Aseptic Process Simulations (Media Fills) Workshop
Time: Tuesday, December 3 at 3:45 - 5:15 PM
Location: Ballroom A, Anantara Riverside Resort
Participants The workshop is open for BFS Operators only
Registration: No registration, please be seated in Ballroom A after coffee and tea break to participate
Moderator: Kevin Downey, BFS IOA Technical Officer
Introduction to workshop:
It is a Regulatory expectation that the controls in place for aseptic processing should be periodically verified. Part of this verification includes performing a process simulation test using an appropriate sterile nutrient media (also referred to as a media fill).
This is a well-established requirement, applicable to all aseptic processes, including Blow-Fill Seal. However, whilst the Regulatory expectation of carrying out a process simulation is clear, the various aspects of a process simulation is subject to a certain degree of interpretation. This is certainly true across the BFS industry where differing approaches and interpretation of the Regulatory guidelines have been discussed at previous BFS IOA meetings over the years.
In order to bring these discussions, and our collective understanding of what is currently common practice amongst BFS Operators, up to date, we are delighted to invite members of the BFS IOA to a pre-Conference Workshop on Tuesday December 3 at 3:45 PM.
During the Workshop, we will discuss various aspects of performing a BFS process simulation with the aim of sharing best practice and understanding the commonalities and differences amongst BFS Operators.
Some of the topics that will be discussed include:
- Interventions – same approach for all machine types (open or closed parison)? Number of interventions performed?
- Duration of fill – entire duration to simulate a commercial batch size or risk based approach?
- Number of units filled?
- Incubation temperature – dual temperature or single?
- Regulatory experience – any specific BFS media fill expectations/interpretations stated by an Inspector?
We strongly encourage all Operators of BFS equipment to join this important Workshop. We are aiming for an open and engaging series of discussions that hopefully will be of benefit to all attendees.