GORE PFL Series STA-PURE Pump Tubing

Manufacturer: Gore (日本ゴア)
Made in Japan
Model: PFL Series

Overview of PFL Series

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:

Chemically Inert	Provides better chemical compatibility than silicone or thermoplastic elastomer (TPE) tubing Performs reliably with common organic solvents Minimizes incidence of premature rupture
High Resilience	Maintains process stability Delivers consistent flow rate
Available in Standard Sizes	Retrofits easily to industry-standard peristaltic pumps. See a complete list of all our standard dimensions.
Compatible with CIP/SIP and Autoclave Sterilization	Provides a flexible solution for industry-standard cleaning/sterilization procedures Supports sterile fluid processing

Chemical Resistance

Series PFL was tested to ensure reliable performance with aggressive chemicals as compared to deionized (DI) water. Twelve (12) samples were tested in a Watson-Marlow 600 Series two-roller peristaltic pump at a discharge pressure of 10 psig and speed of 165 rpm. The samples had a nominal ID of 12.7 mm and nominal WT of 3.2 mm. The samples were subjected to CIP/SIP conditions for 5 cycles (3 before and 2 during testing). Working fluids consisted of DI water (6 samples), and 99% concentrations of acetic acid, acetone, and ethanol (2 samples each). The mean tube life of the samples that underwent pumping of organic solvents was not significantly different from the samples that underwent pumping of DI water.

Product Information

Closeup of tubing structure shows composite of silicone and ePTFE.

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. Shown: Cross-section of tube wall in detail.

Materials and Construction

A patented composite of platinum-cured perfluororelastomer and expanded polytetrafluoroethylene (ePTFE)

Fluid Contact Surface

Platinum-cured perfluoroelastomer

Performance Testing

Series PFL was tested for durability in peristaltic pumps over a wide range of discharge pressures and working fluids (see table).

Results Summary

Discharge Pressure (psig)	Tube Life (hours)
10	>330^b
60	85 ± 48^c

^a Continuous pumping of room temperature deionized water 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). Samples selected represent the worst-case configuration of pump and tube size based on mechanical stresses imposed by the pump on the tube.
^b Tube size = 12.7 mm (ID) x 3.2 mm (WT); When testing was terminated at a minimum of 330 hours, all 6 samples were performing without failure. Failure is defined as rupture, leakage, sustained flow reduction of 25 percent or more, or inability to sustain operating pressure. Tubing was subjected to conditions similar to 5 CIP/SIP cycles (3 before and 2 during testing).
^c Tube size = 6.4 mm (ID) x 2.4 mm (WT); 6 samples were tested until failure as defined in (b) above. The operating life until failure is presented as the average and standard deviation for all samples. The minimum observed value was 28 hours. Before testing, tubing was subjected to conditions similar to 1 CIP/SIP cycle.

Sterilization

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.

Biocompatibility Testing*

Biological Testing	USP <87> Biological Reactivity Tests In Vitro
Biological Testing	USP <88> Biological Reactivity Tests In Vivo, Class VI

*Results are verified annually.

Manufacturing Environment and Quality

Series PFL is manufactured and packaged in an ISO 14644-1 Class 7 cleanroom in a manner that adheres to relevant current Good Manufacturing Practices (cGMP) as defined in the Gore PharmBIO Products’ quality system which is certified to ISO 13485 and ISO 15378. Every Series PFL product is visually inspected for contamination and for defects in materials and workmanship. The inner diameter, wall thickness, and length of the tubing are measured for each manufacturing lot and checked to ensure conformance to specifications.

Storage/Shelf Life

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 standard sizes through select channel partners. To request a Validation Guide, or to connect with a trusted channel partner to discuss your specific needs, contact us.

Illustration of tube showing inner diameter, wall thickness, and tube length.

Example	Z	A	12	FE
Attribute	Inner diameter (ID)	Wall thickness (WT)	Length (L)	Series PFL
Nominal 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)	FE
Example: ZA12FE 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).

Gore (日本ゴア)