Join Mark Bumiller as he discusses the importance of subvisible particulate testing and provides an overview of solutions from Entegris to meet the qualification requirements.
To watch this webinar, contact Entegris here.
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 discusses solutions from Entegris to help meet these qualification requirements.
Key Topics 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
Presenters
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.
Production Partner
Entegris
As a global leader in advanced materials science, we have the expertise and determination to help solve your most advanced technology challenges.
Every day, and for more than 50 years, our singular mission has been to help customers utilize our advanced, science-based solutions to support a safer workplace; to innovate faster and more efficiently; and ultimately to transform the world.
Related Content
Rethink your Impurity Analysis Strategy
In this webinar, Dr. Ejvind Mørtz discusses the benefits and applications of mass spectrometry (MS)-based host cell protein (HCP) analysis and why HCP ELISAs are insufficient for documenting product-related impurities. Watch to learn where to apply the assay in a typical process and what you gain from deploying it to your workflow.
Exploring Oligomerization and Stoichiometry of Protein Complexes with MALS: Case Studies from Phage-Bacteria Conflict
Experts discuss the utility of SEC-MALS in characterizing protein oligomerization and how it can complement protein structure determination and prediction tools.
A Novel Approach to Removing Urea from Dialysate: Methods and Validation by Amino Acid Quantification
Dr. Guozheng Shao and Dr. Anna Scott discuss the development of an osmotic membrane for use in a portable dialysis device and its validation using amino acid analysis to quantify urea removal using this novel membrane.