Single-use technology solutions have become the norm in cutting-edge practices in the global pharmaceutical industry. Ensuring the sterility and reliability of pipe connections between disposable container components such as mixing bags and liquid storage bags is the key to the successful application and optimization of disposable systems in pharmaceutical processes.

Cobbett's Lifemeta Tube Welder-Pro series of sterile welding device meets this market demand and has been successfully approved by many users for field applications. At the same time, to better support our customers’ needs for tube welder consumables, we have specially developed the CLGB-I blade for Company C sterile tube welding, and the CLSB-II blade for Company S second generation sterile tube welding. This will bring new solutions for customer supply chains and applications.

Figure 1 CLGB-I Blade Compatible with Company C Sterile Tube Welding

Application Leads to Design, Design Gives Birth to Features

A Short Story about Design

Sterile Tube Welding is widely used in biopharmaceutical and other production processes that require sterile conditions to transport fluids, so the product needs to have good stability and ease of use. The Cobetter CLGB-I blade is made of black polytetrafluoroethylene (PTFE) coated with a special nickel-chromium alloy (NiCrA), which has excellent heating properties, and the PTFE coating is not only suitable for high temperature conditions, but also for cleaning the TPE hot melt layer on the outer surface of the welded blade.

Product Features

• High-quality welding
• Low TPE hot melt residue
• PTFE coating, high compatibility, eliminates potential contamination
• Black non-reflective coating, enhances the accuracy of the equipment's recognition of blade temperature.

Excellent Welding Performance

The Lifemeta CLB series blade is able to weld TPE thermoplastic tube samples various specifications and different brands, and test results show that it has comparable or stronger welding performance, in terms of the welding stability and welding strength when compared with the original manufacturer’s blade, which can meet the needs of users.

As shown in the following figure, in multiple groups of test results, the welding area is stable with a "ring" welding bump, which can preliminarily prove the welding stability, and the bump is also a key observation item for the sterile guarantee of the welding process.

Figure 3 Welding Performance

Based on visual inspection, we conducted mechanical property tests, including tensile strength, on the welded areas and compared the results. 

As shown in the figure below, we used the reference blade (equipment original blade) and three groups of CLGB-I blades to test the welded 1/4" ID*7/16"OD TPE tubing after gamma irradiation and steam sterilization, and the tensile strength was all above 100N.

For the sealing performance of the welded parts, we use water intrusion (observation of bubbles in water) and pressure-holding method to verify, the results are shown in the following table:

For CLSB-II blades, we have done a lot of experiments both in the laboratory and at the user's end, and the results of sample testing have been fully approved.

Figure 5 Welding Tests of CLSB-II Blades Welding Gamma Sterilization Tubing

The test results are shown in the above figure, which indicates that multiple batches of this blade model have passed the welding pressure resistance test and tensile test, and its welding safety and stability are comparable to the original blade of the equipment.

Note:

Pressure Resistance Test: visually check whether the welded connecting area is flat; connect the tubing to the test device, slowly add pressure to 1.5 bar and hold it for 10 minutes, observe whether there are air bubbles in the welded area, and if there are no air bubbles, it is considered that the pressure resistance test has been passed.

Tensile Test: Visually check whether the whether the welded connecting area is flat, use servo tensile testing machine to carry out tensile test, the test process refer to ASTMD412-04, tensile rate of 150mm/min, the test environment temperature of 23 ℃, and record the average tensile force peak at rupture.

Complete Process Validation Services

For the Lifemeta CLB series Sterile Tube Welder Blade, Cobetter offers not only customisation, but also matching and complete process validation services, providing a high value experience on the application side.

Validation Service Case Sharing

Case 1:

A biopharmaceutical customer has a process application involving the welding of different brand TPE tubes, and Cobetter is required to verify the welding process using CLGB-I and other series blades on these brand TPE tubes and provide relevant comparative validation reports.

Case 2： 

A biopharmaceutical customer needed to reuse CLSB-II blades and requested Cobetter to conduct a pre-validation for the repeated use, including a comprehensive assessment of the flow rate, strength, and endotoxin levels of the welded tubing on the repeated-use blades.

Figure 6 Validation Report Sample

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