The risk of end product contamination in pharmaceutical plants can be significantly reduced by using only certified materials, especially when the material comes into direct contact with the medium. Failure to do this could hinder the reproduction of microorganisms, or even lead to the production of toxic by-products of metabolic processes.
Since it is unusual for manufacturers to disclose the material composition of pH electrodes to the user, it is of enhanced significance that Endress+Hauser is the first manufacturer of pH electrodes to offer certification of all proprietary materials according to ISO 10993-5, 'Biological evaluation of medical devices'. This certification also covers current USP25 directive 87 standards, and includes materials such as Teflon and ceramic diaphragms, various types of reference gels and the semiconductor chip used in the new generation of non-glass pH electrodes in the TopHit H family.
To further increase process safety, the TopHit H sensor with ISFET technology, in the UniFit H insertion holder, has received clean in place (CIP) and sterilise in place (SIP) certification. When installed against the flow, the pH sensor is self-cleaning, while the lack of a protection guard enables optimum sensor cleaning. The UniFit H adapter is available in standard hygienic process connections, such as the dairy fitting or TriClamp. A new, profiled seal flush also makes cleaning easier, and a DN25 connection is available for standard installations at fermenters.
The flexible sensor housing, made from polyether ether ketone (PEEK), can handle rapid temperature changes of up to 140°C during steam sterilisation. There is also no mechanical weakening of glass junctions, as is the case with glass electrodes, offering the user more economical cost of ownership, thanks to longer sensor life.
The TopHit H sensor exhibits a dual-chamber reference to further protect the system from contamination. The first chamber contains a high-viscosity KCL gel behind a ceramic diaphragm. The second chamber is filled with low-viscosity gel, which, due to its more solid structure, offers particularly high resistance to the further progression of contaminants.
The CleanFit H retractable holder can be used for fermenter applications with long process times. This enables monitoring, recalibration and steam sterilisation of the pH electrode during the process run. Another advantage is that the CleanFit H uses standard electrodes of 120 mm in length, thereby reducing installation time.
The TopCal S system from Endress+Hauser is available for fully automated pH measurement, and cleans, calibrates and sterilises either in intermittent or remote modes. Additional monitoring functions, such as 'sensor condition check' or buffer container level monitoring, simplify plant servicing and increase the operational reliability of the pH measuring point.
The TopHit H sensor with ISFET technology comes with manufacturer certification of all proprietary materials according to ISO 10993-5.
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