Making Aseptic Disconnections – What are the options?

When disconnecting bottles or bags from a manifold, or taking samples, it is critical that sterility be maintained. I remember being asked how confident I would be disconnecting a sample bag from a 1000L bag, in a process where the value of the product was in the region of £1/2m. After some thought, I deduced the one method I would feel most confident with was a Tube Sealer.

The tube sealer is a reliable and long established method of making disconnections from processes.

However, the one downside of the Sealer method is that it is only compatible for TPE and PVC tubing (Which is not widely used in Biopharm process applications). With many single use transfer sets manufactured using platinum-cured silicone, an alternative method of disconnecting needs to be found. This leads us into disconnect fittings and crimping options…

Disconnecting with platinum-cured silicone

There are various sterile disconnect couplings available, for use with platinum-cured silicone, with the added benefit of not requiring any tools or machinery to make the disconnection. Depending on the product selected, they can also prevent reconnection of the assembly. Introducing crimp collars to platinum-cured silicone is also a reliable method of disconnecting. With the collar fitted at the time of making the assembly, this method does however require investment in tools for making the disconnection, which on larger sized tubing can become quite bulky and difficult to handle.

Seal of approval

When it comes to disconnecting TPE tubings such as CFlex or Advantaflex, BioPharma Dynamics often recommend using the NEW Vante Sealer. With up to 16 programmes, that can be stored for quick access, for ease of use by operators.

There are separate password levels that allow access either just to change which programme is used, with a 2nd level of password protection to give access to the programme parameters. From here the process can be fine-tuned for varying process conditions and stored under a user specified name, to make operation as simple as possible. The clever use of sealer head at the end of an umbilical cord also allows for easier sealing on more difficult designs, in areas that are hard to access.

What is best for your process?

As with all applications the best solution is dependent on the process parameters, the particular requirements and the products being used in the process. This is where the open architecture approach of BioPharma Dynamics comes into it’s own, we want to know about your process before we start making recommendations of which method might work best.

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