Curiosity, Legacy, and Practical Wisdom at PMF 2025

It was late, 10:30 p.m., when I finally stepped out of the muggy Tampa night and into the hotel lobby. I had just got in from a delayed and turbulent flight out of BWI, and instead of a quiet check-in line, I was greeted by a sea of people sitting on the floor, charging their phones, looking weary. It was humid inside, and the front doors had a sheen of condensation. Everyone was wearing that unmistakable “travel-day-gone-wrong” look. As the front desk informed me…A power outage had knocked out the hotel’s electricity, NO lights and air-conditioning. Exhausted, I decided, what’s one more adventure? I’ll tough it out. I got up to my room (elevators still worked, thankfully!), found the emergency flashlight on my wall and began unpacking in the dark. Fifteen minutes later the power returned, and I fell asleep grateful for small mercies.

That rocky start turned out to be a fitting beginning for the PMF 2025 conference: even when things don’t go as planned, the people who care about this industry find ways to keep moving forward.

Of course I had heard of Scott Sutton, the founder of PMF… when you enter the world of micro it’s hard not to find someone who knew him, his work and influence. But at the conference I came to understand the depth of his impact. Attendees and presenters alike shared stories of how he mentored them and shaped their approach to pharmaceutical microbiology. Though he passed away in 2015, his presence was palpable- woven into the DNA of the meeting.

That legacy matters. It reminds us that innovation and compliance are built not just on data or regulations, but on people who care about doing things right and passing that ethos forward. 

Anthony Grilli, CEO of Focus Labs –  Aseptic Process Validation for Media Fills:
Tony highlighted how defensible media fill results depend on planning before the fill itself- He underscored the value of a clear link between micro lab readiness and production operations. His perspective challenged many of us from production-focused organizations to consider the lab’s challenges and contributions.

Crystal Booth, Director of Microbiology ThermoFisher Scientific –  Mold Remediation in Cleanrooms:
Crystal delivered a nuanced talk on mold remediation (one of my personal favorite topics). She detailed how molds grow and proliferate in cleanrooms and offered a practical eight-step remediation framework. I left with pages of notes that I know colleagues back home will benefit from.

Tim Cser, Senior Technology Specialist Millipore Sigma – Rapid Microbiological Methods (RMM):
Tim contrasted traditional sterility testing timelines (often 14 days) with modern rapid methods, with keys points I found helpful:

• The scientific foundation of ATP bioluminescence, CO₂ detection, and flow cytometry.
  
• Regulatory support in updated USP chapters, enabling broader adoption of RMM.
  
• Benefits such as shorter investigation cycles and less product at risk, especially for short-shelf-life products.

Vanessa Vasadi Figueroa, Chief Microbiologist at VVF Science – Training and Qualification for Aseptic Technique:
Vanessa stressed that training is not just a compliance checkbox, it’s a core part of contamination control. Her stepwise qualification model (referencing PDA TR22, new update coming!!) illustrated how to translate training into measurable performance.

Michael J. Miller, President of Microbiology Consultants – Annex 1: Contamination Control Strategies in Practice:
Mike’s presentation was one of my personal favorites. He gave a clear-eyed interpretation of EU Annex 1’s expanded expectations for integrating risk assessments into contamination control strategies.

Karen McCullough, Principal Consultant at MMI Associates – Endotoxin Control Strategy:
Even while recovering from COVID and presenting virtually, Karen dissected common pitfalls in endotoxin testing and control, illustrating why these errors persist and how to address them through tighter process integration and training.

Rick Jakober, VP of Lab Services at Perritt Laboratories – Antimicrobial Effectiveness Tests (AETs):
Rick’s session stood out for practical guidance on choosing challenge organisms, understanding preservative system limitations, and accounting for formulation factors that can mask microbial recovery- critical nuances often overlooked.

Frank Settineri, President and Founder of Veracorp LLC – FDA Microbiological Investigations:
Frank shared compelling case studies showing how gaps in root-cause analysis and CAPA execution have repeatedly surfaced in recent FDA 483s and Warning Letters. His session validated much of the work I’ve been doing in my LinkedIn series on EM compliance trends.

My Session – Building a Robust Environmental Monitoring Program:
I concluded the conference by discussing the core pillars of EM programs: risk-based design of sampling locations, sound data trending, root-cause analysis training, and the value of cultivating a culture that sees deviations as learning opportunities rather than blame.

Throughout the event, I noticed a shared thread-curiosity. Whether it was about new technologies like rapid methods, the implications of Annex 1, or improving how we train staff, curiosity drove the discussions.

For SherpaPharma and our clients, that curiosity translates into:

• Reinforcing a mindset that curiosity is a compliance asset, encouraging quality and microbiology teams to question assumptions, challenge legacy practices, and improve systems proactively rather than reactively.
• Guiding organizations to explore and adopt science-forward testing methods, from rapid microbial detection to EM software solutions like SherpaPharma, that enable quicker, more confident decision-making.
• Bridging lab and production perspectives, fostering collaboration so that contamination control decisions reflect both the science of detection and the realities of manufacturing operations.

Though this was my first PMF, I certainly hope it will not be my last. I left feeling inspired by a community that, despite different roles and companies, shares a commitment to advancing microbiology in ways that protect products and patients.

Looking back to that powerless hotel room, I think of how quickly the lights came back on and how everyone carried on. That resilience, curiosity, and dedication define not just this conference but also the people like the ones present this week who keep raising the bar in pharmaceutical microbiology.

To the PMF organizers and attendees: thank you for reminding me that our industry’s real power lies not just in the data or the tools, but in the community we build.