Pharmaceutical Silicone Tubing

Pharmaceutical Silicone Tubing
Details:
Pharmaceutical silicone tubing is a flexible tube made from high-purity silicone specifically designed for the pharmaceutical, biopharmaceutical, biotechnology, and related high-cleanliness industries. Its main features include compliance with strict biocompatibility and hygiene standards, enabling safe transmission of liquids, gases, or sensitive substances. It is widely used in scenarios requiring high purity and contamination-free environments.
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Description
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Pharmaceutical silicone tubing is a flexible tube made from high-purity silicone specifically designed for the pharmaceutical, biopharmaceutical, biotechnology, and related high-cleanliness industries. Its main features include compliance with strict biocompatibility and hygiene standards, enabling safe transmission of liquids, gases, or sensitive substances. It is widely used in scenarios requiring high purity and contamination-free environments.

 

Advantages of Medical Silicone Tubing

 

 

1

High Biocompatibility

Medical-grade silicone tubing meets stringent standards such as USP Class VI, ISO 10993, and FDA 21 CFR 177.2600, and does not react with human tissues or fluids, making it suitable for medical and pharmaceutical applications.

It is non-toxic, odorless, and free of plasticizers or harmful substances, ensuring the purity of drugs and biological samples.

2

Excellent chemical inertness

Silicone does not react with most chemicals, preventing contamination of the transported material by the tubing material, making it suitable for transporting sensitive drugs or laboratory reagents.

3

Wide temperature tolerance

It maintains flexibility and structural integrity within a temperature range of -40°C to 200°C, making it suitable for high-temperature sterilization or low-temperature environments.

4

Exceptional flexibility and durability

Silicone tubing is soft and highly elastic, allowing for easy bending and installation in complex systems, and is resistant to deformation or cracking, making it suitable for long-term use.

5

Easy to clean and sterilize
Smooth inner and outer surfaces prevent bacterial growth, and the tubing supports high-temperature steam, chemical cleaning, or gamma ray sterilization, meeting high hygiene requirements.

6

High transparency

Platinum-cured silicone tubing is typically transparent or semi-transparent, enabling real-time monitoring of fluid flow and ensuring operational safety.

7

Low outgassing
The platinum-curing process minimizes byproduct outgassing, ensuring that the tubing does not release harmful substances into the transmitted medium, making it particularly suitable for high-purity pharmaceutical processes.

 

Specifications

 

 

Inner Diameter 0.5 mm – 50 mm
Wall Thickness 0.5 mm – 10 mm
Shore Hardness 50 ~ 80 Shore A
Colors Transparent, translucent, or customized
Packaging Sterile or non-sterile; coil, cut lengths, or bagged

 

Applications of pharma silicone tubing

 

 

pharma silicone tubing is widely used in the following fields due to its high purity, biocompatibility, and durability:

Biopharmaceuticals and Pharmaceuticals

Peristaltic pump systems: Used for contamination-free fluid transfer to prevent cross-contamination.

Drug delivery systems: Ensuring precise, sterile drug delivery, such as in the production of injectable solutions and vaccines.

Single-use systems (SUS): Used in rapid deployment biopharmaceutical production to reduce cleaning validation costs.

Medical Devices

Catheters and drainage tubes: Used in hemodialysis, intravenous infusion, and drainage systems due to their biocompatibility and safety for contact with the human body.

Respiratory devices: Such as oxygen machines and ventilators, due to their high-temperature resistance and gas exchange properties.

Laboratory Applications

Used for transporting sensitive biological samples or reagents, ensuring contamination-free and chemically stable conditions.

Food and Beverage

Silicone tubing compliant with FDA food-grade standards, used for beverage dispensing, water filtration, and dairy processing.

 

About Us

 

 

We are a professional company with 15 years of experience in silicone tubing research, development, and manufacturing, located in Dongguan, China. Our factory covers an area of 5,000 square meters and has a team of 160 people, including 30 R&D engineers, with strong independent innovation capabilities. With advanced automated production lines and precision testing equipment, we have achieved a complete production process from extrusion, weaving, platinum vulcanization to molded forming and pressure testing, ensuring that our products meet international quality standards. Our products are widely used in the medical, food and beverage, biopharmaceutical, hydrogen-powered vehicle, and industrial equipment sectors, and we offer OEM/ODM customization to meet the high-standard requirements of global customers.

 

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FAQ

 

Q: 1. What is pharmaceutical silicone tubing used for?

A: Pharmaceutical silicone tubing is used for fluid transfer in drug manufacturing, bioprocessing, and medical devices. It ensures purity, sterility, and biocompatibility in critical applications.

Q: 2. Is pharmaceutical silicone tubing FDA approved?

A: Yes, high-quality pharmaceutical silicone tubing complies with FDA 21 CFR 177.2600 for food-grade and pharmaceutical contact, along with USP Class VI and ISO 10993 standards.

Q: 3. Can silicone tubing be sterilized?

A: Absolutely. Pharmaceutical silicone tubing is autoclavable and compatible with steam-in-place (SIP), clean-in-place (CIP), gamma irradiation, and ethylene oxide (EtO) sterilization methods.

Q: 4. What is the temperature range of pharmaceutical silicone tubing?

A: Typical working range is from -60°C to +200°C, making it ideal for both cryogenic and high-temperature processes.

Q: 5. Is silicone tubing safe for medical use?

A: Yes. Pharmaceutical-grade silicone tubing is non-toxic, non-reactive, and meets strict biocompatibility standards required for medical applications.

Q: 6. Is silicone tubing compatible with aggressive chemicals?

A: Silicone has good resistance to many chemicals, but it is not ideal for strong acids, bases, or solvents. For aggressive fluids, fluoropolymer tubing may be more suitable.

Q: 7. Is pharmaceutical silicone tubing flexible?

A: Yes, it's known for excellent flexibility and kink resistance, even at small bend radii and low temperatures.

Q: 8. Can silicone tubing be customized for my application?

A: Definitely. We offer custom sizes, hardness, colors, cut lengths, packaging, and branding to fit your pharmaceutical or medical process needs.

 

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