Posted in | Qualitative Analysis

Particulate Contamination in Medical Devices and Single Use Systems

Subvisible particulate testing is critical to assess the safety of medical devices, and particulate contamination should be minimized to avoid possible negative health consequences to the patient.

A wide range of standards, USP tests, and FDA guidance documents provide test methods and acceptance criteria for particulate contamination in medical devices. In this webinar, Mark Bumiller will discuss solutions from Entegris to help meet these qualification requirements.

Key topics will include:

  • The importance of subvisible particulate testing of medical devices and single use systems
  • Why and how subvisible particulate testing of medical devices is performed using the single particle optical sizing (SPOS) technique
  • Detailed results from infusion sets and enteral bags
  • Particulate testing for Entegris single-use systems (SUS), including Aramus bag assemblies
  • Internal particulate testing protocol and results comparing Entegris with competitors' products


Mark Bumiller

Scientific Instruments Technology Manager, Entegris

Mark has worked in the field of particle size analysis for over 35 years. Positions held include product manager at Hiac Royco (5 years), technical support manager and vice president of business development at Malvern Instruments (17 years), vice president of particle products at Horiba (6 years) and technology manager at Particle Sizing Systems, LLC, and now Entegris (6 years). He has served as a member of the expert committee for USP <788>, the executive committee of the International Fine Particle Research Institute (IFPRI), and the executive committee of Particle Technology Forum of the American Institute of Chemical Engineers. Mark is an active member of Technical Committee 24 within ISO helping to write standards for particle size and zeta potential analysis. His B.S. in chemical engineering was earned at Carnegie Mellon University in Pittsburgh, PA.

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