Qualification of Non-Compendial Equipment

If the equipment is a commercial product, the installation and operational qualifications can be obtained from the equipment vendor. This would include the vendor specifications and 

The dissolution fluid flow characteristics should consist of a predictable pattern that is free of irregularities or variable turbulence. Observations of the product dissolution behavior are critical when choosing a dissolution apparatus. If there are aberrant or highly variable data that can be attributed to the apparatus, then it may be unsuitable for that product. 

The USP Dissolution General Chapter 711 describes the basket (Apparatus 1) and paddle (Apparatus 2) in detail. There are certain variations in usage of the apparatus that occur in the industry and are allowed with proper validation. The literature contains a recommendation for a new USP general chapter for dissolution testing (6). In this article, guidance for method validation and selection of equipment is described. It may be a useful guide when showing equipment equivalence to compendial equipment. 

In 711 , there is a paragraph titled the Apparatus Suitability test. In this paragraph, the use of the USP calibrator tablets (Fig. 1) is required. There is some debate as whether 

Since the O-ring style is not an official design, the analyst should show that it does not give results different from the clipped shafts when testing the product. As part of validation, the two basket shaft types should be compared and equivalence shown. If the types do not give comparable results, there could be problems with technology transfer. In addition, if a 

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