The different water values

Water vapors in the pharmaceutical industry

The pharmaceutical or physico-bacteriological quality of water vapors explained simply and quickly in the following table comparing the name of water vapors with the type of feed water, the type of generation and its qualifying parameters.

 

TYPE Feed water Generator Qualifying parameters
INDUSTRIAL Softened from 0 to 7° df

+ Anti-corrosion filming amines

Black steel

Energy :

  • Gas
  • Fuel
  • Electric
Flow and pressure

0.95 < title < 0.99

FILTERED Softened from 0 to 7° df

+ Anti-corrosion filming amines

Black steel

Energy :

  • Gas
  • Fuel
  • Electric
Flow and pressure

0.95 < title < 0.99

Reduction in particle content depending on porosity (often 1µ)

CLEAN Treated without additives by demineralization or reverse osmosis, bacteriologically clean (< 1000 CFU/mL) Body and contact surfaces in chemically neutral material: AISI 321 stainless steel or AISI 316 L stainless steel or AISI 316 Ti stainless steel

Energy :

  • Gas
  • Electric
  • Industrial Steam
Flow and pressure

0.95 < title < 0.99

Condensates: GMP January 2000

  • Compliance: purified water
    bacteriological: < 100 CFU/mL
  • Apyrogenicity: < 0.25 EU/mL
  • Particle rate: not controlled
WHITE Intended for human consumption, food processed without reverse osmosis additives or any other technique excluding ion exchange resins, bacteriologically clean (< 1000 CFU/mL) Body and contact surfaces in chemically neutral material: AISI 321 or AISI 316 L or AISI 316 Ti stainless steel

Energy :

  • Gas
  • Electric
  • Industrial Steam
Flow and pressure

0.95 < title < 0.99

Condensates:

  • Compliance: purified water
  • Bacteriology: < 100 CFU/mL
  • Apyrogenicity: not sought
  • Particle rate: not controlled
PURE Purified* without additives

(Compliant with reference pharmacopoeias)

Body and contact surfaces in chemically neutral material: AISI 321 or AISI 316 L or AISI 316 Ti stainless steel

Energy :

  • Gas
  • Electric
  • Industrial Steam

No contamination* possible between primary and secondary fluids

Low and controlled climbing speed* to reduce priming/blistering (recommendation: < 2m/s)

 

Flow and pressure

0.98 < title < 0.99

Condensates*:

  • Compliance: Water PPI (USP WFI in force)
    Conductivity corrected at 25°C <1.3 µS/cm
    TOC < 500 ppbSterility: < 10 CFU / 100 mLApyrogenicity: < 0.25 EU/mLParticle rate:

    -10 microns: <50 /mL

    -25 microns: < 5 /mL

 

* These 4 quasi-normative elements are recommended by the profession to qualify a Pure Steam Generator

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