How do you do a media fill test?
The Media Fill Test Process
- Acquire testing medium.
- Choose the time and circumstances of the test.
- Carry out the test.
- Incubate the test sample.
- Assess the results.
- Follow up.
What is a media fill Challenge Test?
Media-fill challenge testing (media-fill verification of technique) is used to verify that personnel have the necessary skills to compound aseptic preparations. During media-fill challenge testing, personnel are instructed to prepare a CSP using sterile liquid culture medium.
How often is media fill testing required?
The incubation period of a media fill should be no less than 14 days and the containers should be examined every 2 or 3 days. All steps in a media fill should be done in the same locations as the drug production steps.
What is a fill test?
Media fill test is a process simulation testing which is carried out in the same manner as that of normal production except that an appropriate microbiological growth medium is used in place of the drug.
WHO guideline on 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.
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.
What is media fill PPT?
The Media fill or Broth fill technique is one in which a liquid microbiological nutrient growth medium is prepared and filled in a simulation of normal manufacturing operation.
How do I select media fill batch size?
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.
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.
What is the media used in media fill?
Media considerations: Aerobic media is typically used in a media fill trial. In this case, standard practice is to use Soybean-Casein Digest Broth (SCDB), also known as Trypticase Soy Broth (TSB).
Why nitrogen is not used in media fill?
Use of nitrogen can affect the growth of microorganisms or better to say growth promotion properties in media. Hence you can get a false negative growth in the filled unit. So, it is not accepted doing vacuum break through nitrogen in lyophilizer .