PathO₃Gen Solutions

05/01/2026

The FDA PreCheck Pilot Program is changing what it means to build a compliant pharmaceutical facility in the U.S.

Launched in February 2026, the program gives new domestic manufacturing facilities early engagement with the FDA — technical advice, pre-operational reviews, and a clearer path through inspection — before a single product ships.

The goal: less regulatory uncertainty, faster routes to market, and a stronger U.S. pharma supply chain.

For facilities entering the program, every element of your hygiene and contamination control infrastructure is going to be scrutinized from day one.

That includes your entry points.

Dry shoe sanitation — automated, consistent, zero liquid introduction — is exactly the kind of control that holds up under that level of scrutiny.

Building a new facility? It's worth getting the fundamentals right from the ground up.

Learn more at: patho3gen.com

04/30/2026

Still relying on liquid solutions for shoe sanitation?

Chemicals need to be mixed to the right concentration. Solutions need to be changed at the right frequency. That means the effectiveness of your entry point hygiene depends entirely on whoever's doing it — and whether they got it right that day.

Dry shoe sanitation like UVZone reduces the variability of manual interventions.

Automated. Consistent. No mixing, no monitoring. Every single person who walks through gets the same shoe treatment — regardless of shift, staff, or how busy the floor is.

In food safety, consistency isn't a nice-to-have. It's the whole point.

04/30/2026

04/28/2026

Still using shoe covers? Automated footwear sanitizing offers a simple, standardized fix: step on, step off, consistent at every transition point. See the true cost of disposable shoe covers with our cost calculator: patho3gen.com/calculator/

04/27/2026

USP 797 compliance starts at the door

Maintaining cleanroom integrity is non-negotiable in pharmaceutical compounding and manufacturing. But one of the most common contamination risks walks right in — on your staff's shoes.

"To help improve our compliance with USP 797 and minimize the risk of pathogens contaminating our cleanroom, we added PathO3Gen Solutions' shoe sanitizing station to our action plan. Our last air and surface samples were negative for any growth in both rooms." — Jeffrey Miley, Pharm. D.

If your contamination control strategy doesn't adequately address footwear, it has a gap. UVZone® stations are plug-and-play, work in seconds, and create a disinfection checkpoint that works the same way every single time — automatically.

How does your facility handle footwear contamination control?

04/24/2026

Every step can carry contamination forward. The UVZone shoe sanitizing station helps turn a weak point in your hygiene program into a visible, active control step.

To learn more, visit patho3gen.com/

04/23/2026

Is Footwear the Missing Link in your Infection Control Protocol?
Floors and shoes are one of the most overlooked vectors of contamination. A no-touch shoe sanitizing station fits naturally into workflow while helping reduce contamination risk from shoes and floors.

Wondering if Shoe Sanitizing Stations could help your facility? Watch the link below.

3 likes. "The Missing Link"

04/22/2026

Your gowning protocol has a blind spot. And it's right under your feet.
In pharmaceutical and compounding environments, we control air, surfaces, hand hygiene, and gowning with precision. But shoes contact everything the floors collect (dust, residue, microbial burden) then carry it forward with every step.

Most facilities acknowledge this with a disposable shoe cover - but is that really the best option? In our blog this week, we ask the question "Can We Do Better with Floors and Shoes?"

Read the full article here: patho3gen.com/blog/can-we-do-better?

04/21/2026

The average pair of shoes carries 800,000 CFUs of bacteria.
Transfer rate from shoes to floors? 90–99%.
And if even one pathogenic cell makes it onto your production floor, it can replicate to 1,000,000 cells in an average of 6.6 hours – within a single shift.
How are you addressing shoe-borne contamination in your facility?

If you're ready to learn more about our patented UVZone® Shoe Sanitizing Stations, visit: patho3gen.com/

04/20/2026

Nobody in your facility thinks footwear contamination is their problem. That's exactly why it stays unresolved. Hospital leadership sees it as a consumable cost. Quality leaders see a compliance checkbox. Facility directors see something managed by policy rather than practical engineering.

Everyone acknowledges it. Nobody owns it.
Meanwhile, shoes are crossing zone thresholds all day, carrying whatever the floor collected with them.
We broke down what this problem looks like from each seat at the table, and what a real fix might look like.

Read the breakdown here: patho3gen.com/blog/can-we-do-better?

04/17/2026

EU GMP Annex 1 is clear: personnel are a primary contamination risk in sterile pharma manufacturing and reducing human intervention is now a regulatory expectation, not just a best practice.

The guidance calls directly for automation, isolators, and barrier systems to minimize human touchpoints across every stage of sterile manufacturing. Facilities that still rely on procedural compliance alone are increasingly exposed during inspections.

The UVZone Shoe Sanitizing Station automates footwear sanitization at every personnel entry point and fully aligns with the automation-first framework Annex 1 demands.

Want to Learn More? patho3gen.com/industries/pharmaceutical/

04/16/2026

FSMA's Preventive Controls rule is clear: facilities must identify hazards, implement preventive controls, and verify they are working. If your contamination control program doesn't effectively address what's walking in at every shift change, that's a gap and experienced auditors know where to look.

UVZone Shoe Sanitizing Stations placed at key entryways close that contamination gap, providing a consistent, verifiable and documentable preventive control.

Learn more about UVZone Shoe Sanitization at: patho3gen.com/industries/food-manufacturing/