Pharmaceutical grade silicone tubing and braided silicone tubing are the best choices for fluid transfer tubing in medical and biopharmaceutical applications. Strict control over the raw materials and additives used in the production of silicone tubing and braided tubing is necessary to reduce contamination risks and ensure the safety and efficacy of biopharmaceutical products. Therefore, the government has put forward several guiding opinions on consumables used in biopharmaceutical processes, including applicability studies, biosafety studies, biocompatibility studies, and other recommendations.
Silicone fluid transfer tubing is made of silicone rubber and typically requires vulcanization or curing to polymerize the monomers into polymers for shaping. Thus, two main types of silicone tubing are produced: platinum-cured silicone tubing and peroxide-cured silicone tubing.
Peroxide-cured silicone tubing is opaque and produces a noticeable odor and unavoidable by-products during production. In contrast, platinum-cured silicone tubing is transparent in color, odorless, and free of by-products during production.
Platinum-cured silicone fluid transfer tubing performs significantly better than peroxide-cured silicone tubing after exposure to gamma irradiation, with platinum-cured silicone tubing exhibiting superior physical properties. Therefore, more biopharmaceutical companies choose platinum-cured silicone tubing for production.
To address this, BioLink uses imported medical-grade raw materials. Through unique production processes, BioLink has introduced the cost-effective SynaLinX® TST platinum cured silicone tubing and SynaLinX® RST braided platinum cured silicone tubing. In terms of biocompatibility, the products exhibit low dissolved matter, low toxicity, low adsorption, and have undergone physical, chemical, and biological performance tests, meeting standards such as USP Class VI, and ISO 10993, and certified by SGS.
Production process flow chart
Transparent color for easy observation of fluid
Withstand three ways of sterilization, including high temperature and pressure, ethylene oxide, and gamma irradiation
Operating temperature from -60°C to 200°C
Good tensile strength and elongation at break
ISO Class 7 clean room production
No animal-derived ingredients
Excellent biocompatibility
Filter components
Fluid transfer
Cell culture
Tube assembly
Withstand three ways of sterilization, including high temperature and pressure, ethylene oxide, and gamma irradiation
Operating temperature from -40°C to 180°C
Excellent mechanical performance
CIP/SIP
Ultrafiltration system tube assembly
Connection of stainless steel liquid distribution system
Single-use pressure-resistant tubing assembly
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