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Business Field

Water for Biopharmaceutical

We Provide optimized Solution for water treatment system in Bio-Phamaceutical industry, that is available to meet the
Requirement of the U.S. Pharmacopoeia and Korea Pharmacopoeia.

SOLUTION

Purified Water Generation
Storage & Distribution
Water For Injection Distillation
Pure Steam Generation

SCOPE OF WORK

Project Design & Execution
Quality & Execution Plan
Technical Service
Installation & Commissioning
Validation

PW SYSTEM

Conceptual Design / Basic Design / Detail Design

KEY DESIGN PHILOSOPHIES
- Suitable Process
  - Water Conductivity
  - Total Organic Carbon
COMPONENTS
- Softner & Filter
- Degassing Membrane
- Ion Exchanger Columns
- Reverse Osmosis
- EDI

Parameter	Unit	USP	Ph.Eur
TOC	ppb C	≤500	≤500
Conductivity	㎲/㎝@20℃	-	≤1.1
Conductivity	㎲/㎝@25℃	≤1.3	-
Nitrate(NO3)	ppm	-	≤0.2
Aerobic Bacteria	CFU/100ml	≤10	≤10
Bacterial Endotoxins	EU/ml	≤0.25	-
Bacterial Endotoxins	I.U./ml	-	≤0.25

WFI & PS

KEY DESIGN PHILOSOPHIES
- Suitable Process with Distillation
  - Bacterial Endotoxin
  - Microbial Growth
COMPONENTS
- WFI Generator
- PS Generator

Parameter	Unit	USP	Ph.Eur
TOC	ppb C	≤500	≤500
Conductivity	㎲/㎝@20℃	-	≤1.1
Conductivity	㎲/㎝@25℃	≤1.3	-
Nitrate(NO3)	ppm	-	≤0.2
Aerobic Bacteria	CFU/100ml	≤10	≤10
Bacterial Endotoxins	EU/ml	≤0.25	-
Bacterial Endotoxins	I.U./ml	-	≤0.25

PROCESS OF WATER FOR BIOPHARMACEUTICAL

REFERENCE
- - US Pharmacopia - Purified water by distillation or a purification process that is equivalent or superior
    to distillation in the removal of chemicals and microorganisms
  - European Pharmacopoeia - Purified water by distillation
  - Japanese Pharmacopia - Distillation or Reverse Osmosis-Ultrafiltration
  - Canadian GMPs - Produced by Distillation or RO
  - ISPE Guide Line Volume 4 - Water and Steam System