Addressing the Options and Challenges in Subvisible Particulate Contamination Monitoring in Single Use Systems 

Recorded Webinar

Particulate contamination in pharmaceutical and biopharmaceutical products produced using single use systems (SUS) can create detrimental health risks that are required to be minimized by regulatory agencies. This contamination can be divided into the visible and subvisible ranges, and these two ranges of particles are evaluated using different techniques. Testing in the subvisible range is more easily automated and will be the focus of this presentation. An ASTM E3230 method is described for testing subvisible particulate contamination. Example results indicate that data of submicron particulates with sizes below the USP <788> limits of 10 and 25 µm provides useful insight into product cleanliness levels. For cell and gene therapies which cannot use a final sterilizing grade filter, choosing SUS with cleanliness levels exceeding USP <788> requirements can be a good practice to ensure safety, potency, and quality of therapeutics. 

Key learning objectives: 

  • Contamination measurement for visible and subvisible ranges, evaluated using different techniques.
  • Equipment and methods for testing for submicron particulates with sizes below the USP <788> limits of 10 and 25 µm.
  • How ASTM E3230 provides a helpful framework for testing particulates below USP <788>
  • Extraction method development and effects on results  

 

Speaker:

Mark Bumiller
Technology Manger, Entegris, Inc.

lp-bioprocess-webinar-may-16-2024-Bumiller Entegris Photo

Mark has worked in the field of particle size analysis for forty years. Mark has published more than a dozen papers on particle characterization and has presented over 200 webinars on this topic. 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. At Entegris Mark is the Technology Manager for the AMH Instrumentation Division.