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ChP/USP/EP/GMP 300L/H Deionized Water System For The Raw Water Pretreatment Of Preparing WFI
ChP/USP/EP/GMP 300L/H Deionized Water System For The Raw Water Pretreatment Of Preparing WFI
Specifications
Brand Name :
HJW
Certification :
ISO 14001,ISO 9001,CE,EPA,ChP,USP,EP,GMP
Place of Origin :
Shenzhen,Guangdong
MOQ :
1set
Price :
≤US$2105
Payment Terms :
L/C,D/P,T/T,Western Union
Supply Ability :
>300sets/month
Delivery Time :
1-7working days(depand on raw materials stocking)
Packaging Details :
export standard wooden case
Capacity :
30L/H(Customizable)
Pipes/Tanks Material :
316L stainless steel (Ra ≤ 0.6 μm) or PVDF
Disinfection Methods :
Pasteurization (80–85°C cycle) or ozone sterilization
Monitoring System :
Online conductivity meter + TOC analyzer
Documentation System :
DQ/IQ/OQ/PQ validation documents (core items for EMA/FDA audits).
Microorganism :
≤100 CFU/mL
Description

I. Overview
Deionized water (DI water) equipment plays a central role in the raw water pretreatment stage of preparing water for injection (WFI), and its quality directly determines whether the final WFI meets the stringent standards of national pharmacopoeias.
The irreplaceable role of DI water in WFI preparation: The irreplaceable role of DI water in WFI preparation, economic barriers, the cornerstone of sterility assurance, and the core of green transformation.
System selection principles:
Choose CEDI-type DI water equipment (no chemical regeneration) + 316L stainless steel high-temperature circulation system + online TOC/conductivity monitoring, and reserve an inlet interface for the distillation unit to meet FDA/EMA dynamic production review requirements

II.Main Process
Raw Water→Pretreatment→RO Reverse Osmosis→CEDI →PW Storage Tank→Distillation/Pure Steam→WFI

III.DI Water Equipment Core Section (PW Preparation)

Step Measures Parameters
Enhanced Pretreatment Ultrafiltration (UF, 0.03 μm): Remove colloids/microorganisms SDI < 3; TOC < 50 ppb; Hardness < 1 ppm
Activated carbon: Adsorb organics
Softener: Prevent scaling
Dual Desalination Primary/Secondary RO: Desalination rate > 99% Produced water conductivity < 5 μS/cm; Resistivity 5–18 MΩ·cm
CEDI: Deionization
Microorganism Control 254 nm UV disinfection Microorganisms < 10 CFU/mL
Storage tank: Heat preservation circulation (>80°C)

IV.DI Water System Critical Process Points (CPP)

Risk Point Control Measures Pharmacopoeia Compliance Basis
Microbial Growth Storage tank/pipeline > 80℃ circulation + Ozone disinfection USP <1231>: High - temperature or sterile filtration recommended
TOC Exceedance RO membrane + CEDI + Activated carbon three - stage interception EP 9.0: TOC detection is mandatory
Endotoxin Source UF ultrafiltration (Retention of substances > 10 kDa) ChP 2020: Endotoxin only tested for final products
Resistivity Fluctuation Online conductivity meter + Automatic drain valve GMP: Real - time monitoring of key parameters

V.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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ChP/USP/EP/GMP 300L/H Deionized Water System For The Raw Water Pretreatment Of Preparing WFI

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Product Detail
Brand Name :
HJW
Certification :
ISO 14001,ISO 9001,CE,EPA,ChP,USP,EP,GMP
Place of Origin :
Shenzhen,Guangdong
MOQ :
1set
Price :
≤US$2105
Payment Terms :
L/C,D/P,T/T,Western Union
Contact Supplier
ChP/USP/EP/GMP 300L/H Deionized Water System For The Raw Water Pretreatment Of Preparing WFI

Shenzhen HongJie Water Technology Co., Ltd.

Verified Supplier
1 Years
shenzhen
Since 2013
Business Type :
Manufacturer
Main Products :
Pure Water Equipment, Ultrapure Water Equipment, Reverse Osmosis Systems
Total Annual :
25000000-30000000
Employee Number :
180~200
Certification Level :
Verified Supplier
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