Finally Official: New USP Monograph on Pure Steam

GMP News No. 687

GMP News
9 March 2006
 
Finally Official: New USP Monograph on Pure Steam
 
As we reported in our GMP News of 13 September 2005, the USP29 includes several new requirements on pharmaceutical water and pure steam. These changes had been intended for the beginning of 2006, however, they have not yet been implemented according to schedule.

Now it is a fact that the monograph on pure steam will become official. It will be published in supplement 1 to USP29 on 1 April 2006. There will not be any tolerance period for the implementation.

The monograph itself is not very extensive. However, its interpretation provides enough material for discussion, e.g.

  • whether non-condensable gases have to be quantified according to USP,
  • whether the percentage of humidity of the steam has to be determined,
  • how non-condensable gases have to be measured at all,
  • where the steam is used and
  • which requirements there are on the steam quality.

Furthermore, the measuring methods represent a discussion point that has not had any significance for steam up to now, but which will be an integral part of quality inspections starting from April.

Author: 
Stefan Raabe
Mettler-Toledo THORNTON

Source: United States Pharmacopeia (USP) Web page http://www.usp.org/products/USPNF/


 

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