An application frequently requested in our material characterization testing laboratory is a simple assessment of surface cleanliness testing. Materials and pieces used in medical devices may be handled multiple times, by multiple departments and/or specialty contractors. To maintain quality control through these multiple steps, a simple testing procedure is needed to confirm that the materials have been properly handled.
Variations on a frequently used procedure may include a rinsing with Purified Water for Injection (WFI), with or without agitation for a period of time at a specified temperature. The material will be removed from the container and the rinsate will be separated into aliquots for one or more analyses that typically include:
- Total Organic Carbon (TOC), USP <643> or an in-house quantification method
- Microbial Bioburden, USP <1227>
- Bacterial Endotoxins (LAL), USP <85>, Kinetic Chromogenic or Kinetic Turbidimetric
- Particulate Matter, USP <788> Method I Laser Particle Counting method