eBook: TOC and Microbial Detection Monitoring - 4

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THORNTON
Leading Pure Water Analytics

Batch or Continuous:

Real-time TOC measurement Real time compliance
TOC systems from METTLER TOLEDO Thornton enable
continuous assurance through unique, real-time measurement systems with complete confidence in compliance. Confidence is maintained by engineering systems
to address all globally recognized requirements of regulated waters and providing continuous measurements to
prevent undetected issues from shutting down production.
Introduction
Continuous, real-time, on-line TOC measurements, as opposed to
batch or grab samples, deliver Pharmaceutical regulated water
systems the greatest confidence in maintaining compliance with
regulatory requirements. Facility owners are provided with uninterrupted monitoring of their critical Purified Water (PW), Water
for Injection (WFI), or Highly Purified Water (HPW) systems for
continuous compliance assurance. Real-time systems also detect
upset conditions before Out Of Specifications (OOS) levels are realized. Instantaneous detection allows for remediation effort deployment before OOS conditions shut down production.
USP Guidance
USP <1231> Water for Pharmaceutical Purposes states: "Water
systems should be monitored at a frequency that is sufficient to
ensure that the system is in control and continues to produce water
of acceptable quality." USP <1231> does not quantify the frequency of measurement but only continuously monitored systems
can provide continuous assurance that inorganic, organic and

microbial contaminants are being controlled within regulatory
limits. Continuous, in-line measurement of conductivity, pH, DO,
pressure, temperature, flow and other measurements are commonly used for monitoring pure water systems. Similarly, rapid,
continuous measurement of TOC can provide an invaluable tool
when monitoring pharmaceutical waters.
Similarly, the main objective of FDA's Process Analytical Technology
(PAT) initiative is the assurance of product quality through continuous, process monitoring that provides true process
understanding.
"PAT is considered to be a system for designing,
analyzing and controlling manufacturing through timely
measurements of critical quality and performance
attributes of raw and in-process material and processes
with the goal of ensuring final product quality".
eBook: TOC and Microbial Detection Monitoring

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