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

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

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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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