Make Aseptic Disconnections

C-Flex® Tube Disconnector - Characteristics and Use

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

C-flex tubing sealer

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 110V and 220/230V – 50/60 Hz mains, this machine does not require compressed air.

Different Brands of TPE Tubing Suitable for Aseptic Disconnection

 

Different brands of TPE tubing have properties that enable them to withstand heat sealing. The five major brands of thermoplastic elastomer tubing that are most visible on the market are

PharmaPure®

The Saint-Gobain Group has developed this premium brand of tubing for peristaltic pumps which are biologically compatible. PharmaPure® tubes have been specially designed for pharmaceutical, laboratory and biotech applications. They also benefit from extremely low particle spallation. Thanks to their low permeability, they have a long shelf life.

PharMed®

PharMed® TPE tubing has been manufactured by the Saint-Gobain Group to offer high resistance to peristaltic pumping. For sensitive bioprocessing applications, they have also been designed to provide the necessary biocompatible fluid surface. Biopharmaceutical manufacturing processes are simplified thanks to their considerable flexural life. This reduces production downtime due to pump tube failure. They have properties that allow them to minimize erosion of the inner walls of tubing. As a result, the overall efficiency of filter systems is improved.

Production downtime due to pump tube wear is significantly reduced due to their characteristics. These tubes are most suitable for sensitive cell cultures, process monitoring, sterile filling, purification, separation and fermentation.

C-Flex®

The Saint-Gobain Group specialises in hoses for the processing of single-use fluids and has also developed the C-Flex® brand tubes. These can be glued, moulded and formed. They are also suitable for tubing, overmoulding and bag collectors. The fact that they are manufactured from thermoplastic elastomers allows them to be used in the biotechnology and pharmaceutical industries.

C-Flex® brand braided tubes have also been developed by the Saint-Gobain Group to meet biopharmaceutical and pharmaceutical requirements when processing fluids at high pressure. They are manufactured with C-Flex formula 082 (no animal components) and braided with reinforced polyester.

AdvantaFlex®

This brand of tubing is also developed by Saint-Gobain. AdvantaFlex® tubes are widely used in the pharmaceutical and biotechnology industries for fluid transfer and processing. They are the perfect answer to the need for sterilizable, weldable, heat-sealable, translucent and flexible biopharmaceutical tubing for fluid handling.

AdvantaFlex® brand tubes are able to retain their physical properties even after sterilisation processes. They offer good visibility of product flow as they do not become gummy, resist kinking and remain translucent.

SaniPure®

SaniPure® tubes are single-use and are suitable for biotreatment systems. They are developed by Saint-Gobain to manage the transfer of sensitive biological fluids. They are easily welded and sealed to allow aseptic disconnection and connection while protecting fluids from contamination. Indeed, any risk of particle entrapment or microscopic buildup during biopharmaceutical manufacturing is greatly reduced by their ultra-smooth internal bore. They have the advantage of being animal-free and have low absorption.

About MGA Technologies

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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