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 discusses solutions to help meet these critical 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
About the Presenter:
Scientific Instruments Technology Manager, Entegris