New USP Drafts on Pharmaceutical Water and Steam

GMP News No. 605

GMP News
13 September 2005

New USP Drafts on Pharmaceutical Water and Steam

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.

Stefan Raabe
Mettler-Toledo THORNTON

Top GMP Conference "Pharmaceutical Water Systems"
- With a guided tour of Novo Nordisk -

The recently re-elected chairman of the USP Water Quality Expert Committee, Dr. A.C. Bevilacqua, will inform you about the latest USP developments at this conference.

Further top speakers, e.g. EDQM expert Peter Castle, will bring you up to date on the current GMP requirements!

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