Thermoplastic Eastomer Tube
Thermoplastic elastomer tubes are intended for pharmaceutical, food, medical and biotechnological applications. They are also designed to resist chemical corrosion and high pressure. Generally used for transferring fluids between several devices, thermoplastic elastomer tubing has a relatively long service life, avoiding the need for frequent replacement and repetitive downtime of the machines it is installed on.
Unique Feature of Thermoplastic Elastomer Tubes
Thermoplastic elastomer tubes have the unique feature of melting and hardening easily under the action of heat, and this also works in a reversible way. This makes it easier to cut and weld them when disconnected and connected. All these operations must be carried out in a clean room to ensure aseptic handling of the tubes, from their manufacture to their packaging. There are two techniques for sterilizing thermoplastic elastomer tubes: autoclaving and gamma radiation sterilization.
Before leaving the manufacturing facilities, the tubing is subjected to various extensive tests on its chemical, physical, biological and extractable properties. They must also be manufactured in accordance with the requirements of various standards: ISO10993-1, USP Class VI, European Pharmacopoeia 3.1.9. They are also tested according to the latter in order to assess their compliance.
Depending on requirements, manufacturers can offer two types of tubes: translucent tubes to allow visibility of fluid flow and opaque tubes to facilitate the use of light-sensitive fluids.
Each thermoplastic elastomer tube supplied by manufacturers must be marked with the batch number to ensure traceability. This provides information about the raw material, quality control steps, initial manufacturing equipment, reference, product description, expiry date and production data.
For pharmaceutical applications, it is necessary to use a specific device to disconnect and connect thermoplastic elastomer tubes aseptically.
Connectors and Disconnectors for Thermoplastic Elastomer Tubes
In order for the connection of the tubes to be completely aseptic, the use of a sterile connector in a clean room is essential. This is a device that is integrated into FDA processes, specially designed for zone welding (class 100 / ISO5 dynamic). It allows sterile connections to be made outside the area without the risk of cross-contamination. Operators can also handle the device safely. It is suitable for connecting tubes from 1/4” to 1”.
The use of the sterile connector increases operator productivity. In fact, operators are no longer required to go into a sterile area to connect the tubes. In order to ensure the quality of the connections, the cycle is fully automated. The connector is easy to use and easy to maintain. In addition, its robust heating blades allow it to carry out up to 200 welds.
When disconnecting two devices, a sterile disconnector is required. The tube is to be placed in a clamp which will be locked by an electromagnet after closing. The operator can then start the disconnection cycle. The temperature rise is ensured by a ceramic heating device until it slightly exceeds the melting point of the tube.
The temperature level is maintained to eliminate germs that may enter on either side of the clamp. The device incorporates a vane pump that lowers the temperature after melting so that the operator can handle the tube safely. The opening of the clamp is released by the electromagnet at the end of the cycle. The operator then cuts the tube with a pair of scissors after a visual check of the fusion process.
This device is suitable for disconnecting new or autoclaved thermoplastic elastomer tubes with a diameter of 1/4″, 1/2″ and 3/4″. For format changes, the device has several sets of anodized aluminium clamps. In addition, no compressed air is required for its use.
To obtain the brochure and pricing of the MGA Technologies disconnection machine, contact our team of technicians directly via the contact form or call us on +33 4 78 83 03 22 (Monday to Friday, from 8am to 6pm).
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