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 99
OP 114
DO 10.5731/pdajpst.2021.012710
VO 77
IS 2
A1 Robin Wagner
A1 Peter Masatani
A1 Dana GRACE
A1 Gianpiero TORRACA
A1 Stephanie Moore
A1 David Semin
YR 2023
UL http://journal.pda.org/content/77/2/99.abstract
AB In the biopharmaceutical industry, the observation of a single particle in a vial or syringe may result in entire lots of drug product recalls. U.S. Pharmacopeia <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 article 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 the subsequent qualification results to measure the visible particle load of nonsiliconized and siliconized primary packaging systems.