Biowelder® S: Automated Sterile Connection Device for PVC & TPE Tubing
Streamline CGT processes with safer and less labor-intensive handling
Biowelder® S was developed to support cell and gene therapy (CGT) product development along with good manufacturing practice requirements. It enables fast, sterile connection of small polyvinyl chloride (PVC) and thermoplastic elastomer (TPE) tubing in a non-classified environment as well as Grade B and C clean rooms — helping you keep running costs low while supporting paperless GMP manufacturing.
- Welds dry, wet, & liquid-filled tubing out-of-the-box
- Universal parameters, no need for accessories
- Supports most sizes & materials
- Electronic recording to support 21 CFR part 11 | EU GMP Annex 1
- Turns on in one minute, welds in 30 seconds
- Completes cycle even if external power supply fails
Biowelder® S for Cell and Gene Therapies
Out of the box, Biowelder® S supports most tubing sizes and materials used for cell and gene therapy bioprocessing from cell sourcing to cryopreservation. You can use it to streamline your aseptic tube connections at high speed and low cost in your perfusion process — as well as throughout bioprocessing in cell and gene therapy.
GMP-Compliant Sterile Welding for PVC and TPE Tubing
While traditional welders use a horizontal movement that restricts support to one tubing size per holder, Biowelder® S uses a vertical movement to cover three different tubing sizes without the need for interchanging holders.
The Biowelder® S Cartridge includes up to 50 stainless steel blades with a high level of uniformity designed to optimize heat distribution during cutting and welding.
The device is automated and easy to use with a five-inch touchscreen, which visually guides operators through the process.
| Biowelder® S Automated Aseptic Welding Device | |
|---|---|
| Automation & intuitive operation | Fully automated welding process with visual guidance displayed on five-inch touchscreen. |
| Flexibility | Validated for common tubing including Saint-Gobain Tygon® ND 100-65 and C-Flex® 374, Tuflux® TPE, and MED 6536 from RAUMEDIC. Validation guide available for quality assurance. |
| Short welding time | Produces fast, reliable, and automated connections in 30 seconds. |
Designed for Fast, Flexible, Automated Welding
Biowelder® S is designed to meet the need for aseptic thermal welding in CGT and GMP manufacturing. You can use it to aseptically connect two tubes made of PVC or TPE. At the end of the operation, the device will provide one welded tube and discard two leftover ends.
Streamline Your Processes in CGT
Enhance Your CGT Workflow With a One-Size-Fits-All Welder
Traditionally, most cell and gene therapy welders were developed for blood transfusion or biopharmaceutical applications. But they come with limitations — they either don’t support all sizes, or they don’t work with both PVC and TPE, forcing users to purchase multiple devices for a single application. This is not only more costly in terms of upfront investment and maintenance, but also in terms of space, as more equipment increases your workflow’s footprint in your lab or manufacturing area.
By covering PVC and TPE in all relevant sizes for cell and gene therapy, Biowelder® S is designed to streamline your aseptic connections from cell sourcing to cryopreservation.
Biowelder® S | Comprehensive Welding in One Device
Biowelder® S is designed to enable aseptic thermal welding for GMP and CGT manufacturing. The device is automated and easy to use with a five-inch touchscreen that visually guides operators through welding. Weld logs and audit trails are simple to export using USB or ethernet, enabling paperless and easy documentation.
Biowelder® S Components, Accessories, and Services
Maximize performance and ensure uninterrupted operation with single-use components, accessories, and service from Sartorius.
Learn More About Biowelder® S
Frequently Asked Questions
A sterile connection device is hardware that can join two fluid paths (e.g., tubing, bags, bioreactors) together while maintaining a closed, aseptic system—meaning no microorganisms or particles are introduced before, during, or after the connection. These are widely used in biopharma and cell therapy to transfer media, buffers, intermediates, and samples without exposing the fluid to the environment.
Common types are:
- Aseptic connectors: Two mating halves with protective membranes or barriers. When joined, an internal mechanism removes the barriers and brings sterile surfaces into contact, creating a leak-tight, sterile path.
- Sterile tube welders: Heat-weld two compatible thermoplastic tubes to form a continuous sterile connection. Often used with thermoplastic elastomer (TPE) or polyvinyl chloride (PVC); silicone generally can’t be welded.
Sterile tube welding connects tubes in classified or non-classified environments. Biowelder® S uses a clean, hot blade for cutting and welding to ensure integrity. In the first step, tubes are squeezed, then cut, moved, and welded. After this process, a new connection is formed, and the two ends are discarded. By bacterial challenge tests, it has been demonstrated that even in the event of contamination on the tubing and blade surface, the media within the tube remained uncontaminated during welding.
Key factors are sterility validation, weld quality, material compatibility, ease of use, and industry compliance. Biowelder® S is a tube welder that ensures aseptic, reliable welds with proven bacterial challenge testing. The validation guide also shows that tensile strength and pressure resistance have been successfully tested.
Yes. Biowelder® S can weld PVC to PVC tubing and TPE to TPE tubing in three different sizes. The sizes are 3/32" x 5/32“ (2.4 mm x 4 mm), 1/8" x 3/16“ (3.2 mm x 4.8 mm), and 1/8" x 1/4“ (3.2 mm x 6.4 mm), also known as size 16. Brands such as Saint-Gobain Tygon® ND 100-65, C-Flex® 374, and Sartorius Tuflux® TPE are validated.
A welder should support PVC for medical applications, such as cell sourcing, and TPE for bioprocessing. Modern visual user guidance ensures smooth operation with minimal training requirements. User management and electronic recording ensure a future-proof investment. Of course, features like reliability, ease of use, and support for regulatory compliance are essential.
An aseptic connector uses a sterile interface to create a connection while minimizing contamination. It leverages self-sealing to maintain sterility in non-sterile environments. The fluid paths keep sealed behind sterile barriers until the two halves are fully mated and sealed. Then the path is internally opened, so the product-contact surfaces are never exposed to the non-sterile room air.
Yes. Biowelder® S logs every weld and all software-related changes of the device in weld logs and the audit trail. Both can be exported. Possible export targets are USB sticks and remote network servers via FTP. If you want to monitor Biowelder® S, it can be connected via OPC-UA. This way, standard properties and performed welds are monitored.
