In sanitary manufacturing, compliance isn’t just a box to check—it’s essential for market access, product safety, and operational integrity. At Duva Sanitary, we work with certified manufacturing partners who meet industry-specific and international regulatory standards, ensuring the components we provide align with the expectations of global markets.
What Regulatory Compliance Means in Practice
Across the food, beverage, pharmaceutical, and biotech industries, regulatory compliance affects everything from surface finish and weld quality to documentation and traceability. These requirements protect public health and enable manufacturers to operate across borders with confidence.
Key Regulatory Standards That Shape Sanitary Manufacturing
International Standards (ISO)
ISO 9001 and similar frameworks promote quality consistency and process control. Our partners often follow these guidelines to ensure a reliable, well-documented production process.
3A and BPE Certifications
For food and pharmaceutical applications, compliance with 3A Sanitary Standards and ASME BPE (Bioprocessing Equipment) is critical. These certifications validate that components meet hygiene, cleanability, and material safety requirements.
FDA and GMP Compliance
In regulated industries, components must be suitable for use in systems that follow Good Manufacturing Practices (GMP) and meet FDA expectations. That includes traceability, documentation, and validated performance.
Why It Matters
- Product Safety: Compliance ensures materials and designs meet hygiene standards
- Global Market Access: Certified components help meet export requirements
- Regulatory Readiness: Supporting documentation streamlines audits and inspections
- Operational Integrity: Ensures that systems run safely and predictably
What to Consider When Planning for Compliance
- Certification requirements by region or industry
- Traceability of materials and production batches
- Cleanability and surface finish specs
- Compatibility with CIP/SIP and other sanitation processes
Duva Sanitary’s Role in Regulatory Support
We supply sanitary components from partners who follow documented, third-party-audited processes. Whether your systems are bound for food, dairy, pharma, or biotech use, we help ensure every valve, fitting, and assembly meets the standards required for safe, compliant operation.