Significance of detection of initial contaminating bacteria in cell factories

The cell factory is a multi-layer structure of cell culture consumables, which has the advantages of large culture area, small plant space occupation, and low pollution degree. In order to ensure the quality of the product, various tests are required, and the initial contamination bacteria test is one of them.

Generally speaking, the initial contamination bacteria test is the estimated value of the bioburden of the product to be sterilized. It is a microbial limit test, which refers to the degree of microbial contamination of non-specified sterilized products and raw materials, auxiliary materials and finished products before sterilization, including the amount of contamination and control bacteria. , that is, the usual colony count, coliform and pathogenic bacteria inspection. The purpose of this test is to provide a reference index for the next sterilization of the cell factory, such as the sterilization dose, so as to ensure the sterilization effect. It can be said to be a test to monitor the effectiveness of the sterilization process.

For bioburden analysis, at least 10 samples were drawn from three separate batches of product for testing. Bioburden analysis must be performed according to a validated and available method. The average bioburden of each batch was calculated and the average bioburden of 30 samples was used as the total average bioburden of the three batches. If the average bioburden of one of the three batches is two or more times greater than the total average bioburden, the batch average is used for dose verification, otherwise, the overall average of the three batches is used for dose verification.

To sum up, the purpose of the initial contaminating bacteria detection in the cell factory is to confirm the sterilization dose, monitor the effectiveness of the sterilization process, and thus ensure the sterility of the product.

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