Metrohm NIRS Analyzer PRO - Manual (Page 8)

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The Analyzer PRO vides non-destructive analysis of
chemical and pharmaceutical products directly in
the process line, without use of a bypass loop.
Because most materials can be measured directly,
with no need for sample dilution or preparation,
the material can be measured as produced, with
no loss of end product.
Operation of the Analyzer PRO is through
Metrohm Vision™ software, which is robust,
powerful, and easy to use. This validated software
package meets all 21 CFR Part 11 requirements,
and comes with a test script to prove compliance
for internal regulatory personnel. Combined with
normal customer procedures for network and user
access, all 21 CFR Part 11 requirements are met.
Vision provides excellent tools by which to develop an analytical model for sample prediction. The
NIR sample information is correlated with quantitative lab data from the primary analysis method,
and a predictive model is used to report values for ongoing sample analysis.
Communication between instrument and computer is by Ethernet line, using standard connectors.
Commands use a proprietary, encrypted language which is not susceptible to hacking, support of
viruses, or other means of hacking. Only authorized operators may communicate with the Analyzer
PRO instrument, and only by valid entry through Vision.
Measurements may be displayed in a control room area on the computer screen as they are reported
in the Routine Analysis section of Vision. Provision is made for digital electronic transfer to most
supported plant controller languages.
Use of the Analyzer PRO helps to optimize the use of raw materials by ongoing measurement in real
time. This permits adjustment and correction of the process to target values, eliminating or
minimizing waste product. The Analyzer PRO fits into Process Analytical Technology (PAT) planning,
in support of recent FDA process initiatives.
Precise instrument matching enhances method development, minimizes implementation efforts, and
ensures straightforward calibration model transferability between analyzers.