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This situation requires a systematic re-thinking of the pre-clinical validation protocols.
As already stated above, cleaning validation protocols are less critical in case single-use, disposable systems are used.
Validation protocols should be numbered following a logical order, using appropriate codes depending on the validation extent.
Subsequently, the stored data are evaluated by the application of different standard validation protocols and later read by an application loader that periodically queries new measurements.
However, the development of models for mixtures requires very substantial effort regarding the storage and representation of mixtures, calculation of descriptors, and implementation of correct validation protocols.
Worst case approach might allow to "bracket" the different cleaning products and procedures, thus reducing the need for multiple validation protocols.
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Cleaning validation protocol should be considered as a mean to validate cleaning procedures and cleaning media at the same time.
This is the weakest validation protocol.
This is the most rigorous validation protocol.
The default validation type was "compounds out", i.e., the most rigorous validation protocol.
Figure 2 shows the flowchart of FINDSITEcomb methodology [12] in combination with experimental validation protocol.
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