Enaps

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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

    Feedwater - Preparation/softening - pw production - Storage - Distribution
  • 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