GORE STA-PURE Pump Tubing®

®

SERIES PFL

Durable, resilient, chemically resistanttubing for peristaltic pump applications

Validation Guide

GORE STA-PURE Pump Tubing®

Validation Guide®

SERIES PFLTable of Contents
1.0 Product Overview		

3

4.0 Performance Test Methods and Results

5

1.1 Description 		3

1.2 Part Numbering 		

3

1.3 Materials of Construction

4

1.4 Performance Specifications		 1.4.1 Biocompatibility				1.4.2 Physicochemical
1.5 Handling/Operating Specifications		 1.5.1 Cleaning and Sterilization
1.5.2 Flow, Durability, and Operating Pressure		1.5.3 Chemical Resistance
1.5.4 Packaging		
1.5.5 Product Shelf Life444444444

4.1				4.25555

2.0 Compliance Statements		

42.1 FDA-Regulated Status		

4

2.2 Animal-Derived Materials

4

2.3 Product Stewardship 		

4

3.0 Quality Control Statements

5

3.1 Manufacturing Environment

5

3.2 Quality Management System

5

3.3 Traceability		

5

3.4 Lot Release Testing		

5Biocompability		
4.1.1 USP <87> Biological Reactivity Tests In Vitro
4.1.2 USP <88> Biological Reactivity Tests In Vivo
Physicochemical		

5.0 Handling/Operating Test Methods and Results

5

5.1 Flow, Durability, and Operating Pressure

55.1.1
5.1.2
5.1.3

Cleaning and Sterilization
Test Method Summary
Test Results		

5.2 Chemical Resistance		
5.2.1
5.2.2

Test Method Summary
Test Results		

566666

5.3 Product Shelf Life 		

6Appendix A: GORE® STA-PURE® Pump Tubing,Series PFL Part List		

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GORE STA-PURE Pump Tubing®

Validation Guide®

SERIES PFL

1.0 Product Overview

Figure 1: Series PFL, Composite Structure in Detail

1.1 Description
GORE® STA-PURE® Pump Tubing, Series PFL is a durable, resilient
tubing product used in peristaltic pumps in pharmaceutical andbiopharmaceutical manufacturing. The product delivers consistentflow rate and low incidence of rupture, even with aggressive
chemicals. Series PFL enables the pump to work reliably atoperating pressures up to 60 pounds per square inch gauge (psig).
The product achieves this performance via a unique combinationof thermoplastic and elastomeric materials (Figure 1).

Platinum-cured
perfluoroelastomer
ePTFE

1.2 Part Numbering
Series PFL is available in standard configurations as defined inTable 1 and Figure 2. See Appendix A for the standard part list.

Table 1: Part Number DescriptionExampleZA

12F

FormatAlphabetic

Alphabetic

Numeric

Alphabetic

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.)F

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.).

Figure 2: Critical Dimensions of GORE® STA-PURE® Pump Tubing, Series PFL
ID Inner diameter
WT Wall thicknessWTIDL

L Length3

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Validation Guide

SERIES PFL

1.3 Materials of Construction

1.5.1 Cleaning and Sterilization

GORE STA-PURE Pump Tubing, Series PFL is a composite of
expanded polytetrafluoroethylene (ePTFE) and a platinum-cured
perfluoroelastomer material (Table 2). No peroxide curing agentsare used in the formulation.

Series PFL has been validated to operate after steam-in-place/clean-in-place (SIP/CIP) and autoclave sterilization.

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Table 2: Materials of Construction
Description

MaterialTubing

Composite of thermoplastic andperfluoroelastomer material

Thermoplastic material

ePTFE membrane

Elastomeric material

Platinum-cured perfluoroelastomer

Fluid contact surface

Platinum-cured perfluoroelastomer

1.4 Performance Specifications
Actual performance depends on the specific system in which
the tubing is used and may vary depending on the design ofthe pump and how it is integrated into the drug manufacturing
process. To simulate challenging, real-world applications, Gore
tested Series PFL under rigorous conditions up to 60 psig.

1.4.1 Biocompatibility
Series PFL is verified annually to meet the requirements of thefollowing tests:• USP <87> Biological Reactivity Test In Vitro• USP <88> Biological Reactivity Test In Vivo, Class VI

1.4.2 PhysicochemicalThe Series PFL tubing was evaluated against the Physicochemical
Tests outlined in USP <661> Containers — Plastics and met thelimits for each of the specified tests.

1.5 Handling/Operating Specifications
As with other equipment and components, the user is mostknowledgeable about the formulation of the working fluid.
Therefore, the user is responsible for validating that the Series
PFL is suitable for use with the specific formulation of the working
fluid. The user is also responsible for validating that Series PFL
is suitable for use in the process after sterilization, including
determining the number of cycles and sterilization conditions.

Irradiation sterilization methods such as gamma or electron beam
should never be used because they may damage or degrade themechanical properties of the product.

1.5.2 Flow, Durability, and Operating Pressure
Series PFL maintains reliable and consistent flow up to 60 psig
following sterilization.

1.5.3 Chemical Resistance
Series PFL maintains reliable and consistent flow in a peristaltic
pump when tested with organic solvents commonly used as
pharmaceutical feedstock chemicals.

1.5.4 Packaging
Each Series PFL tube is heat sealed in a single polyethylene bag.
Each bag is labeled with the part number, lot number, productdescription, critical dimensions, and date of manufacture.

1.5.5 Product Shelf LifeThe expiration date for Series PFL is four years from the date ofmanufacture. This date is based on an accelerated aging study tosimulate storage of the product for four years at room temperature
and applies to the product in its original packaging.

2.0 Compliance Statements
2.1 FDA-Regulated Status
Series PFL is neither classified nor regulated as a medical device
and is not subject to FDA regulation. Series PFL is not intended
to be used in medical device applications and is not certified tocomply with food contact regulations.

2.2 Animal-Derived Materials
No materials of animal origin are used as raw materials oradditives. No packaging materials of animal origin come indirect contact with Series PFL tubing.

2.3 Product StewardshipSeries PFL and its primary packaging materials are manufactured
following the appropriate material and regulatory requirements.
Please contact Gore for current compliance statements.

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Validation Guide

SERIES PFL

3.0 Quality Control Statements
3.1 Manufacturing Environment
GORE® STA-PURE® Pump Tubing, Series PFL is manufactured
and packaged in an environment that follows clean concepts
principles in order to reduce particulates. In general, clean
concepts include, but are not limited to, the use of hair nets,
clean room gowns, designated shoes or booties, nitrile gloves, achanging room separate from the manufacturing area, and tackymats before the changing room entrance. HEPA filters are used forsupply air into the changing room and manufacturing area. Thefilters are changed out according to a preventative maintenanceschedule.

3.2 Quality Management System
Series PFL is manufactured within a quality system that iscertified to ISO 9001.

3.3 Traceability
Each lot of Series PFL is given a unique identifier to allow fortraceability of all raw materials.

3.4 Lot Release Testing
The inner diameter, wall thickness, and length of the tubing aremeasured for each manufacturing lot per standard operatingprocedures. The product is checked to ensure that these
dimensions meet tolerance specifications.

4.0 Performance Test Methods and Results
4.1 Biocompatibility
4.1.1 USP <87> Biological Reactivity Tests In Vitro
The purpose of this study of Series PFL was to determine thepotential for cytotoxicity in accordance with USP <87> Biological
Reactivity Tests In Vitro. The sample of Series PFL was extractedwith single-strength Minimum Essential Medium (1X MEM) at
37°C (98.6°F) for 24 hours. Extracts from positive and negative
control articles were similarly prepared. The results of this testverified that the Series PFL extract was non-cytotoxic and met therequirements of the USP standard.

4.1.2 USP <88> Biological Reactivity Tests In Vivo
Series PFL tubing was subjected to USP Plastic Class VI testing.
Systemic toxicity and intracutaneous toxicity studies used
extracting media for the Series PFL test article at 70°C (158°F) for
24 hours. In both studies, the test article extracts did not produce
a significantly greater systemic or tissue reaction than the control
extracts. For the muscle implantation study, the macroscopic
reaction was not significant when compared to the controlmaterial. The results of the testing verified that Series PFL met
the requirements of a USP Plastic Class VI.

4.2 Physicochemical
The purpose of this study was to describe the physicochemical
attributes of Series PFL. A sample of Series PFL was extracted at
70°C (158°F) for 24 hours in purified water. A control of purified
water without a Series PFL sample was similarly prepared. Nonvolatile residue, residue on ignition, heavy metals, and buffering
capacity were determined for the Series PFL sample. Test results
confirm that Series PFL meets the limits for USP <661> Containers— Plastics, Physicochemical Tests.

5.0 Handling/Operating Test Methods and Results
5.1 Flow, Durability, and Operating Pressure
Series PFL was tested for flow stability and durability in aperistaltic pump to ensure reliable performance. For this testing,Gore defined failure as any of the following:• Rupture• Leakage• Sustained reduction in flow of 25 percent or more
• Inability to sustain desired operating pressure

5.1.1 Cleaning and Sterilization
Samples of Series PFL were subjected to CIP/SIP conditions
before and during pump testing. Each CIP cycle consisted of two
chemical rinse cycles — one with Steris CIP 100® Alkaline Processand Research Cleaner and the other with Steris CIP 200® AcidBased Process and Research Cleaner. The cleaning agents wererecirculated through the tubing at 82°C (180°F) for 30 minutes.
Each SIP cycle was conducted at 125°C (257°F) for 30 minutes.
Five CIP/SIP cycles were employed in conjunction with pumptesting at 10 psig, and one cycle was employed with pump testingat 60 psig.

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Validation Guide

SERIES PFL

5.1.2 Test Method Summary
Starting at room temperature, cleaned and sterilized GORE
STA-PURE® Pump Tubing Series PFL tube elements underwent
continuous pumping of deionized (DI) water until they failed.
®

Six Series PFL samples were tested in Watson-Marlow 600 Series
two-roller peristaltic pumps at a discharge pressure of 10 psig anda pump speed of 165 revolutions per minute (rpm). Taken frommultiple manufacturing lots, these samples had an inner diameter(ID) of 12.7 mm and a wall thickness (WT) of 3.2 mm.

Starting at room temperature, the cleaned and sterilizedsamples underwent continuous pumping of the organic
solvents until they failed.

5.2.2 Test Results

Eighteen additional Series PFL samples were tested in WatsonMarlow 500 Series two-roller pumps at 60 psig and 220 rpm. Also
taken from multiple manufacturing lots, these samples had a 6.4mm ID and 2.4 mm WT.

Based on a statistical comparison (using an alpha of 0.05), theoverall performance of the samples that underwent pumpingof organic solvents was not significantly different from theperformance of the samples that underwent pumping of DI waterat 10 psig (Sections 5.1.2 and 5.1.3). For each organic solvent,
the samples’ average operating life was equal to or greaterthan 194 hours, which was the average life of all samples thatunderwent pumping with DI water at 10 psig.

5.1.3 Test Results

5.3 Product Shelf Life

The 12.7 mm x 3.2 mm tubing elements were tested at 10 psig
until they failed. Based on a one-sided lower-limit prediction
interval, there is a 95 percent probability that any tube will
perform without failure for at least 95 hours, with the averagetube performing for 194 hours. Just prior to failure, the flow ratewas 2 percent less on average than the initial flow rate.

To ensure that the Series PFL meets its functional requirements
for the labeled shelf life of four years, a product shelf-life studyof representative samples was conducted. The evaluation within
this study focused on Series PFL after accelerated aging per
ASTM F1980-07. Testing was conducted to evaluate mechanical,physicochemical, and cytotoxic functionalities.

The 6.4 mm x 2.4 mm tubing elements were tested at 60 psig
until they failed. Based on a one-sided lower-limit prediction
interval, there is a 95 percent probability that any tube will
perform without failure for at least 76 hours, with the averagetube performing for 130 hours. Just prior to failure, the flow rate
was 15 percent less on average than the initial flow rate.

To simulate the potential impact of shipping and handling prior
to aging, all samples were pre-conditioned at worst-case hot andcold transit conditions. They were also subjected to simulated,worst-case distribution cycles in accordance with ASTM D4169-09.

5.2 Chemical Resistance
Series PFL was tested for flow stability and durability in aperistaltic pump to ensure reliable performance with aggressive
chemicals. For this testing, Gore defined failure as described inSection 5.1.

5.2.1 Test Method Summary
Three sets of Series PFL samples were taken from multiple
manufacturing lots and tested in a Watson-Marlow 600 Series tworoller peristaltic pump at a discharge pressure of 10 psig and pumpspeed of 165 rpm. All three sets consisted of two samples with an
ID of 12.7 mm and WT of 3.2 mm. As described in Section 5.1.1,
all samples were subjected to CIP/SIP conditions for five cycles.

Accelerated aging was conducted in an environmentallycontrolled chamber at 90°C (194°F), based on ASTM F1980-07
using a Q10 = 2 aging model. Material characterization studies
confirmed that 90°C (194°F) was acceptable. Assuming a room
temperature of 23°C (73°F), the accelerated aging time of 14days was considered equivalent to a real-time aging period offour years. After accelerated aging, the samples underwent asingle autoclave cycle of 121°C (250°F) for 30 minutes.
Acceptance criteria were met for all samples upon completion of
the following tests:• Burst pressure per ASTM D380-94• USP <661> Containers — Plastics, Physicochemical Tests• USP <87> Biological Reactivity Tests In Vitro
The results of the accelerated aging study support an expiration
date of four years from the date of manufacture.

• One set ran with acetic acid (99% concentration) as theworking fluid• One set ran with acetone (99% concentration) as theworking fluid• One set ran with ethanol (99% concentration) as theworking fluid
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Validation GuideSERIES PFLAppendix A: GORE® STA-PURE® Pump Tubing, Series PFL Part List
Gore Part
NumberInner Diameter(mm)

Wall Thickness(mm)Length(mm)XZ14F

2.80 ± 0.20

0.8 ± 0.1

355.6 ± 3.0

YA12F1.60 ± 0.20

1.6 ± 0.2

304.8 ± 3.0

YA14F1.60 ± 0.20

1.6 ± 0.2

355.6 ± 3.0

ZA12F3.20 ± 0.25

1.6 ± 0.2

304.8 ± 3.0

ZA14F3.20 ± 0.25

1.6 ± 0.2

355.6 ± 3.0

AA12F4.80 ± 0.25

1.6 ± 0.2

304.8 ± 3.0

AA14F4.80 ± 0.25

1.6 ± 0.2

355.6 ± 3.0

BA12F

6.40 ± 0.25

1.6 ± 0.2304.8 ± 3.0

BA14F

6.40 ± 0.25

1.6 ± 0.2355.6 ± 3.0

CA12F

8.00 ± 0.25

1.6 ± 0.2

304.8 ± 3.0

CA14F

8.00 ± 0.25

1.6 ± 0.2355.6 ± 3.0

YB14F1.60 ± 0.20

2.4 ± 0.2

355.6 ± 3.0

ZB14F

3.20 ± 0.25

2.4 ± 0.2

355.6 ± 3.0

AB14F4.80 ± 0.25

2.4 ± 0.2355.6 ± 3.0

BB14F

6.40 ± 0.25

2.4 ± 0.2355.6 ± 3.0

CB14F8.00 ± 0.25

2.4 ± 0.2355.6 ± 3.0

DB24F

9.50 ± 0.25

2.4 ± 0.2609.6 ± 3.0BC24F

6.40 ± 0.25

3.2 ± 0.2609.6 ± 3.0

DC24F

9.50 ± 0.25

3.2 ± 0.2609.6 ± 3.0

EC24F12.70 ± 0.25

3.2 ± 0.2609.6 ± 3.0

FC24F

15.90 ± 0.50

3.2 ± 0.2609.6 ± 3.0

LH15F

12.00 ± 0.25

4.0 ± 0.4

381.0 ± 3.0

NH15F

17.00 ± 0.50

4.0 ± 0.4

381.0 ± 3.0

ED24F

12.70 ± 0.25

4.8 ± 0.4609.6 ± 3.0

FD24F15.90 ± 0.50

4.8 ± 0.4609.6 ± 3.0

GD24F

19.10 ± 0.50

4.8 ± 0.4609.6 ± 3.0HD24F

25.40 ± 0.50

4.8 ± 0.4

609.6 ± 3.07

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SERIES PFLGore PharmBIO Products
Our technologies, capabilities, and competencies influoropolymer science are focused on satisfying the evolving
product, regulatory, and quality needs of pharmaceutical andbioprocessing customers.
GORE® STA-PURE® Pump Tubing, Series PFL products, likeall products in the Gore PharmBIO Products portfolio, aretested and manufactured under stringent quality systems.
These high-performance products provide creative solutions
to our customers’ design, manufacturing, and performancein-use needs.

402 Vieve’s Way • Elkton, MD 21921 • USA
Phone: +1 410 392 4100 • Toll-free (US): 1 800 294 4673
Email: pharmbio@wlgore.com
Europe | W. L. Gore & Associates, GmbH

Wernher-von-Braun-Strasse 18 • 85640 Putzbrunn, Germany
Phone: +49 89 4612 3456 • Toll free: 0 800 4612 3456
Email: pharmbio_eu@wlgore.com

Not intended for use in medical device or food contact applications or with irradiation sterilization methods.
All technical information and advice given here is based on our previous experiencesand/or test results. We give this information to the best of our knowledge, but
assume no legal responsibility. Customers are asked to check the suitability andusability of our products in the specific applications, since the performance of theproduct can only be judged when all necessary operating data is available. Gore’sterms and conditions of sales apply to the purchase and sale of the product.
ASTM and test designations are trademarks and property of ASTM International.
Watson-Marlow is a registered trademark of Watson-Marlow Limited.
CIP-100 and CIP-200 are trademarks of STERIS Corporation.
GORE, STA-PURE, and design are trademarks of W. L. Gore & Associates.
© 2016 W. L. Gore & Associates, Inc.

PB3299_Rev2_TEC_US_FEB16

Americas | W. L. Gore & Associates, Inc.