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RE: When should we passivate to remove rouge?

Dear Robert,

>  Are there any test methods for quantifying the degree of rougeing?
we know no test methods für quantifying the degree of rougeing,
you have to make a visual rating of the surface.

>  Are there any published standards with defined
>  metrics or criteria that specify when passivation
>  should be performed, or is it subjective for each
>  location based upon the inspector?
No, I don´t know any standard.

>  At what point, between a new/clean tank and the
>  observation of flaking rouge, does it become
>  necessary to (re)passivate?
Usually the whole systems shows rouging, and not only
a tank, a piping or an other part of the system. Normally
you can only passivate the whole system.

>  > What sort of methods, criteria, and intervals are
>  other pharmaceutical organizations using to
>  determine the need to re-passivate?
There are some procedures that are published,
e.g. Collentro - pharmaceutical water, or Meltzer -
Pharmaceutical Water Systems.

Kind regards
Thomas Peither
thomas.peither@gmp-publishing.com

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