Aseptic Process Simulations – A Comprehensive Guide for Proper Execution
Duration : 60 Minutes
Danielle DeLucy, Pharmaceuticals, Biotechnology
Danielle DeLucy, MS, is 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, suc Read more
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 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.
Course Objectives:
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, 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.
Course Outline:
• 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.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Lab managers,
• Regulatory personnel,
• Quality control analysts and
• QA professionals,
• Manufacturing operators,
• Sterility assurance professionals
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
