Selection of Media for Process Simulation or Media Fills

Why Selection of correct culture media is critical in Process simulation or Media Fill Process?

Ashutosh Mohan, Certifed Six Sigma Black Belt, cGMP, QMS Auditor

1/17/20251 min read

What is process simulation?

Process simulation is a tool through which aseptic techniques and manufacturing processes are evaluated using microbiological culture media instead of sterile drugs or biological products. The purpose of using microbiological culture media instead of drug solutions or biological products is to evaluate whether the utilized aseptic procedures are adequate to prevent contamination during the drug or biological production.

Purpose of Media-Fill

The purpose of media fill is to evaluate the following:

  • Qualify the operators

  • Assess operators technique

  • Environmental controls are within the range to produce sterile drugs or biological products

  • Aseptic Assembly

  • Operation of critical equipment

    Note: The process simulation or media fill does not validate the ability of the filter to sterilize microbial culture media.

How to design media fill?

  • Ensure the process simulation represents all the aseptic processes and techniques performed during the production of drugs or biological products

  • Include all the steps involved in the production of drugs and biological products, including the preparation of the product, the assembly of the product containers, and the transfer of the product containers to the filling area. Furthermore, it encompasses all process steps that occur downstream from the "sterilizing filter" through to the release of the final product.