Challenging biopharmaceutical processes demand superior solutions — including peristaltic pump tubing that provides greater reliability and security against rupture. Conventional extruded silicone pump tubing may balloon or rupture at high pressure. GORE STA-PURE Pump Tubing, Series PCS employs a unique, patented composite structure that overcomes this limitation. Even at pressures up to 100 psig, Series PCS tubing delivers consistent flow rates. Series PCS offers:

Patented composite of thermoplastic material (expanded polytetrafluoroethylene) and elastomeric material (platinum-cured silicone)

Platinum-cured silicone

To simulate challenging real world applications, Gore tested Series PCS tubing for durability in peristaltic pumps under rigorous conditions, up to 100 psig, following multiple cleaning and sterilization cycles. Testing was performed over a wide range of discharge pressures.

Series PCS 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 PCS 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.

The expiration date is four years from the date of manufacture based on an accelerated aging study. The product should be stored in its original packaging at room temperature.

Series PCS 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.

Detailed test information is provided in the GORE STA-PURE Pump Tubing, Series PCS Validation Guide, available upon request.

Pharmaceutical or biotechnology manufacturers may be reluctant to use peristaltic pumps, due to pressure or durability limitations of conventional silicone pump tubing.

Series PCS provides an innovative solution to these performance limitations. A comparison with silicone tubing shows how greatly Series PCS has advanced tubing performance.

Tests demonstrate the significant performance advantages of using Series PCS pump tubing rather than silicone in long-duration applications. Series PCS dramatically outperforms silicone in terms of both flow-rate decay and extended service life.

• Continuous pumping of room temperature water in Watson-Marlow 500 Series peristaltic pumps, with discharge pressure of 10 psig and pump head speed of 220 rpm (two rollers).
• Tube size: 9.5 mm (inner diameter) x 2.4 mm (wall thickness). Series PCS was subjected to five CIP/SIP cycles, (three cycles before testing, two cycles during testing. Silicone tubing was not subjected to CIP/SIP cycles.

Series PCS products are available in standard configurations, sized for easy retrofit with industry-standard equipment. See a complete list of all our standard dimensions. To request a Validation Guide, or to connect with a trusted channel partner to discuss your specific needs, contact us.