Pharmacopoeia Compliance: USP <1231>, EP 0169, ChP 2015, JP XVII for WFI conductivity (<1.3 µS/cm), TOC (<500 ppb), and bacterial endotoxin (<0.25 EU/mL).
Regulatory Certifications: FDA 21 CFR Part 211, EMA Annex 1, WHO PQ, GAMP 5 for computerized systems.
Validation Protocols: Full DQ/IQ/OQ/PQ packages with SAT/FAT testing, including media fills, endotoxin challenge tests, and worst-case recovery studies.
Design Specifications: Multi-effect falling film or climbing film evaporation, vapor compression options for energy savings, and SIP/CIP automation.
Material and Safety Standards: FDA/USDA approved seals (EPDM, FKM), sanitary tri-clamp fittings (ASME BPE), and overpressure relief per SIL 2.
Environmental Compliance: RoHS, REACH, and energy-efficient designs reducing CO2 emissions by up to 40% versus single-effect systems.
Quality Assurance: 100% factory hydro-testing at 1.5x design pressure, helium leak detection (<10^-6 mbarL/s), and third-party witnessing available.
Everheal's Multi Effect Distilled Water Machine Manufacturer processes incorporate risk-based FMEA analysis and annual audits, guaranteeing audit-ready performance worldwide.