Process Simulation Media Fill Test Protocol

Process Simulation (Media Fill) Test Protocol 

The purpose is to describe the format and contents of the process simulation (media hll) test protocol. 

It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance. 

To demonstrate the control of aseptic operations maintained by well-trained personnel, defined procedures, and appropriately designed equipment and facilities. Media filling in conjunction with comprehensive environmental monitoring will be conducted three times to demonstrate that the aseptic processing of lyophilized powder is functioning as intended. 

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