■ 24 NOV/DEC 2013 | PHARMACEUTICAL PROCESSING
Analyzer concentrated on three areas.
1. The stabilizing thermal conditions.
2. Increasing the radiation density.
3. Optimizing the sample flow in the system.
The technical solutions presented have verifiably improved the
precision and accuracy of direct UV-oxidation.
Moreover, the exacting requirements of the pharmaceutical industry, with reference to the standards for calibration and verification
were specifically taken into consideration during the development.
All of these technical innovations are present in the instrument
AMI-Line-TOC from SWAN Analytical. The TOC-Analyzer is cutting
edge technology and can cope with future demands.
PW Purified Water
UPW Ultra-Pure Water
WFI Water for Injection
TC Total Carbon
TIC Total Inorganic Carbon
TOC Total Organic Carbon
Verification: Is the process of checking that a product, or system
meets specifications and that it fulfills its intended purpose
Validation: Is defined as the documented act of demonstrating
that a procedure, process, and activity will consistently lead to the
Calibration: Operation under
specified conditions that first
establishes a relation between
the quantity values with mea-
surement uncertainties provided
by measurement standards and
corresponding indications with
associated measurement uncer-
tainties and then, in a second
step, uses this information to
establish a relation for obtaining
a measurement result from an
NOTE: Calibration should not
be confused with adjustment of a
measuring system, often mistak-
enly called “self-calibration”, nor
with verification of calibration.
NOTE: Often, the first step
alone in the above definition is
perceived as being calibration.
Adjustment: Set of operations
carried out on a measuring
system so that it provides pre-
scribed Indications correspond-
ing to given values of a quantity
to be measured.
NOTE 2: Adjustment of a mea-
suring system should not be con-
fused with calibration, which is a prerequisite for adjustment.
NOTE 3: After an adjustment of a measuring system, the measur-
ing system must usually be recalibrated.
USP <643> Volume 32
USP <645> Volume 32
USP <1231> Volume 32
EP 2. 2. 38 / 2005
EP 2. 2. 44 / 2005
Automated Release of Water Using On-Line TOC Analysis and FDA
Risk-Based cGMP, Inspection and PAT Principles. By Richard Codec
and Nissan Cohen ISPE Vol. 25 No.1
ABOUT THE AUTHOR
After 8 years of employment in various pharmaceutical companies
in Switzerland, Roger Schmid joined Mettler-Toledo. He worked in
sales and key account management, specializing in pharmaceutical
and biotech industry projects. In 2008 he moved to Australia to work
as a product application specialist. He then joined Swan Analytical
Instruments, Switzerland in 2009. As Product Manager, he was
responsible for the development process of the online TOC analyzer
and associated instruments for the pharmaceutical industry. Since
2010 he has been the Industry Application Manager for UPW and
pharmaceutical product lines at Swan. ■
Pioneering Continuous Thermal Solutions
Process Development, Testing & Equipment
Increase your product quality, decrease your risk and costs!
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Micro Thermics, Inc / www.mtibiopharm.com / +1 919 878 8045
Reduced Validation / Increased product quality
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Completely Uniform product within & between batches
Figure 10: Swan AMI Line TOC‘s straight
and user-friendly structure.