Applitech AbioWelder™ 100 Sterile Tube Welder
| Brand | Applitech |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | AbioWelder™ 100 |
| Pricing | Upon Request |
Overview
The Applitech AbioWelder™ 100 Sterile Tube Welder is an engineered solution for aseptic, thermoplastic tube joining in single-use bioprocessing systems. It employs resistive heating and rotational blade fusion to create hermetic, particle-free welds between thermoplastic elastomer (TPE) tubing—without requiring solvent, adhesives, or external clamping fixtures. Designed for integration into ISO Class 5–8 cleanrooms or controlled non-classified environments, the system enables robust, repeatable connections of empty or fluid-filled TPE tubing from multiple vendors—including C-Flex® (Saint-Gobain), Tygon® LS-33, Pharmapure®, and other USP Class VI-compliant materials. Its core principle relies on precise thermal energy delivery to the tube interface, inducing localized polymer melt flow under controlled axial pressure and rotational shear, resulting in molecular-level fusion with minimal thermal degradation and zero extractables.
Key Features
- 7-inch industrial-grade capacitive touchscreen HMI with intuitive graphical workflow navigation and preloaded SOP templates
- Rotating heated blade welding mechanism—eliminates positional dependency; accommodates variable tube orientation without realignment
- Full process transparency: optically clear polycarbonate enclosure with integrated UV-resistant shielding ensures visual monitoring while maintaining ISO 14644-1 particulate containment
- Configurable weld parameters (temperature ramp profile, dwell time, rotational speed, axial force) for optimization across wall thicknesses (0.8–3.2 mm) and outer diameters (6.4–25.4 mm / 1/4″–1″)
- Validated weld cycle duration: 90–150 seconds per joint, independent of fluid presence or internal pressure up to 1.0 bar (gauge)
- Minimum functional tube length: 450 mm—ensuring sufficient rigidity for stable clamping and thermal uniformity during fusion
- FDA 21 CFR Part 11–compliant firmware with role-based user access control (admin/operator/auditor), electronic signatures, and immutable audit trails
Sample Compatibility & Compliance
The AbioWelder™ 100 supports TPE tubing meeting USP Class VI biological reactivity requirements and ISO 10993-5 cytotoxicity standards. Compatible tubing includes, but is not limited to: Saint-Gobain C-Flex® (standard factory preset), AdvantaPure® AP-2000, Cole-Parmer PharMed® BPT, and Zeus Biocompatible Polyolefin Blends. All welds undergo post-process integrity verification via visual inspection (absence of voids, flash, or discoloration) and optional pressure hold testing (1.0 bar for ≥30 s). The system complies with ISO 13485:2016 quality management requirements for medical device manufacturing and supports GMP-aligned validation documentation packages (IQ/OQ/PQ).
Software & Data Management
Embedded firmware v3.2+ provides full data governance capabilities compliant with FDA 21 CFR Part 11 and EU Annex 11. Each weld event logs timestamp, operator ID, tube OD/ID, selected protocol, thermal profile trace, final weld resistance value, and pass/fail status. Audit trails are tamper-evident, time-stamped, and stored locally on encrypted internal memory (≥10,000 cycles). Data export options include CSV (for LIMS integration), PDF e-signature reports, and encrypted USB dump. Optional Ethernet/IP or OPC UA connectivity enables centralized monitoring within MES or SCADA environments.
Applications
- Aseptic connection of storage bag inlet/outlet tubing to bioreactor manifolds or downstream purification skids
- Integration of feed/acid/base addition lines to single-use bioreactors without breaking sterility
- On-demand sterile spiking of sampling bags for in-process testing (e.g., glucose, pH, titer assays)
- Modular assembly of multi-bag fluidic circuits for cell therapy manufacturing workflows
- Pre-sterilized tubing manifold fabrication for ATMP (Advanced Therapy Medicinal Product) fill-finish suites
FAQ
Does the AbioWelder™ 100 require compressed air or external utilities beyond standard AC power?
No—only 100–240 VAC, 50/60 Hz, 1.5 A input is required. No pneumatic or vacuum sources are needed.
Can it weld tubes containing media, buffers, or cell culture supernatants?
Yes—validated for fluid-filled operation at ≤1.0 bar internal pressure and ambient temperatures between 15–30°C.
Is calibration traceable to NIST or equivalent national standards?
Temperature sensors are factory-calibrated against PT100 reference probes with ±0.5°C uncertainty; calibration certificates are provided with each unit.
What documentation is supplied for regulatory submissions?
Standard package includes Factory Acceptance Test (FAT) report, IQ/OQ protocols and executed records, Part 11 compliance statement, and material declarations (RoHS/REACH/California Prop 65).
