Hygienic SS316L valves, CIP-compatible centrifugal pumps and FDA/USP Class VI elastomer seals for food, beverage and pharmaceutical process lines. Surface finish (Ra), triangulation and electropolishing are documented on every order — the details a hygienic audit actually checks.
Each requirement below drives a specific material, design or documentation choice — miss any and the item fails inspection, or fails in service.
Crevices, dead legs and un-drainable low points harbor bacteria that a CIP (clean-in-place) cycle cannot reach — the design has to eliminate them, not just use the right material. Sanitary butterfly and diaphragm valves with full-bore, self-draining geometry are the category default.
Crevice-free · Self-drainingElastomers need FDA 21 CFR 177.2600 or USP Class VI compliance for food/pharma contact, and equipment design is checked against 3-A Sanitary Standards (US) or EHEDG guidelines (EU) — paperwork a hygienic auditor asks for by document number, not by description.
FDA · 3-A · EHEDG · USP VITri-Clamp (ASME BPE), DIN 11851 and SMS fittings are not interchangeable — mixing standards on one line forces adapters that become the next crevice problem. Connection standard has to be fixed project-wide before the first fitting is ordered.
Tri-Clamp · DIN 11851 · SMSWetted surface finish (commonly Ra ≤0.8µm, electropolished for pharma) affects both cleanability and product adhesion, and pharma GMP requires batch traceability on every wetted component, not just the main vessel.
Ra ≤0.8µm · GMP traceableFeed the working condition into the selector below and the bundle in the next section is what a compliant spec resolves to.
SS316L sanitary butterfly valves give the crevice-free, self-draining geometry hygienic audits require, in a connection standard (Tri-Clamp) that is near-universal in food/beverage lines.
CIP-compatible centrifugal pumps run the clean-in-place cycle through the same wetted path as production, avoiding a separate flush circuit and the dead-leg risk it introduces.
FDA/USP Class VI elastomer gaskets are the one component touching product at every joint — the compliance document has to be on file per batch, not assumed from the valve's overall listing.
Electropolishing is added for pharma-grade duty where surface finish requirements exceed standard mechanical polish — it is a cost step taken only where the spec demands it, not a default.
| Parameter | Typical range | What we select | Driver |
|---|---|---|---|
| Body material | SS316 / SS316L | SS316L (low carbon, weld-friendly) standard | Hygienic weld integrity |
| Surface finish | Mechanical / electropolished | Ra ≤0.8µm food; electropolished pharma | Cleanability & product adhesion |
| Connection standard | Tri-Clamp / DIN 11851 / SMS | Fixed project-wide, matched to existing line | Interchangeability, avoid adapter crevices |
| Elastomer | EPDM / Silicone / FKM | FDA / USP Class VI certified compound | Product contact compliance |
| Pump seal | Mechanical seal, CIP-rated | Single or double mechanical seal | CIP cycle compatibility, no dead leg |
| Documentation | Material cert + compliance letter | Batch-traceable for pharma GMP | GMP audit requirement |
The six line items below are what a typical package resolves to. Request the bundle as one RFQ — we quote, consolidate and ship under a single bill of lading, with documentation matched across all items.
| Line | Item | SKU | Key spec | Material | |
|---|---|---|---|---|---|
| 01 | SS316L Sanitary Butterfly Valve — product transfer isolation | PF-SBV-316L-DN50 | DN25–DN100, Tri-Clamp, Ra ≤0.8µm | SS316L | Details → |
| 02 | Sanitary Diaphragm Valve — CIP circuit & dosing | PF-SDV-316L-DN25 | DN15–DN50, Tri-Clamp, crevice-free | SS316L / PTFE diaphragm | Details → |
| 03 | Hygienic Centrifugal Pump — product & CIP transfer | PF-HCP-316L-DN40 | flow 8 m³/h, head 25 m, CIP-rated seal | SS316L wetted parts | Details → |
| 04 | Tri-Clamp Fitting Set — line distribution | PF-TC-316L-50 | DN25–DN100, ASME BPE | SS316L | Details → |
| 05 | FDA/USP Class VI Gasket Set — joint sealing, product contact | PF-GK-FDA-50 | EPDM / silicone, FDA 21 CFR 177.2600 | EPDM / silicone | Details → |
| 06 | Surface Finish & Batch Cert Package — documentation for GMP audit | PF-DOC-GMP | Ra report + material batch cert | n/a | Details → |
Each item ships with the certification its destination and standard demand. See the full material selection guide for body/seat alloy detail across all categories.
| Standard | Scope | Where it applies in this bundle |
|---|---|---|
| FDA 21 CFR 177.2600 | Food-contact elastomer compliance (US) | All product-contact gaskets & seals |
| 3-A Sanitary Standards | Hygienic equipment design standard (US dairy/food) | Valve & pump geometry, surface finish |
| EHEDG | European Hygienic Engineering & Design Group guidelines | Equipment design for EU-bound food/beverage lines |
| USP Class VI | Biocompatibility standard for pharma-contact elastomers | Elastomers on pharmaceutical API transfer lines |
| ISO 9001 | Quality management system | All partner factories across the bundle |
| Material 3.1 | Mill material certificate, batch traceable | SS316L wetted components, pharma GMP requirement |
A dairy processor upgrading a product transfer line needed sanitary valves and a CIP-compatible pump matched to its existing Tri-Clamp fitting standard, with FDA documentation ready for the next hygiene audit.
Scope: SS316L sanitary butterfly valves for product transfer isolation, a hygienic centrifugal pump with CIP-rated mechanical seal, and FDA 21 CFR-compliant EPDM gaskets at every joint.
All wetted components were supplied with surface-finish reports and material batch certificates, consolidated into a single shipment aligned to the line's planned shutdown window for installation.
FDA 21 CFR documentation · Ra-verified finish · single shutdown-window delivery
The same checks our engineers run before quoting a package for this duty.
One RFQ covers every item in this solution. We select, price and consolidate the bundle, and reply within 12h in EN / RU / ES / AR.