PTI - international

Agenda: Day One

• Define alert and action levels
• Compare aseptic processing vs. terminal sterilization-current concepts
• Understand common terminology associated with aseptic processing

II. Meet Regulatory Expectations for Aseptic Processing Simulation Testing

• Define GMPs relevant to process simulation testing
• Familiarize yourself with contemporary FDA thinking - aseptic processing
• Address the primary problems with aseptic processing
• Comply with cGMPs

III. Developing the Sterile Dosage Form

• Critique distinctive characteristics in terms of developing sterile dosage forms
• Examine associated critical factors 
• Discuss alternatives to aseptic processing

Excercise: Discuss in Small Groups Ideas Regarding "Weak Links in Aseptic Processing Train"

IV. Defining the Key Issues With Aseptic Processing

• Analyze control of the processing environment
• Determine viable and non-viable considerations
• Critique design concepts
• Determine factors to avoid with aseptic processing

Exercise: Critique Commonly Observed Problems with Aseptic Processing

V. Address Principles for Aseptic Processing

• Examine attributes of cleanroom management
• Implement sampling methods
• Select test sites - factors to consider
• Utilize disinfectants and contamination control
• Analyze media fill technology limitation concerns

Exercise: Using the Provided Example, Apply Information from this Module to Enhance Cleaning and Disinfection of Classified Areas

VI. Develop Media Fill Requirements in an Aseptic Environment

• Establish successful media filling requirements
• Learn current regulatory expectations and common deficiencies with current media filling practices

Exercise: Determine Common Issues with Developing Requirements for Media Fills