(M0930-06-36) Particulate Contamination on Medical Devices and Single Use Systems

Purpose: Create method for testing medical devices and single use systems (SUS) for subvisible particulate contamination using a liquid particle counter.

Methods: Use USP 788 and ISO standards as basis for the testing and data interpretation. Define methods for physically releasing particles from the surface of the device or SUS. Optimize instrument configuration and protocol for analysis. Use USP 788 and ISO standards as guidelines for determining acceptable pass/fail criteria. Test multiple devices and SUS using the created methods.

Results: Most medical devices and SUS met the predetermined pass/fail criteria. Some SUS samples failed to meet the USP 788 LVP criteria.

Conclusion: Existing standards can be used to create robust medical device and SUS subvisible particulate contamination methods. Examining particle counts at smaller size ranges provided the ability to better rank cleanliness levels.

References: USP , Particulate Matter in Injections, available at: https:// www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revision¬GeneralChapter788.pdf
ISO 8536-4:2010, Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed, available at: https://www. iso.org/standard/55799.html
AAMI TIR42:2010, Evaluation of Particulates Associated with Vascular Medical Devices, available at: https://webstore.ansi.org/Standards/ AAMI/AAMITIR422010TIR42
ISO 14708-3:2017, Implants for surgery – Active implantable medical devices — Part 3: Implantable neurostimulators, available at: https:// www.iso.org/standard/60539.html


Particle Adhesion Forces


ISO 8536 - 4: 2010; Infusion sets


Extrinsic vs. Intrinsic Particles