Media Fill Test
Validation of Aseptic Processes should include a process simulation test using a nutrient medium (media fill). The selection of the nutrient medium should be made based on the dosage form of the product and selectivity, clarity, concentration, and suitability for sterilization of theт nutrient medium.
The process simulation test should imitate as closely as possible the routine aseptic manufacturing process and include all the critical subsequent manufacturing steps. It should also take into account various interventions known to occur during normal production as well as worst-case.
Process simulation tests should be performed as initial validation with three consecutive satisfactory simulation tests per shift and repeated at defined intervals and after any significant modification to the HVAC-system, equipment, process, and number of shifts. Process simulation tests should be repeated twice a year per shift and process.
The number of containers used for media fill should be sufficient to enable a valid evaluation. For small batches, the number of containers for media fills should at least equal the size of the product batch.
One of the most important tests confirming the acceptable operation of equipment, personnel, utilities, sterilization processes is the media fill test.
The test is based on the worst-case conditions and simulation of critical operations.
Before carrying out the media fill test, analysis of the documentation, equipment, and utilities for compliance with best practices is conducted. Under the best practices, we understand the European GMP requirements, cGMP US FDA requirements, PIC / S recommendations, and up-to-date approaches.
Media fill test the process most fully imitate the routine production process in aseptic conditions and include all subsequent critical stages of production.
We help pharmaceutical companies conduct MFT in accordance with GMP requirements and best practices. To do this, we help to conduct a risk assessment for intervention. Particular attention is paid to interventions and critical operations (for example, the loading of a sterile substance, the loading of products to a freeze-drier). After analyzing the risks, we develop the MFT protocol, consulting during MFT and check the report.