Process Simulation Media Fill Test

SUBJECT Process Simulation (Media Fill) Test 

This procedure describes methods and procedures for the conduct of process simulation tests of sterile products, including media fill procedures, media selection, fill volume, incubation, time and temperature, inspection of filled volume, documentation, interpretation of results, and possible corrective action required where its main purposes are to 

It is the responsibility of all concerned departmental managers to follow the procedure. The quality assurance (QA) manager is responsible for SOP compliance. 

The QC manager, QA manager, and production manager will evaluate and approve the results in case of failure and determine the remedial actions. 

Three media hll runs are required for the following (this list is not all inclusive)  

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Our normal frequency for media hlls is dehned in the manufacturing site SOP Process Simulation (Media Fill) Test. At a minimum, media fills are performed twice a year for the hlling line and each shift. 

After filling, the units are stored in a controlled temperature environment for 7 days at 20 to 25°C and 14 days at 30 to 35°C. The units are inspected for growth positives per SOPs for Process Simulation (Media Fill) Test and Media Fill Run Investigation. ... 

Process simulation (media fill) test Media fill run investigation... 

Process Simulation Media Fill Test Microbiological Report Summary of Results... 

Process simulation media-fill test report... 

For corrective actions, see SOP, Val 1800.10 Process Simulation (Media Fill) Test. 

Comprehensive process simulation (media fill) test, media fill microbial examination, process simulation test protocol and template media fill run reports are provided in Section Val. 1800. 

Aseptic fill processes are validated by simulating production conditions and using a bacterial culture medium as the product. This process simulation test is commonly referred to as a media fill. ... 

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