Diaphragms

Pure-Flo®

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Table of Contents

Introduction . . . . . . . . . . . . . . . . .3Diaphragm Selection . . . . . . . . . .4Diaphragm Design . . . . . . . . . . . .5Grade TM17 PTFE . . . . . . . . . . .6-7Grade 17 EPDM . . . . . . . . . . . . . .8Qualification Testing . . . . . . . . . .9Pressure Equipment Directive . . .10Service Recommendations . . . . .11Traceability . . . . . . . . . . . . . . . .12Validation . . . . . . . . . . . . . . . . . .13Packaging . . . . . . . . . . . . . . . . . .14Application . . . . . . . . . . . . . . . .15

2www.ittpureflo.com

Introduction

ITT has manufactured diaphragmvalves for nearly 50 years and takesgreat pride in its reputation forsupplying the highest qualityhygienic diaphragm valves to theBiopharm industry.

The diaphragm is the most criticalcomponent of a diaphragm valve.Diaphragms are the valve compo-nent that provide positive shut-offbetween process fluids, protectsthe process from the environmentand in some cases protects theenvironment from the process.

Genuine ITT diaphragms feature:

• Engineered safety• Reliability• Industry proven performance• Reduced total cost of ownership• Complete product range• Pure-Flo Topworks compatibility• Material traceability• Original Equipment Manufacturer

(OEM) materials and specifica-tions

• Global availability• Global technical support• Preventative maintenance pro-

gram development assistance

Regulatory Compliance to:

• FDA 21CFR Part 177 • US Pharmacopea 28 Class VI • Pressure Equipment Directive

97/23/EC • EMEA/410/01 - TSE/BSE

(Transmitting Animal SpongiformEncephalopathy)

ITT Pure-Flo diaphragms are quali-fied and approved for use withPure-Flo diaphragm valves. Othermakes of diaphragms are notrecommended and/or guaranteedby Pure-Flo for use with Pure-Flovalves.

3 www.ittpureflo.com

Diaphragm Type ComplianceGrade Material FDA USDA 3A USP

B Black Butyl Rubber � �17 EPDM � �P Buna N � � �**

TM17 PTFE � �* �W1 White Butyl Rubber � �

4

DiaphragmSelection

The Pharmaceutical and Biotechindustries consider a number offactors to determine the bestdiaphragm solution for a givenprocess or application.

Key factors include:• Regulatory Compliance

• FDA• USP 28• 3A

• Biocompatability• Material extractibles • Application temperatures• Cleaning in place• Steaming in place• Passivation• Failure mode

Applications within the Biotechindustry are particularly sensitive todiaphragm materials because ofthe fact that many of the processeswithin the industry utilize livingorganisms. A balance or compro-mise must be struck between all ofthe key factors listed. Regulatorycompliance in most cases is notsufficient by itself to guarantee aproperly functioning system.

The worldwide network of ITTPure-Flo technical resources areavailable to assist in determiningthe proper diaphragm for yourapplication.

* Class I applications** Class III applications

Pure-Flo® FDA Compliant Diaphragms shown clock-wise: Buna N Grade P, White Butyl Grade W1, BlackButyl Grade B, Pure Gum Rubber Grade A, Grade 17,Grade TM17 PTFE

Diaphragm Type Size TemperatureGrade Material Inch DN °F °C

B Black Butyl Rubber 1/4–12 6–300 -20–250 -29–12117 EPDM1 1/4–4 6–100 -4–1942 -20–902

P Buna N 1/2–12 15–300 10–180 -12–82TM17 PTFE 1/4–6 6–150 -4–329 -20–165W1 White Butyl Rubber 1/2–8 15–200 0–225 -18–107

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1 For high temperature and/or high cycle applications, contact ITT.2 Temperature range is as follows:-4–194°F (-20–90°C) for liquid applications-22–285°F (-30–140°C) for continuous steam-22–302°F (-30–150°C) for intermittent steam

5

Diaphragm Design

Pure-Flo’s two-piece PTFEdiaphragms have proven throughyears of outstanding service to bea robust and forgiving design. Thetwo-piece construction eliminatesthe delamination problems inher-ent in competitive “PTFE faced”diaphragms.

PTFE diaphragms utilize a floatingtube nut connection. The floatingtube nut design assures that down-ward closing forces will beabsorbed by the elastomer backingcushion and evenly distributedacross the closing surface (weir) inthe valve body.

Design Benefits:• Reduced cold flow• Improved sealability• Longer diaphragm life• Reduced point loading• Eliminates stud pullout

ElastomerDiaphragmConstruction

Pure-Flo elastomer diaphragms areproduced by a compressionmolding process. The completedelastomer diaphragm is of a one-piece design. The diaphragm isconstructed with layers of polymermaterial and a high performancewoven fabric reinforcement formaximum strength and durability.

Elastomer diaphragms utilize athreaded connection to the valvecompressor. PTFE and Elastomerdiaphragm threads are not inter-changeable.

PTFE Diaphragm Compressor AssemblyShowing Floating Tube Nut Design

High PerformanceWoven FabricReinforcement

Layer ofPolymer Material

ThreadedConnection

Layer ofPolymer Material

* 970 Manual Bonnets use a T-slot compressor

Stem*

Floating Tube Nut

Compressor

EPDM Backing Cushion

PTFE Diaphragm

Diaphragm Stud

Compressor

Pin

Backing Cushion

PTFE Diaphragm

Tube nut andDiaphragm stud “float”

along axis withoutvertical force

Downward forcetransmitted throughthrust collar to toparea of compressor

Downward forceon stem

Stem

Thrust Collar

Tube Nut

Compressor Pin

Compressor

Downward force on top of compressor by-passed bytube nut and transformed to distributed pressure onbottom area of compressor. Compressor pressesdiaphragm over weir area of valve body.

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6

Grade TM17 PTFE

ITT Pure-Flo has developed a modified PTFE diaphragm to betterwithstand the critical process protocols associated with thePharmaceutical and Bioprocessingindustries, resulting in increasedperformance and longer life.

Type: TM17

Size Range: BT–6” (DN6 - DN150)

Temperature Rating:-4°F to 329°F (-20°C to 165°C)

Pressure Rating:See Pressure & Temperature chart onpage 11

Material (2 Piece Construction):Product Contact Surface: ModifiedPTFE with PPVE*Backing Cushion: Grade 17 EPDM

Regulatory Compliance:21CFR 177.1550 (a)USP28 Class VI, Chapter <87>, <88>21CFR177.2600 (Backing cushion)

*TM17 Material is considered ahomopolymer according to ISO 12086, ASTM D-4894 due to < 1%perfluoropropyl vinyl ether (PPVE)modification

PTFE ProductContact Surface

EPDM BackingCushion

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7

Grade TM17 PTFE

The enhanced material of theTM17 diaphragm retains all ofindustry proven advantages ofconventional PTFE with severalsignificant enhancements.

Overall improved sealing and flexlife due to:• Reduced cold flow • Reduced permanent deformation

under cyclic load• Greater dimensional stability• Reduced embrittlement• Greater crack resistance

Improved steam life due to:• Reduced voids• Reduced permeation• Reduced permanent deformation

under cyclic load• Reduced embrittlement• Greater crack resistance

Improved cleanability due to:• Reduced permeation• Reduced voids, pore free surface• Non-stick properties

Permanent Deformation Under Load (1 Cycle)

Moisture PermeationVoid Content

Permanent Total Deformation at 23ºC/74ºFCyclic Loading

Permanent Total Deformation at 150ºC/302ºFCyclic Loading

TM Modified PTFEConventional PTFE

Unfilled Compound(25% glass fibers)

Compound(25% carbon)

Cycle

Cycle

% V

oid

Con

tent

Moi

stur

e C

onte

nt

(1) Per ASTM F1249 (2) Permanent deformation after 100 hours under load. Measured 24 hours afterload removal. Based on ASTM D621

See Note 2

See Note 2

See Note 2

g *

mm

m2

* da

yTM17 is comparable to25% carbon reinforcedconventional PTFE

See Note 1

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Grade 17 EPDM

Grade #17 is comprised of a highmolecular weight EPDM elastomer,which provides increased mechan-ical properties while reducingcompression set. In addition, thediaphragm is peroxide cured*enhancing the biocompatibility ofthe material.

Type: Grade 17

Size Range: BT–6” (DN6 - DN150)

Temperature Rating:• -4–194°F (-20–90°C) for liquid

applications1

• -22–285°F (-30–140°C) for contin-uous steam1

• -22–302°F (-30–150°C) for inter-mittent steam1

Pressure Rating:See Pressure & Temperature charton page 11Consult factory for steam rating

8

Material:Ethylene Propylene Diene MonomerPeroxide Cured (EPDM)

Regulatory Compliance:21CFR 177.2600USP 28 Class VI, Chapter <87>,<88>

Benefits:• Improved biocompatability • Better mechanical properties• Reduced compression set• Improved steam resistance (inter-

mittent)

* Peroxide has replaced sulfur asthe preferred method of EPDMcuring as sulfur was found to bea biocide which could adverselyaffect sensitive bioprocesses.

1 For high temperature and/or highcycle applications, contact ITT.

Elastomer Diaphragms forVacuum ServiceThe standard Pure-Flo diaphragm valve is ideallysuited for vacuum service, providing dependableperformance and good service life from atmosphericpressure down to nearly full vacuum (-30 in Hg, 0 Bar A) The diaphragm is bi-directional and presentsa smooth face with no hidden voids on either side ofthe valve, whether open, closed or throttling.

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9

QualificationTesting

Quality, performance and reliabilityof all Pure-Flo diaphragms isassured through extensive testingand comprehensive controls on thediaphragm material manufacturingprocess. Pure-Flo has years of expe-rience in the development ofdiaphragm materials for use in thechallenging applications within thePharmaceutical and Bioprocessingindustries. This knowledge isapplied to each new materialdevelopment. Successful comple-tion of all appropriate regulatoryrequirements and operationalperformance benchmarks must bemet before any new diaphragmmaterial is released to the industry.

Typical conformance andperformance tests:• FDA extraction per

21CFR177.2600 (Elastomers)• FDA extraction per

21CFR177.1550 (PTFE)• USP28 Class VI Chapters <87>

and <88>• Cycle testing using air, water,

and/or steam• Cycle testing against vacuum and

positive pressure at 100% and0% �P conditions

• Cycle testing at ambient and ele-vated temperatures

Note: ITT Pure-Flo diaphragms arequalified and approved for usewith Pure-Flo diaphragm valves.Other makes of diaphragms arenot recommended and/or guaran-teed by Pure-Flo for use withPure-Flo valves.

Diaphragm Development

Qualification Testing

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10

Pressure Boundary

The diaphragm is a critical pressure boundarycomponent of a typical diaphragm valve in conjunc-tion with the valve body, fasteners and manual oractuated bonnet. These components are designed,manufactured and tested to achieve specific pressureratings and performance criteria. Changes in mate-rials, dimensions or even tolerances of any of thesecomponents can have an adverse affect on theoverall performance and safety of the valve. ITT PureFlo conducts extensive testing to support theperformance of the valve and pressure boundary.

European PressureEquipmentDirective 97/23/EC

Diaphragm valves must complywith European Union PressureEquipment Directive 97/23/EC.Valves must meet certain EssentialSafety Requirements and designcriteria. This includes diaphragmsas they are an integral componentof the valve pressure boundary.

The PED requires the manufacturerto maintain a technical file prima-rily consisting of:• Design calculations or proof test• Material testing• Performance testing• Declaration of Compliance to the

PED 97/23/EC (available onrequest)

An excerpt from a guideline for thePressure Equipment Directive97/23/EC states:

“Pressure equipment which hasbeen subject to important modifi-cations that change its originalcharacteristics, purpose and/or typeafter it has been put into servicehas to be considered as a newproduct covered by the directive.”1

Note:The use of unauthorized and there-fore undocumented componentswithin the valve constitutes amajor modification to the valveand renders the original ITTDeclaration and compliance to theDirective invalid. The end user orthe supplier of the unauthorizedreplacement component must takethe responsibility for compliance to93/23/EC.

1 http://europa.eu.int/comm/enter-prise/pressure_equipment/ped

ValveBonnet

Valve Body

Pressure Boundary

Diaphragm

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Vac

uu

m (

Bar

A,

Bar

(g))

* This line shows the limitation of plastic bonnets including the 963 and AdvantageActuators.Note: Elastomer diaphragms may be used in vacuum service within above temperaturerecommendations. For services exceeding charted pressure/temperature recommendations,consult factory. The chart does not pertain to steam or corrosive services. Consult ITT DV-06Technical Manual and Service Guide for specific recommendations.

1/2” - 1” (DN15 to 25) valves1 1/2” - 2” (DN32 to 50) valves

2 1/2” - 3” (DN65 to 80) valves4” (DN100) valves

6” (DN150) valves

Temperature °C

Max

imu

m P

ress

ure

Lin

e P

ress

ure

(P

SIG

)

Temperature °F

Lin

e P

ress

ure

(B

ar(g

))

Pressure/Temperature Recommendations

Limitation of Plastic Bonnets*

PTFE Diaphragms for Vacuum Service

Notes:1. Service conditions falling to the right of these lines will require

bonnet evacuation.2. PTFE-Diaphragms, 6" (DN 150) size and larger, will not with-

stand full vacuum at any temperature unless bonnets are evac-uated.

3. With evacuated bonnets any size PTFE-Diaphragms can beused up to 329°F (165°C).

4. See page 8 for Elastomer Diaphragms for Vacuum Service

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1/2”

- 2

” (D

N15

to

55)

valv

es

2 1/

2” (

DN

65)

valv

es

3” (

DN

80)

valv

es

4” (

DN

100)

val

ves

Temperature °C

Vac

uu

m (

in H

g)

Temperature °F

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12

Validation andCompliance

ITT Pure-Flo recognizes the impor-tance of product and processvalidation to the Pharmaceutical andBioprocessing industries. A completeselection of documentation is avail-able to facilitate the validationprocess.

• Diaphragm ingredients and processing aids are FDA compliant

• Physical properties, raw materials,compounding and moldingprocess are documented

• All diaphragms are available withFDA Certificate of Conformance

• 21CFR177.2600 - Elastomers• 21CFR177.1550 - Perflourocarbon

• All diaphragms are available withUSP 28 Class VI Certificate ofConformance

• Chapter 87 In-Vitro• Chapter 88 In-Vivo

• Certificate of Compliance toEMEA/410/01 "Guidance onMinimising the Risk ofTransmitting Animal SpongiformEncephalopathy Agents via Humanand Veterinary Medicinal Products"available upon request

• Certificate of Traceability to EN 10204 3.1 B available uponrequest

• Third party testing and in-houseperformance data available uponrequest

Note: ITT Pure-Flo diaphragms arequalified and approved for use withPure-Flo diaphragm valves. Othermakes of diaphragms are not recom-mended and/or guaranteed byPure-Flo for use with Pure-Flo valves.

Certificates of Compliance

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PTFE Date Codes

PTFE Code - MonthsA JanuaryB FebruaryC MarchD AprilE MayF JuneG JulyH AugustI SeptemberJ OctoberK NovemberL December

13

Diaphragm Tab Codes

Date

Size

MaterialGrade*

Vendor ID

FrontBack

DiaphragmTraceability

All diaphragm materials and phys-ical properties are batch traceablevia permanent codes molded intothe diaphragm tabs. The moldingdate, material grade, anddiaphragm size provide traceabilityto original batch records.

Elastomer MaterialGrade Codes

Elastomer material grades arelisted on page 4 (Type 1). Fordiaphragms with a clock (Type 2)the arrow points to the materialgrade.

Elastomer DateCodes

The date is a two digit year codeand dots corresponding to monthsType 1: April 2001

For diaphragms with a clock, thetwo digits in the middle are theyear and the arrow points to themonth. Type 2: December 2008

PTFE Date Codes

The first letter identifies the monththe lot was manufactured. For atwo digit code, the second digit isthe year (Type 1: B7 = February2007). For a four digit code, thenext two digits indicate the year,and the last number indicates thebatch number (Type 2: B071 =February 2007, batch 1).

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PTFE Code - YearYear 4 Digit Code 2 Digit Code2003 03 32004 04 42005 05 52006 06 62007 07 72008 08 82009 09 9etc. etc. etc.

Type 1 Type 2

Type 1

Elastomer Material GradeCodes

Type 2

Type 1 Type 2

*Hole in tab indicates TM for material grade. Other materialgrades are listed on page 4.

Elastomer Date Codes

Packaging

All Pure-Flo diaphragms are sealedin individual tamper evident pack-ages to prevent damage andcontamination during transporta-tion, handling and storage.Tamper evident packaging providesan extra level of assurance that thediaphragm has not been exposedto potential contamination duringstorage or maintenance activitiesprior to installation.

All Pure-Flo Diaphragm packagescontain important informationnecessary for validation and main-tenance.

• Diaphragm part number• Description• Material• Pack date• Cure date• Installation graphic

StorageRecommendations

• Storage temperature should bebetween 40-75°F (5-25°C).Higher temperatures may affectoverall service.

• Diaphragms should be stored ina cool dry envinronment so thatcondensation does not occur.

• Diaphragms should be protectedfrom direct sunlight and UltraViolet light sources.

• Where possible diaphragmsshould be protected from circu-lating air. Storage in bags orother air tight containers is rec-ommended for longest servicelife.

• Physical properties and perform-ance of rubber diaphragms candeteriorate when stored for longperiods. The diaphragm maybecome unsuitable for servicedue to environemental, physical,and chemical factors.

European Market Packaging

14

Packaging Method ofUS based Pure-Flo Sites

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Shelf Life

Material Grade Shelf LifeButyl B, W1 10EPDM 17 6

Buna N P 6PTFE1 TM17 10

1 PTFE diaphragm face only.

Application

Pure-Flo diaphragms are suitablefor a wide range of utility andprocess applications utilized in thePharmaceutical and Biotech indus-tries. However, not all diaphragmmaterials are suitable for allprocesses and conditions. Theaccompanying tables should beused as a reference.

The worldwide network of ITTPure-Flo technical resources areavailable to assist in determiningthe proper diaphragm for yourapplication.

Typical Process Applications:• WFI• Purified water• Product solutions• Buffer solutions• Cell culture solutions• Media• Solvents• Protein solutions• Ultra filtration

Typical Utility Applications:• Passivation protocols• Cleaning protocols• Sterilization protocols

15 www.ittpureflo.com

Saturated Steam1

DryHeat2 Ozone320 psi

1.4 Bar(g)30 psi

2.1 Bar(g)40 psi

2.8 Bar(g)PTFE R R R R REPDM R* R* R* U RButyl R* R* R* U RSilicone U U U U R

1 20psi/1.4 Bar(g) = 259ºF/126ºC30psi/2.1 Bar(g) = 274ºF/135ºC40psi/2.8 Bar(g) = 286ºF/142ºC

Sterilization

Nitric Acid15%1

Phosphoric10%1

Citric Acid15%1

MixedChelants2

PTFE R R R REPDM U R R RButyl R R R RSilicone U U R R

Passivation

R = ResistantU = Unsatisfactory

1 At 60ºC/140ºF2 Amonium citrate Base at 80ºC/176ºF

Sodi

umH

ydro

xide

NaO

H

Sodi

umH

ypoc

hlor

ite

NaO

CI

Pota

ssiu

mH

ydro

xide

KOH

Phos

phor

icA

cid

H3P

O4

Hyd

roge

nPe

roxi

deH

2O2

PTFE R R R R REPDM R R R R RButyl R R R R USilicone R R U U R

Cleaning

2 338ºF/170ºC3 3% at 80ºF/27ºC

* Limited life and undesirable failure mode

Consult factory for specific temperature and concentration limi-tations.

For more information, please contact:

Pure-Flo Headquarters33 Centerville RoadLancaster, PA 17603-2064 USAPhone +1 (800) 787-3561Phone +1 (717) 509-2200Fax +1 (800) 239-9402

Website: www.ittpureflo.comE-mail: pureflo.custserv@itt.com

Valve Office Locations:

Pure-Flo110-B West CochranSimi Valley, CA 93065 USAPhone +1 (800) 926-8884Phone +1 (805) 520-7200Fax +1 (805) 520-7205

Pure-FloRichards StreetKirkham, LancashirePR4 2HU, EnglandPhone +44-1772-682696Fax +44-1772-686006

© 2008 ITT CorporationIndustrial Process

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PFDIA-08