Make Aseptic Disconnections

The pharmaceutical, biotech and medical industries have an increasing need for aseptic tube disconnections on different process equipment that are connected to each other. Tubes are used to ensure the circulation of fluids between these devices and operators are required to connect and disconnect pharmaceutical tubes.

In case of tube replacement, it is necessary to disconnect the devices. To be able to carry out this operation, the use of a specific machine allowing a sterile disconnection is essential. But how can the operator make aseptic disconnections?

 

The Aseptic Disconnection Machine

This machine is specially designed to make aseptic tube disconnections. It is most often used in clean rooms to prevent any risk of contamination of the tube being disconnected. The tube must be made of TPE (thermoplastic elastomer) so that it can be disconnected by fusion. This is how an aseptic disconnection works:

  1. First, the tube is inserted between two clamps by the operator. The clamp is then locked by an electromagnet after closing
  2. The disconnection cycle is then started by the operator. Note that in this cycle, there are two phases:
    1. In the first phase, the temperature of the clamps is increased until the melting point of the tube is slightly exceeded
    2. In the second phase, the temperature is maintained to destroy all germs that may be present on both sides of the clamp and to allow the tube to melt
  3. Using a vane pump integrated in the unit, the temperature level is lowered so that the tube can be handled safely by the operator
  4. The electromagnet then unlocks the clamp opening
  5. The operator then carries out a visual inspection to validate the disconnection process. He will then cut the tube using a pair of scissors.

Another machine is required to connect the tube so that the disconnected devices can operate again. It is a flexible sealing machine, made by MGA Technologies and Sanofi Pasteur. This machine is also used in clean rooms to ensure that the tube connection is completely aseptic.

Technical Characteristics of the Aseptic Disconnection Machine

 

The aseptic disconnector is designed and manufactured by MGA Technologies. It is a machine compatible with TPE (thermoplastic elastomer) tubes with a diameter of 1/4″, 1/2″ and 3/4″, whether new or autoclaved. To allow it to support different formats, different sets of clamps/jaws are included. These clamps are made of anodized aluminium. Connecting to the 220/230V – 50/60 Hz mains, this machine does not require compressed air.

MGA Technologies is specialized in the design and manufacture of various machines and equipment, including the aseptic disconnector, for professionals in the pharmaceutical, biotech and medical industries. MGA Technologies also creates custom-made machines for several other sectors such as precision mechanics, agri-food, aeronautics and automotive.

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