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Single-Use Tubing & Assemblies

Single-Use Tubing & Assemblies
Overview

Precise and contamination-free fluid transfer is critical for biopharmaceutical manufacturing. Single-use tubing assemblies play a vital role in ensuring sterile, reliable, and efficient liquid handling. 

Cobetter tubing assemblies or transfer sets are made of silicone and TPE tubing, connectors, with/o filters. With Cobetter tubing assemblies, you can easily connect multiple containers, vessels and process lines in one system. 

Cobetter Lifemeta™ Tubing are Available in:

Lifemeta™ STT Pt-cured Silicone Tubing: Biopharmaceutical grade Pt-cured silicone tubing. Can be widely used in fluid transmission in different aspects of the biopharmaceutical industry. It has good resilience and tear resistance, translucent color and smooth inner surface.

Lifemeta™ STF TPE Tubing: High-performance tubing extruded from medical-grade thermoplastic elastomer (TPE) material. Compatible with common tube sealers and aseptic tube welders, achieving excellent performance of frequent aseptic disconnection and connection of tubings.

Lifemeta™ ST5P Pt-cured Silicone Pump Tubing: Can be applied to most peristaltic pumps and has a long pump life. Excellent wear resistance reduces wear on the outer wall of the tubing and improves the overall efficiency of the filtration system.

Lifemeta™ ST8H High Pressure Silicone Tubing: It has very good resilience and kink resistance and typically has a higher pressure rating than softer alternatives. It is the optimal choice for single-use applications such as TFF, virus filtration, inline integrity testing of filtration assemblies, and high volume fluid transfer.

Applications of Tubing Assemblies in Biopharma

  • Single-Use Bioreactors: Transfer cell cultures and media
  • Filtration & Purification: Connecting filters, chromatography systems
  • Fill & Finish Operations: Final sterile filling
  • Vaccine Production: Handling sensitive biologics
  • CIP/SIP Systems: Clean-in-place and sterilize-in-place processe

Quality Assurance 

The entire manufacturing process of Cobetter Lefemeta™ tubing from raw material storage to product packaging is completed in the ISO Class 7 clean zones, which ensures the cleanliness of the product and prevents pollution. The air purification system is confirmed and maintained regularly to ensure that the cleanliness of environment continuously meets the requirements of ISO Class 7. The suspended particles, sedimentation bacteria, temperature, humidity and differential pressure are monitored periodically to provide for a highly controlled clean environment.

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FAQ

Q: What's the application of STS platinum-cured silicone tubing?

Cobetter STS platinum-cured silicone tubing is designed to facilitate fluid transfer in many pharmaceutical and biopharmaceutical applications.

Q: How many internal diameters are available for platinum-cured tubings?

Cobetter STS platinum-cured silicone tubing is available in 7 different internal diameters ranging from 1/8" (3mm) to 3/4" (19mm).

Q: What's the sterility method?

Gamma irradiation and autoclave.

Q: Cobetter’s custom tubing assemblies are non-sterile, can customers sterilize it by themselves?

1. Yes, customers can sterilize only the tubing assemblies and the connectors, excluding any bags.

2. When customers sterilize the connectors and tubing, all ports should be opened, such as connector plugs and blind caps on clamps. After sterilization is completed, they can be connected and used.

3. Especially attention shall be taken that you will need to add an additional cable tie to offset the leakage risk caused by the high-temperature deformation of the original cable tie after off-line sterilization.

Q: What is the recommended length to be reserved for thermoplastic tubing for aseptic connection and aseptic sealing?

Cobetter's aseptic connection machine and aseptic sealing machine can achieve aseptic connection and disconnection in general environments. It is recommended to reserve a length of 15cm for each connection and disconnection.

Q: Can silicone tubing and pump tubing be used for organic solvent solutions?

Silicone tubing is not resistant to organic solvents.

For pump tubing, we need to confirm specific details of the process, such as pipe diameter, operating pressure, duration of use, and the acidity/alkalinity of the fluid being pumped. If organic solvents are involved, it is recommended not to choose silicone tubing and instead opt for pump tubing that is resistant to organic solvents.

Q: Will a single-use system that has been irradiated have any impact on the product? Can irradiation residues be detected in the irradiated items?

No. The irradiation dose is validated to ensure sterilization effectiveness. Moreover, the irradiation process only involves energy absorption and does not involve direct contact with the radiation source. Therefore, there are no issues of irradiation residues in the disposable system.

Q: Are the integrity testing of bags and tubings conducted together?

The pressure resistance of the bags and tubings is different. The bag can withstand a pressure of 0.02 kg. For the bag, we apply a gas pressure of around 0.015 bar or 0.02 bar after clamping with bag clamps. After a certain period, we measure the pressure decay. The tubing and fittings can withstand pressure of up to approximately 2 bar, and we apply a pressure of 1.6 or 1.7 bar to measure the pressure decay.

Q: How do the drawings correspond to the product packaging?

Each product shown on a drawing represents the product within one package. If separate packaging or simultaneous use of multiple products is required, they can be split/integrated into a single drawing.

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