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10.15.2025 |

When specifying valves for sanitary, pharmaceutical, food, biotech, or any application involving product contact, it’s critical to ensure they meet FDA requirements and hygienic design standards. Below is a guide, based on CleanFLOW™ valve features, on what to check and how to verify compliance.

Materials & Certifications

One of the first steps is verifying that all components in product contact areas are made of FDA-compliant materials. In the CleanFLOW valve series, all materials comply with FDA, USDA and 3A requirements. Additionally, for hygienic integrity, manufacturers often use 316L stainless steel for critical parts like the stem and the ball.

 

Surface Finish Requirements

Surface finish critically affects how easily a valve can be cleaned and whether residues, bacteria, or particulates can cling to its surface. The CleanFLOW valves’ interior standard finish is 15 Ra, with electro-polishing options as low as 5 Ra available. 

A lower Ra (roughness average) indicates smoother surface; sub-10 Ra is commonly required in hygienic applications. Always request documentation or test reports confirming the actual finish.

 

Sealing & Seat Design

Valve seat design must be hygienic and avoid entrapment zones (places where fluids can stagnate). The CleanFLOW series uses TFM1600 seats with a non-slotted, hygienic design that eliminates entrapment areas, reduces particle generation, and lowers torque. 

Make sure the valve has proper sealing and that seat materials are FDA-compatible and rated for the intended temperature and chemical exposure.

 

Cleanability & Drainability

A key requirement is that the valve be fully cleanable (CIP/SIP) and drainable. CleanFLOW valves feature a “Tube-ID” design, meaning the port opening matches adjacent tubing dimensions, enhancing predictable flow, cleaning performance, and full drainability. 

Also, check whether the valve provides purge ports (integral bosses) to support CIP (Cleaning-in-Place) or SIP (Sterilization-in-Place). CleanFLOW includes optional purge ports.

 

Connections & Welding Integrity

In hygienic systems, connections must preserve the sanitary design. CleanFLOW valves have fully encapsulated body seals so that in-line welding can occur without disassembly, maintaining sealing integrity through the process.

Also, verify that end connections like tri-clamp, tank pad, compression ends, or extended Tube-ID are available and well-matched to your process piping to avoid dead legs or crevices.

 

Verification Checklist

Before final selection or installation, confirm the following:

  • All product contact materials declared as FDA, USDA, 3A compatible
  • Supplier provides a Certificate of Compliance (CoC) or test report for material standards
  • Interior surface finish in Ra, with confirmation of ≤ 15 Ra (or better) where required
  • Seat design avoids entrapment zones, e.g. non-slotted TFM1600 or equivalent
  • Valve design supports full cleanability and drainability (Tube-ID, purge ports)
  • Weldable and encapsulated body seals if welding is required post-installation
  • Match end connections to process piping hygiene standards (tri-clamp, etc.)

By following this guide, you can confidently validate that “FDA approved valves” are not just marketing terms, but meet rigorous hygienic design expectations for product contact zones.

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