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25th September 2023  Content supplied by: Condalab

Reliability in your Microbiological QC for All Biomanufacturing Steps

Ensuring the safety and quality of bioproducts in the industry is undoubtedly one of the field’s main challenges. As a result, environmental and process monitoring has been chosen to ensure sterility.

Media Fill Test (MFT) is an aseptic filling validation process that simulates the actual production process by interchanging the product with a culture media that promotes microbial growth. The culture media commonly used is TSB, however there are other options such as TSB with vegetable peptone sources or Thyoglicollate Fluid Medium (TFM). These must be subjected to quality and sterility controls, as well as tests such as growth promotion in order to verify the sterility and performance of the media. 

On the other hand, quality control (QC) of bioproducts usually depends if the final product is sterile or not. The main goal of QC is to determine whether a product is within the established parameters, and when required, identify the specific contaminant microorganism(s). The Ph. Eur. has established the Sterility Test for verifying that a pharmaceutical product complies with this quality. The result will indicate if there is or is not a contaminating microorganism in the sample tested. TSB and TFM are the culture media used. 

In non-sterile products, the screening of certain species is performed, and the media used will depend on the target microorganism.

In Condalab we have available culture media according to standardized methods to perform all the mentioned tests without complications as each batch is assessed to comply with high-quality standards for ensuring their sterility and performance.

We invite you to download our Microbiological Analysis in the Pharmaceutical Industry booklet

For further information about this topic, register to watch our CondalabTalk Sterility Test and Media Fill Testing!

For further information, do not hesitate to contact us via the green "Request Information" button below.

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Date Published: 25th September 2023

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