Cleaning Validation System for Biopharmaceutical Cell Culture TanksUsing On-Line TOC Analyzer

User Benefits

- The cleaning effect can be confirmed immediately by using an on-line TOC analyzer, reducing lost time and cost in the manufacturing process. - Because combustion type TOC is not affected by salts in the culture solution and unexpected and hard-to-analysis substances can also be measured, high measurement accuracy is possible.

Introduction

Biopharmaceutical products are produced by culturing and refining cells, E.coli, yeast, and other biomaterials. A large number of culture tanks are used in a single production line, and it is necessary to confirm that the cleanliness of each of these tanks passes regulations before proceeding to the next process. Cleaning of culture tanks is an extremely important process because the homogeneity of the following culturing process cannot be guaranteed if there are variations in the condition of contamination in the tanks after cleaning. In addition, because culturing requires several weeks, culturing will not progress as assumed and all of this time will be lost if cleaning is inadequate. This article introduces an example of cleaning validation of biopharmaceutical culture tanks using a Shimadzu on-line total organic carbon (TOC) analyzer. It is possible to minimize retention time and work between processes by using an on-line TOC analyzer. In particular, cleaning validation work can be substantially reduced by utilizing an on-line system because the culture tank rinse water is automatically sampled and measured periodically, and the acquired data are transferred successively to the upper level system. Use of this system in continuous production is also expected.

September 24, 2021 GMT