At Eurofins Infinity Laboratory Group, we are proud of our expansive global network of laboratories, each offering unique capabilities that fuel innovation and quality in pharmaceutical and medical device development. Our Crown Point, Indiana laboratory is quickly making waves as a nimble, responsive, and highly specialized microbiology testing facility.

Led by Alexis Mathews, a ten-year veteran and the site’s director, the Crown Point team brings a deeply experienced, solutions-focused approach to supporting pharmaceutical and medical device manufacturers across the U.S. Their mission? Deliver accurate, high-quality microbiology results—fast.

The Crown Point Laboratory specializes in an impressive array of microbiological and sterility testing services, designed to meet the most stringent regulatory standards and client needs across the drug and device lifecycle. Here’s a quick overview of what they offer:

• USP Microbiology Testing: Full support for USP methods including sterility testing (USP <71>), microbial limits (USP <61>, <62>), and endotoxin testing (kinetic turbidimetric, chromogenic, and gel clot).
• Container Closure Integrity Testing (CCIT): Including both dye ingress and microbial ingress testing to ensure product sterility.
• Environmental Monitoring Performance Qualification (EMPQ): From writing protocols to executing site sampling, the team provides comprehensive EMPQ services, including cleanroom certification, compressed air and surface sampling, as well as organism library storage.
• Bioburden and Biological Indicator Testing: Bioburden counts for anaerobes, aerobes, spores, fungi, and BI population verification.
• Cleaning Validation & Disinfectant Efficacy Studies: To validate cleaning and disinfection processes, including aerosolization studies that challenge devices with aerosolized organisms to confirm sterile fluid paths.
• Sterilization Validation Support: Including drop testing for autoclave sterilization cycle validation and method suitability testing for all services.

This extensive testing menu makes Crown Point an ideal partner for both pharmaceutical and medical device manufacturers, especially those seeking support throughout the later stages of the development lifecycle.

What truly sets Crown Point apart isn’t just the range of services, it’s the speed and precision with which they deliver them. Alexis and her team have cultivated a culture of responsiveness and cross-functional collaboration that allows them to do what many larger labs struggle with: act fast.

• Quote Turnaround Within 24 Hours: While many competitors take one to two weeks to generate quotes, Crown Point typically responds within a single day.
• Project Launch Within Days: Rather than waiting weeks, Crown Point can begin work as soon as samples arrive.
• Final Reports in 24 Hours Post-Testing: Thanks to a meticulous and efficient QA process, clients receive final reports promptly after testing is complete.

This operational excellence is made possible by a tightly knit, cross-trained team with daily alignment meetings and a shared commitment to client satisfaction.

Many clients come to the Crown Point Lab in crisis—facing FDA findings, contamination issues, or urgent process validation needs. The lab is built to respond quickly and effectively, helping clients recover timelines and meet compliance requirements with confidence. Whether it’s a cleaning validation after a contamination event or an EMPQ for a new cleanroom, the Crown Point team is ready to jump in.

With the addition of Crown Point, Eurofins now has a “focal micro lab” in the Midwest—complementing microbiology offerings in Portage, MI, and Lancaster, PA, and bringing localized support to a broader client base.

Crown Point’s location and speed make it ideal for serving clients within driving distance—offering hands-on sampling support, quick turnaround, and enhanced collaboration. And with Alexis’ deep experience in protocol development and method validation, the site is already contributing best practices across the broader Eurofins network.

As Alexis put it in her own words, “We’re a great micro lab that supports needs across the board—from med device to pharma, from startup to finish. I have a very capable team that gets things done quickly, efficiently, and to the highest standards.”

If you’re part of the Eurofins community and haven’t yet explored what the Crown Point lab can do for you or your clients, now is the time. Visit the lab, meet the team, and discover a partner that’s as fast and flexible as they are scientifically rigorous.

Contact us today to learn how our microbiology expertise can support your next project—from early method development to critical GMP testing.