Thursday, February 8, 2018
12:00 Noon – 1:30 pm EST
Instructor: Marsha Steed (Hardiman)
The Aseptic Process Simulation (APS), which is commonly referred to as the Media Fill, is a critical piece in the aseptic manufacturing of sterile pharmaceutical and medical device products. Verification of the aseptic manufacturing process to produce sterile products is performed by simulating the manufacturing process with media. The APS allows companies to understand the capabilities of their aseptic process from the sterilization of components to the final closure of the product containers.
This presentation will discuss how the use of scientific knowledge and risk based approaches aids in designing robust media fill programs.
- What are the greatest potential contamination risks in your process?
- What are your worst case conditions?
This presentation will review the critical aspects of the APS such as the number and frequency of APS runs required by regulators, equipment set up and facility considerations, media selection, line speed for filling line, fill volumes, container/closure considerations and Microbiological testing.
Interventions are activities carried out by personnel in close proximity to the aseptic processing area. Performing interventions can increase the risk of microbial contamination. Interventions will be discussed including utilization of risk tools for selection of interventions during APS design.
Qualification of personnel is another critical component of aseptic process simulations. The course will review the impact of people to the process in regards to contamination risks. Personnel monitoring, qualification, requalification and loss of qualification status will be discussed.
In addition, this course will discuss APS results and interpretation including incubation time and temperature, examination of units, qualifications for examining units, growth promotion of media, acceptance criteria and investigations.
By attending, you will learn:
- Current regulatory requirements for APS
- Application of quality risk management into APS
- APS design for a robust media fill program
- Microbiological testing for APS
- APS acceptance criteria and results interpretation
$385 for one person
$700 2-5 people
$999 6-10 people