5-6
IRAffinity-1
Chapter 5 Maintenance and Inspection
5.1.1.4 Validation Program
The validation program inspects the FTIR condition instead of Power spectrum check.
IRAffinity-1 provides the validation programs according to the Japanese Pharmacopoeia, European
Pharmacopoeia and ASTM. Refer to the Instruction manual - validation program for detail.
Validation program for European Pharmacopoeia and Japanese Pharmacopoeia
The IRAffinity-1 can automatically execute the inspection in conformance to the European
Pharmacopoeia 5.0 and the Fifteenth Edition of the Japanese Pharmacopoeia. This inspection
evaluates the measurement data acquired by using polystyrene as sample. In this inspection, use
polystyrene with thickness of approximately 40 μm. When traceability is required in the inspection
result, separately purchase the standard sample supplied by NIST or its secondary standard, and
use it in the inspection.
The validation executed by this validation software conforms to the European Pharmacopoeia 5.0
and the Fifteenth Edition of the Japanese Pharmacopoeia. There are five validation items; power
spectrum, resolution, wavenumber accuracy, wavenumber reproducibility and transmittance
(absorbance) reproducibility. The performance of the FTIR-8400S is validated through comparison
between the measurement result and the standard value.
Validation program for ASTM
The IRAffinity-1 can automatically execute the inspection in conformance to the ASTM E1421-94
("Level Zero"). Use a polystyrene film in conformance to the Japanese Pharmacopoeia with
thickness of approximately 40 μm. When traceability is required in the inspection result, separately
purchase the standard sample supplied by NIST or its secondary standard, and use it in the
inspection.
Though the ASTM specifies the inspection technique and the contents, it does not specify the
standard values. The initial standard values are specified by SHIMADZU.
There are three parameters checked by this program: Energy Spectrum Test, One Hundred
Percent Line Test, and Polystyrene Test.
5.1.2 Periodic Inspection
The Periodic inspection is an inspection to be done once a week even if your FTIR is not operated.
• Dry indicator check This check must be done before turning ON.
• Silica gel check This check must be done before turning ON.
5.1.2.1 Dry Indicator Check
This is same as 5.1.1.1 "Dry Indicator Check". See section 5.1.1.1.
5.1.2.2 Silica Gel Check
This is same as 5.1.1.2 "Silica Gel Check". See section 5.1.1.2.
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