BioPharma - Water Distribution and Sterilisation (SIP)
The purest water is created. It is now kept in a storage tank until water is needed somewhere in the production process. Pure water is not only used for production. The plant (tanks, reactors, pipes, etc.) are regularly sterilised with steam. Of course, this steam itself must also be sterile and is therefore generated from sterile water.
Sterile is sterile - ozonisation takes care of it!
The pure water leaves from the storage tank in a circulation pipe to (part of) the production. This is tapped at places where water is needed, the so-called "Points of Use”. The rest eventually returns to the storage tank. Shortly after the storage tank, the water is initially disinfected with ozone. The excess ozone is then converted back into oxygen by means of UV light. Monitoring and control of this circulation line is obviously necessary.
TOC
Possible organic contamination is detected with a Total Organic Carbon (TOC) analyser. Given the importance of this analysis, it is very important to have a very fast and continuous response time. Classic analysers have an analysis time of up to 6 minutes or more. That is far too long and you do not know what happens between two measurements. An analyser that measures continuously gives you the security you are looking for.
Bioburden – RMS
The only way to determine bacterial contamination is to measure it. A "Real-Time Microbial System" constantly analyses the water flow. Each individual bacterium is detected! These "Bioburden" analysers replace the expensive and time-consuming (up to more than 5 days) lab analysis.
Ozone, O3
For sterilisation, you need ozone that’s created on site. The ozone oxidises every organic molecule and kills all bacteria. The excess ozone is broken down again into oxygen. Of course, it’s necessary to check whether the concentration of the newly created ozone is sufficient and whether all excess ozone has been broken down again. Usually an additional ozone measurement is placed on the return line.
SIP – Sterilisation In Place
For the sterilisation of the installations, the pure water is turned into sterile steam. This steam, or rather its condensate, is analysed again by a TOC analyser and a Bioburden analyser. Sterilising (SIP) with non-sterile steam is unthinkable.
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