• Live Webinar
Stopper treatment: governing closure safety through process design
With Annex 1, stopper transfer into the isolator is no longer a simple operational step.
Join Fedegari’s webinar and explore how the process changes when the fragility of BetaBag-based systems becomes a strategic choice.
With Carlo Cattenati – Product Manager, Fedegari
Online
Two sessions available:
9:00 a.m CET ( 4:00 p.m JST )
6:00 p.m CET (12:00 p.m EST)
The sterile process comes first
In stopper treatment, the question is not which system to adopt. The question is which process logic truly enables sterility to be governed, from treatment to transfer into the isolator.
With Annex 1, this step is no longer just an operational detail; it becomes a critical point in the sterile process. A formally closed system is not sufficient, what matters is how risk is distributed throughout the process.
This webinar focuses on precisely this point within aseptic transfer: the transfer of stoppers into the isolator. A step that may appear limited in scope, but in reality involves principles, decisions, and process responsibility.
Why this topic matters today
It is no longer enough to ask whether the system is formally closed. What matters is how risk is distributed throughout the process.
BetaBag systems introduce distributed fragility
Multiple transfers, repeated connections, manual interventions, and limited capacity make sterile continuity more fragile as volumes increase.
The point is not only how to introduce a component into the isolator. The point is where control, responsibility, and risk are located.
Stopper treatment is not a handling issue. It is a process issue.
Stoppers are part of the primary packaging. They must maintain sterility and reach the isolator without interrupting the logic of the sterile process.
For this reason, it is not enough to view them simply as components that must be correctly introduced into the line.
They must be understood for what they really are: a point at which the sterile process is put to the test.
Where fragility begins
In the case of sterile stoppers supplied in BetaBag (RTU), the sterility is not generated within the proess: it is received and must be preserved.
This approach works.
But as volumes increase, it also multiplies:
- transfers
- connections
- interventions
- points of exposure
Each bag means one more transfer.
Each transfer means one more instance of sterile continuity that must be preserved.
Each instance of sterile continuity that must be preserved means one more process responsibility.
The issue is not initial sterility. It is how often the process is exposed to its loss.
The Fedegari perspective
Fedegari starts here: from the sterile process.
From the principles that govern sterilization, the physical limits that define what a process must guarantee, and the responsibility to maintain that guarantee over time.
That is why Fedegari now offers an alternative to bag-based systems based on tanks and on a process logic aimed at reducing distributed fragility, bringing control back into a more governable continuity.
When the choice is about process, it becomes strategic
If you want to explore stopper treatment starting from principles, physical limits, and process responsibility - and understand why, with Annex 1, the choice between bags and tanks becomes a strategic one - this webinar is where to begin.
In the webinar, we will explore:
why, with Annex 1, the key issue is not only the formal compliance of the solution