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ABB-KT/449

Date:


ABB LAUNCHES SPECIAL-PURPOSE ANALYSER

FOR PHARMACEUTICAL INDUSTRY

A new, special-purpose on-line conductivity analyser system from ABB Kent-Taylor provides the pharmaceutical industry with an early solution for compliance with new US regulations.


Pharmaceutical companies wishing to sell into the US market must now satisfy the FDA on compliance with ‘Pharmacopoeia 23’ - the new legislation governing the quality requirement for pharmaceutical process waters. With the development of its special-purpose 4623 and 4628 Conductivity Analyser systems, ABB is one of the first analytical instrument manufacturers to meet this new requirement.


Conductivity, a key parameter for measuring water quality, is traditionally analysed with automatic temperature compensation, referencing back to 25oC. Under the new regulations - geared to reduce the level of manual conductivity analysis - these measurements are required to be non-temperature compensated. The instruments, however, must also be capable of displaying the temperature and temperature compensated values for information purposes. Traceable test certificates validating the

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instruments’ conformity are required for presentation to FDA inspectors when necessary.


A unique feature of the new ABB analysers is the optional ‘moving setpoint’ facility. Conductivity differs according to temperature and, with the new ABB facility, the conductivity setpoint automatically changes to provide an alarm status corresponding to changes in the water temperature. This has been achieved by incorporating data from the regulation tables into the instrument’s software, thus freeing users from manually having to establish compliant temperature compensated values through the use of cross-reference charts.


The advanced ABB 4623 and 4628 on-line conductivity instruments are fully compliant with the US Pharmacopoeia 23. They incorporate the required 2-inch Tri Clamp stainless steel cells and validation certificates are supplied as standard.


The new analysers further extend the ABB 4600 Series of high-performance analyser systems covering reliable and accurate measurements of conductivity, pH, dissolved oxygen and turbidity in a variety of applications world-wide.


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