The technical requirements for purified water equipment usually include water quality standards, process design, materials and structures, automation control, etc., as follows:

-Water quality standard: It should comply with the purified water standard of the Chinese Pharmacopoeia 2025 edition, with a conductivity of ≤ 5.1 μ S/cm at 25 ℃, a microbial limit of ≤ 100CFU/mL, and a total organic carbon (TOC) of ≤ 0.50mg/L. Special departments such as endoscopy centers require a bacterial colony count of ≤ 10CFU/100mL.

-Process design: The pre-treatment system should include quartz sand filters, activated carbon filters, softeners, and precision filters. The core process can adopt two-stage reverse osmosis (RO) or single-stage RO+EDI process. The post-processing system is equipped with ultraviolet sterilizers or ozone disinfection devices to prevent secondary microbial contamination.

-Materials and Structure: Equipment and pipelines should be made of 316L stainless steel to avoid dead corners and blind pipe designs. The storage tank needs to be equipped with a respirator and a circulation pump to maintain a water temperature of ≤ 25 ℃ or above 70 ℃ for insulation and circulation.

-Key component parameters: The desalination rate of the reverse osmosis host is ≥ 98%, and the water resistivity of the EDI module is ≥ 15M Ω· cm.

-Automation control: Adopting PLC control system, integrating TOC, residual chlorine, and hardness online monitoring instruments, supporting remote monitoring and audit tracking functions, in compliance with GMP data integrity requirements.

-Verification and acceptance: Installation confirmation (IQ), operation confirmation (OQ), and performance confirmation (PQ) documents are required. Equipment recovery rate ≥ 75% (dual stage RO process), energy consumption ≤ 1.5kW · h/m ³, continuous operation for 2 months trial period, stable water quality up to standard.

-Safety performance: equipped with water free protection, high/low pressure protection and other devices to prevent equipment damage due to abnormal situations and ensure safe operation.