RT Journal Article SR Electronic T1 Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP pdajpst.2021.012710 DO 10.5731/pdajpst.2021.012710 A1 Wagner, Robin A1 Masatani, Peter A1 Grace, Dana A1 Torraca, Gianpiero A1 Moore, Stephanie A1 Semin, David YR 2022 UL http://journal.pda.org/content/early/2022/12/26/pdajpst.2021.012710.abstract AB ABSTRACT: In the biopharmaceutical industry, the observation of a single particle in a vial or syringe may result in entire lots of drug product recalls. USP chapters <787> and <788> describe light obscuration methods and particle collection (membrane filtration) followed by light microscopy for particle counting of filled drug products. However, there are no corresponding pharmacopeial methods for determining the particle levels of unfilled primary packaging components or their packaging materials (tubs, nests, bags, etc.). This publication describes a quantification method to accurately assess the number of particles in primary containers and corresponding closures. As a microscopic method, the size ranges can be set by the user and are limited only by the optical properties of the microscope and analysis time. Particle load is a critical quality attribute that has a direct impact on product safety. Applying a standardized method to compare the effect of process changes on particle load can aid manufacturers in refining their processes to minimize particulates. Described herein are the critical parameters to develop physical rinse methods and subsequent qualification results to measure the visible particle load of non-siliconized and siliconized primary packaging systems.