Sanitary Industry Standards Reference

Compliance with international standards is essential for sanitary valves and fittings. This reference guide covers the key standards governing the design, manufacture, and testing of hygienic fluid system components.

3-A Sanitary Standards

3-A Sanitary Standards specify design criteria for equipment used in food, dairy, and beverage processing. Key requirements include: crevice-free construction, self-draining capability, surface finish Ra <= 0.8 um, and CIP cleanability. 3-A certification is widely recognized in North America.

FDA 21 CFR 177

The FDA (U.S. Food and Drug Administration) regulates materials that contact food products under Title 21 CFR Part 177. This covers material composition, extractables limits, and acceptable uses for food contact surfaces.

ASME BPE

ASME BPE (Bioprocessing Equipment) standards govern the design, materials, fabrication, and inspection of equipment for biopharmaceutical manufacturing. Includes specifications for surface finish (SF1-SF5), orbital welding, material traceability, and dimensional standards for tube and fittings.

DIN Standards

DIN 11850 (tube dimensions), DIN 11851 (sanitary unions), and DIN 32676 (tri-clamp connections) are European standards commonly used in food and pharmaceutical applications. DIN standards define dimensional specifications for interchangeability.

ISO Standards

ISO 2037 (stainless steel tubes for food industry), ISO 2852 (tri-clamp couplings), and ISO 9001 (quality management systems) provide international specifications for sanitary components and manufacturing quality.

Compliance Verification

ONEMO products are manufactured to meet applicable standards. Material certificates (EN 10204 3.1), surface finish measurement reports (Ra), and dimensional inspection reports are available upon request.

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