Aseptic welder for fully automatic welding of thermoplastic pipes

High-Precision Aseptic Welder: Fully Automated Sterile Tubing Connector for TPE & PVC

Product Overview

The Aseptic Welder is a state-of-the-art, fully automated system designed for the high-integrity sterile connection of thermoplastic and PVC tubing. It enables the seamless joining of disposable bag assemblies and tubing manifolds within non-classified environments while maintaining the absolute sterility of the fluid path. Engineered for Biopharma Single-Use Technology (SUT), this compact device provides a robust thermal weld that replaces the need for laminar flow hoods.

The aseptic welder (sterile welder) is a fully automated device for connecting thermoplastic tubing in a sterile welding operation.

The fully automated device allows sterile connection of tubing with outer diameter from 1/4" to 3/4".

Operating Principle & Sterile Integrity

Our advanced thermal welding process ensures total security:

• Depyrogenation: The specialized blade is flash-heated to >400°C to ensure complete depyrogenation before welding.

• Infrared Precision: An integrated IR sensor monitors the blade temperature in real-time, precisely cooling it to the optimal welding point to prevent material carbonization.

• Aseptic Path: The system cuts and fuses tubes simultaneously, creating a burr-free, smooth internal fluid path.

  
  

  
  

  
  

  Technical Specifications

  Core Advantages & Features

  1. Dual-Material Flexibility

  • Hybrid Support: Unlike standard welders, this unit simultaneously meets the requirements for both TPE thermoplastic and PVC pipes.

  • Dry & Wet Welding: Supports both dry joint and liquid-filled (wet seal) modes for versatile bioprocessing applications.

  • Customizable Fixtures: Comes standard with 4 sets of tube adapters; expandable up to 12 customized sets.

  2. Software Excellence & GMP Compliance

  • Audit Trail: Built-in audit tracking ensures all "takeover" data is logged and stored, complying with modern data integrity standards.

  • Temperature Optimization: Allows users to verify and lock in the most suitable welding parameters for specific tubing brands.

  3. Rigorous Validation Support

  • The system is engineered for easy validation and has successfully passed:

    • Microbial Challenge Tests (Ensuring 100% sterility).

    • Tensile & Burst Testing (Confirming weld strength exceeds tubing ratings).

  4. User-Centric Design

  • One-Key Efficiency: Features one-touch welding and one-touch reset. The reset function remains active even when the upper cover is open.

  • Compact Portability: At only 10kg, it is easily moved between cleanrooms or sampling stations.

Example of operation:

We provide various customized services (OEM&ODM) to global buyers, informing us of the requirements for bioprocess single use bags or  other equipment, such as pipeline materials, length, diameter, clamp types, usage or photos of the products currently in use.

FAQ

1. 1. What tubing materials are compatible with this aseptic welder?

   The device is compatible with a wide range of thermoplastic elastomers (TPE) such as C-Flex, PharMed BPT, and Advantaflex, as well as PVC tubing.

2. 2. Can this sterile welder perform connections in a non-sterile environment?

   Yes, the aseptic welder is designed to create a high-integrity sterile connection in non-classified environments without the need for a laminar flow hood.

3. 3. How does the blade ensure sterility during the welding process?

   The blade undergoes a depyrogenation process by heating to over 400°C before cooling down to the precise welding temperature monitored by infrared sensors.

4. 4. What is the typical welding cycle time for a sterile connection?

   The high-efficiency welding process typically takes between 1 minute 45 seconds and 2 minutes, depending on the tubing specifications and brand.

5. 5. Does the device support welding for liquid-filled tubes?

   Yes, the welder is versatile and supports both dry joint and liquid seal (wet welding) modes for various biopharmaceutical applications.

6. 6. What tubing sizes can the standard aseptic welder accommodate?

   The standard configuration supports tubing with outer diameters (O.D.) ranging from 1/8" to 3/4", covering most common single-use bag assembly requirements.

7. 7. How many customized tube adapters can the system support?

   While it comes with standard sets, the device is highly scalable and can support up to 12 sets of customized fixtures for different tubing diameters.

8. 8. Does the software include features for GMP data integrity?

   Yes, the software includes an audit trail function and allows for takeover data storage and export via SD card to meet GMP and regulatory requirements.

9. 9. What is the alignment accuracy of the welding process?

   The device features an ultra-high welding positioning accuracy of 5 $\mu$m, ensuring a smooth internal fluid path free of burrs or obstructions.

10. 10. Can the device be disinfected with standard laboratory agents?

    The exterior is constructed from medical-grade stainless steel, which is fully compatible with 75% alcohol disinfection protocols.

11. 11. The equipment is validation-ready and has successfully passed microbial challenge tests, tensile strength testing, and blast pressure testing.. 

12. What validation tests has the aseptic welder passed?

13. 12. Is the equipment portable for use in different cleanroom areas?

    Yes, the compact design weighs only 10 kg, making it easy for staff to transport and use across different sampling or production stations.