Proper Execution of Aseptic Process Simulations
Danielle DeLucy, MS, is the owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
Aseptic processing, the technique used to ensure sterile drugs are packaged in sterile containers, is one of the most important steps in biopharmaceutical manufacturing, because of the risk that contamination poses to patient safety. An Aseptic Process Simulation is performed by these biopharmaceutical firms to ensure the process can be performed with minimal contamination. This is accomplished by using a growth medium instead of the actual product in the processing steps.
Regulators look for these Aseptic Processing Simulations or Media Fills, as they are sometimes called, to demonstrate control of the process and also the operators executing the tasks. These simulations must be done periodically and with the knowledge of the regulations that govern them.
This webinar will help those using APS/media fills to determine their risks of contamination in the process and how they can prevent it. A complete review of what elements need to be included in the APS design will be discussed, which includes, the frequency of performance, number of operators, what types of growth media to use, how slow or fast the filling line needs to operate and how to read the units after they have been incubated
- We will review the current regulatory requirements for Aseptic Process Simulations (APS)
- The elements of a successful APS (interventions, worst-case conditions, etc.)
- How to use an APS to qualify operators
- What types of risk exist that could cause contamination in your process
- How to properly examine the units once incubated.
Who Should Attend
- Lab Managers
- Regulatory Personnel
- Quality Control Analysts and QA Professionals
- Manufacturing Operators
- Sterility Assurance Professionals