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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