Pharmaceutical manufacturers are rethinking contamination control as advanced therapies, automation, and modular cleanroom strategies reshape production. In this conversation, Lisa Stasi, VP and GM of Ecolab Life Sciences, explains why proactive bio-decontamination, right-sized cleanroom grades, and data-driven decision-making are becoming essential for pharmaceutical manufacturing resilience, compliance, and speed-to-market.

When Contamination Strikes: Speed and Strategy Matter

"I'll share an example that really demonstrates what's at stake," Lisa begins. "We had a large pharmaceutical manufacturer facing microorganisms spreading rapidly through their facility with an unknown source. Production was drastically reduced, and they were looking at a 10-day manual disinfection effort."

She explains that the challenge wasn’t just about eliminating contamination, it was identifying the source and reaching contamination in hard-to-access production equipment. “We deployed more than 30 automated bio-decontamination generators on-site with a one-day response time. But here’s what made the difference: we expanded the scope beyond cleanrooms to include stairs, elevators, and HVAC surfaces, areas not routinely cleaned where organisms create challenges.”

The result? Three days of downtime instead of ten. "But what I'm most proud of is what happened next," Lisa adds. "The facility implemented an annual automated bio-decontamination service plan. They shifted from reactive firefighting to proactive contamination control. The predominant bacteria species involved often endure standard disinfection, so this preventive approach was critical for their long-term success."

The Economics of Right-Sizing Cleanroom Environments

The pharmaceutical industry is investing heavily in Grade C and D cleanrooms. We asked Lisa what's driving this strategic shift.

"There are three major drivers," Lisa explains. "First, flexibility and speed to market. Modular cleanrooms reduce capital expenditures by up to 30% and are operational in weeks rather than months or years. Companies can deploy Grade C operations now and scale to Grade A or B later if required. It's about building what you need today while planning for tomorrow."

The economics are equally compelling. “Pharmaceutical cleanrooms consume up to fifteen times more energy than commercial buildings, with over 50% going to HVAC,” Lisa notes. “Not every process requires Grades A or B. Grades C and D handle less critical manufacturing stages but can house Grade A environments like isolators, delivering significant operational savings while maintaining product quality. It’s really about right-sizing the environment to the risk. “Lisa also points to the growth of advanced therapies. “ATMP growth drives demand for smaller-scale, flexible manufacturing. Many ATMP processes operate at smaller volumes due to personalized therapies, reducing the need for expansive cleanroom spaces. Grade C and D facilities with modular designs enable rapid deployment of distributed manufacturing networks, critical for personalized medicine.”

Cell and Gene Therapy: A New Contamination Control Paradigm

With cell and gene therapies transforming the industry, we asked Lisa about the new opportunities for contamination control innovation.

"Personalized manufacturing scale is fundamentally different," Lisa emphasizes. "Cell and gene therapies are shifting to personalized, patient-specific production. Managing multiple batches simultaneously, each critical to an individual patient, requires flexible, modular contamination control systems that isolate and protect parallel processes without cross-contamination risk."

She highlights another critical challenge: “Autologous therapies introduce human biological material into cleanrooms, elevating contamination risks in both directions, protecting product from environment and protecting operators and other products from biological hazards. We’re innovating closed-system processing, advanced barrier technologies, and enhanced biocontainment strategies to address these dual challenges.”

Beyond Products: Supporting Change with Expertise

In an industry constantly pushing for continuous improvement, we asked Lisa how Ecolab Life Sciences supports customers through change management.

“It's about dedicated expertise, not just products,” Lisa responds. “In highly regulated pharma, lack of internal resources often obstructs change. Our Global Technical Consultants, pharmaceutical microbiologists with cleanroom expertise, provide expert guidance and implementation support to drive operational excellence, compliance, and timely regulation implementation.”

The support is comprehensive. “Our Change Management program delivers customized plans through our digital platform. Our experts review processes, provide SOP guidance, and outline the right chemistry efficacy and regime. We handle documentation, validation, and training so customers can focus on their core business.”

Lisa also emphasizes the role of digital tools. “By evaluating equipment performance, production yields, and labor data, manufacturers can identify inefficiencies. This shifts the approach from reactive problem-solving to predictive, data-driven decision making.”

Setting the Record Straight on Automation

We asked Lisa about common misconceptions she encounters regarding cleanroom automation.

"The first misconception is that automation is only about replacing people," Lisa says. "In reality, it removes human variation and eliminates a huge contamination source, machinery generates far less contamination than humans. It's about elevating people from routine tasks to higher-value work requiring specialized skills and judgment."

She continues: "Another misconception is that automation requires a complete overhaul. It's all-or-nothing thinking. Successful implementations use phased approaches, pilot projects, refinement, then scaling. Companies start manual and move toward automation as products approach approval. Start small, prove value, scale strategically. Evolution, not revolution."

The biggest misconception? "That technology replaces expertise. The opposite is true," Lisa insists. "Automation amplifies expertise, handling repetition with precision while freeing experts for optimization, troubleshooting, and continuous improvement."

From Vendors to Strategic Partners

Finally, we asked Lisa how the relationship between pharmaceutical manufacturers and their technical partners has evolved.

"The relationship has evolved from transactional purchasing to strategic partnership," Lisa reflects. "Manufacturers now seek partners who understand long-term business objectives, not just immediate technical needs. At Ecolab Life Sciences, we're involved in strategic planning discussions, helping shape clients' roadmaps and operational strategies for years ahead."

This shift has enabled something powerful. "Manufacturers no longer receive off-the-shelf solutions, they're co-creating them. We see deeper collaboration where clients bring operational insights and we bring technical expertise, developing customized solutions that address specific industry challenges. This drives real innovation that benefits the entire industry."

The Path Forward

As pharmaceutical manufacturing continues to evolve, with personalized medicines, advanced therapies, and increasing automation, Lisa's perspective is clear: success requires more than just products and technology. It requires strategic partners who bring deep expertise, digital capabilities, and a genuine commitment to co-innovation.

The shift from reactive problem-solving to proactive, data-driven strategies represents not just a technical evolution but a fundamental change in how manufacturers approach operational excellence. And as Lisa's insights reveal, those who embrace this transformation, with the right partners alongside them, will be best positioned for the future.

To learn more about Ecolab Life Sciences’ contamination control, cleanroom and bio‑decontamination solutions for pharmaceutical manufacturing, visit www.ecolab.com/lifesciences.