Media Fill by Aseptic Enclosures

media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.

 

In aseptic processing, it is intended that a product and its containment system (separately sterilized) are brought together without them becoming microbiologically contaminated. The media fill is an investigative tool which can show us if the aseptic process actually does what it is intended to do.

 

In other words, we are simulating the aseptic process in order to find out if it is safe.

 

For example, commercial airline pilots are trained on flight simulators to ensure that they are safe to be in charge of aircraft.

The unsatisfactory part of media fill simulation is this:

– There are lots of reasons why unsafe aseptic processes could still give perfect media fill results (zero contaminants)

  • Media does not support growth
  • Media Fill done in “best conditions” which do not reflect reality
  • Routine risks omitted (accidentally or deliberately)

– The only way media fills give us any useful information about our aseptic processes is when they fail.

 

Therefore we perform media fills on every size and in replicates. Failure helps us “de-bug” any problems before they turn up in commercial production.

 

Good Manufacturing Practices require pharmaceutical preparers to regularly perform Media Fill Tests in order to verify the adequate microbiological state of their aseptic production process.

 

Media fill tests are critical microbiological tests carried out to simulate the normal manufacturing conditions by replacing the pharmaceutical product with culture media. Manual reading of several thousands of pharmaceutical containers is the current practice and this can be extremely time-consuming and be a source of potential errors.

 

The purpose of Aseptic Processing Simulation with media filling is to ensure that qualified process and personnel can aseptically produce drug product that consistently and reliably meets the required quality. We can also assess the capability of facility, personnel, equipment, procedures, and process controls to aseptically produce a sterile drug product. Also, we demonstrate the acceptability of appropriately designed facilities.

 

Media fill testing identifies weaknesses of the process, evaluates the proficiency of aseptic processing personnel & demonstrates the appropriateness of operating practices used in support of aseptic processing.

 

Aseptic Enclosures has participated in many Media Fill testings since 2004 and had consulted a huge number of facilities on how to acquire conditions to Re-establish Qualification and how to approach and correct Specific Deficiencies.

 

We also provide cleanroom techniques training in addition to Media Fill tests that furtherly improves the level of aseptic processing readiness of the personnel and the facility.

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