Metrohm NIRS XDS MasterLab Analyzer - Manual (Page 150)

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Wavelength Accuracy, Photometric Certification, and Wavelength Certification. These factory tests
are performed under controlled, ideal conditions, and serve as an important baseline for all
subsequent testing.
Test results are included for each module or configuration ordered. These test results are included in
an informative brochure that explains the tests, what they measure, and how they relate to
instrument performance. The Instrument Test Guide and the user instrument test results form the first
part of the instrument log recommended by regulatory bodies.
Installation and Operating Qualification Documents
Laboratory-based Industrial instruments come with Installation Qualification (IQ) and Operating
Qualification (OQ) Documents included as part of the Vision® Spectral Analysis Software package.
These documents are presented in checklist fashion, to guide the user through each step of
instrument set-up and qualification.
NIRStandards® for Instrument Performance Verification
Various regulatory agencies recommend regular
testing of NIR reflectance instrumentation to
verify continuing stability of photometric and
wavelength response. These reflectance
standards include Metrohm IPV® Software. It
records "first use" instrument response, and
permits regular verification of subsequent
response to the original measurements.
NIRStandards are designed for easy use with all Metrohm reflectance instruments used in the
pharmaceutical industry, and most instruments used in other industries. They are calibrated on our
Master Instrument for use with the Instrument Performance Certification Program.
Note that most regulatory documents do not address tablet analyzers (as of this release) and provide
minimum information on transmission testing. Metrohm NIRSystems has established suitable
procedures to verify correct instrument operation.
Instrument Performance Certification
The United States Code of Federal Regulations, Title 21, requires regular testing, as well as periodic
testing of a deeper nature to assure instrument response and reliability. Instrument Performance
Certification (IPC) is offered to meet these requirements. It is performed every six (6) months, on site,
by a certified technician. Some key program features:
Measures instrument response using standards calibrated to Metrohm Master Instrument
• Assures consistent response between instruments of identical design.
Performed by factory-trained service personnel
• Periodic maintenance is performed on-site to assure consistent ongoing performance.
Serves as Installation Qualification and Operating Qualification for new instrument installations
• Meets CFR 21 requirements for instrument qualification.