Mastering Media Fill Aseptic Process Simulation for Pharma Industry

About the Course

This training module on Media Fill/Aseptic Process Simulation offers a focused overview of the purpose, design, and regulatory expectations of media fills in sterile manufacturing. It explains why media fills are critical to validating aseptic processes, outlines the step-by-step execution—from prerequisites to incubation and evaluation—and emphasizes a risk-based approach. The module also addresses failure investigations, documentation, common pitfalls, and real-world regulatory observations, equipping participants with practical insights and compliance know-how.

Content

• Media Fill/Aseptic Process Simulation
  • Introduction to Media Fill
  • What and why is it required; and how it is performed
  • Importance of media fill
  • Regulatory requirements
• Designing and executing a media fill study
  • Requirements of a media fill study
  • Types and Timing of media fills
  • Process flow of a media fill study
  • Step 1: Pre-requisites for a media fill
  • Step 2: Media fill execution
  • Step 3: Incubation & evaluation
  • Execution of a simulation
  • Acceptance criteria
  • Risk Based approach in Media Fill
• Failures and Investigations
  • Media fill failures
  • Documentation and records
  • Case study
  • Common pitfalls and best practices
  • Regulatory observations
  • Auditing media fill operations

Summary and Conclusion: Importance of media fill in aseptic operations

Final Evaluation: 3 attempts to achieve the passing score in the evaluation