Purified water systems that stay in control.
Water is the first ingredient in most consumer products, and a common source of microbial problems. Claraxis brings hands-on experience leading a USP purified water system modernization.
The problem
Why water deserves its own attention
Water-borne organisms drive recalls
Seven recalls in the last three years named water-borne organisms such as Burkholderia, Pseudomonas and Achromobacter.
Investigators look at it first
FDA wrote 14 observations on objectionable-microorganism controls in non-sterile drug plants (21 CFR 211.113(a)) in the last 12 months.
Small drifts become big events
Rising micro counts, missed sanitizations and dead legs often show up in the data before they show up in product.
How Claraxis helps
What Claraxis reviews and improves
- System design, dead legs and distribution loop condition
- Sanitization method and frequency
- Sampling plan, point coverage and trending
- Alert and action limits, and excursion response
- Operational dashboards that make the system visible
- Modernization planning and validation readiness
- Led a USP purified water system modernization and built an operational dashboard.
- Primary site FDA contact; hosted FDA inspections and quality audits.
- Plant Manager of a global R&D pilot manufacturing center (2021–2025), supporting 350+ scientists.
Roles held before founding Claraxis Group.
Questions
Do you design water systems?
Claraxis supports owners operationally: reviewing performance, controls and data, and leading modernization projects with your engineering partners and suppliers.
What does a water review look like?
A site visit to walk the system, a look at sampling and trend data, and a short ranked list of risks with owners.
Where can I see current water recalls?
Claraxis tracks them on the USP Water Watch section of FDA Watch.
Related
Start with the real challenge.
A 30-minute call, then a written scope before any commitment. Kobe replies personally within one business day.