New Year Top Choice | BioLink SynaLinX® Pharmaceutical-Grade Tubing: Safeguarding the “Pulse” of Biopharmaceutical Processes

As the new year begins, the biopharmaceutical industry is presented with a golden opportunity to accelerate innovation. In this race for “purity, safety, and efficiency,” have you fully prepared your fluid transfer system?

Tubing, the "lifeline" of liquid flow, directly impacts the quality and compliance of drug production. The safety of its material, the precision of its dimensions, and its durability are all critical factors. Choosing a reliable tubing solution is the first step in ensuring smooth production operations throughout the year.

Why Choose SynaLinX®?

BioLink SynaLinX® series pharmaceutical-grade tubing is specifically designed for the entire biopharmaceutical process, from upstream cell culture to downstream purification and formulation filling. Offering over 100 specifications of silicone and thermoplastic tubing, we ensure precision at every stage. As we know that safety lies in the details, and purity is paramount.

Comprehensive validation, strengthening the security defense

Every SynaLinX® tubing undergoes rigorous "tempering":

• Endotoxin < 0.25 EU/mL, eliminating pyrogen risks.

• Particles≥10 μm, < 25 particles/mL; particles ≥25 μm. < 3 particles/mL, ensuring exceptional fluid purity.

• Fully compliant with USP Class VI, ISO 10993 cytotoxicity and sensitization, and other biocompatibility tests, supported by a complete BPOG extractables study report, making customer validation far easier.

• Compatible with autoclave, ethylene oxide (EtO), and gamma irradiation, meeting sterility requirements across diverse bioprocess applications.

Breakthroughs in key applications, adapting to high-difficulty process scenarios

• Ultra-low protein adsorption to preserve biological activity: Designed for the production of biologics such as monoclonal antibodies, SynaLinX® TST/PST silicone tubing has been professionally tested and verified to show adsorption levels of < 0.11 μg/cm² for bovine immunoglobulin (IgG) and bovine serum albumin (BSA). This minimizes protein loss to the greatest extent, ensuring product activity and yield.

• Enhanced chemical resistance for complex processes such as ADC manufacturing: In response to the common use of organic solvents—including DMSO, DMAC, and DMF—in ADC production, SynaLinX® silicone tubing (TST/MST/HST series) and SynaLinX® B-Flex® thermoplastic tubing demonstrate excellent compatibility. They remain stable for 30 days in 35% solvent concentrations, and can withstand short-term use even in 100% high-concentration solvents, delivering reliable support for complex drug manufacturing.

Ultra-pure materials empowerment, cleanliness throughout the entire process

Selected 100% medical-grade elastomers and other raw material particles with no animal-derived components (ADCF), preventing additive interference and contamination risks from the source. A secondary curing process ensures extremely low extractables and adsorption. Advanced platinum-catalyzed vulcanization technology enables breakthroughs in pressure resistance, wear resistance, and fatigue resistance while maintaining exceptional flexibility. Manufacturing takes place in an ISO Class 7 cleanroom, under fully closed-loop control. The production process strictly follows the ISO 9001:2015 quality management system and cGMP regulations, with all process parameters repeatedly validated internally.

Precision manufacturing control, consistent quality

An integrated extrusion-and-molding production line is equipped with an online laser measurement system to perform closed-loop control of tubing dimensions, ensuring every batch meets precise specifications for dimensional tolerance and hardness. From raw material melting to final cutting, the single-machine end-to-end production model completely eliminates contamination risks in intermediate steps.

Core product matrix, precisely matching needs

• Platinum-cured silicone tubing family (TST/MST/HST): Ranging from 50A (short-term peristaltic pump use) to 80A (demanding 3–5 bar conditions), covering standard, medium-pressure, and high-pressure applications. These products offer both biocompatibility and kink resistance, and comply with USP Class VI, ISO 10993, and other regulatory validations.

• High-performance pump tubing (PST): The 60A hardness formulation is specifically designed for peristaltic pumps, providing excellent fatigue resistance. It can run continuously for over 100 hours without deformation, ensuring stable and accurate fluid transfer.

• Reinforced tubing (RST/WST): Enhanced with polyester braid or steel-wire reinforcement, achieving working pressures up to 22 bar. Supports CIP/SIP inline cleaning and sterilization, and is compatible with stainless-steel systems and high-pressure/vacuum environments.

• Wear-resistant & thermoplastic solutions (BPT / B-Flex®): BPT wear-resistant tubing can run continuously on pumps for over 1000 hours, significantly reducing maintenance costs. SynaLinX® B-Flex® thermoplastic tubing supports aseptic welding, contains no silicone oil and no animal-derived components, offering exceptional cost-performance.

• Molded silicone assemblies: One-piece molded construction eliminates risks of leaks and dead volume.

Not just pipelines, but solutions

In addition to standard tubing, BioLink also provides:

• Single-use integrated tubing systems: Pre-assembled and pre-sterilized, ready to use out of the box, helping reduce validation and maintenance costs.

• Custom assembly services: Personalized tubing-set design and manufacturing based on your specific process requirements.

• Crimped hose systems: Suitable for stainless-steel systems, supporting high pressure, high temperature, and in place sterilization.

Figure 1: Components Used Together with the Tubing

BioLink SynaLinX® series is more than just a tube. It's a complete fluid-transfer solution, spanning everything from materials to validation, from standard products to fully customized services. We aim to be the most dependable “vascular guardian” of your production in the year ahead.