A robust Aseptic Transfer is not a checklist, it is an integrated ecosystem.
Components enter the facility contaminated from the external manufacturer and must undergo a rigorous process:
After all these steps, the sterile process is completed. But for the chain to hold, every single link must be unbreakable, starting from the very first one: washing.
Carlo Cattenati, Product Manager at Fedegari and Alessia Cina, Training and process development expert at Fedegari Americas talked extensively about this topic in our latest live webinar, “Washing the hidden key to sterility”, that we also analyzed in our blog.
Check out our resources:
[watch the webinar recording] or read our [latest blog post]
In the context of pharmaceutical production, Annex 1 stands as the primary regulatory reference. Among its directives regarding product sterilization, it strongly encourages the use of closed systems to protect both the sterile product and the environment.
Closed systems guarantee:
This regulatory stress on closed systems directly affects the choice of sterilization techniques and aseptic transfer methods, pushing the industry to evaluate packaging solutions more critically.
To support this process-level understanding, we created an infographic that provides a clear, high-level view of the aseptic transfer flow, highlighting:
A practical tool to align technical, quality and engineering teams around the same process view.