In the past months, there were hot discussions about the topics
'water' and 'pure steam' at USP. Some new monographs will be published,
existing ones will be changed. This will inevitably lead to questions
like:
- How big is the impact on pharmaceutical waters and steam?
- How big is the impact on existing systems and plants?
- How to interpret the monographs correctly?
Especially text passages in the monograph USP <1231> were
recently misinterpreted in leading industry journals, which could finally
confuse the end user group.
In the following we have compiled first pieces of information on the
changes:
USP <644> Conductivity
The measurement of conductivity is controversially described within EP
2.2.38 with regard to the equipment used as well as the formerly
recommended calibration solutions. However, USP never had a Monograph
dedicated to conductivity. This is changing, and the Monograph <644>
will cover the requirements on conductivity within USP. It clearly
describes the measurement as well as the correct calibration procedures
for instrumentation and the cell constant.
USP <1231> Water for Pharmaceutical Purposes
The content of USP <1231> changed during the past years. The
latest chapter gives rise to enhanced discussions and considerations about
storage and distribution, sampling, sanitisation and other critical topics
in a water purification system. It can help in checking and improving
existing validation procedures as well as in establishing a URS for a new
water system. The nature of the Monograph is highly technical and supports
engineering as well as QA.
USP <1232> Instrumentation for Analysis of High-Purity
Pharmaceutical Waters
TOC is one of the critical parameters in pharmaceutical waters. But
which technology to prefer out of a variety of different instruments? And
for which application? USP <1232> keeps the focus on the differences
between analytical instruments for TOC monitoring and also highlights the
conductivity requirements. For the first time, it also gives advice on the
frequency of calibration to the end-user group.
<Pure Steam>
Steam has a wide range of applications in the pharmaceutical industry.
But how do you define your steam? Is it "Clean Steam" or is it
"Pure Steam"? Steam never had an accepted definition within the
pharmaceutical industry globally. The USP Monograph brings more light into
this discussion and clearly defines the requirements on High-Purity Steam.
Author:
Stefan Raabe
Mettler-Toledo THORNTON
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