Challenging pharmaceutical and biopharmaceutical processes demand high performance solutions — including durable peristaltic pump tubing that reliably withstands aggressive chemicals and protects against catastrophic failure.
Silicone pump tubing has limited resistance to chemicals like organic solvents. But the patented composite of GORE STA-PURE Pump Tubing, Series PFL is engineered to resist aggressive chemicals including organic solvents. Series PFL tubing also delivers consistent flow rates at pressures up to 60 psig and is designed to work seamlessly in your existing processes. Series PFL is:
|Available in Standard Sizes||
|Compatible with CIP/SIP and Autoclave Sterilization||
Unlike silicone tubing, Series PFL is manufactured with a patented composite of platinum-cured perfluoroelastomer and expanded polytetrafluoroethylene (ePTFE) for increased reliability with aggressive chemicals in peristaltic pumps.
Materials and Construction
A patented composite of platinum-cured perfluororelastomer and expanded polytetrafluoroethylene (ePTFE)
Fluid Contact Surface
Series PFL was tested for consistent flow and durability in peristaltic pumps over a wide range of discharge pressures and working fluids. Series PFL maintains consistent flow up to 60 psig following steam sterilization conditions. Failure of the tube was defined as: rupture; leakage; sustained reduction in flow of 25% or more; inability to sustain desired operating pressure.
|Discharge Pressure (psig)||Working Fluids||Tube Life (hours)||Loss of Initial Flow Rate (%)|
|10||Acetic acid, acetone, ethanol||Equivalent to DI waterc||2|
a Continuous pumping of room temperature working fluids in Watson-Marlow 500 and 600 Series peristaltic pumps. The 500 Series pumps were used for testing at 60 psig with pump head speed of 220 rpm (two rollers). The 600 Series pumps were used for testing at 10 psig with pump head speed of 165 rpm (two rollers).
b Tube size = 12.7 mm (ID) x 3.2 mm (WT); 6 samples were tested until failure. Tubing subjected to conditions similar to 5 CIP/SIP cycles (3 before and 2 during testing). Based on a 1-sided lower-limit prediction interval, there is a 95% probability that any tube will perform without failure for at least 95 h.
c Tube size = 12.7 mm (ID) x 3.2 mm (WT); 6 samples were tested until failure (2 samples with acetic acid, acetone, and ethanol separately). Tubing subjected to conditions similar to 5 CIP/SIP cycles (3 before and 2 during testing). With 95% confidence, overall performance of the samples was not significantly different from performance of samples that pumped DI water. For each organic solvent, the tubing’s average operating life was greater than or equal to the average operating life of the tubes that pumped DI water.
d Tube size = 6.4 mm (ID) x 2.4 mm (WT); 18 samples were tested until failure. Before testing, tubing was subjected to conditions similar to 1 CIP/SIP cycle. Based on a 1-sided lower limit prediction interval, there is a 95% probability that any tube will perform without failure for at least 76 h.
Series PFL has been validated to operate after steam-in-place/clean-in-place (SIP/CIP) and autoclave sterilization. Irradiation sterilization methods such as gamma or electron beam should never be used because they may damage or degrade the mechanical properties of the product.
Biological and Physicochemical Testing*
|Biological Testing||USP <87> Biological Reactivity Tests In Vitro|
|USP <88> Biological Reactivity Tests In Vivo, Class VI|
|Physicochemical Testing||Physicochemical testing as set forth in the Test Method section of USP <661> Containers — Plastics|
*Results are verified annually.
Manufacturing Environment and Quality
Quality is integrated into the manufacture and inspection of every Gore product. Series PFL is produced in an ISO 9001-certified facility, in an environment that follows clean concept principles. Each manufacturing lot is measured to ensure all dimensions confrm to specifications, and each Series PFL product is visually inspected for contamination or defects in materials and workmanship.
The expiration date is four years from the date of manufacture. This date is based on an accelerated aging study to simulate storage of the product for four years at room temperature and applies to the product in its original packaging.
Dimensions & Availability
Series PFL products are available in 27 standard configurations, sized for easy retrofit with industry-standard equipment. To request a Validation Guide, or to connect with a trusted channel partner to discuss your specific needs, contact us.
|Attribute||Inner diameter (ID)||Wall thickness (WT)||Length (L)||Series PFL|
|Range||1.6 – 25.4 mm (0.063 – 1.0 in.)||0.8 – 4.8 mm (0.031 – 0.19 in.)||304.8 – 609.6 mm (12.0 – 24.0 in.)|
|Example: ZA12F is a Series PFL tube with a nominal ID of 3.2 mm (0.13 in.), WT of 1.6 mm (0.063 in.), and L of 304.8mm (12 in.).|