Aseptic Process Simulations: Designing and Evaluating Media Fills

This course helps teams design and evaluate media fills that meaningfully challenge aseptic operations, address contamination risks, support operator qualification, and provide evidence that the process remains appropriately controlled.

Aseptic Process Simulations (APS), commonly called media fills, provide evidence that aseptic processing can be performed with minimal contamination risk when sterile drugs are filled into sterile containers. By replacing product with growth medium, the simulation challenges the process and the operators performing critical activities. Regulators use APS results to assess whether the aseptic process and personnel remain under appropriate control.

Effective media fill design requires deliberate choices about interventions, worst-case conditions, execution frequency, participating operators, growth media, filling line speed, and evaluation of incubated units. This webinar addresses how these elements should be incorporated into an APS and how contamination risks should influence simulation design. Participants will also consider the use of media fills for operator qualification and the proper examination of units after incubation. The focus is on designing and evaluating periodic simulations that provide meaningful evidence of aseptic process control.

_{WHY YOU SHOULD ATTEND:}

Design APS Conditions That Meaningfully Challenge the Process

Participants will develop a clearer basis for selecting interventions, worst-case conditions, operating speeds, growth media, and participating personnel when designing an APS. These choices determine whether the simulation meaningfully represents contamination risks within the aseptic process and provides useful evidence that process execution remains controlled.

Strengthen Operator Qualification and Simulation Evaluation

Media fills also provide evidence about the personnel executing aseptic activities. Participants will strengthen their ability to use APS for operator qualification, evaluate contamination risks, and examine incubated units correctly. These capabilities support periodic assessment of process control and the evidence regulators expect from organizations performing aseptic processing.

_{AREAS COVERED:}

• Current regulatory requirements for Aseptic Process Simulations
• Interventions and worst-case conditions in APS design
• Frequency and operator participation in media fills
• Growth media selection and filling line operating speeds
• Contamination risks within aseptic processing
• Operator qualification using Aseptic Process Simulations
• Incubation of media fill units
• Examination and evaluation of incubated units

_{WHO SHOULD ATTEND:}

• Lab Managers
• Regulatory Departments
• Quality Control Departments
• Quality Assurance Departments
• Manufacturing Departments
• Operations Departments
• Sterility Assurance Professionals

Course Director: Daniell DeLucy

Danielle DeLucy, has 15 years of pharmaceutical and biologics industry experience across Quality Management, Product Quality, Sterility Assurance, and QA oversight of filling and packaging operations. Her background as a Quality Control Pharmaceutical Microbiologist, combined with experience leading regulatory health inspections, directly supports the aseptic processing, contamination control, and media fill considerations addressed in this webinar.