In pharmaceutical manufacturing, maintaining the integrity of water systems is critical to product safety. A key requirement under EU GMP Volume 4, Clause 6.9 is the use of turbulent flow in water distribution systems to prevent microbial adhesion and biofilm formation. However, verifying this condition in real time—without compromising hygiene or system performance—has long posed a challenge.
Hanley Technology offers a cutting-edge solution through the deployment of FLEXIM non-invasive ultrasonic flow meters. These clamp-on devices measure flow from the outside of the pipe, eliminating the need for process interruptions or equipment that meets high-purity water.
Meeting Regulatory Demands with Precision
Clause 6.9 mandates not only the design of water systems to maintain turbulent flow—commonly defined by a Reynolds number > 4000—but also requires routine monitoring and documented validation. FLEXIM meters enable compliance by delivering:
High-accuracy, non-invasive measurement of flow velocity—even in small-bore pipes or at low flow rates.
Real-time data logging and alerts, supporting proactive GMP documentation and corrective actions.
Portable or fixed installations, ideal for both qualification and ongoing system verification.
Real-World Impact: Proven Results
In one case, a leading EU biopharma company installed FLEXIM meters on their WFI (Water for Injection) return loop. Following implementation, the system continuously demonstrated Reynolds numbers above the turbulent threshold. As a result, water quality deviations were reduced by 35%, and regulatory audit readiness was significantly improved.
Why Choose FLEXIM for Pharmaceutical Applications?
Feature GMP Benefit
Clamp-on ultrasonic design Zero risk of contamination
Onboard flow trending and alarms,
Meets “routine monitoring” requirements,
Accurate across PW, WFI, and loop systems,
Supports diverse pharma processes,
Data traceability & audit support,
Facilitates Clause 6.9 documentation.
Future-Proofing Compliance
Biofilm prevention is not a one-time task—it requires continuous assurance of turbulent conditions. With FLEXIM ultrasonic meters, pharmaceutical manufacturers can meet the evolving expectations of GMP regulators, avoid costly deviations, and protect patient safety—all without interrupting production.