Stable Water Quality Output, Low Operational Costs
After-Sales Service:
24/7 Technical Support, 2-Year Maintenance
Industry Standard:
GMP
Microorganism:
< 10 CFU/100mL
TOC:
≤500 Ppb
Packaging Details:
export standard wooden case
Highlight:
50m3/H ultrapure water systems
,
Automated ultrapure water systems
,
50m3/H pure water treatment plant
Product Description
Thorough Purification 50 m³/h sterile preparation Water Purifier Filter with Electrodeionization Module
I.Overview
Ultrapure water (UPW) plays a critical role in the preparation of sterile formulations (such as injectables, eye drops, and biopharmaceuticals), with its extremely high purity being a core element in ensuring product safety, efficacy, and compliance. From system design (compliant with ASME BPE standards), real-time monitoring, to strict GMP management, every step must ensure that water quality consistently meets the “zero-tolerance” standards for microbial/chemical contamination.
II.Process Raw Water → Pre-treatment → Double-stage RO Reverse Osmosis → Continuous Electro-deionization (EDI) → Dual-wavelength UV Disinfection → Membrane Degassing Unit → High-temperature Distillation → High-temperature Recirculation Distribution → Final Filtration
III.Key Quality Indicators (Real - time Monitoring)
Parameter
Pharmacopoeia Standard
Actual Control Requirement
Microorganism
< 10 CFU/100mL
< 1 CFU/100mL
Endotoxin
≤0.25 EU/mL
≤0.001 EU/mL
Conductivity (25°C)
≤1.3 μS/cm
≤1.0 μS/cm
TOC
≤500 ppb
≤50 ppb
IV.Core Functions: As a Solvent or Carrier Dissolving Active Pharmaceutical Ingredients (APIs): UPW serves as the primary solvent for dissolving sterile APIs or lyophilized powders. Dilution and Volume Adjustment: Used to precisely adjust formulation concentration to target specifications. Cleaning Critical Components: Equipment directly contacting pharmaceutical solutions, such as formulation tanks, piping, and filters, must be cleaned with UPW to prevent contamination.
V.Optimization for Special Applications Biologics: Incorporate TFF (Tangential Flow Filtration) to remove nucleases. ADC (Antibody-Drug Conjugates): Heavy metal control (Cu²⁺ < 0.1 ppb). mRNA Vaccines: DNase/RNase-free certification (terminal ultrafiltration material selection).
VI.Here is a guideline for you to get a proper quotation
Tell us the raw water/source of water(tap water, well water, or sea water, etc) Provide water analysis report(TDS , conductivity, or resistivity, etc) Required production capacity( 5m³/H, 50m³/H,or 500m³/H, etc) What's the pure water used for( industrial,Food and Beverage,or agriculture, etc )
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