Biocompatible Silicone Tubes: Ensuring Sterility in Biopharmaceutical Fluid Transfer

In the biopharmaceutical industry, where even microscopic contaminants can compromise drug safety and efficacy, the choice of fluid transfer tubing is critical. Biocompatible silicone tubes have emerged as the gold standard for sterile fluid handling, offering unparalleled purity, reliability, and regulatory compliance. As a leading manufacturer with over 40 years of expertise, Jinan Chensheng Medical Technology Co., Ltd. delivers premium biopharmaceutical-grade silicone tubing engineered to meet the most stringent industry demands.

The Critical Role of Biocompatibility in Biopharmaceutical Manufacturing

Biopharmaceutical processes—from cell culture to drug formulation—require materials that interact safely with sensitive biological fluids and active pharmaceutical ingredients (APIs). Unlike conventional elastomers, medical-grade biocompatible silicone undergoes rigorous testing to ensure it meets global standards:

• USP Class VI Certification: Validates non-toxicity and biocompatibility through in vivo and in vitro tests, including systemic toxicity and intracutaneous reactivity.

• ISO 10993 Compliance: Ensures compatibility with human tissues and fluids, with specific testing for cytotoxicity, sensitization, and irritation.

• Low Extractables Profile: Platinum-cured silicone minimizes leachables, preventing contamination of APIs during long-term storage or repeated use.

For biopharmaceutical manufacturers, these certifications are not just regulatory checkboxes—they are essential for maintaining product integrity and patient safety.

Key Features of Jinan Chensheng’s Biocompatible Silicone Tubes

Our Biopharmaceutical Grade Platinum-Custom Sterile Tubing is engineered to address the unique challenges of sterile fluid transfer. Here’s how it stands out:

1. Ultra-Pure Platinum-Cured Silicone

Unlike peroxide-cured alternatives, our tubing uses a platinum-curing process that eliminates residual byproducts, ensuring:

• Animal-origin-free formulation: Eliminates the risk of zoonotic contamination, critical for cell-based therapies and vaccines.

• Consistent material purity: Batch-to-batch uniformity with strict raw material sourcing from ISO 13485-certified suppliers.

• Smooth inner surface: Ra ≤ 0.8μm finish reduces protein adsorption and particle retention, minimizing the risk of biofilm formation.

2. Sterilization Versatility

Our silicone tubes withstand multiple sterilization cycles without degradation, supporting flexible process design:

• Autoclaving: Stable at 121°C (250°F) for 30 minutes, compatible with steam sterilization protocols.

• Gamma Irradiation: Resistant to doses up to 50 kGy, ideal for pre-sterilized single-use systems.

• Ethylene Oxide (EtO): Compatible with low-temperature EtO sterilization, preserving integrity for heat-sensitive applications.

3. Customizable Design for Diverse Applications

We offer tailored solutions to match specific process requirements, with a wide range of dimensions and configurations:

Table 1: Standard dimensions of biocompatible silicone tubes (custom sizes available upon request)

4. Mechanical Durability for Critical Processes

Our tubing maintains performance under demanding conditions:

• Hardness: 60±5 Shore A, balancing flexibility with kink resistance.

• Tensile Strength: ≥7 MPa, ensuring resistance to burst pressure during fluid transfer.

• Elongation at Break: ≥300%, accommodating dynamic movement in peristaltic pump applications.

Applications Across the Biopharmaceutical Value Chain

Our biocompatible silicone tubes are trusted in critical processes, including:

• Bioreactor Fluid Transfer: Safe handling of cell culture media, nutrients, and harvests.

• Single-Use Systems (SUS): Integration into disposable bioprocess containers and manifolds.

• Chromatography and Purification: Transfer of sensitive APIs during column chromatography and filtration.

• Laboratory and Pilot-Scale Research: Reliable performance in R&D settings, ensuring scalability to commercial production.

Why Choose Jinan Chensheng as Your Biocompatible Silicone Tube Partner?

With over four decades of specialization in medical silicone manufacturing, we bring unmatched expertise to every project:

1. Regulatory Excellence

• ISO 13485 Certified Facilities: Our production lines adhere to strict quality management systems, with Class 7 cleanrooms for sterile tubing assembly.

• Global Compliance: Products meet CE, FDA, and NMPA requirements, facilitating market access in Europe, the Americas, and Asia.

2. Vertical Integration and Quality Control

From raw material testing to finished product inspection, we control every step:

• In-House R&D: A dedicated team develops custom formulations for unique process needs (e.g., low-protein binding, high-temperature resistance).

• Batch Traceability: Comprehensive documentation ensures full traceability from material receipt to shipment.

3. OEM/ODM Capabilities

We collaborate closely with clients to deliver tailored solutions:

• Custom Extrusions: Specialized tooling for unique diameters, wall thicknesses, and surface treatments.

• Sterile Packaging: Options for double-bagged sterile packaging with ethylene oxide (EtO) indicators.

Partner with Jinan Chensheng for Your Biopharmaceutical Tubing Needs

When sterility, biocompatibility, and reliability are non-negotiable, Jinan Chensheng’s biocompatible silicone tubes deliver peace of mind. Our commitment to quality and customization has made us a trusted supplier to leading biopharmaceutical companies worldwide.

Ready to optimize your fluid transfer processes? Contact our team today to discuss your requirements:

• Email: info@jngxj.cn

• Phone: +86-531-85600186

• WhatsApp: +86-18560016197

• Product Page: Biopharmaceutical Grade Platinum-Custom Sterile Tubing

Jinan Chensheng Medical Technology Co., Ltd.—Your Partner in Biopharmaceutical Excellence.