PTI - international

Agenda: Day Two

VII. Implementing Filling Requirements

• Determine aseptic filling design features
• Acknowledge process requirements
• Identify conditions and practices to avoid 

Exercise: Critique Common Deviations that Occur When Implementing Filling Requirements

VIII. Examine Process Simulation Variables  

• Incorporate statistical basis for determining contamination rates
• Establish the minimum number of vials to fill
• Examine number of runs
• Determine container size/line speed
• Critique personnel/shifts
• Define incubation conditions
• Consider interventions

IX. Determine the Process Simulation Size 

• Identify considerations in developing a simulation run
• Define the size of the simulation run
• Choose the simulation mode

Exercise: Analyze Examples of Simulation Runs

X. Interpreting Results of Process Simulation Runs

• Conduct examination of media fill units
• Incorporate documentation/observation methods
• Implement good cleanroom management practices

XI. Process Maintenance and Current Regulatory Issues 

• Review the current regulatory environment regarding aseptic processing and actual 483 citations
• Anticipate regulatory expectations, and prepare for an audit
• Develop the necessary procedures required for maintaining the validated state of the process
• Understand both party requirements when using contract filling companies