Series PCS
Validation Guide

For Peristaltic
Pumps Used in Drug
Product Manufacturing

GORE STA-PURE Pump Tubing®

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Validation Guide

SERIES PCS

Table of Contents
1.0 Product Overview

3

1.1

Description

3

1.2

Part Numbering

4

1.3

Materials of Construction

4

1.4

Manufacturing and Lot Traceability

4

1.5

Performance Characteristics

4

1.5.1

Cleaning and Sterilization

4

1.5.2

Flow, Durability, and Operating Pressure

4

1.5.3

Biological and Physicochemical Testing4

1.6

Compliance Statement

5

1.6.1

Quality Management System

5

1.6.2

Restricted Substances

5

1.6.3

Animal-Derived Materials

51.6.4

FDA-Regulated Status

51.7

Product Shelf Life

51.8

Packaging and Labeling52.0 Test Methods and Results

52.1

Flow, Durability, and Operating Pressure

52.1.1

Cleaning and Sterilization

52.1.2

Test Method Summary

52.1.3

Test Results

52.2

Biological and Physicochemical Testing

62.2.1		USP <88> Biological Reactivity Tests in Vivo,
USP Plastic Class VI

62.2.2		

USP <87> Biological Reactivity Tests in Vitro,
USP Elution Cytoxicity

62.2.3		

USP <661> Containers —Plastics, Physicochemical Tests (Aqueous)

62.3

Product Shelf Life

6

Appendix A: Part List for GORE® STA-PURE® Pump Tubing Series PCS

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Validation Guide

SERIES PCS

1.0 Product Overview

Figure 1: GORE® STA-PURE® Pump Tubing– Series PCS

1.1 Description
GORE® STA-PURE® Pump Tubing Series PCS is a durable,
resilient tubing product used in peristaltic pumps inpharmaceutical and biopharmaceutical manufacturing.
The product delivers consistent flow rate and low incidenceof rupture, even at operating pressures up to 100 pounds
per square inch gauge (psig) — enabling the pump to work
reliably under challenging conditions. The product achieves
this performance via a unique combination of thermoplastic
and elastomeric materials (Figure 1).

1.2 Part Numbering
Series PCS is available in standard configurations as defined inTable 1 (Figure 2). See Appendix A for a standard part list.
Table 1: Part Number Description
ExampleZA

12

M

FormatAlphabetic

Alphabetic

Numeric

Alphabetic

Attribute

Inner diameter (ID)

Wall thickness (WT)

Length (L)Series PCS

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)M

Example: ZA12M is a Series PCS tube 12 inches long with a nominal inner diameter of 3.2 mm and a wall thickness of 1.6 mm.

Figure 2: Critical Dimensions of GORE® STA-PURE® Pump Tubing — Series PCS
ID Inner diameter
WT Wall thickness

WTID

L

L Length3

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SERIES PCSValidation Guide

1.3 Materials of Construction

1.5.1 Cleaning and Sterilization

Series PCS is a composite of expanded polytetrafluoroethylene(ePTFE) and platinum-cured silicone (Table 2). No peroxide
curing agents are used in the formulation.

Series PCS has been validated to operate after the following:

Table 2: Materials of Construction

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 theSeries PCS is suitable for use in the process after sterilization,
including determining the number of cycles and sterilization
conditions.

Description

Material

TubingComposite of thermoplastic andelastomeric materials

Thermoplastic material

Expanded polytetrafluoroethylene(ePTFE) membraneElastomeric material

Platinum-cured silicone

Fluid contact surface

Platinum-cured silicone

1.4 Manufacturing and Lot Traceability
Series PCS is manufactured and packaged in an environmentthat follows clean concepts principles in order to reduce
particulates. In general, clean concepts include, but are notlimited to, the use of hair nets, clean room gowns, designatedshoes or booties, nitrile gloves, a changing room separate fromthe manufacturing area, and tacky mats before the changing
room entrance. HEPA filters are used for supply air into thechanging room and manufacturing area. The filters are changedout according to a preventative maintenance schedule.
A batch control system is used to assure lot traceability for all
raw materials. The inner diameter, wall thickness, and lengthof the tubing are measured for each manufacturing lot perstandard operating procedures. The product is checked toensure that these dimensions meet tolerance specifications.

• steam-in-place/clean-in-place (SIP/CIP)• autoclave sterilization

Series PCS has not been validated for use after radiation
sterilization or any sterilization mode that is not SIP/CIP orautoclave. Radiation sterilization should never be employed.

1.5.2 Flow, Durability, and Operating Pressure
Series PCS maintains reliable and consistent flow up to 100
psig. See Section 2.1 for specific test data.

1.5.3 Biological and Physicochemical Testing
Series PCS is verified annually to meet the requirements of thefollowing tests:• USP <88> Biological Reactivity Tests In Vivo, USP Plastic Class VI• USP <87> Biological Reactivity Tests In Vitro, USP Elution
Cytotoxicity Study• USP <661> Containers – Plastics, Physicochemical Tests(Aqueous)
For information on biological and physicochemical testing
performed on Series PCS, see Section 2.2.

1.5 Performance Characteristics
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 PCS under rigorous conditions up to 100 psig.

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SERIES PCS

1.6 Compliance Statement
1.6.1 Quality Management SystemGORE® STA-PURE® Pump Tubing Series PCS is manufactured
within a quality system that is certified to ISO 9001.

1.6.2 Restricted Substances
Series PCS and its primary packaging materials are compliant
with restricted substances per RoHS (2011/65/EU) and REACH(EC 1907/2006).

1.6.3 Animal-Derived Materials
No materials of animal origin are used as raw materials orcome in direct contact with Series PCS tubing. This includes
raw materials, additives, and packaging materials.

1.6.4 FDA-Regulated Status
GORE® STA-PURE® Pump Tubing Series PCS is neither classified
nor regulated as a medical device and is not subject to FDA
regulation. Series PCS is not intended to be used in medical
device applications, nor is it certified to comply with foodcontact regulations.

1.7 Product Shelf LifeThe expiration date is four years from the date of manufacture.
This is based on an accelerated aging study to simulate storageof the product for four years at room temperature and applies
to the product in its original packaging.

1.8 Packaging and Labeling
Each Series PCS tube is heat-sealed in a single polyethylene
bag. Each bag is labeled with the part number, lot number,product description, critical dimensions, and date ofmanufacture.

2.0 Test Methods and Results

Validation Guide

2.1.1 Cleaning and Sterilization
Samples of Series PCS were subjected to clean-in-place (CIP)/
steam-in-place (SIP) conditions before and during pumptesting. Each CIP cycle consisted of two chemical rinse cycles— one with Steris CIP 100® Alkaline Process and Research
Cleaner and the other with Steris CIP 200® Acid-Based Process
and Research Cleaner. The cleaning agents were recirculated
through the tubing at 82°C for 30 minutes. Each SIP cycle wasconducted at 125°C for 30 minutes. Five CIP/SIP cycles wereemployed in conjunction with pump testing at 10 psig, and one
cycle was employed with pump testing at 100 psig.

2.1.2 Test Method Summary
Series PCS was tested in a Watson Marlow 500 Series, tworoller peristaltic pump. Two sets of samples were taken frommultiple manufacturing lots:• one set with an inner diameter (ID) of 9.5 mm and wall
thickness (WT) of 2.4 mm• one set with an ID of 3.2 mm and WT of 2.4 mm
Each sample was tested as a tube element with LoadSure®
fittings. Starting at room temperature, the tube elements
underwent continuous pumping of de-ionized water at a pumpspeed of 220 revolutions per minute (rpm) until failure wasobserved.

2.1.3 Test Results
The 9.5 x 2.4 mm tubing elements operated without failurefor 2,160 hours at a pump discharge pressure of 10 psig.
When testing was terminated at 2,160 hours, all samples
were performing without failure as defined in the Section 2.1
introduction. At the end of the tests, the flow rate was
5.6 percent less on average than the initial flow rate.
The 3.2 x 2.4 mm tubing elements were tested at a pumpdischarge pressure of 100 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 atleast 28 hours. Just prior to failure, the average flow rate was
4.1 percent less on average than the initial flow rate.

2.1 Flow, Durability, and Operating Pressure
GORE® STA-PURE® Pump Tubing Series PCS was tested forflow and durability in a peristaltic 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
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SERIES PCS

2.2 Biological and Physicochemical Testing
2.2.1 USP <88> Biological Reactivity Tests
in Vivo, Plastic Class VI
Series PCS tubing was tested in accordance with USP, General
Chapter <88>, Biological Reactivity Tests in Vivo. Systemictoxicity and intracutaneous toxicity studies used extracting
media for the Series PCS test article at 70°C for 24 hours.
In both studies, the test article extracts did not produce asignificantly greater systemic or tissue reaction than the control
extracts. For the muscle implantation study, the macroscopic
reaction was not significant when compared to the control
material. Series PCS met the requirements of a USP Plastic
Class VI.

2.2.2 USP <87> Biological Reactivity Tests
in Vitro, Elution Cytotoxicity Study
The purpose of this study on Series PCS was to determine
the potential for cytotoxicity in accordance with USP General
Chapter <87>, Biological Reactivity Tests in Vitro. The sampleof Series PCS was extracted with single strength Minimum
Essential Medium (1X MEM) at 37°C for 24 hours. Extracts frompositive and negative control articles were similarly prepared.
The Series PCS extract showed no evidence of cell lysis or
toxicity and met the requirements of the USP.

2.2.3 USP <661> Containers – Plastics,
Physicochemical Tests (Aqueous)
The purpose of this study was to describe the physicochemical
attributes of Series PCS. A sample of Series PCS was extracted
at 70°C for 24 hours in purified water. A control of purifiedwater was similarly prepared without a Series PCS sample.
Non-volatile residue, residue on ignition, heavy metals, andbuffering capacity were determined for the Series PCS sample.
Test results confirm that Series PCS meets the USP limits for USP<661> Containers – Plastics, Physicochemical Tests (Aqueous).

Validation Guide

2.3 Product Shelf LifeTo ensure that the product will meet 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 PCS after accelerated
aging per ASTM F1980-07. Testing was conducted to evaluatemechanical, physicochemical, and cytotoxic functionalities.
To simulate the potential impact of shipping and handlingprior to aging, all samples were pre-conditioned at worst case,
hot and cold transit conditions, and they were subjected tosimulated, worst-case distribution cycles in accordance withASTM D4169-09.
Accelerated aging was conducted in an environmentallycontrolled chamber at 90°C, based on ASTM F1980-07 using
a Q10 = 2 aging model. Material characterization studies
confirmed that 90°C was acceptable. Assuming a room
temperature of 23°C, the accelerated aging time of 14 days
was considered equivalent to a real-time aging period of fouryears. After accelerated aging, the samples underwent a single
autoclave cycle of 121°C for 30 minutes.
Acceptance criteria were met for all samples upon completion ofthe following tests:• Burst pressure per ASTM D380-94• USP <661> Containers – Plastics, Physicochemical Tests(Aqueous)• USP <87> Biological Reactivity Tests In Vitro, USP Elution
Cytotoxicity Study
The results of the accelerated aging study support an expiration
date of four years from the date of manufacture.

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SERIES PCSValidation GuideAppendix A: Part List
Gore Part
NumberInner Diameter(mm)

Wall Thickness(mm)LengthXZ12M

2.8 ± 0.1

0.8 ± 0.1

304.8 ± 3.0

YA12M

1.6 ± 0.2

1.6 ± 0.2

304.8 ± 3.0

YA14M

1.6 ± 0.2

1.6 ± 0.2

355.6 ± 3.0

ZA12M

3.2 ± 0.25

1.6 ± 0.2

304.8 ± 3.0

ZA14M

3.2 ± 0.25

1.6 ± 0.2

355.6 ± 3.0

AA12M

4.8 ± 0.25

1.6 ± 0.2

304.8 ± 3.0

AA14M

4.8 ± 0.25

1.6 ± 0.2

355.6 ± 3.0

BA12M

6.4 ± 0.25

1.6 ± 0.2304.8 ± 3.0

BA14M

6.4 ± 0.25

1.6 ± 0.2355.6 ± 3.0

CA12M

8.0 ± 0.25

1.6 ± 0.2

304.8 ± 3.0

CA14M

8.0 ± 0.25

1.6 ± 0.2355.6 ± 3.0

CA16M

8.0 ± 0.25

1.6 ± 0.2

406.4 ± 3.0

YB14M

1.6 ± 0.2

2.4 ± 0.2

355.6 ± 3.0

ZB14M

3.2 ± 0.25

2.4 ± 0.2

355.6 ± 3.0

AB14M

4.8 ± 0.25

2.4 ± 0.2355.6 ± 3.0

BB14M

6.4 ± 0.25

2.4 ± 0.2355.6 ± 3.0

CB14M

8.0 ± 0.25

2.4 ± 0.2355.6 ± 3.0

DB14M

9.5 ± 0.25

2.4 ± 0.2355.6 ± 3.0

DB24M

9.5 ± 0.25

2.4 ± 0.2609.6 ± 3.0

BC24M

6.4 ± 0.25

3.2 ± 0.2609.6 ± 3.0

DC24M

9.5 ± 0.25

3.2 ± 0.2609.6 ± 3.0

EC24M12.7 ± 0.25

3.2 ± 0.2609.6 ± 3.0

EC26M12.7 ± 0.25

3.2 ± 0.2660.4 ± 3.0

FC24M

15.9 ± 0.5

3.2 ± 0.2609.6 ± 3.0

CH15M

8.0 ± 0.25

4.0 ± 0.4381.0 ± 3.0

LH15M

12.0 ± 0.25

4.0 ± 0.4

381.0 ± 3.0LH24M

12.0 ± 0.25

4.0 ± 0.4609.6 ± 3.0

NH15M17.0 ± 0.5

4.0 ± 0.4

381.0 ± 3.0

NH24M

17.0 ± 0.5

4.0 ± 0.4609.6 ± 3.0

DD24M

9.5 ± 0.25

4.8 ± 0.4609.6 ± 3.0

ED24M

12.7 ± 0.25

4.8 ± 0.4

609.6 ± 3.0

FD24M15.9 ± 0.5

4.8 ± 0.4609.6 ± 3.0

GD24M

19.1 ± 0.5

4.8 ± 0.4609.6 ± 3.0

HD24M

25.4 ± 0.5

4.8 ± 0.4609.6 ± 3.0

EE27M

12.7 ± 0.25

6.4 ± 0.45

685.8 ± 3.0GE27M

19.1 ± 0.5

6.4 ± 0.45

685.8 ± 3.0

JF80M

25.0 ± 0.5

9.0 ± 0.5

796.0 ± 6.0

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SERIES PCS

About Gore PharmBIO Products
Our technologies, capabilities, and competencies influoropolymer science are focused on satisfying the evolving
product, regulatory, and quality needs of pharmaceutical andbioprocessing customers.

North America | W. L. Gore & Associates, Inc.

Not intended for use in medical device or food contact applications or with radiation sterilization

402 Vieve’s Way • Elkton, MD 21921 • USA
Phone: +1.410.392.4100 • Toll-free (US): 1.800.294.4673
Email: pharmbio@wlgore.com

All technical information and advice given here is based on our previous experiences
and/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.

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

LoadSure and Watson-Marlow are registered trademarks of Watson-Marlow Limited.
CIP-100 and CIP-200 are trademarks of STERIS Corporation.
GORE, STA-PURE, and designs are trademarks of W. L. Gore & Associates, Inc.
© 2015 W. L. Gore & Associates, Inc.

PB3298-Rev1-TEC-US-FEB15

GORE® STA-PURE® Pump Tubing — Series PCS 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.