Beckman Coulter Life Sciences -Enhancing Root-Cause Investigations in Pharmaceutical Water System Contamination Using TOC Analyzers.
The FDA’s 21CFR guidance highlights the importance of corrective and preventative action (CAPA) in addressing deviations that could affect product quality. Regulatory authorities expect thorough investigations, corrective measures, and ongoing assessment to prevent recurrence of these deviations.
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 sanitization 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 oxidized 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.
- Benefits:
ANATEL PAT700 Total Organic Carbon (TOC) Analyzers are specifically designed to help demonstrate compliance to the pharmacopeial requirements for TOC and conductivity for Purified Water and Water For Injection.
- TOC, Uncompensated Conductivity and Temperature from just one analyzer – can be fully calibrated and validated to USP<643> and USP<645>
- Low cost of ownership – 12-month service and calibration intervals
- Root-cause analysis support – water sample automatically taken if there is a TOC excursion
- All SOPs are pre-loaded into the PAT700, leading users step-by-step with on-screen pictures and prompts
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