TY - JOUR 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 DO - 10.5731/pdajpst.2021.012710 SP - pdajpst.2021.012710 AU - Robin Wagner AU - Peter Masatani AU - Dana Grace AU - Gianpiero Torraca AU - Stephanie Moore AU - David Semin Y1 - 2022/01/01 UR - http://journal.pda.org/content/early/2022/12/26/pdajpst.2021.012710.abstract N2 - 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. ER -