Root Cause Investigation For Pharmaceutical Water Systems
Root cause investigation for pharmaceutical water systems
Credit to: https://www.beckmancoulter.com/
Introduction
In their 21CFR guidance, the FDA emphasize 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. For example, a water system that is experiencing gradual biofilm build up may experience TOC excursions in the distribution loop just after sanitisation cycles as biofilm sloughs off the inside of the pipework. This excursion in the distribution loop can quickly disappear
by being diluted as the water passes into the large quantity of water in the storage tank, or by being oxidised and broken down by UV lamps connected to the distribution network put in place to discourage microbial build-up. 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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