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Crane ChemPharma & Energy www.cranecpe.com www.cranecpe.com Saunders® ER Resilience EPDM Diaphragm Enhanced surface finish integrity to assist process purity (ASME BPE compliant) Up to 40% improvement in compression set characteristic compared to typical EPDM diaphragms to reduce need for re-torque and ensure seal to atmosphere Excellent chemical resistance to typical Biopharm process media Front to back technology ownership optimizes security & reliability Key features include: NEW! Saunders® ER grade diaphragm is manufactured from a specially formulated EPDM compound. The ER material is peroxide cured for optimum cross linking and to minimize extractables and leachables. The ER grade diaphragm is suitable for typical applications in the bioprocess industries such as buffers, CIP and SIP, protein solutions and other products. This diaphragm is FDA compliant to 21CFR part 177. 2600, has been third party tested to USP Class VI <87>, <88>, complies with ASME BPE part SG, is certified ADCF (Animal Derived Component Free) and is fully lot traceable to EN 10204 3.1. The ER grade EPDM diaphragm has been developed and manufactured entirely in-house by Saunders®. Use only Genuine Saunders® Replacement parts to ensure optimum performance, reliability and regulatory conformance. The Saunders® ER diaphragm is fabric reinforced to provide full support for the elastomer face and to increase flex performance. The ER diaphragm uses the Saunders® threaded compressor attachment for easy “error free” engagement of diaphragm and compressor.

Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

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Page 1: Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

Crane ChemPharma & Energy www.cranecpe.com

www.cranecpe.com

Saunders® ER Resilience EPDM Diaphragm

Enhanced surface finish integrity to assist process purity (ASME BPE compliant) Up to 40% improvement in compression set characteristic compared to typical EPDM diaphragms to reduce need for re-torque and ensure seal to atmosphereExcellent chemical resistance to typical Biopharm process mediaFront to back technology ownership optimizes security & reliability

Key features include:

NEW!

Saunders® ER grade diaphragm is manufactured from a specially formulated EPDM compound. The ER material is peroxide cured for optimum cross linking and to minimize extractables and leachables.

The ER grade diaphragm is suitable for typical applications in the bioprocess industries such as buffers, CIP and SIP, protein solutions and other products.

This diaphragm is FDA compliant to 21CFR part 177. 2600, has been third party tested to USP Class VI <87>, <88>, complies with ASME BPE part SG, is certified ADCF (Animal Derived Component Free) and is fully lot traceable to EN 10204 3.1.

The ER grade EPDM diaphragm has been developed and manufactured entirely in-house by Saunders®. Use only Genuine Saunders® Replacement parts to ensure optimum performance, reliability and regulatory conformance.

The Saunders® ER diaphragm is fabric reinforced to provide full support for the elastomer face and to increase flex performance.

The ER diaphragm uses the Saunders® threaded compressor attachment for easy “error free” engagement of diaphragm and compressor.

Page 2: Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

Crane ChemPharma & Energy, Saunders®Crane Co., and its subsidiaries cannot accept responsibility for possible errors in catalogues, brochures, other printed materials, and website information. Crane Co. reserves the right to alter its products without notice, including products already on order provided that such altera-tion can be made without changes being necessary in specifications already agreed. All trademarks in this material are property of the Crane Co. or its subsidiaries. The Crane and Crane brands logotype, in alphabetical order, (ALOYCO®, CENTER LINE®, COMPAC-NOZ®, CRANE®, DEPA®, DUO-CHEK®, ELRO®, FLOWSEAL®, JENKINS®, KROMBACH®, NOZ-CHEK®, PACIFIC VALVES®, RESISTOFLEX®, REVO®, SAUNDERS®, STOCKHAM®, TRIANGLE®, UNI-CHEK®, WTA®, and XOMOX®) are registered trademarks of Crane Co. All rights reserved.

Grange Road, CwmbranGwent NP44 3XX,United Kingdom

Phone: +44 1633 486666Fax: +44 1633 486777

www.cranecpe.com

Diaphragm Marking

Backing

GRADE IDENTIFICATION

Facing—Wetted Face

WEEK/YEAR

SIZE

SCREW ATTACHMENT

Size Grade Catalogue Code Connection TypeDN8–DN150 (0.25" – 6") ER ER Screw

Saunders® ER Grade Diaphragm

Construction• ER grade EPDM:

• Organic peroxide cured • Excellent mechanical and thermal properties • Excellent resistance to compression set• Fabric reinforced to optimize flex

Size Range • DN8- DN150 (0.25” – 6”)

Temperature Range• -40 to 110˚C Liquid Media• 150˚C Max Steam Sterilisation (max 180 minutes per cycle)

Valve Body Temperature/Pressure Relationships DN8 to DN50 rubber diaphragms

DN65 to DN150 rubber diaphragms

Saunders EE EPDM Diaphragm

Saunders EE Grade Diaphragm

Construction:EE grade EPDM:

- Organic peroxide cured- Excellent mechanical and thermal properties- Excellent resistance to compression set- Fabric reinforced to optimize flex

Size range: DN8- DN200 (0.25” – 8”)

Maximum Temperature 140⁰ C

Insert address detail Cwmbran, Conroe, India -Marcom

Diaphragm Marking

Grade Identification Week/Year

Size

Back Front – wetted face Screw attachment

DN8 to DN50 rubber diaphragmsDN65 to DN150 rubber diaphragms

Size Grade Catalogue Code

Connection Type

DN8 0.25" to DN200 8" EE EE Screw

Note – Diaphragms with button attachment are available as spares. only (Code EB DN15 0.5” and DN20 0.75”). Please contact your representative for details

Line

Pre

ssur

e (b

ar)

Temperature (°C)

Temperature (°F)

Line Pressure (psi)

Page 3: Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

Crane ChemPharma & Energy www.cranecpe.com

www.cranecpe.com

Saunders® PR Pure Resilience PTFE/EPDM Diaphragm

100% virgin PTFE face with EPDM backing

Suitable for bioprocess applications

Full industry conformance

Key features include:

NEW!

Saunders® PR grade diaphragm features two piece leaf type construction. The diaphragm consists of a wetted PTFE face with a non-wetted fabric reinforced EPDM backing cushion.

The PR grade diaphragm is suitable for typical applications in the bioprocess industries such as Compendium Waters, buffers, CIP and SIP, protein solutions and other products.

This diaphragm is FDA compliant to 21CFR part 177, has been third party tested to USP Class VI <87>, <88>, complies with ASME BPE part SG, is certified ADCF (Animal Derived Component Free) and is fully lot traceable to EN 10204 3.1.

Both the PTFE face and the EPDM backing have been developed and manufactured entirely in-house by Saunders®.

Use only Genuine Saunders® Replacement parts to ensure optimum performance, reliability and regulatory conformance.

The Saunders® PR diaphragm features the Saunders® bayonet type compressor attachment which allows the diaphragm to float freely relative to compressor to avoid point loading of the PTFE at the stud. The bayonet fit also facilitates easy error free engagement of diaphragm and compressor.

Page 4: Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

Crane ChemPharma & Energy, Saunders®Crane Co., and its subsidiaries cannot accept responsibility for possible errors in catalogues, brochures, other printed materials, and website information. Crane Co. reserves the right to alter its products without notice, including products already on order provided that such altera-tion can be made without changes being necessary in specifications already agreed. All trademarks in this material are property of the Crane Co. or its subsidiaries. The Crane and Crane brands logotype, in alphabetical order, (ALOYCO®, CENTER LINE®, COMPAC-NOZ®, CRANE®, DEPA®, DUO-CHEK®, ELRO®, FLOWSEAL®, JENKINS®, KROMBACH®, NOZ-CHEK®, PACIFIC VALVES®, RESISTOFLEX®, REVO®, SAUNDERS®, STOCKHAM®, TRIANGLE®, UNI-CHEK®, WTA®, and XOMOX®) are registered trademarks of Crane Co. All rights reserved.

Grange Road, CwmbranGwent NP44 3XX,United Kingdom

Phone: +44 1633 486666Fax: +44 1633 486777

www.cranecpe.com

Diaphragm Marking

Facing

GRADE IDENTIFICATION

Backing

WEEK/YEAR

SIZE

BAYONET ATTACHMENT

Size Grade Catalogue Code Connection TypeDN8 (0.25") PR PR Button

DN15–DN150 (0.5"–6") PR PR Bayonet

Saunders® PR Pure Resilience Diaphragm

Construction• 214 grade PTFE wetted face

• Fully fluorinated carbon backbone• Widest temperature range of any polymer • Inert to corrosive chemicals• Excellent anti-stick properties

• EPDM backing cushion• Organic peroxide cured• Excellent mechanical and thermal properties• Excellent resistance to compression set• Fabric reinforced to optimize flex

Size Range • DN8-150 (0.25”- 6”)

Maximum Temperature• Constant: 150°C• Intermittent: 160°C

Valve Body Temperature/Pressure Relationships

Saunders 214/EE Diaphragm

Saunders 214/EE Grade Diaphragm

Construction

214 grade PTFE wetted face

- Fully fluorinated carbon backbone- Widest temperature range of any polymer- Inert to corrosive chemicals- Excellent anti-stick properties

EE grade EPDM wetted face

- Organic peroxide cured- Excellent mechanical and thermal properties- Excellent resistance to compression set- Fabric reinforced to optimize flex

Diaphragm Marking

Maximum Temperature – Constant 150⁰ CMaximum Temperature - Intermittent 160⁰ C

Backing

Week/year

Facing

Grade Identification

Bayonet attachment

Size Range DN8-150 (0.25”- 6”)

SizeMonth/year

Insert address detail Cwmbran& Conroe

Week/year

Size GradeCatalogue

CodeConnection

TypeDN8 0.25" 214 EE P8 Button

DN15 0.5" to DN150 6" 214 EE P8 Bayonet

All sizes Moulded Open

Maximum for Valves DN8 to DN100 (0.25" to 4") Grade 214 PTFE Diaphragm

Maximum for Valves DN150 (6") Grade 214 PTFE Diaphragms

Line

Pre

ssur

e (b

ar)

Temperature (°C)

Maximum for Valves DN8 to DN100 (0.25" to 4") Grade 214 PTFE Diaphragms

Maximum for Valves DN150 (6") Grade 214 PTFE Diaphragms

Page 5: Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

Crane ChemPharma & Energy www.cranecpe.com

www.cranecpe.com

Saunders® SR Steam Resilience TFM/EPDM Diaphragm

TFM face with EPDM backing

Suitable for bioprocess applications

Full industry conformance

Key features include:

NEW!

Saunders® SR Steam Resilience diaphragm features two piece leaf type construction. The diaphragm consists of a wetted modified PTFE face (TFM™) with a non-wetted fabric reinforced EPDM backing cushion.

The SR grade diaphragm is suitable for typical applications in the bioprocess industries such as Compendium Waters, buffers, CIP and SIP, protein solutions and other products. The SR diaphragm is especially recommended for applications subjected to intermittent steam service.

This diaphragm is FDA compliant to 21CFR part 177, has been third party tested to USP Class VI <87>, <88>, complies with ASME BPE part SG, is certified ADCF (Animal Derived Component Free) and is fully lot traceable to EN 10204 3.1.

Both the TFM face and the EPDM backing have been developed and manufactured entirely in-house by Saunders®.

Use only Genuine Saunders® Replacement parts to ensure optimum performance, reliability and regulatory conformance.

The Saunders® SR diaphragm features the Saunders® bayonet type compressor attachment which allows the diaphragm to float freely relative to compressor to avoid point loading of the TFM at the stud. The bayonet fit also facilitates easy error free engagement of diaphragm and compressor.

Page 6: Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

Crane ChemPharma & Energy, Saunders®Crane Co., and its subsidiaries cannot accept responsibility for possible errors in catalogues, brochures, other printed materials, and website information. Crane Co. reserves the right to alter its products without notice, including products already on order provided that such altera-tion can be made without changes being necessary in specifications already agreed. All trademarks in this material are property of the Crane Co. or its subsidiaries. The Crane and Crane brands logotype, in alphabetical order, (ALOYCO®, CENTER LINE®, COMPAC-NOZ®, CRANE®, DEPA®, DUO-CHEK®, ELRO®, FLOWSEAL®, JENKINS®, KROMBACH®, NOZ-CHEK®, PACIFIC VALVES®, RESISTOFLEX®, REVO®, SAUNDERS®, STOCKHAM®, TRIANGLE®, UNI-CHEK®, WTA®, and XOMOX®) are registered trademarks of Crane Co. All rights reserved.

Grange Road, CwmbranGwent NP44 3XX,United Kingdom

Phone: +44 1633 486666Fax: +44 1633 486777

www.cranecpe.com

Diaphragm Marking

Facing

GRADE IDENTIFICATION

Backing

WEEK/YEAR

SIZE

BAYONET ATTACHMENT

Size Grade Catalogue Code Connection TypeDN8 (0.25") SR SR Screw

DN15–DN150 (0.5"–6") SR SR Bayonet

Saunders® SR Steam Resilience Diaphragm

Construction• 214S grade Modified PTFE (TFM) wetted face

• Increased level of crystalline structure versus conventional PTFE

• Widest temperature range of any polymer• Optimum resistance to deformation during steam

sterilisation• Excellent anti-stick properties

• EPDM backing cushion• Organic peroxide cured• Excellent mechanical and thermal properties • Excellent resistance to compression set• Fabric reinforced to optimize flex

Size Range • DN8-150 (0.25”- 6”)

Maximum Temperature• Constant: 150°C• Intermittent: 160°C

Valve Body Temperature/Pressure Relationships

Saunders 214/EE Diaphragm

Saunders 214/EE Grade Diaphragm

Construction

214 grade PTFE wetted face

- Fully fluorinated carbon backbone- Widest temperature range of any polymer- Inert to corrosive chemicals- Excellent anti-stick properties

EE grade EPDM wetted face

- Organic peroxide cured- Excellent mechanical and thermal properties- Excellent resistance to compression set- Fabric reinforced to optimize flex

Diaphragm Marking

Maximum Temperature – Constant 150⁰ CMaximum Temperature - Intermittent 160⁰ C

Backing

Week/year

Facing

Grade Identification

Bayonet attachment

Size Range DN8-150 (0.25”- 6”)

SizeMonth/year

Insert address detail Cwmbran& Conroe

Week/year

Size GradeCatalogue

CodeConnection

TypeDN8 0.25" 214 EE P8 Button

DN15 0.5" to DN150 6" 214 EE P8 Bayonet

All sizes Moulded Open

Maximum for Valves DN8 to DN100 (0.25" to 4") Grade 214 PTFE Diaphragm

Maximum for Valves DN150 (6") Grade 214 PTFE Diaphragms

Line

Pre

ssur

e (b

ar)

Temperature (°C)

Maximum for Valves DN8 to DN100 (0.25" to 4") 214S TFM Steam Grade Diaphragms

Maximum for Valves DN150 (6") 214S TFM Steam Grade Diaphragms

Page 7: Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

Crane Process Flow Technologies Ltd • GRANGE ROAD • CWMBRAN • GWENT • NP44 3XX • UK

TELEPHONE +44 (0) 1633 486666 FAX +44 (0) 1633 486777 WEBSITE www.cranecpe.com

Crane Process Flow Technologies Ltd • COMMERCIAL REGISTRY England, 447239

ChemPharma & Energy

Letter of Equivalency – Saunders ER EPDM Diaphragm

27th April 2018 Dear Customer, As part of continuous development in core elastomer technology, Saunders is introducing a new and improved EPDM-based diaphragm. The new Saunders® ER Resilience will provide improved performance against traditional EPDM grades and will be available to order from 30th April 2018. As part of this launch, the existing EE (EPDM) and 425 (EPM) diaphragms will be rationalised from the Saunders HC4 aseptic diaphragm range and will be obsolete after 1st March 2019. We can confirm that the new ER EPDM grade will provide full equivalency with previous EPDM/EPM grades in all the following attributes:

1. Equivalent chemical and temperature resistance parameters. ER grade is rated to a higher maximum temperature (150˚C) compared with previous EPDM grades

2. Dimensionally equivalent and fully interchangeable with Saunders valve bodies and top works 3. Full testing and compliance with all international test accreditations:

a. FDA Chapter 1, Title 21, Part 177, para 2600 “Rubber Articles Intended for Repeated Use b. USP Class I to Class VI. This polymer has been tested and certified in accordance with U.S.

Pharmacopoeia Class VI, Sections <87> and <88> Biological Reactivity Tests, In-Vivo and In-Vitro

c. ASME BPE Part SG d. Diaphragms manufactured using this grade of polymer utilise ingredients that are of an

Animal Derived Compound Free (ADCF) origin. This includes bovine and Transmissible Spongiform Encephalophathies (BSE and TSE). This material complies with European legislation EC 999/2001

e. Diaphragms manufactured from this grade of rubber do not use components containing Latex nor other allergens as per EC 2007/68

Samples will be available on request to support test validation and assist with Internal Change Control processes. Below you can find an equivalence table to facilitate the transition. Elastomer Grades

Rationalised Grade New Grade

EE EPDM

ER Resilience (EPDM) 425 EPM

EF EPDM Post Cured

E3 EPM Post Cured

Should you have any questions, please do not hesitate to contact us at [email protected] Rodrigo De Moraes Global HC4 Business Line Manager

Page 8: Saunders® ER Resilience EPDM Diaphragm - klinger.dk · The SR diaphragm is especially recommended for applications subjected to intermittent steam service. This diaphragm is FDA

Crane Process Flow Technologies Ltd • GRANGE ROAD • CWMBRAN • GWENT • NP44 3XX • UK

TELEPHONE +44 (0) 1633 486666 FAX +44 (0) 1633 486777 WEBSITE www.cranecpe.com

Crane Process Flow Technologies Ltd • COMMERCIAL REGISTRY England, 447239

ChemPharma & Energy

Letter of Equivalency – Saunders Diaphragms Grade PR – PTFE/EPDM Backing Support

Grade SR – Modified PTFE/EPDM Backing Support 26th April 2018 Dear Customer, As part of continuous development in polymer technology, Saunders is introducing new and improved PTFE and Modified PTFE (TFM) 2 Piece Diaphragms with EPDM backing support. The new Saunders® PR and SR diaphragm grades will provide improved performance compared with existing PTFE grades and will be available to order from 30th April 2018. As part of this launch, the existing PTFE diaphragm grades listed below will be rationalised from the Saunders HC4 aseptic diaphragm range and will be obsolete after 1st March 2019. We can confirm that the new PR and SR grades will provide full equivalency in all the following attributes:

1. Material and design of wetted “product contact” face will not change and will remain 100% consistent with existing diaphragm grades

a. PR diaphragm will be supplied with virgin PTFE facing b. SR will be supplied with Modified PTFE (TFM) facing

2. Backing support diaphragm will be manufactured from new formulation EPDM 3. PR and SR diaphragm grades will provide equivalent chemical and temperature resistance

parameters. 4. PR and SR grades are dimensionally equivalent and fully interchangeable with Saunders valve

bodies and top works 5. PR and SR diaphragm grades have been fully tested and comply with all international test

accreditations: a. FDA Chapter 1, Title 21, Part 177, para 2600 “Rubber Articles Intended for Repeated Use”

and para 1550 “Perfluorocarbon resins” b. USP Class I to Class VI. These polymers have been tested and certified in accordance with

U.S. Pharmacopoeia Class VI, Sections <87> and <88> Biological Reactivity Tests, In-Vivo and In-Vitro

c. ASME BPE Part SG d. Diaphragms manufactured using these grades of polymer utilise ingredients that are of an

Animal Derived Compound Free (ADCF) origin. This includes bovine and Transmissible Spongiform Encephalophathies (BSE and TSE). This material complies with European legislation EC 999/2001

e. Diaphragms manufactured in these grades do not use components containing Latex nor other allergens as per EC 2007/68

Samples will be available on request to support test validation and assist with Internal Change Control processes. Below you can find an equivalence table to facilitate the transition. PTFE and Modified PTFE (TFM) Grades

Rationalised Grade New Grade

214/EE (PTFE/EPDM) PR Pure Resilience (PTFE/EPDM)

214/425 (PTFE/EPM)

214S/EE (TFM/EPDM) SR Steam Resilience (TFM/EPDM)

214S/425 (TFM/EPM)

Should you have any questions, please do not hesitate to contact us at [email protected] Rodrigo De Moraes Global HC4 Business Line Manager