COURSE DESCRIPTION

OVERVIEW

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.

This course 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.

LEARNING OBJECTIVES

By attending this interactive, 90-minute session, you will learn:

• 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