Sani-Tech® SPT-60L 

High Accuracy Applications

Biocompatible

Sani-Tech® SPT-60L tubing is manufactured from platinum-cured silicone materials and tested to a variety of specifications including:

ADCF/BSE/TSE statements

ISO 10993-3 / ISO 10993-5

USP <88> Class VI

EP 3.1.9

For additional compliance data visit www.biopharm.saint-gobain.com to download the Technical Dossier.

*Actual Tested Burst Pressure Part Numbers Burst Pressure Test Method = ASTM D1599 Test Media = Water

The values listed for burst pressures are derived from tests conducted under controlled laboratory conditions. Many factors will reduce the tubing's ability to withstand pressures, including temperature, chemical attack, stress, pulsation and the attachment to fittings. It is imperative that the user conduct tests simulating the conditions of the application prior to specifying the tubing for use.

Peristaltic Pump Tubing Life

Due to its specific formulation, Sani-Tech® SPT-60L provides exceptional continuous pumping duration.

As demonstrated in Table 1, Sani-Tech® SPT-60L provides over 3x the pump life compared to other extruded silicone tubing that are marketed for final fill applications.

Vial Fill Accuracy and Precision (Non-Irradiated Tubing)

Table 2 demonstrates the degradation in vial fill accuracy from the nominal (1.8 mL) target with the number of vial fills. Sani-Tech® SPT-60L maintains higher precision compared to competitors' tubing throughout the duration of the filling trial. (See white paper for more details.)

Spallation

Using flow-imaging microscopy, spallation within the fluid path was measured as the number of particles produced (number of particle/ml) and the relative size of the particles generated (µm2/ml) over a number of simulated vial fills. The study was per- formed with Ultra-Pure water using a dual six-roller peristaltic pump, operating at 300 rpm (no back pressure at room tempera- ture). The following table summarizes the spallation results for 1/16" x 3/16" ID x OD (1.6 x 4.8 mm) silicone tubing and repre- sents the average sum of all particles produced after 3000 vial fills. The test was done in triplicate.

Sani-Tech® SPT-60L was tested against four final fill marketed silicone tubes and generated 50% less spallation (particles/ml) than the closest competitor.

ValPlusTM Certification

ValPlus™ provides customers with an industry first opportunity to mitigate risk and add value into their production process steps. This enhanced level of tubing validation certification offers a higher level of quality assurance in single-use fluid handling components. Saint-Gobain Life Sciences validates the fluid path of the tubing using a single, normal ANSI Level II sampling plan to meet the following standard industry requirements:

• USP <788> for Sub-visible Particulates

• USP <85> and <161> for Endotoxins

• ISO 11737-1 for Bioburden

For more information on ValPlusTM, please visit www.biopharm.saint-gobain.com/valplus