Certification of Standard Reference Material® 1989 Monodisperse Irregularly Shaped Epoxy-Based Particles (Nominal 100 µm, 150 µm, 220 µm)

Published

May 2, 2025

Author(s)

Srivalli Telikepalli, Dean Ripple, Michael Carrier, Kristen Steffens, David Newton, Christopher Montgomery, Nicholas Ritchie, Anthony Asmar, Michael Halter

Abstract

Standard Reference Material (SRM) 1989 is a NIST particle standard produced using photolithographic methods and delivers a certified value for particle size of an irregularly shaped particle. This SRM was developed to allow a more accurate monitoring of visible protein-like particles that may be found in biotherapeutics. The material is intended to be used as a particle size standard for qualifying and training visual inspection analysts on the visual inspection processes. One unit of SRM 1989 contains three (3) vials of irregularly shaped particles that are monodisperse in terms of size and morphology. The 3 vials consist of particles that have Area Based Diameters of nominally 100 µm, 150 µm, and 220 µm and Maximum Feret Diameters of nominally 1.5× the area based diameter. These sizes were measured using optical and electronic microscopy methods in terms of apparent size, as obtained by experimental optical systems, and actual size, which is corrected for diffraction effects arising from the experimental methods. This publication provides information on the production, measurement, and statistical determination of the uncertainties involved in the certification of SRM 1989.

Citation

Special Publication (NIST SP) - NIST SP 260-255

Report Number

NIST SP 260-255

NIST Pub Series

Special Publication (NIST SP)

Pub Type

NIST Pubs

Download Paper

https://doi.org/10.6028/NIST.SP.260-255

Local Download

Keywords

Aggregate, Protein Particles, Protein Particle Surrogate, Photolithographic Particles, Photoresist, Reference Material, Standard, Standard Reference Material (SRM), Visible Particle, Visual Inspection

Citation

Telikepalli, S. , Ripple, D. , Carrier, M. , Steffens, K. , Newton, D. , Montgomery, C. , Ritchie, N. , Asmar, A. and Halter, M. (2025), Certification of Standard Reference Material® 1989 Monodisperse Irregularly Shaped Epoxy-Based Particles (Nominal 100 µm, 150 µm, 220 µm), Special Publication (NIST SP), National Institute of Standards and Technology, Gaithersburg, MD, [online], https://doi.org/10.6028/NIST.SP.260-255, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=959560 (Accessed May 5, 2025)