Ozone is a strong oxidizing agent that is able to kill microorganisms particularly effectively, thus making it possible to disinfect water safely and effectively. Ozone has been used to treat drinking water for over 130 years. Ozonization is an effective method with an increasing trend towards the sanitization of ultrapure water in pharmaceutical and semiconductor production as well as other treated waters. However, ozone is also a highly toxic gas for humans and poses a health risk at high concentrations. In order to ensure that the ozone concentration remains within safe limits during cold sanitization and that there is no overdosing of ozone, ozone measurements should be carried out regularly. In addition to the theoretical principles, the generation of ozone, the possible applications and the correct installation in the water system, this presentation will also look at the technology behind the ozone sensors.

The determination of the bacterial content in purified water and water for injection purposes was previously based almost exclusively on time-consuming laboratory tests based on cell cultures. However, plate counting, which has been practiced for over 130 years, is an estimation of bacteria with high variability. This is based on the visual counting of a colony of cells. The pharmaceutical industry estimates that over 80 % of false positive results are due to human error. These offline tests are costly and time-consuming. Results are usually only available after many days. The latest technical developments enable accurate, timely and comprehensive measurements of contamination by microorganisms and inert particles in pharmaceutical water systems. This enables trending and faster intervention in the event of a decline in quality. In addition to the legal requirements and the historically evolved status quo, this presentation will also consider future-oriented technology.

Conductivity measurement has been a tried and tested electrochemical measurement method for many years and, after pH measurement, is the most frequently used in industrial measurement technology. It has been used in practice for over 100 years. Conductivity measurement is essential for monitoring the quality of water for pharmaceutical purposes. Inline measurements in real time provide constant information on conductivity and temperature. Permanent data recording is thus possible and ultimately serves quality assurance. Compared to offline measurement, inline measurement is simpler and more cost-effective and helps to avoid errors during sampling, handling and transportation. In addition to the theoretical basics, the underlying measuring principle, the influence of temperature and the corresponding temperature compensation will be explained in this presentation. The requirements of the pharmacopoeia for measurement technology, be it limit values or requirements, as well as the latest developments in the form of digital sensors will also be covered.

The monograph "Water for Injection" (WFI) of the European Pharmacopoeia Ph. Eur. has been revised and no longer prescribes the production of WFI by distillation. WFI may now also be produced cold using alternative methods (reverse osmosis, electrodeionization). The advantages for operators of production, storage and distribution systems for pharmaceutical water are significantly lower operating costs. The cold production, storage and distribution of water for injection reduces operating costs, but places higher demands on the analytics used. Seamless quality monitoring is essential. Online TOC analysis is increasingly gaining ground against potentially error-prone offline laboratory analysis and offers many advantages in terms of measurement technology and the associated analysis costs. In this presentation, all aspects of online TOC determination in water for pharmaceutical purposes will be dealt with in a compact form.

Flow cytometry has long been established for determining microbiological quality in a wide variety of applications. In this presentation, a system will be presented for the first time that uses this technology online and almost in real time to monitor production plants for pharmaceutical water. The successful primary validation proves that all intact germs including the so-called VBNC (viable but not culturable) are detected. Robust, reliable and low-maintenance.