Ynto Diaphragm Valve application in a WFI (Water For Injection) system

Zero Tolerance for Leakage: Protecting a Critical WFI Loop

In the pharmaceutical industry, Water for Injection (WFI) is the lifeblood of production. It is the solvent used for making parenteral drugs (drugs injected directly into the body), meaning its purity is not just a quality issue—it is a patient safety issue.

Recently, a mid-sized biopharmaceutical manufacturer in Southeast Asia approached Ynto with a critical problem. They were facing recurring "bio-burden" spikes in their distribution loop, forcing them to halt production frequently for heat sanitization.

The Challenge: Micro-Leakage and Dead Legs

Upon inspecting their existing system, our technical team identified the culprit. The facility was using cast-body diaphragm valves from a generic supplier. Over time, thermal cycling (the shift from cold WFI to hot steam for sanitization) had caused microscopic warping in the valve bodies.

Furthermore, the internal surface roughness of these older valves had deteriorated. This created "dead legs"—tiny pockets where biofilm could attach and grow, protected from the cleaning velocity of the water. They needed a solution that could withstand high-frequency SIP (Steam-in-Place) cycles without compromising seal integrity.

The Solution: Forged Integrity

We proposed a retrofit using the Ynto Sanitary Diaphragm Valve (Forged Series).

Why the switch from cast to forged? Forging compresses the molecular structure of the 316L stainless steel, making it significantly denser and more resistant to thermal expansion and corrosion.

● The Membrane: We utilized our premium PTFE/EPDM composite diaphragms. These are designed to separate the process fluid from the actuator mechanism completely. The backing cushion ensures that the diaphragm presses evenly against the weir, ensuring a bubble-tight seal every time.

● The Surface Finish: Our valves were electropolished to an Ra value of < 0.4µm. This mirror-like finish ensures that bacteria have nowhere to hide.

Implementation and Results

The client replaced the critical point-of-use valves with our specialized pneumatic diaphragm valves. We also recommended upgrading their flow regulation points. By integrating our Control Valves, they achieved stable pressure management throughout the loop, preventing pressure surges that could damage the new diaphragms.

The results after three months were definitive:

1. Bio-burden Spikes Eliminated: The WFI loop passed every sterility test with zero excursions.

2. Reduced Downtime: Because the valves drained perfectly (thanks to the optimized weir angle), the CIP/SIP cycles were faster.

3. Seamless Integration: The new valves were compatible with their existing Electric Valve control system, minimizing installation time.

The Ynto Difference

This case highlights why "good enough" isn't enough in sterile processing. A valve might look simple, but its engineering dictates the safety of your final product. Whether you are managing a complex WFI loop or a simple transfer line requiring a Manual Valve, the integrity of your components is paramount.

Are you facing similar contamination risks? Contact Us or browse our Products to discuss how we can secure your process.