Proper Execution of Aseptic Media Simulations

Event Information
Product Format
Prerecorded Event
Conference Date
Fri, Jan 19, 2018
60 minutes
Product Description

Understand What Elements to Include in APS Design to Ensure Minimum Contamination

The aseptic processing method is used to pack sterile drugs in sterile containers. This process is one of the most critical stages in biopharmaceutical manufacturing, because of the risk contamination poses to patient safety. An aseptic process simulation is performed by 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 session by expert speaker Danielle DeLucy will help those using APS/media fills to determine their risks of contamination in the process, and how they can prevent it. Danielle will give a complete review of what elements need to be included in the APS design, including the frequency of performance, the 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.

Session Highlights

  • Review of 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

Session Agenda

This session will cover:

  • Aseptic process simulation: Overview
  • When to perform a process simulation run
  • Regulatory requirements for aseptic processing
  • Elements of a successful APS
    • Worst case conditions
    • Personnel qualification
    • Activities
    • Frequency and number of runs
    • Study design
    • Documents
  • Selection of growth media
  • Qualification of operators during an APS
  • Test condition considerations
  • Incubation considerations
  • Causes for non-routine interventions
  • Microbial monitoring
  • Best practices for APS

Who Should Attend

  • Lab managers
  • Regulatory personnel
  • Quality control analysts
  • QA professionals
  • Manufacturing operators
  • Sterility assurance professionals

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Danielle DeLucy

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, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous...   More Info
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