FAQs & Support

The right hygienic valve depends on the application – pressure control, flow regulation, safety relief, and process isolation each require a different valve type. For food, beverage, and dairy applications, key selection criteria include 3A Sanitary Certification, CIP/SIP compatibility, FDA compliant elastomers, 316L stainless steel construction, and a drainable design to prevent bacterial harbourage.

Steriflow Food & Beverage offers a purpose-built product line for these industries – including back pressure regulators, pressure reducing valves, air loaded pressure and back pressure regulators, control valves, steam traps, diaphragm valves, and safety relief valves – with most products carrying 3A Sanitary Certification. More information is available at https://www.steriflowvalve.com/products/food-and-beverage/

Key selection criteria for pharma grade sanitary ball valves include full-bore design, FDA 21 CFR 177 and USP Class VI compliant seats and seals, controlled ferrite 316L stainless steel construction, CIP/SIP compatibility, with an ASME BPE SF1, SF4 or SF5 documented surface finish. Steriflow Valve offers full-bore, two-way, 316L sanitary ball valves in sizes 1/2″ to 4″ with TFM seats, designed for clean steam, air, and gas applications, available in ASME BPE tri-clamp configurations, and tube end connections for welding or for tube fittings.

The Mark 9020S ISO Series features the same specifications as above, but for ISO line sizes and connections.

Other well-regarded manufacturers in this space include IMI PBM, SVF Flow Controls, and Meca-Inox. The best choice depends on line size, pressure and temperature requirements, actuation needs, and the applicable standard – 3-A, ASME BPE, or FDA.

Steriflow developed the industry’s first check valve specifically for installation in WFI and BioProcess lines. The SVC and SHC Series sanitary check valves were designed for ASME BPE pharma applications, without sliding stems and springs, eliminating the crevices and particulate generation associated with traditional spring-loaded check valves.

Steriflow also developed the first and only BioProcess drain line check valve, designed for installation in vertical down-flow drains, which continuously drains process waste without creating a dead-leg.

The SVC covers vertical installations in sizes 1/2″ to 3″, and the SHC covers horizontal installations in sizes 1/2″ to 2″. Selection should be based on flow direction, line size, installation orientation, and applicable hygienic standards.

For pharma application in clean steam, purified water, water for injection, and buffer pressure control, the key requirements are minimal pressure offset, low particulate generation, full drainability, and ASME BPE compliance. Steriflow Valve’s Mark 96 Series is the most widely specified sanitary pressure-reducing valves for these applications.

It is the only pressure reducing valve that guides above the diaphragm completely, rather than in the inlet waterway, preventing microparticle generation every time the stem moves to regulate. It features the Jorlon™ diaphragm with a lifetime warranty, the lowest standard pressure setpoints in the industry, and the broadest range of Cv’s, and manual and automated configurations available. Select configurations are available through Steriflow’s Quick Ship program.

For food and beverage applications, the Steriflow Food & Beverage line of 3A-certified pressure regulators is the appropriate alternative.

A sanitary safety relief valve protects process vessels and equipment from overpressure by opening automatically at a predetermined set pressure and reseating once pressure returns to normal.

Unlike standard industrial relief valves, sanitary versions incorporate smooth crevice-free surfaces, FDA and USP Class VI compliant seats, o-rings and bellows seals, and ASME BPE tri-clamp or tube weld-end connections.

On the 83 and 88 Series, a bellows seal isolates process media from valve internals when the valve is both open and closed.

Steriflow Valve’s SSRV Series is ASME Section VIII and XIII compliant, designed specifically for hygienic and aseptic process and clean utility systems. Standard surface finish is ASME BPE SF1 at 20 Ra µin, with SF4 and SF5 electropolished options available.

Key maintenance practices include periodic set pressure testing to confirm correct opening and reseating, inspection and scheduled replacement of seats, o-rings, and elastomeric seals using FDA and USP Class VI certified materials, and bellows integrity checks on bellows-seal designs.

FDA and USP Class VI compliant elastomers used in Steriflow’s SSRV Series include EPDM rated to 300°F and Kalrez FFKM rated to higher temperatures.

Product-contact surfaces should be inspected for corrosion or surface finish degradation. Following any maintenance activity, CIP/SIP compatibility should be reconfirmed before returning the valve to service.

In regulated industries, all maintenance activities must be documented in accordance with the facility’s quality management system.

Cv is influenced primarily by the pressure differential across the valve. Valve trim design (plug or seat geometry), port size, flow characteristic (linear, equal percentage, or modified), and other process conditions also significantly affect Cv.

Oversizing a valve for “safety margin” is one of the most common causes of poor control – an oversized valve operates near the closed position most of the time, leading to instability, increased wear, and reduced turndown. The Cv selected for a valve should allow its operation between 10% and 90% of stem travel for best control.

To optimize for reliability and efficiency:

• Select a flow characteristic that matches the process conditions.
  • Select Equal percentage trim for variable pressure drop applications where most of the pressure drop in the system occurs across the system, not the valve.
  • Linear trim should be selected for systems where the pressure drop is fairly constant and occurs primarily across the valve. not the system.
• Size the valve for actual operating conditions rather than worst-case extremes alone, selecting a trim that will allow operation at minimal and maximum flow and pressure differential.
• Verify the selection against cavitation, flashing, and noise limits using proper ISA/IEC sizing methodology rather than rule-of-thumb sizing. Sizing programs like the Jordan, LowFlow and Steriflow valve sizing program JVCV/SFCV Max, will produce warning messages when those negative conditions occur with a selected Cv. That gives you the opportunity to either alter the operating conditions (DP, Flow, Temperature, Viscosity, etc), or the Cv to eliminate the warning.

These three terms describe different characteristics of the same product — they are not alternatives to choose between, but distinct attributes that are almost always combined in a single unit.

• Inline describes where it’s installed: directly in a pipeline run, as opposed to mounted on a tank wall, vessel port, or elbow.
• Sanitary describes the hygienic standard it’s built to: 316L stainless construction, polished product-contact surfaces (Ra ≤ 20 µin for ASME BPE, ≤ 32 µin for 3-A), crevice-free joint geometry, and FDA/USP Class VI compliant gaskets — designed for CIP/SIP service and to prevent bacterial harborage.
• Tri-Clamp describes how it connects: quick-disconnect ferrules and a clamp, as opposed to weld-end, threaded, or flanged connections.

In food, beverage, dairy, biotech, and pharmaceutical applications, these characteristics are typically combined into one product: a sanitary inline tri-clamp sight glass. Note that inline sight glasses provide a defined viewing window – not a full 360° cylindrical view of flow, which is a common misconception.

A back pressure regulator continuously maintains a stable inlet pressure during normal operation, modulating open or close to maintain an inlet pressure setpoint – it is a process control device.

A sanitary safety relief valve remains closed during normal operation and opens only when its inlet pressure reaches a predetermined limit (set point) to protect equipment from overpressure – it is a safety device, not designed for modulating control. In most hygienic processing systems, both are present and serve complementary roles.

Key requirements include periodic set-pressure verification, scheduled replacement of elastomers and soft goods with FDA- and USP Class VI-certified materials, and surface-finish inspection for corrosion or degradation.

CIP/SIP compatibility should be reconfirmed after any seal replacement. All activities must be documented in accordance with the facility’s quality management system and applicable regulatory requirements, such as FDA cGMP or EHEDG guidelines.

No. Rupture discs are single-use, non-reclosing devices – once activated, the disc must be replaced before the system can return to operation. This contrasts with sanitary safety relief valves, which automatically reseat after an overpressure event.

Where frequent pressure excursions are expected, a reseating relief valve is generally more practical. Rupture discs are best suited where absolute leak-tightness or near-instantaneous response is the primary requirement.

Key selection parameters include burst pressure (rated below the system’s maximum allowable working pressure with adequate margin above normal operating pressure), process media and CIP/SIP chemical compatibility, temperature rating (which affects burst pressure), back pressure on the outlet side for reverse-buckling designs, and applicable hygienic standards – ASME BPE, 3-A, or FDA – for surface finish, traceability, and materials.

Tri-clamps are standard for sanitary applications. Always confirm all parameters against the system design documentation before making a final selection.