Best Practice Techniques for Testing Subvisible Particulate Contamination in Single Use Systems

Interested in subvisible particulate contamination in single-use systems?

Entegris shares its advanced techniques for performing and validating these measurements.

Register Free: https://www.biopharminternational.com/bp_w/subvisible

Event Overview:

Single-use system (SUS) manufacturers and users both need to minimize particulate contamination. A critical step is to quantitatively determine subvisible particulate contamination levels. This webinar will present a detailed description of best practices performed by Entegris to execute and validate these tests. Learn how to optimize methods and data interpretation to generate meaningful results to assure the lowest possible contamination levels, meeting regulatory requirements for safe use of SUS.

Key Learning Objectives:

• Learn how to test SUS for subvisible particulate contamination
• Understand how to validate extraction processes
• Determine which results provide the best insights into contamination levels

Who Should Attend:

• Process engineers at pharmaceutical/biopharmaceutical companies using SUS for drug production
• Quality control experts for drug production
• SUS manufacturer engineers and quality assurance personnel
• Contamination control experts
• Engineers and scientists whose work is related to particulate contamination control

Who Should Attend:

• Any individual involved in the analysis, development, manufacturing, and quality control of biopharmaceutical products

Speakers:

Mark Bumiller
Technology Manager
Entegris, Inc

Mark Bumiller has worked in the field of particle size analysis for over 40 years. Positions he has held include product manager at Hiac Royco, vice president at Malvern Instruments, vice president at Horiba, and technology manager at Entegris. He has served as a member of the PDA expert committee on subvisible particulate matter testing, executive committee of the International Fine Particle Research Institute and the Particle Technology Forum of the American Institute of Chemical Engineers. Bumiller is an active member of Technical Committee 24 within ISO, helping to write standards for particle size and zeta potential analysis.

Joy Xiaohui Chen, PhD
Lead Applications Engineer
Entegris, Life Sciences

Joy Xiaohui Chen, PhD, is Lead Applications Engineer at Entegris, where she brings over 18 years of experience in life sciences and healthcare to support innovation in pharmaceutical manufacturing. Her expertise in advanced therapeutics and single-use technologies has enabled the development of high-impact solutions that improve the efficiency, safety, and scalability of bioprocessing operations. Prior to joining Entegris, Joy held R&D roles at GE Healthcare and GE Global Research, where she contributed to advancements in diagnostic and life science technologies. She is an active member of industry consortia including BPSA and BPOG, helping to shape best practices and standards for single-use systems. Joy is passionate about emerging technologies and cross-disciplinary collaboration, and she is committed to driving progress in global health through smarter, more sustainable biomanufacturing.

Register Free: https://www.biopharminternational.com/bp_w/subvisible