FAQ: What Is Media Fill Simulation?

A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. A media fill is one part of the validation of an aseptic manufacturing process.

What is a media fill test intended to simulate?

Media fill tests are critical microbiological tests carried out to simulate the normal manufacturing conditions by replacing the pharmaceutical product with culture media. The patented color indicator was selected as it showed to be a broad indicator of microbiological growth.

What is media fill trial?

Aseptic process simulation, also known as a media fill trial, estimates the contamination risk of an aseptic production process by using sterile culture media in place of the product constituents. Regulatory agencies hold manufacturers to very high standards for aseptic processing.

How do you perform media fill?

The Media Fill Test Process

1. Acquire testing medium.
2. Choose the time and circumstances of the test.
3. Carry out the test.
4. Incubate the test sample.
5. Assess the results.
6. Follow up.

What is media fill validation?

This process of validation also known as a media fill validation, normally includes exposing the microbiological growth medium to product contact surface of equipment, container closure system, and critical environments to closely simulate the same exposure that the product itself will undergo at the time of processing

How do you investigate media fill failure?

Review the history of media fill for the product last time for contamination. Review the batch filled with the same filling line since last media fill test. List all possible root causes of failure. List the batches to be held, those are suspicious and require re-analysis.

How often is a media fill test performed on high risk level CSPs?

How often are media-fill tests of personnel required? Minimally, USP Chapter<797> requires media fill validation initially upon hire, then annually for low-and medium-risk compounding, and twice annually for high-risk compounding.

WHO Guidelines media fill?

For small batches the number of containers for media fills should at least equal the size of the product batch. The target should be zero growth and the following should apply: when filling fewer than 5000 units, no contaminated units should be detected.

Is media fill required for terminally sterilized products?

Terminal sterilization – where the final filled product is sterilized (e.g. in an autoclave or by irradiation.) Media Fill is not required.

Why compressed air is used in media fill?

As an example, if your product manufacturing employs Nitrogen or Argon purging, for media fills you must choose to purge the broth with compressed air. This way you ensure that contamination if any due to wrong aseptic practices / interventions etc.

How do you perform a growth promotion test?

8 Best Practices for Growth Promotion Testing

1. Test in parallel.
2. Double the inoculum for selective medium, when necessary.
3. Use non-selective agar as a control when testing liquid media.
4. Routinely calibrate pipettes.
5. Use environmental conditions required by species.
6. Keep organisms warm, but not too warm.

What is the recommended frequency of routine media fill?

According to FDA’s principles, the frequency of media fills should be fixed in relation to the shifts on the basis of a risk assessment. In traditional aseptic filling, one media fill per shift per half year is expected. On a line with 2 shifts, this requires at least 4 media fill runs.

What is aseptic validation?

aseptic process validation. risk assessment. Aseptic process simulations, sometimes referred to as media fills, are studies conducted on the aseptic filling process. The process is simulated or run as closely to the actual production procedure as possible. Product is replaced with growth media.

What is cleaning validation in pharma?

Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.

Why is validation important in aseptic preparation?

The purpose is to show that under simulated conditions aseptic products can be consistently pre- pared to the required quality using the defined process. To ensure the reproducibility of quality of the product strict adherence to the validated Standard Operating Procedures is essential.