What is media fill test?
A 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.
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 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.
How often media fill testing?
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.
How do you perform media fill?
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.
Is aseptic and sterile the same?
Aseptic: A surface, object, product, or environment has been treated such that it is free of contamination. Bacteria, viruses, or other harmful living organisms cannot survive or reproduce. Sterile: A product that is completely free of microscopic organisms.
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 intervention in media fill?
17 The media fill activity shall be performed with frequent interventions, which we come across during routine production to simulate actual condition. 7.10. 18 The vials filled during each intervention shall be collected in tray. Transfer the vials at 30-35°C for another 7 days.
WHO TRS 937 Process Validation?
937. Process validation provides documented evidence that a process is capable of reliably and repeatedly rendering a product of the required quality. The principles of planning, organizing and performing process validation are similar to those for qualification.
What is the purpose of a media fill test?
What is a media-fill test? Aseptic media-fill testing is used to quantify the aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce a sterile product without microbiological contamination. During this test, a microbi-ological growth medium, such as soybean-casein digest medium (SCDM), also
When do you use aseptic media fill testing?
Aseptic media-fill testing is used to quantify the aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce a sterile product without microbiological contamination.
What do you need to know about media fill validation?
Preparation of Media Fill:- The nutrient medium must be processed, handled, and filled in a manner that precisely simulates the normal manufacturing process. Thus, the normal manufacturing process has to be analysed. In media fill validation, dried nutrient medium base and Water for Injection (WFI) are used as the compounding starting materials.
Is it necessary to read media fill units?
Reading Media Fill units can be a real bottleneck and a difficult part of MFT since it requires qualified technicians and much time to manually read up to several thousands of filled units.