People are the Chemistry - Michelle Kolodziejski

At Eurofins Medical Device Testing, we believe that our people provide our strength. Their dedication to quality, professional competence and hard work are the key elements in the company’s success. In this regular feature, we introduce you to some of the people who have helped make Eurofins Medical Device Testing an industry leader.

As a Research Fellow for Eurofins’ Extractables & Leachables Team, Michelle Kolodziejski brings 36 years of analytical expertise to safeguarding clients’ biopharmaceutical products from potentially harmful impurities and unknown compounds migrating from pharmaceutical container closure systems, medical and delivery devices, and manufacturing components.

To remain compliant, deliver best-in-class service to clients, and ensure patients receive safe pharmaceuticals, Michelle continually investigates new techniques for ever-changing ISO regulations. “My team is awesome,” says Michelle. “There’s great collaboration when it’s time to solve a problem and help a client identify and quantify product adulteration.”

When Michelle isn’t uncovering potential toxins in drugs or biological products, she and her husband love to go camping, hiking and canoeing near their home in the PA State gamelands. Read more about Michelle:

What does your current job entail?
As a Research Fellow in the Extractables and Leachables team, my job includes leachables method development and validations, peak identification investigations, and routine extractables testing. New techniques, such as ISO 18562 Part 4 gas pathways process development are also part of my role.

What is the scope of your team?
The extractables/leachables team performs testing to evaluate potential contaminants that may be introduced into pharmaceutical products from direct or indirect contact with polymeric materials during storage or production. Medical device testing for potential extractable or leachable compounds is also performed. This includes mass spectrometry analyses for volatile, semi-volatile, nonvolatile compounds, and ICP analysis for multiple elements.

What process improvements does your team initiate to serve clients better?
We are always striving to provide lower detection limits, widen our scope of testing, and develop our analysts to improve skills in interpretation.

Why should clients trust us with their projects?
The Extractable /Leachables team at Eurofins Medical Device Testing have been performing extractables/leachables testing for nearly two decades. Our team includes highly skilled analysts.

You’ve been here for many years and seen countless changes. Is there anything that hasn’t changed during your tenure?
In the 26 years at Eurofins Medical Device Testing in Lancaster, PA, the constant has been the focus on quality and ethics.

How does your team’s work impact/benefit society?
Our work contributes to the safety of pharmaceutical products and medical devices. Everything from over-the-counter medications to vaccines are evaluated to ensure that they are safe.

And when you’re not working?
When I am not working, I enjoy audiobooks, Celtic music, hiking, canoeing, and travel. My favorite trips have been to Scotland and Iceland. Next year, my husband and I are planning a cross Canada trip to Alaska, assuming it is open.