as well as pharmaceutical, healthcare, and biotech companies manufacturing products with ISO 21501-4 certified OPCs in a ISO 14644 classified cleanroom. The ISO 21501 standard delivers a calibration method designed to improve the repeatability and reproducibility of air particle counters. It deals comprehensively with statistical uncertainty and defines limits to a set of performance parameters which must be covered in routine periodic calibration. Conformance to ISO 21501-4 ensures that air particle counter instruments 1) size particles correctly to an acceptable uncertainty level, and 2) count particles accurately to a defined counting efficiency level. ISO 14644 is a widely used standard for cleanroom classification using OPCs. The 4D Series comes conveniently packaged in dropper-tipped bottles to enable direct dispensing of the beads into the sampling chamber of the OPC