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 :
|
Flow and pressure
0.95 < title < 0.99 |
FILTERED | Softened from 0 to 7° df
+ Anti-corrosion filming amines |
Black steel
Energy :
|
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 :
|
Flow and pressure
0.95 < title < 0.99 Condensates: GMP January 2000
|
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 :
|
Flow and pressure
0.95 < title < 0.99 Condensates:
|
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 :
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*:
|
* These 4 quasi-normative elements are recommended by the profession to qualify a Pure Steam Generator