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Root cause investigation for pharmaceutical water systems

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In their 21CFR guidance, the FDA emphasise the importance of corrective and preventative action (CAPA) for any deviations potentially impacting product quality. Regulatory authorities expect manufacturers to investigate deviations take corrective action, put in place interventions to prevent recurrence of the deviation and to assess the effectiveness of those interventions. Without adequate root-cause investigation, the success of those interventions is questionable.

However, TOC or conductivity contamination events can be transient in nature. This transient nature makes root-cause investigations difficult as it is not easy to get a sample of the excursion as there is not enough time to do so. However, this rapid disappearance may mask the increasing biofilm build up until there is a breakdown of system control and run-away microbial contamination.

In this paper, we discuss some typical sources of contamination in water systems and how root-cause investigations can be supported using on-line Total Organic Carbon (TOC) analysers.

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