SEPT 5 - Addressing the Challenges in Subvisible Particulate Contamination Monitoring in Single Use

This presentation emphasizes the significance of minimizing particulate contamination in pharmaceutical and biopharmaceutical products produced through the use of single-use systems (SUS). The contamination can be categorized into visible and subvisible particles, with the latter being more readily detectable through automated techniques. Mark Bumiller outlines a method for testing subvisible particulate contamination, and the obtained results demonstrate that data on submicron particles below specified limits offer valuable insights into the cleanliness levels of the products. For cell and gene therapy products that cannot employ a final sterilizing grade filter, it is advisable to select SUS with cleanliness levels that surpass regulatory requirements to guarantee the safety, potency, and quality of the therapeutics.

The new ASTM E3230 standard “Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing” was followed to profile the extraction of subvisible particles in a variety of SUS. Results are presented for several different SUS showing the effect of water volume, extraction energy, and particle size.

Mark Bumiller

Mark is Technology Manager for the instrumentation group (formerly Particle Sizing Systems) at Entegris, Inc. Mark has worked in the field of particle size analysis for over thirty five years. He has served as a member of the expert committee for USP 788, the executive committee of the International Fine Particle Research Institute, and the executive committee of Particle Technology Forum of the American Institute of Chemical Engineers. Mark is an active member of ISO Technical Committee 24, SC4 helping to write standards for particle size and zeta potential analysis.