A clean surface isn’t always a safe surface. In controlled environments—whether in pharmaceutical manufacturing, biotech research, or medical device production—disinfectants must do more than wipe away dirt. They must eliminate the microbial threats that jeopardize product integrity, regulatory compliance, and ultimately patient safety. At Eurofins Crown Point, our Disinfectant Efficacy (DE) Studies provide clients with the data and confidence they need to validate cleaning protocols and ensure their facilities remain under control.

DE Studies are designed to qualify disinfectants in real-world applications. Our team doesn’t just test products in a vacuum; we replicate the actual cleaning procedures of your facility. From surface sprays to floor mopping, we simulate the way disinfectants are applied and challenge them with relevant organisms.

We test against industry-recognized microorganisms—often referred to as the “fab five”:

• Mold
• Yeast
• Gram-positive cocci (common skin organisms)
• Gram-negative rods (water-loving organisms)
• Spore-forming rods (the most difficult to eradicate)

Additionally, we incorporate client-specific environmental monitoring isolates to create a tailored program that mirrors the unique conditions of your facility.

To demonstrate efficacy, disinfectants must achieve at least:

• 3-log reduction for vegetative organisms
• 2-log reduction for mold and spore formers

This rigorous approach ensures confidence in both compliance and safety.

Crown Point’s DE services are ISO 17025 accredited and aligned with USP <1072> (Disinfectants and Antiseptics). Our procedures are also in line with EN 13697, a key European standard addressing disinfectant performance without mechanical action. This ensures our clients’ data stands up to scrutiny in multiple regulatory jurisdictions.

Sponsors often face hurdles in disinfectant validation: shipping products and isolates, managing timelines, or navigating unrealistic performance expectations. For example, some disinfectants—like 70% isopropyl alcohol—are not designed to kill spores. Our team helps clients interpret results with context, offering insights gained from years of experience so that failures can be reframed as knowledge, not setbacks.

One of Crown Point’s strongest differentiators is turnaround time. Our lab operates like a well-oiled machine, capable of executing complex studies faster than many competitors. This speed is not about cutting corners—it’s about precision planning, daily team coordination, and robust safeguards:

• Positive and negative controls
• Inoculum verification
• Duplicate plating
• Full raw data transparency

The result? Rapid, high-quality results that keep your projects moving forward and your facilities operational sooner.

Unlike larger labs where clients may feel like they’re “taking a ticket,” Crown Point provides a dedicated project manager for each study. This ensures clients always have a real person to call for updates, clarifications, or strategy discussions.

We pride ourselves on being approachable, communicative scientists who not only run the studies but also share insights from our bench-side experience. This collaborative style builds trust and helps clients anticipate outcomes, troubleshoot challenges, and plan future studies with confidence.

As the industry evolves, clients are increasingly requesting worst-case scenario testing—validating disinfectants without the benefit of mechanical action. With EN 13697 and other emerging frameworks, Crown Point is already ahead of the curve, prepared to deliver studies that reflect both current practices and future expectations.

• Proven Experience: Hundreds of DE studies executed across diverse disinfectants and surfaces
• Regulatory Alignment: Accredited to global standards including USP <1072> and EN 13697
• Rapid Turnaround: Projects completed faster without sacrificing quality or compliance
• Personal Touch: Dedicated project managers and open client communication
• Comprehensive Reporting: Final reports include background, methodology, and clear graphical data

At Eurofins Crown Point, we don’t just test disinfectants—we empower our clients to safeguard their facilities, their products, and ultimately the patients they serve.