Biowelder S

The Biowelder® S represents a breakthrough in aseptic thermal welding technology, specifically engineered to address the unique challenges of cell and gene therapy (CGT) manufacturing. This automated welding device enables fast, sterile connections of small-diameter polyvinyl chloride (PVC) and thermoplastic elastomer (TPE) tubing in both non-classified environments and Grade B & C cleanrooms.

Traditional welding solutions developed for blood transfusion or large-diameter biopharma applications fall short in CGT workflows, often requiring multiple devices and limiting material compatibility. The Biowelder® S bridges this critical gap by supporting both PVC and TPE materials across all CGT-relevant tubing sizes: 3/32" × 5/32", 1/8" × 3/16", and 1/8" × 1/4".

The device's innovative single-blade technology significantly reduces operational costs compared to traditional dual sterile connector systems. Each Biowelder® S Cartridge contains 50 precision-manufactured stainless steel blades, equipped with RFID tracking for automated inventory management and full traceability through batch numbers.

Key technical capabilities include validated welding parameters for Tuflux® TPE, C-Flex® 374, Tygon® ND 100-65, and MED6536 tubing materials. The advanced tube holder utilizes vertical movement to accommodate three different tubing sizes without requiring holder changes, while robust calibration enables easy transport between manufacturing suites.

The five-inch touchscreen interface guides operators through each welding cycle with visual instructions, supporting paperless GMP manufacturing requirements through electronic record keeping. Ethernet connectivity and USB ports facilitate seamless integration into existing quality management systems.

Applications span the complete CGT workflow from upstream processes including media preparation and cell expansion, through downstream operations encompassing harvest, clarification, and cryopreservation. The device addresses critical process steps including collection bag sourcing, media bag preparation, cell culture container connections, centrifugation and filtration systems, and cryobag handling.

Operating at maximum validated pressures of 1 bar with minimum tubing lengths of 200 mm, the Biowelder® S maintains sterility while welding both dry and liquid-filled tubing. The compact design (410 × 270 × 230 mm with cover inserts) weighs 14.2 kg and operates efficiently at temperatures from 20°C to 32.2°C with humidity tolerance up to 80%.