As more pharmaceutical companies are born, so are stricter guidelines regarding adequate process control. Media fill runs refer to a required demonstration by a pharmaceutical company that accurately and efficiently performs and showcases controlled processes. Some of these guidelines include cleaning and disinfectant protocols, environmental monitoring, and equipment and process simulations.
One of the most important things to understand regarding media fills, is that they work on the assumption that all other sterility dangers, such as container purity and equipment and filtration efficiency, are checked and in order. Media fills will only produce results that reflect if contamination can occur during the normal filling process.

Process Simulations & Preparation

These simulations are meant to assess the likelihood of a microbial contamination during the aseptic manufacturing process. As process simulations are extremely important to media fill runs it is beneficial to have prepared for them beforehand. While this is a trial it must include all permitted contaminant events. Specifically, events in which human intervention is necessary due to contamination.

  • A few of these include:
  • Replenishing closures or vials
  • Adjusting dose volume or filling machine speed
  • Removing fallen vials
  • Shift changes

In order to prepare for the simulation, prepare for these events. Create easy-to-follow guidelines, detailed process documents, and educate staff on permitted contaminant events that will be simulated in the media fill run.

Failure

Per the World Health Organization, the simulations should yield a zero growth result, yet a contamination rate with a 95% confidence level will also provide a passing grade. A 95% confidence level (.10% contamination rate), should reflect only 1 contaminated unit within 5000 filled units).

When a failure occurs the origin or root cause needs to be identified and the following aspects must be addressed:

  • Isolate the microorganisms
  • Develop a corrective action plan
  • Put in place a preventative action plan
  • Determine possible contamination of released lots

After addressing the above, a new media fill run is performed and should yield a 100% confidence rate or zero growth result. This media fill run will also be determining the efficacy of the companies corrective and preventative action plans.

For more information, feel free to visit the below links:
Media Fill Guidelines for the Pharmaceutical Industry
Pharma Treasure: Media Fill 483’s
Process Validation: Aseptic Processes for Pharmaceuticals

ParmEng Technology is a reliable and fully capable compliance firm for the biotechnology and pharmaceutical industries available for advisement through this process. For more information or to speak directly with a representative please feel free to contact us.