Chromatography

Cleaning validation of manufacturing equipment involved in pharmaceutical production is an essential factor in GMP. However, it requires complicated and laborious processes such as sampling from the equipment, sample pretreatment, analysis of the compound concerned, and evaluation of the residue amount. Setting the threshold values, which have to be determined taking into consideration various factors such as the effective amount and dosage of the medicine, the size of the production batch, and the size of the equipment, is also a difficult procedure. The Co-Sense CV is an HPLC application system addressing this demand. The unique system configuration and special software dramatically enhance the efficiency of cleaning validation by automatically conducting all processes from sample concentration to analysis and data processing.

A column-switching technique is used to concentrate the target component within the sample onto the concentration column, then send it to the analysis column for separation and detection. Complex sample pretreatment is therefore unnecessary, as the target component is concentrated from a large amount of sample, even a trace amount of component can be detected with high sensitivity.

The target component is concentrated while diluting the sample by any desired rate, assuring creation of a clear peak, as well as a high recovery rate regardless of the type of the sample solvent used for extraction (patent pending).