The pharmaceutical, biotech and medical industries have a growing need to make aseptic disconnections of tubing between interconnected process equipment. Flexible tubing carries fluids from one unit to the next, and operators regularly have to connect and disconnect this pharma tubing. MGA Technologies developed AseptiSeal, its aseptic tube sealer for thermoplastic tubing, designed for use directly in the cleanroom.
When a tube has to be replaced, the equipment must be disconnected. This operation requires a dedicated machine that guarantees a sterile disconnection. So how can operators make aseptic disconnections safely?
Our solution: AseptiSeal, the sterile disconnector for pharmaceutical tubing. Discover the product and its features.
The Aseptic Disconnection Machine
This machine is specially designed to make aseptic tube disconnections. It is most often used in cleanrooms to rule out 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:
- First, the operator inserts the tube between two clamps. Once closed, the jaws are locked by an electromagnet.
- The operator then starts the disconnection cycle, which has two phases:
- In the first phase, the temperature of the clamps is raised until it slightly exceeds the melting point of the tube.
- In the second phase, the temperature is maintained to destroy any germs that may be present on both sides of the jaws and to let the tube fuse.
- A vane pump built into the unit then lowers the temperature so that the operator can handle the tube safely.
- The electromagnet unlocks the jaws.
- The operator carries out a visual inspection to validate the disconnection, then cuts the tube with a pair of scissors.
A second machine is needed to reconnect the tube so that the disconnected equipment can run again: the sterile tube welder developed by MGA Technologies with Sanofi Pasteur. It is also used in cleanrooms so that the tube connection remains fully aseptic.
Technical Characteristics of the Aseptic Disconnection Machine
The aseptic disconnector is designed and manufactured by MGA Technologies. It is compatible with TPE (thermoplastic elastomer) tubing with a diameter of 1/4″, 1/2″ and 3/4″, whether new or autoclaved. Different sets of clamps/jaws are supplied so that it can handle each format. These jaws are made of anodized aluminum. The machine connects to 110 V and 220/230 V – 50/60 Hz mains power and does not require compressed air.
It has a precise heating system that delivers a clean, controlled seal and cut of the tube. Its cycle is fully automated, which considerably reduces the risk of human error. Its stainless steel frame is suited to clean environments, making it a reliable and hygienic tool for aseptic processes.
It also integrates temperature and timing controls that ensure optimal repeatability from one operation to the next. Its ergonomic design makes it easy to use in the cleanroom and simplifies maintenance. Altogether, it ensures a safe disconnection of fluid lines while meeting the requirements of pharmaceutical and biotech environments.
Different Brands of TPE Tubing Suitable for Aseptic Disconnection
Several brands of TPE tubing have properties that allow them to withstand heat sealing. The five major brands of thermoplastic elastomer tubing most visible on the market are:
PharmaPure®
The Saint-Gobain Group developed this premium, biocompatible brand of tubing for peristaltic pumps. PharmaPure® tubing is specially designed for pharmaceutical, laboratory and biotech applications. It also features extremely low particle spallation, and its low permeability gives it a long service life.
PharMed®
PharMed® TPE tubing is manufactured by the Saint-Gobain Group to offer high resistance to peristaltic pumping. For sensitive bioprocessing applications, it is also designed to provide the necessary biocompatible fluid surface. Its long flex life simplifies biopharmaceutical manufacturing processes and reduces production downtime caused by pump tubing failure. Its properties also minimize erosion of the inner walls of the tubing, which improves the overall efficiency of filtration systems.
Production downtime due to pump tubing wear is significantly reduced thanks to these characteristics. This tubing is best suited to sensitive cell culture, process monitoring, sterile filling, purification, separation and fermentation.
C-Flex®
Saint-Gobain, which specializes in tubing for single-use fluid processing, also developed the C-Flex® brand. C-Flex® tubing can be bonded, molded and formed. It is also suitable for tubing sets, overmolding and bag manifolds. Because it is made from thermoplastic elastomer, it is used in the biotech and pharmaceutical industries.
Saint-Gobain has also developed braided C-Flex® tubing to meet biopharmaceutical and pharmaceutical requirements for high-pressure fluid processing. It is made with C-Flex formula 082 (no animal-derived components) and braided with reinforced polyester.
AdvantaFlex®
This brand of tubing is also developed by Saint-Gobain. AdvantaFlex® tubing is widely used in the pharmaceutical and biotech industries for fluid transfer and processing. It is the perfect answer to the need for sterilizable, weldable, heat-sealable, translucent and flexible biopharmaceutical tubing for fluid handling.
AdvantaFlex® tubing retains its physical properties even after sterilization. It offers good visibility of product flow because it does not become gummy, resists kinking and remains translucent.
SaniPure®
SaniPure® tubing is single-use and suited to bioprocessing systems. Saint-Gobain developed it to handle the transfer of sensitive biological fluids. It is easy to weld and seal, so aseptic disconnections and connections can be made while protecting fluids from contamination. Its ultra-smooth inner bore greatly reduces the risk of particle entrapment or microscopic buildup during biopharmaceutical manufacturing. It contains no animal-derived components and has low absorption.
Secure Your Processes with Reliable, Certified Aseptic Disconnections
In pharmaceutical and biotech environments, reliable aseptic disconnections are key to maintaining sterility and protecting sensitive products. A poorly controlled disconnection can lead to cross-contamination or compromise the integrity of an entire production batch. That is why it is important to use equipment specifically designed to perform these operations in a repeatable, precise and safe way.
Certified aseptic disconnections make it possible to separate two fluid systems without compromising their sterility, even after prior sterilization. This equipment is designed to work with different tubing diameters and to fit standardized processes. With robust clamping systems and optimized cutting cycles, it ensures a clean, safe operation, even in critical conditions.
By integrating these technologies into your production lines, you gain better traceability, fewer human errors and easier compliance with regulatory requirements, in particular GMP (Good Manufacturing Practice). Certified aseptic disconnectors such as AseptiSeal are therefore an essential step in securing your sterile manufacturing processes.
Aseptic Disconnection Machine Manufacturer
Most manufacturers in this field offer components for single-use aseptic processes. MGA Technologies is a leading French company in this area. The machine we offer makes aseptic disconnections that preserve the integrity of the tube, so the same tube can later be reconnected with our sterile connection device for TPE tubing. Repeated disconnections and reconnections are useful, for example, during sampling operations.
Our teams of technicians and engineers bring the right skills to every type of project. They know the requirements and constraints of the pharmaceutical and medical industries, which allows them to deliver solutions that match each customer’s specific needs.
About MGA Technologies
MGA Technologies specializes in the design and manufacture of machines and equipment, including the aseptic disconnector, for professionals in the pharmaceutical, biotech and medical industries. MGA Technologies also builds custom machines for many other sectors such as precision mechanics, food processing, aerospace and automotive.
The company stands out for its ability to meet demanding specifications by integrating the latest mechatronics, robotics and automation technologies. With our know-how, we help our customers optimize their industrial processes in compliance with current quality standards. Also discover our sterile tube welder for thermoplastic tubing.
We also focus on continuous innovation and on improving industrial performance, in order to offer reliable, robust solutions suited to the most demanding environments. Contact us!
