According to USP Chapter <1058>, Analytical Instrument Qualification is “the collection of documented evidence that an instrument performs suitably for its intended purpose”.
Whilst mensuration or calibration is an important part of the qualification process, it does not in itself qualify the whole inhaler testing system for use.
The Installation Qualification/Operation Qualification Documentation (IQ/OQ) provided by Copley Scientific guides the user through this important process and confirms that the system is fully qualified for use.
The documentation concerned is designed to qualify the complete test system including the test apparatus (DUSA or cascade impactor), vacuum pump, critical flow controller (where applicable), flow meter and/or any other accessories that form part of the inhaler testing system.
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