How Trusted Data Unlocked Growth for Leading EtO Sterilization Facility

With the data-driven strategy implemented by leadership, the effect was immediate and dramatic. Trusted data poured in, and for the first time, the facility saw a clear picture of its emissions – one that told a very different story than the legacy monitoring systems. The existing LESNI catalytic oxidizer, it turned out, was performing extraordinarily well. Over the course of normal operations, Picarro’s system measured EtO levels going into and out of the oxidizer and calculated an actual DRE that stunned everyone. The oxidizer was destroying 99.99934% of EtO and yielding stack concentrations of barely 1–2 ppb – essentially zero from any practical perspective. This wasn’t just a hair better than required – it was an order of magnitude beyond the EPA’s mandate of 99.99% DRE.

The revelation carried immediate financial and strategic consequences. The $15 million earmarked for a new abatement system was swiftly taken off the table. With regulatory compliance now assured by empirical continuous monitoring results, there was simply no need to invest in redundant abatement hardware. Instead, those funds were redirected to core operations – specifically, expanding sterilization capacity. The company ordered new sterilization chambers and increased its EtO throughput, confident that it could scale production with data that they knew would reassure stakeholders both internal and external to the facility.

By the numbers, the facility’s environmental performance went from uncertain to undeniably world-class, and capital that was about to be sunk into “just-in-case” control devices was freed up for growth.

Perhaps the most profound change was qualitative: uncertainty was replaced with visibility and confidence – from employees who long believed there was an emissions issue to local communities who couldn’t get a clear answer on risk. With continuous monitoring in place, staying within emissions limits became a worry-free aspect of daily operations – practically compliance on autopilot. Instead of scrambling to hire a consultant for data analysis and quarterly reporting or fearing surprise EPA inspections, the facility staff could pull up a live dashboard at any moment and show anyone exactly what was (or rather, wasn’t) coming out of their stack as they achieved near-zero EtO emissions. This level of transparency not only satisfied regulators; it actively rebuilt trust with skeptical stakeholders. Community members, who had been alarmed by past false reports, could breathe easier knowing the facility was making the right decisions. Internally, company employees and leadership alike felt a weight lifted: the data was no longer something to dread. As the EPA has noted, requirements for continuous emissions monitoring and reporting are designed to provide assurance to both agencies and communities that emissions are under control – and that burden, once seen as impossible, was fully realized here.

Freed from chasing operational risk issues associated with bad data, the company refocused on its core mission: producing safe, sterile medical devices at scale. The reallocated $15 million financed additional capacity that enabled the company to process a higher volume of products, reducing bottlenecks in the healthcare supply chain. In an era when sterilization demand is rising (and alternatives to EtO remain limited for many critical devices), this additional throughput can have a direct impact on the market.

By embracing a data-first approach, the sterilization leader transformed a compliance cost center into a growth enabler. It proved that when you eliminate operational uncertainty, you unlock the headroom to shore up a sterilization process and expand further. No longer bogged down by public concern, the leadership could plan for the future – opening new sterilization lines - knowing that their environmental controls were solid.