Components, Fluid Transfer

PharmaPure® Low Spallation Pump Tubing

PharmaPure® is an ultra-pure pump tubing with exceptional pump life. Download the new white paper here.

 

PharmaPure® is a premium, low spallation, biologically compatible peristaltic pump tube developed especially for pharmaceutical, biotechnology, and laboratory applications. This tubing meets the challenges of providing unsurpassed pump life with ultra-low particulate spallation and very low permeability. The superior flex life characteristics of PharmaPure reduce production downtime due to pump tubing failures. In addition, PharmaPure’s low permeability is ideal for protecting sensitive cell cultures, fermentation, separation, purification, process monitoring, and sterile filling.

Features & Benefits

  • Ultra-low particulate spallation
  • Outlasts silicone tubing in peristaltic pumps by up to 30 times
  • Provides an excellent gas barrier with very low permeability
  • Autoclavable and sterilizable
  • Custom molding and design capabilities
  • Meets the requirements of USP, Biological Test for Plastics, Class VI
  • Documented biocompatibility – validation summary available upon request

Applications

  • Media Process Systems
  • Vaccine Manufacturing
  • Bioreactor Process Lines
  • Sterile Filling
  • Diagnostic Test Products
  • Production Filtration and Fermentation
  • Shear-Sensitive Fluid Transfer

Application Impact

Critical Applications Rely on PharmaPure® Purity

Low spallation tubing is essential across the most sensitive modalities in the biopharma industry:

Application Why Low Spallation Matters Modality Focus
Sterile Fill-Finish Protects the final drug product after filtration, directly impacting patient safety and regulatory compliance. Aseptic Processing
Cell & Gene Therapies (CGT) Prevents contaminants from impacting sensitive cell viability, growth, and function in bioreactors and media transfer. High-Value/Low-Volume Products
Separation and Purification Prevents the fouling of costly chromatography resins and TFF membranes, maintaining process efficiency. Peristaltic Pumping
Process Monitoring Ensures samples accurately reflect fluid purity without contamination from the tubing itself. Single-Use Systems (SUS)

Resource Center

Product Documents

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PharmaPure® Low Spallation Peristaltic Pump Tubing
Datasheet
PharmaPure® Low Spallation Peristaltic Pump Tubing
PharmaPure® Tubing Performance: Effects of Gamma Irradiation and Autoclaving
White Paper
PharmaPure® Tubing Performance: Effects of Gamma Irradiation and Autoclaving

The PharmaPure® Purity and Stability Advantage

Proven stability and ultra-low spallation, even after rigorous sterilization.

Your high-value applications demand a tubing solution that won't compromise purity or performance - especially after sterilization. Our latest research confirms that PharmaPure® tubing delivers on both fronts. We've proven its mechanical and chemical stability after exposure to autoclaving and high-dose gamma irradiation (up to 50 kGy) while demonstrating a superior commitment to ultra-low particle shedding (spallation).

The Low Spallation Advantage

Particles shed from tubing during pumping are a major threat to your drug substance. PharmaPure® is engineered to minimize this risk:
Ultra-Low Particle Shedding

Testing confirms minimal spallation even after both gamma irradiation and autoclaving.

Protecting Your Drug

Our data shows excellent resistance to releasing larger particles, giving you confidence in your product's final quality.

Beyond the Standard

While gamma can initially increase subvisible particles, our study suggests this is primarily non-shedding oil that rapidly decreases, not true polymer spallation.

New White Paper - PharmaPure® Tubing Performance: Effects of Gamma Irradiation and Autoclaving

PharmaPure® tubing maintains mechanical integrity even at elevated sterilization levels:

Exceptional Pump Life

Even at 50 kGy, PharmaPure® still achieved over 500 hours of pump life, continuing to outlast standard silicone tubing up to 10x.

Gamma Stability

Proven to maintain crucial performance characteristics up to 50 kGy - significantly higher than standard industry recommendations.

Mechanical Integrity

Negligible changes to burst pressure, minimum bend radius, and durometer after gamma and autoclave cycles, ensuring consistent flow and safety.

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