In the biopharmaceutical industry, silicone tubing plays a crucial role in liquid transfer. If the biopharmaceutical process is like the metabolic cycle of the human body, then various types of equipment represent the organs within this process, with tubing undoubtedly becoming the "blood vessels" for transporting nutrients and metabolites. The stability and longevity of these "blood vessels" directly affect the robustness of the entire process. In October 2020, the Drug Evaluation Center issued the "Technical Guidelines for Compatibility Studies of Plastic Components Used in the Production of Chemical Drug Injections (Trial)", which stated that "component system manufacturers should fully control the quality of the selected materials". 

Therefore, how to produce silicone tubing with excellent performance and safety through reasonable processes has become a challenge for many suppliers. Shouldering the mission of providing better performance and more reliable quality for pharmaceutical companies, Cobetter proudly introduces the new generation of high-performance Lifemeta STT Platinum Cured Silicone Tubing. This product uses medical-grade raw materials and is developed and produced based on the concept of quality originating from design. Compared to conventional silicone tubing, it boasts advantages such as longer lifespan, higher purity, superior performance, and lower extractables. In this article, we will introduce what make Cobetter's STT Platinum Cured Silicone Tubing unique and a great choice.

Excellent Physical Properties

Figure 1 Overview of the Production Process of Platinum Cured Silicone Tubing

The production of silicone tubing generally involves mixing, extrusion, and curing processes. In the mixing process, silicone, colorants, and curing agents are mixed together. During extrusion, silicone tubing is formed using an extruder. Finally, the silicone tubing undergoes secondary curing at high temperatures to ensure thorough cross-linking of the silicone and to remove any odor and prevent discoloration. Throughout these processes, control of parameters is crucial. Adjusting tool design and processing parameters, such as extrusion pressure, can have a significant impact on the texture of the inner and outer surfaces of the tubing, reducing issues such as minor cracks and scratches, thus improving the product's tensile and burst resistance capabilities, among other properties.

Cobetter's Lifemeta STT silicone tubing is optimized for maximum performance through the ultimate production process. Therefore, in terms of demonstrating the most important physical properties of silicone tubing, Lifemeta STT silicone tubing exhibits excellent tensile strength, burst strength, pumping life, and sterilization stability. Based on test results and data comparison, Lifemeta STT silicone tubing has the highest tensile strength among several competitor brands. Meanwhile, its burst strength can reach 0.7 MPa, and even after sterilization 25 times, the burst strength can still reach 0.6 MPa, demonstrating excellent burst resistance and sterilization stability. The average pumping life is 4-6 times that of ordinary Platinum Cured silicone tubing. In the 80-hour 500 rpm pump flow rate decay test, Lifemeta STT showed a decay rate of less than 10%, comparable to the performance of competitor’s high-efficiency pump tubing. It is particularly suitable for long-term or pressurized processes such as perfusion culture, gas-liquid transfer, filtration operations, and formulation filling, minimizing the risk of tubing rupture and leakage.

Figure 2 Demonstration of Tensile Strength of Cobetter Lifemeta STT Platinum Cured Silicone Tubing

Figure 3 Demonstration of Pumping Flow Rate Variation of Cobetter Lifemeta STT Platinum Cured Silicone Tubing

Strict Quality Management System

Product quality stability is one of the key factors in assessing whether a product can sustain its presence in the market in the long term. In terms of quality assurance, Cobetter adopts a rigorous Japanese-style quality management system. Every process from research and development to production is strictly monitored. Various tests are conducted, including inspection of incoming particles, optimization of processing conditions, evaluation of surface flow marks, examination of contaminants, measurement of inner and outer diameters, and assessment of wall thickness. Additionally, leveraging Cobetter's strong analytical capabilities, in-depth research has been conducted on the smoothness of the inner wall and meticulous inspections of pipe diameter information have been carried out, ensuring the uniform and reliable quality of each tubing.

The production process of tubing strictly adheres to the ISO9001:2015 quality management system. Each batch of products comes with material qualification certificates and traceability of batches, ensuring maximum control over quality stability. Cobetter can provide users with comprehensive product verification and quality assurance documents, including validation guides, extractables, MSDS, CoQ, and declarations of animal origin-free materials, ensuring users' safety in production.

Figure 4 Research on the Different Cytotoxicity of Cobetter Lifemeta STT Platinum Cured Silicone Tubing

Excellent Biocompatibility and Chemical Compatibility

In terms of biocompatibility, Cobetter's Lifemeta STT silicone tubing features low extractables, low toxicity, and low adsorption characteristics. It has undergone rigorous in vitro and in vivo biocompatibility testing and complies with relevant requirements of USP<85>, <87>, <88>, and the 2020 edition of the Chinese Pharmacopoeia. This ensures stable cell growth and, through toxicity studies on various cell lines, confirms that Lifemeta STT silicone tubing provides comprehensive protection in terms of biological safety.

Lifemeta STT silicone tubing is resistant to various solutions, including 100% acetic acid, 10% sulfuric acid, 50% NaOH, 95% ethanol, and 30% hydrogen peroxide. It is suitable for applications such as preparing and transferring culture media and buffer solutions, ultrafiltration concentration, and bulk liquid filling. It can operate in various laboratory and factory environments, providing comprehensive chemical compatibility validation reports.

Stable Supply and Various Specifications of Tubing and Other Components

Figure 5 Lifemeta STT silicone tubing is resistant to 100% acetic acid, 10% sulfuric acid, 50% sodium hydroxide, 30% hydrogen peroxide, and 95% ethanol. It is suitable for applications including preparation and transfer of culture media and buffer solutions, ultrafiltration concentration, and bulk liquid filling.

The Lifemeta STT silicone tubing is available in a variety of standard specifications, covering inner diameter sizes ranging from 1/8 inch to 3/4 inch. Additionally, customized specifications for inner and outer diameter, length, and packaging can be produced according to user requirements. Furthermore, by utilizing Cobetter's self-produced quick connectors, connectors, 2D/3D storage bags, and other disposable components, Lifemeta STT silicone tubing can be combined with various components to meet the diverse needs of different departments in biopharmaceutical companies. This allows for the design of tubing components that meet specific user requirements.

The upcoming Lifemeta STF series thermoplastic tubing and silicone rigid tubing will also be available soon. These products can be used in a range of applications, from upstream cell culture sampling bag components to downstream liquid transfer components and formulation filling bag system components.

Cobetter's Lifemeta series products also have a significant advantage in supply stability. They can meet the increasing demands of biopharmaceutical process applications. Currently, our lead time for supply can be maintained at 1-2 weeks, and there is sufficient stock available for select products.