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Primary Validation for an Automated Colony Counter per EP 9.2, 5.1.6 

 

Primary Validation for an Automated Colony Counter per EP 9.2, 5.1.6

The European Pharmacoepia (EP) 9.2 Chapter 5.1.6 on alternative methods includes a clear structure for primary validation and validation of intended use, with directives for validation process for both technology supplier and the end user. 

 

This poster presented by technical experts at Rapid Micro Biosystems illustrates a validation study for Growth Direct System. Data generated from this study indicates the colony counting method of Growth Direct complies with assay performance requirements in EP Chapter 5.1.6.

 

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