APR March 2021 - 33

VENDOR VIEWPOINT

Pharmaceutical Grade Water
Monitoring - The Story of Total
Organic Carbon
Michelle Neumeyer
Life Sciences Product Applications Specialist for
the Sievers line of Analytical instruments
SUEZ - Water Technologies & Solutions

Water quality is a common thread among pharmaceutical manufacturers striving to meet
minimum standards for different applications. Whether used as a raw material or for processing,
formulation, reagents, intermediates, and/or cleaning, water is fundamental to GMP processes
and must be monitored as such. USP <1231> Water for Pharmaceutical Purposes defines
different types of water alongside minimum water quality requirements for those waters.
USP <1231> also introduces design, installation, operation, performance, maintenance, and
monitoring requirements that support validation and qualification of a water system.
Once a water system is validated, routine monitoring must occur on a designated frequency
to ensure control of the system and acceptable water for intended use. Sampling locations,
frequency, and attributes being sampled and tested should be based on the validation as well
as criticality of the water. These tests may include microbial analysis, endotoxin, total organic
carbon (TOC), conductivity, nitrates (EP), and pH. Unlike microbial testing, some chemical tests
can be conducted online to avoid sampling, such as TOC and conductivity analysis.
TOC and conductivity are critical quality attributes that must be monitored to ensure
appropriate water for use in GMP manufacturing. While the requirement for monitoring
these quality attributes is discussed in USP <1231>, USP <643> Total Organic Carbon and
USP <645> Conductivity mandate the explicit testing and sample acceptance criteria. When
choosing technology for water monitoring of TOC and conductivity, it is compulsory to meet
the requirements outlined in the compendia. For example, USP <643> requires that TOC
technology must have a specified limit of detection of 0.05mg/L C or lower, must be able

Michelle Neumeyer is the Life
Sciences Product Applications
Specialist for the Sievers line of
Analytical instruments at SUEZ
- Water Technologies & Solutions. Previously,
Michelle worked in Quality at Novartis and
AstraZeneca, ensuring compliant water
systems, test methods and instrumentation.
Michelle has a B.A. from University of
Colorado, Boulder in Molecular, Cellular and
Developmental Biology.

to demonstrate system suitability, and must be able to discriminate between the inorganic
carbon resulting from atmospheric CO2 that could be present in a given sample and the CO2
generated from oxidation of the sample itself.
An important consideration to make when choosing technology is how the TOC is actually
measured and reported from a sample. The vast majority of online TOC instruments employ
conductivity as a means to measure carbon. Sievers TOC Analyzers, such as the Sievers
M500, are carbon analyzers, wherein a gas-permeable membrane separates interfering
compounds from CO2 to allow for accurate measurement of carbon. This technology instills
confidence in the accuracy and precision of the measurement. Whereas sensors work by
33
American Pharmaceutical Review | March 2021



APR March 2021

Table of Contents for the Digital Edition of APR March 2021

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Manufacturing
Microbiology
Equipmet Focus
Microbiology
Vendor Viewpoint
QC Corner with Millipore Sigma
Manufacturing
Biopharmaceutical Development
Biopharmaceutical Development
Manufacturing
Microbiology
Manufacturing
Separation and Purification
P.I.N. Points
Advertiser's Index
APR March 2021 - Cover1
APR March 2021 - Cover2
APR March 2021 - 1
APR March 2021 - 2
APR March 2021 - 3
APR March 2021 - 4
APR March 2021 - 5
APR March 2021 - Editor's Message
APR March 2021 - 7
APR March 2021 - Editorial Advisory Board
APR March 2021 - 9
APR March 2021 - CN Perspectives
APR March 2021 - Social Media Connections
APR March 2021 - Manufacturing
APR March 2021 - 13
APR March 2021 - 14
APR March 2021 - 15
APR March 2021 - 16
APR March 2021 - 17
APR March 2021 - 18
APR March 2021 - 19
APR March 2021 - Microbiology
APR March 2021 - 21
APR March 2021 - 22
APR March 2021 - 23
APR March 2021 - 24
APR March 2021 - Equipmet Focus
APR March 2021 - Microbiology
APR March 2021 - 27
APR March 2021 - 28
APR March 2021 - 29
APR March 2021 - 30
APR March 2021 - 31
APR March 2021 - 32
APR March 2021 - Vendor Viewpoint
APR March 2021 - 34
APR March 2021 - 35
APR March 2021 - QC Corner with Millipore Sigma
APR March 2021 - 37
APR March 2021 - Manufacturing
APR March 2021 - 39
APR March 2021 - 40
APR March 2021 - 41
APR March 2021 - Biopharmaceutical Development
APR March 2021 - 43
APR March 2021 - 44
APR March 2021 - Biopharmaceutical Development
APR March 2021 - 46
APR March 2021 - 47
APR March 2021 - Manufacturing
APR March 2021 - 49
APR March 2021 - 50
APR March 2021 - 51
APR March 2021 - 52
APR March 2021 - 53
APR March 2021 - 54
APR March 2021 - 55
APR March 2021 - Microbiology
APR March 2021 - 57
APR March 2021 - 58
APR March 2021 - 59
APR March 2021 - Manufacturing
APR March 2021 - 61
APR March 2021 - 62
APR March 2021 - 63
APR March 2021 - 64
APR March 2021 - Separation and Purification
APR March 2021 - 66
APR March 2021 - 67
APR March 2021 - 68
APR March 2021 - 69
APR March 2021 - P.I.N. Points
APR March 2021 - 71
APR March 2021 - Advertiser's Index
APR March 2021 - Cover3
APR March 2021 - Cover4
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