Overview

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:

High Flex Durability

  • Enables long production cycles

  • Minimizes incidence of rupture at high pressures
High Resilience
  • Maintains process stability
  • Delivers consistent flow rate
Standard Sizes
  • Retrofits easily to industry-standard peristaltic pumps.
  • Series PCS comes in standard sizes, available through our select channel partners. 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

 

Product Information

Cross section image showing detailed structure of STA-PURE? PCS Tube

Unlike conventional tubing, Series PCS is manufactured with a patented composite of platinum-cured silicone rubber, reinforced with expanded polytetrafluoroethylene (ePTFE) for added strength and resilience. Shown: Cross-section of tube wall in detail.

Materials of Construction

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

Fluid Contact Surface

Platinum-cured silicone

Performance Testing

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.

Results Summary: Series PCS Tube Life and Flow Decay at End of Testa

Discharge Pressure (psig) Tube Life (hours)
10 >2,160b
100 106 ± 48c

a Continuous pumping of room temperature deionized water in Watson-Marlow 500 Series peristaltic pumps, with pump head speed of 220 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 = 9.5 mm (ID) x 2.4 mm (WT). When testing was terminated at 2,160 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 cycles before testing and 2 cycles during testing).

c Tube size = 3.2 mm (ID) x 2.4 mm (WT). Six tubing 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 52 hours. Before testing, tubing was subjected to conditions similar to 1 CIP/SIP cycle. 

Biocompatibility Testing*

GORE STA-PURE Pump Tubing, Series PCS meets the following requirements:

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

*Results are verified annually.

Manufacturing Environment and Quality

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.

Storage and Shelf Life

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.

Sterilization

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.

 

Product Comparison

GORE STA-PURE Pump Tubing, Series PCS Signifcantly Outperforms Silicone

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.

GORE STA-PURE Tubing Series PCS

  • exceptional
    :
    High-pressure applications (up to 100 psi)
  • exceptional
    :
    SIP / CIP compatible
  • exceptional
    :
    Long tube life
  • exceptional
    :
    Minimal flow-rate decay

Conventional Silicone Tubing

  • not
    :
    High-pressure applications (up to 100 psi)
  • not
    :
    SIP / CIP compatible
  • not
    :
    Long tube life
  • not
    :
    Minimal flow-rate decay
Long-term Reliability

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.

Series PCS Outperforms Silicone Tubing While Lasting At Least 70 Times Longer
Chart shows flow rate decay of Series PCS versus silicone tubing.

■ Series PCS did not fail; testing was terminated at 2,160 hours.
■ Silicone tubing failed within 29 hours.

Test Conditions
  • 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.

Dimensions & Availability

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.

Illustration of tube showing inner diameter, wall thickness, and tube length.
Example Z A 12 ME
Attribute Inner diameter (ID) Wall thickness (WT) Length (L) Series PCS
Nominal Range 1.6 – 25.4 mm
(0.063 – 1.0 in)		 0.8 – 9.0 mm
(0.031 – 0.354 in)		 304.8 – 796.0 mm
(12.0 – 31.3 in)		 ME
Example: ZA12ME is a Series PCS 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).
Standard Configurations

SEE STANDARD DIMENSIONS

  Nominal Dimensions Specifications
Gore Part Number Inner Diameter
(mm)		 Wall Thickness
(mm)

Inner Diameter
(mm)

 Wall Thickness
(mm)		 Length
(mm)
XZ12ME 2.8 0.8 2.80 ± 0.20 0.90 ± 0.10 304.8 ± 3.0
YA12ME 1.6 1.6 1.60 ± 0.20 1.70 ± 0.20 304.8 ± 3.0
YA14ME 1.6 1.6 1.60 ± 0.20 1.70 ± 0.20 355.6 ± 3.0
ZA12ME 3.2 1.6 3.20 ± 0.25 1.70 ± 0.20 304.8 ± 3.0
ZA14ME 3.2 1.6 3.20 ± 0.25 1.70 ± 0.20 355.6 ± 3.0
AA12ME 4.8 1.6 4.70 ± 0.25 1.70 ± 0.20 304.8 ± 3.0
AA14ME 4.8 1.6 4.70 ± 0.25 1.70 ± 0.20 355.6 ± 3.0
BA12ME 6.4 1.6 6.30 ± 0.25 1.70 ± 0.20 304.8 ± 3.0
BA14ME 6.4 1.6 6.30 ± 0.25 1.70 ± 0.20 355.6 ± 3.0
CA12ME 8.0 1.6 7.90 ± 0.25 1.70 ± 0.20 304.8 ± 3.0
CA14ME 8.0 1.6 7.90 ± 0.25 1.70 ± 0.20 355.6 ± 3.0
CA16ME 8.0 1.6 7.90 ± 0.25 1.70 ± 0.20 406.4 ± 3.0
YB14ME 1.6 2.4 1.60 ± 0.20 2.50 ± 0.20 355.6 ± 3.0
ZB14ME 3.2 2.4 3.20 ± 0.25 2.50 ± 0.20 355.6 ± 3.0
AB14ME 4.8 2.4 4.70 ± 0.25 2.50 ± 0.20 355.6 ± 3.0
BB14ME 6.4 2.4 6.30 ± 0.25 2.50 ± 0.20 355.6 ± 3.0
CB14ME 8.0 2.4 7.90 ± 0.25 2.50 ± 0.20 355.6 ± 3.0
DB14ME 9.5 2.4 9.40 ± 0.25 2.50 ± 0.20 355.6 ± 3.0
DB24ME 9.5 2.4 9.40 ± 0.25 2.50 ± 0.20 609.6 ± 3.0
BC24ME 6.4 3.2 6.30 ± 0.25 3.30 ± 0.20 609.6 ± 3.0
DC24ME 9.5 3.2 9.40 ± 0.25 3.30 ± 0.20 609.6 ± 3.0
EC24ME 12.7 3.2 12.50 ± 0.25 3.30 ± 0.20 609.6 ± 3.0
EC26ME 12.7 3.2 12.50 ± 0.25 3.30 ± 0.20 660.4 ± 3.0
FC24ME 15.9 3.2 15.70 ± 0.50 3.30 ± 0.20 609.6 ± 3.0
CH15ME 8.0 4.0 7.90 ± 0.25 4.20 ± 0.40 381.0 ± 3.0
LH15ME 12.0 4.0 11.80 ± 0.25 4.20 ± 0.40 381.0 ± 3.0
LH24ME 12.0 4.0 11.80 ± 0.25 4.20 ± 0.40 609.6 ± 3.0
NH15ME 17.0 4.0 16.80 ± 0.50 4.20 ± 0.40 381.0 ± 3.0
NH24ME 17.0 4.0 16.80 ± 0.50 4.20 ± 0.40 609.6 ± 3.0
DD24ME 9.5 4.8 9.40 ± 0.25 5.00 ± 0.40 609.6 ± 3.0
ED24ME 12.7 4.8 12.50 ± 0.25 5.00 ± 0.40 609.6 ± 3.0
FD24ME 15.9 4.8 15.70 ± 0.50 5.00 ± 0.40 609.6 ± 3.0
GD24ME 19.1 4.8 18.80 ± 0.50 5.00 ± 0.40 609.6 ± 3.0
HD24ME 25.4 4.8 25.00 ± 0.50 5.00 ± 0.40 609.6 ± 3.0
EE27ME 12.7 6.4 12.50 ± 0.25 6.60 ± 0.45 685.8 ± 3.0
GE27ME 19.1 6.4 18.80 ± 0.50 6.60 ± 0.45 685.8 ± 3.0
JF80ME 25.0 9.0 24.60 ± 0.50 9.20 ± 0.50 796.0 ± 6.0

 

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