What is the percentage of concentration of SCDM prepared in media fill validation

Question

Accepted Answer

The percentage of concentration of SCDM prepared in media fill validation varies depending on the specific requirements of the validation process.

The concentration of SCDM in media fill validation is determined based on the desired level of microbial challenge.
It is typically recommended to use a concentration that closely resembles the actual product being manufactured.
The percentage can range from as low as 0.1% to as high as 10% or more, depending on the specific validation protocol.
For example, if the product being manufactured has a high risk of contamination, a higher concentration of SCDM may be used to ensure a more rigorous validation.
On the other hand, if the product has a low risk of contamination, a lower concentration may be sufficient.
The specific percentage of concentration should be determined through a risk assessment and in accordance with regulatory guidelines.
It is important to note that the concentration of SCDM should be accurately measured and documented to ensure the validity of the media fill validation process.

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