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.
Includes live access & recording
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.
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.
By the end of this session, participants will be equipped to design and evaluate media fills that produce meaningful evidence of aseptic process control.
Apply current regulatory requirements for Aseptic Process Simulations.
Select interventions and worst-case conditions that meaningfully challenge the aseptic process.
Determine appropriate media fill frequency and operator participation.
Choose growth media and filling line operating speeds appropriate to the simulation.
Evaluate contamination risks within aseptic processing and reflect them in APS design.
Use Aseptic Process Simulations for operator qualification.
Apply correct incubation practices for media fill units.
Examine and evaluate incubated units and interpret the results.
Focused areas that will strengthen how your organization designs, executes, and evaluates periodic media fills.
Build a clearer basis for selecting interventions, worst-case conditions, operating speeds, growth media, and participating personnel so the simulation represents real contamination risk.
Incorporate routine and non-routine interventions and worst-case conditions that make the media fill a meaningful challenge to the process and the operators.
Use media fills as evidence about the personnel executing aseptic activities and to support periodic assessment of process control.
Apply proper incubation of media fill units and correct examination and evaluation of incubated units after the simulation.
A comprehensive look at how contamination risks should shape the design and evaluation of Aseptic Process Simulations.
Professionals responsible for sterility assurance, quality, and aseptic operations in pharmaceutical and biologics manufacturing.
Lab Managers
Regulatory Departments
Quality Control Departments
Quality Assurance Departments
Manufacturing Departments
Operations Departments
Sterility Assurance Professionals
Aseptic Process Simulations 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 both the process and the operators performing critical activities, and 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. Contamination risks within the aseptic process should directly influence how the simulation is designed and how many units are filled, incubated, and examined.
This webinar addresses how these elements should be incorporated into an APS, how media fills support operator qualification, and how units should be examined and evaluated after incubation — with the focus on periodic simulations that provide meaningful evidence of aseptic process control.
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.
Don't miss this essential training on designing and evaluating media fills that provide meaningful evidence of aseptic process control. Secure your spot now.