Sealing Control

Wear & Friction Control

Tolerance Control

SAINT-GOBAIN SEALS

Life Sciences Industry

Co m p lia n t M ate ria l s Code No.

Base Material

Temperature Range °F

Color

°C

FDA

EU

USP Class VI

Fluoroloy® Sealing Materials A01

PTFE

White

-450°F to +500°F -268°C to +260°C

A02

PTFE

White

✓

-450°F to +600°F -268°C to +316°C

A06

PCTFE

White

✓

-435°F to +400°F -259°C to +204°C

A12

PTFE

✓

A17

UHMW

White

-450°F to +180°F

-268°C to +82°C

A20

FEP

Clear

✓

-320°F to +400°F -196°C to +204°C

A22

PEEK

Tan

✓

-100°F to +600°F

-73°C to +316°C

A23

UHMWPE

Clear

✓

-250°F to +200°F

-156°C to +93°C

A29

PTFE

Black

✓

-400°F to +550°F -240°C to +288°C

A40

PTFE

Beige

✓

-400°F to +550°F -240°C to +288°C

A45

PTFE

Brown -400°F to +550°F -240°C to +288°C

✓

A46

PTFE

White

-400°F to +550°F -240°C to +288°C

A47

PTFE

White

✓

-400°F to +550°F -240°C to +288°C

A66

PFA

Clear

✓

-320°F to +500°F -196°C to +260°C

A79

PTFE

White

✓

-400°F to +550°F -240°C to +288°C

✓

Dull Gold -450°F to +550°F -268°C to +288°C

✓

✓

✓

✓ ✓

✓ ✓

✓

Rulon® Bearing, Sealing and Structural Materials Rulon® 1

PTFE

Rulon® J

PTFE

White

Rulon® 55

PEEK

Tan

Rulon® 123

PTFE

Black

-400°F to +550°F -240°C to +288°C

Rulon® 1337

PTFE

Beige

✓

-400°F to +550°F -240°C to +288°C

Rulon® 641

PTFE

White

✓

-400°F to +550°F -240°C to +288°C

Rulon® 1439

PTFE

White

✓

-400°F to +550°F -240°C to +288°C

✓

-450°F to +550°F -268°C to +288°C

Dull Gold -450°F to +550°F -268°C to +288°C -100°F to +600°F

-73°C to +316°C

✓

✓ ✓

✓ ✓ ✓

✓ ✓

F DA Co m p li a n ce All materials used in the manufacture of the listed Fluoroloy® and Rulon® grades are approved for repeated contact with food or drugs for oral consumption, under Title 21 CFR §177.1550 of the United States Food and Drug Administration (FDA).

U S P Ce r t i f ic at io n Saint-Gobain Seals' Fluoroloy® and Rulon® compounds listed above have full USP Class VI certification that complies with stringent disposable and reusable medical device requirements. The United States Pharmacopeia (USP) is a voluntary, not-for-profit organization that promotes the public health by establishing and disseminating officially recognized standards of quality. Plastics are classified into one of six classes, each requiring different levels of testing. Class VI requires the most extensive testing.

E U 1 935/2 0 0 4 a n d E U 1 0/2 011 All materials used in the manufacture of the specified Fluoroloy® and Rulon® compounds are certified for contact with foodstuff, according to the requirements of EU regulation 10/2011 and 1935/2004. Each compound is tested for specific simulants. Simulants D1, D2, E: Rulon® 641 and 123, Fluoroloy® A29 and A46. Simulants A and B: Fluoroloy® A29 and Rulon® 123. Simulant C: Fluoroloy® A29, A79 and Rulon® 123.

C R ITI C A L PA R T S M A K I N G T H E D I F F E R E N C E

Seals and bearings for surgical tools Seals and wear components for pharmaceutical manufacturing equipment

Seals and bearings for centrifuge

Seals for liquid chromatography

Seals, bearings and structural components for pharmaceutical mixers

Seals, bearings and high-temperature polymers for dental drills and endodontics

Seals and polymer components for hematology analyzers

Seals for portable oxygen concentrators

Rulon® Polymer Cup Seals

OmniSeal® SpringEnergized Seals

Rulon® Wear Components

Meldin® Bearings

DynaLip® Lip Seals

Portable oxygen concentrator

Surgical tools

Surgical tools

Surgical tools

Pharmaceutical Mixer

HPLC/UHPLC

Centrifuge

Endodontics (obtruation)

Home Medical Equipment – Respiratory

Nebulizer

Surgical Tools

Prove n i n t h e Pa s t … For more than 30 years, Saint-Gobain Seals has been a trusted manufacturing partner to the medical, dental, analytical and pharmaceutical markets. Whether the challenge is caustic chemicals, high pressure or cleanliness, we offer a solution to meet your stringent requirements. Our commitment to innovation and sustainable solutions drive our ongoing effort to better serve our customers.

. . . Pre pa re d fo r t h e Fu t u re

Pu ri t y a n d Cl ea n li n es s From material selection to clean room operations, Saint-Gobain Seals offers the technology and infrastructure to support today’s Life Sciences customer. Our extensive material catalog includes 22 materials that are FDA compliant or USP Class VI certified, such as PEEK, PTFE, PCTFE, UHMW-PE and PFA based compounds. Our Garden Grove, California facility has Class 100 and 10K clean rooms to control contamination.

KEY APPLICATIONS HPLC equipment

Hematology analyzers

Pharmaceutical processing

Surgical and dental tools

Cri t ic a l S ea li n g Our seals are designed to provide the precise level of sealing required by the application. In the Life Sciences industry, proper sealing can protect integral components and result in substantial cost savings for the end user by extending maintenance cycles and increasing the overall life of the application.

KEY APPLICATIONS UHPLC Surgical tools

Home medical equipment, oxygen concentrator

Fric t io n Co n t ro l Saint-Gobain Seals offers two material grades, Rulon® and Meldin®, that address the need for structural components and bearings in dynamic applications. These material grades have been formulated for low wear and thermal stability. When it comes to friction and sealing, our OmniSeal® spring-energized and lip seals can be optimized for low and high PV applications, respectively.

KEY APPLICATIONS Home medical equipment – respiratory

Dental drills

Surgical tools

Centrifuges

Ch e m ic a l Co m pat i b ili t y Many applications in the Life Sciences industry deal with extreme chemical environments requiring chemical sterilization and cleaning in place (CIP) techniques. Whether the media is alkaline, acidic or a unique solvent, Saint-Gobain Seals offers a material compound to meet your specific chemical needs as well as providing hundreds of unique compounds, including 22 that are FDA or USP Class VI compliant.

KEY APPLICATIONS Analytical equipment Pharmaceutical processing

Surgical tools

Critical Parts Protecting Core Li fe Scie n ces Syste m s Saint-Gobain Seals has a rich history servicing the unique challenges of the Life Sciences market. With a focus on customer collaboration and new product development, we provide the support and technical expertise to meet just about any challenge.

Our Core Competencies: • Design engineering • Precision fabrication • Material formulation • Customer collaboration • Purity and cleanliness • Critical sealing • Friction control • Weight reduction • Lower cost of ownership for end users

Products

Main Features

High-Performance Spring-Energized Seals

• Temperatures from -253°C to +365°C (-424°F to +690°F) • Pressure: Vacuum up to 3,448 bar (50,000 psi) • Low and controlled friction • Broad chemical resistance

High-Performance PTFE Rotary Lip Seals

• Temperatures from -53°C to +232°C (-65°F to +450°F) • Shaft speed up to 60 m/s and beyond in special cases • Pressures up to 35 bar (508 psi)

High-Performance PTFE Filled Compounds

• Temperatures from -268°C to +316°C (-450°F to +600°F) • Low friction, high wear life and broad chemical resistance

High-Performance Thermoset Polyimide and Thermoplastic Materials

• Temperatures from cryogenic through +316°C (+600°F) intermittently up to +482°C (+900°F) • Superior strength and rigidity combined with self-lubrication properties

Sealing Control

Wear & Friction Control

Tolerance Control

A Global Network of Expertise and Service

Manufacturing and sales locations

Sales only locations

Manufacturing and sales locations

R&D Centers

Sales only locations

7301 Orangewood Ave. Garden Grove, CA USA 92841 Phone: +1-800-544-0080

Av. Independencia, 7031-Jd. Sao Matheus Sao Paulo, Vinhedo, Brazil 13280 Phone: +55 19-2127-8521

Detroit, MI USA Phone (office): +1-248-834-2504 Phone (mobile): +1-248-420-8918

386 Metacom Avenue Bristol, RI USA 02809 Phone: +1-401-253-2000

45-46 Avda Ebro Pol El Sequero 26150 Agoncillo, La Rioja, Spain Phone: +34 941-29-20-53

12941 North Freeway, Suite 226 Houston, TX USA 77060 Phone: +1-832-666-2169

Industria Aeroespacial 3601 Parque Industrial Saltillo-Ramos Ramos Arizpe, Coahuila, Mexico 25900 Phone: +52-844-866-1200

ul. Norton 1 62-600 Kolo, Poland Phone: +48 63-26-17-281

V.le Colleoni 3 Palazzo Taurus 2 20864 Agrate Brianza (MI), Italy Phone: +39 039 657891

Am Nordkanal 37 47877 Willich, Germany Phone: +49 2154-600 Am Herrnberg 8, 98724 Neuhaus am Rennweg, Germany Phone: +49 3679 7913-0 Dertinger Weg 10, 97877 Wertheim Bettingen, Germany Phone: +49 9342 9266-0 Heiveldekens 22 2550 Kontich, Belgium Phone: +32 3-458-2828

10801-5, Haramura Suwa, Japan 391-0106 Phone: +81 266-79-6400 13th FL., Dongshin Bldg, 141-28 Samsung-Dong, Kangnam-Ku Seoul, South Korea, 135-090 Phone : +82-2-554-8041 1468 Kun Yang Road Minhang Development Zone Shanghai, China Phone: +86 21-5472-1568

Grindwell Norton Limited Devanahalli Road, Via Old Madras Road Bangalore, India 560049 Phone: +91 80 30978888 Fuchu South Building 6F, 1-40 Miyamachi Fuchu-City, Tokyo, Japan 183-0023 Phone: +81 42 352 2100 Saint-Gobain Advanced Materials Co., Ltd 3F-1, No. 147, Section 2, Jianguo North Road Taipei, Taiwan 104 Phone: +886-2-2503-4201

[email protected] www.seals.saint-gobain.com OmniSeal®, Rulon®, Meldin®, Fluoroloy® and DynaLip® are registered trademarks of Saint-Gobain Performance Plastics Corporation. Limited Warranty: For a period of 6 months from the date of first sale, Saint-Gobain Performance Plastics Corporation warrants this product(s) to be free from defects in manufacturing. Our only obligation will be to provide replacement product for any portion proving defective, or at our option, to refund the purchase price thereof. User assumes all other risks, if any, including the risk of injury, loss or damage, whether direct or consequential, arising out of the use, misuse, or inability to use this product(s). SAINT-GOBAIN PERFORMANCE PLASTICS DISCLAIMS ANY AND ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTE: Saint-Gobain Performance Plastics Corporation does not assume any responsibility or liability for any advice furnished by it, or for the performance or results of any installation or use of the product(s) or of any final product into which the product(s) may be incorporated by the purchaser and/or user. The purchaser and/or user should perform its own tests to determine the suitability and fitness of the product(s) for the particular purpose desired in any given situation.

BST-4186-LIFE-1117

©2017 Saint-Gobain Performance Plastics