On May 30th, David Exline, Senior V.P. at Gateway Analytical presented a webinar that covered an overview of wear debris characterization for laboratory personnel that evaluate quality issues with medical devices. This webinar focused on the causes of wear debris, the affects of such debris on product quality, acceptable limits and methods for ensuring quality products.
During the webinar, attendees participated in a Q&A session. You can find the transcribed discussion below along with other resource links for this webinar.
- Do you recommend using these automated methods for batch release testing?
Our recommendation is that automated methods of analysis such as automated SEM and automated Raman are part of a program to fully characterize the population of foreign particulate during the R&D phase. Once particle counts are established, faster particle counting methods can be used for product release. If any of the batch release samples become out of specification, automated methods can again be used to understand the identity of the particle populations.
- How specific is automated Raman and SEM to identify particulates?
Automated Raman and SEM are valuable tools to characterize large populations of particles. The degree of characterization is dependent on the type of sample being analyzed. The optimal scenario for complete characterization is single particle analysis by multiple methods, however, when this is not practical automated methods play a critical role of understanding the chemical nature of a population of particles.
- What is the standard for the PM10 used to establish acceptance criteria?
As described in “ Best Practices for Managing Quality and Safety of Foreign Particles in Orally Inhaled and Nasal Drug Products, and an Evaluation of Clinical Relevance,” clinical safety limits for foreign particle exposures can be developed and are most relevant in application to particles less than 10 microns. These limits can be in the range of 5% of the NAAQS. A review of available clinical studies of representative particles suggests that a 5% limit is protective of most particles.