Karen Smith

RJ Lee Group Blog Author Karen Smith

Karen Smith is a senior scientist RJ Lee Group, specializing in the identification and characterization of foreign particulate matter (FPM), as well as root cause failure analysis investigations for the life science industry. This expertise appropriately extends to assisting clients in developing proactive measures to manage their FPM issues. Since joining RJ Lee Group in 2008, she has frequently led training courses and presented at seminars for FPM identification. Ms. Smith works closely with clients on contaminant source analysis by interpreting and reporting data. Karen has a keen eye for detail and precision, making her a multi-faceted scientist in failure analysis and overall process methodology.





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Blog Posts by Karen Smith

Foreign Particulate Matter Investigations

Building a Successful Foreign Particulate Matter (FPM) Program

December 15, 2014

Stories of foreign particulate matter (FPM) found in medication and food products often occur in the news. FPM doesn’t just influence the effectiveness of a product; it can lead to product recall and regulatory action from government entities. Investigating the cause can be expensive, but a carefully designed Quality by Design (QbD) particulate program can help save a manufacturer money and time by providing cost-effective, efficient, and conclusive data. “Forensics in QbD: Addressing Foreign Particulate Matter Investigations” was written by Karen Smith and Julianne Wolfe, both particulate experts for RJ Lee Group. The article was published in American Pharmaceutical Review and explains strategies for FPM investigations. Read More

glass delamination pharmaceutical vial root cause

Making the Case: Using the SEM in Glass Delamination Investigations

March 10, 2014

The life sciences industry faces persistent challenges in assuring glass compatibility with products. One of the most serious challenges is that of glass delamination. Glass delamination, which occurs in vials, is a complex result of various factors including product composition, glass composition, glass forming temperature, and surface treatment. When delamination results in lamellae (flakes) or when other defects are present, patients are put at risk by compromised product quality. Using quality glass to begin with and understanding the potential for and prevention of glass issues are both excellent proactive measures in assuring glass quality. Choosing glass that is less prone to delamination, such as molded glass, reduces risk, as does implementing programs to proactively pretest packaging for stability. But when issues are encountered, strategizing fast and conclusive solutions is likewise important.

The best way to prevent defective glass products from entering the market is to conduct thorough and accurate quality investigations. Since defects can occur either during manufacturing or from adverse reaction to the contents, it is imperative to test the container both before and after product interaction. Read More

Discover Electron Microscopy’s Role in Glass Defect Investigations at the PDA Visual Inspection Forum

September 25, 2013

Event Dates: October 7 - 8, 2013

Wow, I can’t believe that fall has arrived – but with the changing of the seasons comes the 2013 Parenteral Drug Association (PDA) Visual Inspection Forum.  After perusing the agenda, I can’t wait to attend the session presentations and learn from industry case studies. I expect there will be many regulatory updates as well – and in this industry, since we must ensure that quality assurance programs are compliant, it’s imperative to stay “in the know” regarding regulations.  I’m especially interested in participating in discussions about the shift from visual inspection toward automated inspection for particulate detection.

As for my portion of the forum, I will be presenting during the poster session. My poster focuses on how electron microscopy can support glass defect investigations. Read More

Download Our Webinar: “From Detection to Investigation: Know Your Product’s Connection with FPM”

September 21, 2013

In case you missed it, I recently teamed up with Carol Whitinger of SoloHill Engineering to present a free webinar on Foreign Particulate Matter (FPM) entitled, “From Detection to Investigation: Know Your Product’s Connection with FPM.”  I want to invite you to download a copy of the webinar, in case you were unable to attend or you attended and would like a copy.  You can download it now at the bottom of this post. Read More


  • Expertise
    • Materials characterization
    • Foreign particulate matter investigations
    • Microscopy
    • Spectroscopy