Media fill aseptic processing
A media fill aseptic processing 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.
The purpose of this aseptic simulation is to demonstrate the capability of the aseptic process to produce continuously and consistently a sterile drug product & in parallel qualify the personal & environment involve in this process.
Regulatory references for Media fill
ISO 13408-1:2008 states “Process simulation shall cover all parts of the aseptic process and include all aseptic manipulations. It is possible to divide the process into unit operations but all parts of the process shall be simulated (Clause 10.1.1)"
21 CFR 211.113 : " To ensure the sterility of Products Purporting to be sterile, both sterilization and aseptic filling and closing operations must be adequately validated"
EU GMP Annex- 1 : "Validation of aseptic processing should include a process simulation test using a nutrient medium (media fill).Selection of the nutrient medium should be made based on dosage form of the product and selectivity, clarity, concentration and suitability for sterilization of the nutrient medium."
Aseptic process simulation should be done in the following condition;
Initial aseptic process qualification
At least three trials should be taken to ensure that results are repeated and meaningful.
- Normal aseptic process simulation test should be repeated at least twice in a year
- In case of modification in process equipment, HVAC system, and the number of shift operations.
General Guidance for aseptic process simulation by media fill
- Validation of aseptic processing should include a process simulation test using a nutrient media which support in the growth of all the microorganism.
- Include all the critical manufacturing steps.
- Take into account all the interventions which can occur during normal operation.
- Number of containers used for media fill should be sufficient to enable a valid evaluation
- For any run size, intermittent incidents of microbial contamination may be indicative of low-level contamination that should be investigated.
- It should be demonstrated that air-flow patterns do not present a contamination risk, e.g. care should be taken to ensure that air flows do not distribute particles from a particle generating person, operation, or machine to a zone of higher product risk.
- Where filling takes place over extended periods, i.e. longer than 24 hours, the process simulation test should extend over the whole of the standard filling period. In order to prevent excessively high numbers of units being filled, it is usually acceptable to just run the machine for a reasonable time, if the validity of the simulation is not diminished by this procedure.
- Inert gas should not be used in the vial/container as it prevents the growth of microorganisms. In place of inert gas filtered oxygen can be used.
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