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Aseptic Diaphragm Valves

Saunders

Crane Process Flow Technologies2

SaundersConverting Visions into Reality

Page No.

Converting Visions into Reality 2Aseptic Valve Features 3

Standard Two Way AFP BodiesForgings 4Pure Performance 5Investment Castings 5Solid Block and Larger Size Bodies 5Material Specifications 6End Connections & Specifications 7Surface Finish 8Electropolishing 9Valve Dimensions 10/11

Customised Fabrication OptionsTandem Valves 12Tandem Valve Options 13Zero Dead-leg ZDL 14Valve Manifold/Clusters 15

Standard Machined Block BodiesZero Dead-leg (ZDT) 16Technical Data – ZDT 17Close Coupled Branch Valves (CCB) 18Technical Data – CCB 19Point of Use Options (CCB U-Bend) 20Technical Data – CCB U-Bend 21Tank Bottom Valves 22Technical Data – Tank Bottom Valves 23Diverter Valves 24Diverter Multiport Configurations 25

Bio Block Customised Design OptionsComputer Aided Engineering Capability 26Conceptual Approach 27Machined Tandem Valves 28Bio Block Serial Weir 29Chromatography 30Advanced Aseptic Valve Design Tools 31

Manual Bonnets Bio-PharmBonnets & Design Features 32/33Locking/LimitClose/Sealed Options 33

Actuated BonnetsEC/SSC Overview 34ECX Range 35EV and ES 36Valve Throttling and Control 37Materials and Dimensions 38-43Accessories – Positioners & Control Options 44/45

DiaphragmsDiaphragm Design/Performance 46/47Traceability and Validation 48/49USP, EPDM and EPM Grades 50PTFE Grades 51Diaphragm Design/Performance 52

Engineering Data Flow Coefficients 53Applications 54

Approvals/Standards/QualityThe Complete Approach to Quality 55Quality, FDA/ASME-BPE 55

Model Numbering System 56-59

Originator The aseptic diaphragm valve is the most important controlcomponent in today’s biopharmaceutical process systems. As the inventor of the diaphragm valve, Saunders has been akey player in the evolution of high purity valve technology.

Innovator Beginning with the introduction of forged bodies and compactthermoplastic actuators through to today’s machined from solidcompound and multi-port valve solutions, Saunders has takenthe lead in aseptic valve technology.

Leader Current design and construction standards in the pharmaceuticalindustry place ever-higher demands on the sterility, cleanability,integrity and performance of piping components. Utilising thelatest in computer design and manufacturing tools, SaundersBio-Block valves can be engineered and machined from solidstainless steel bar or billet converting visions into solutionswhich can meet your specific process needs.

Technology Our direct design to tool computer interface minimises manufacturing engineering time. Unique design tools enable usto produce e-mailable 3D representations for evaluation andreview before committing to manufacture.

Dynamic Saunders Design Engineering uses Computational Fluid Dynamicsoftware to analyse flow conditions and design the optimumdiaphragm valve solutions.

Total Solution Bio-Block custom machined valves are the perfect complimentto Saunders full range of standard two way valves, machinedbranch valves and welded cluster configurations from which to produce the optimum system design.

All Saunders customised and standard valve bodies are supplied with full material traceability and are used withSaunders FDA (Food and Drug Administration) conforming,traceable and USP Class VI(United States Pharmacopeia)tested diaphragms andSaunders ergonomic range ofmanual bonnets and actuators.All these products are engineeredspecifically for aseptic applicationswithin the biopharm and allied industries.

Contents

Saunders Diaphragm Valve FeaturesFor Aseptic Applications

3

Saunders

DiaphragmsSaunders unique FDA/USPconforming diaphragms are allmanufactured from raw polymerin-house. All diaphragms are fullytraceable back to physicalcharacteristics of the rubber blend.

End ConnectionsBody is machined from single forging with integralends. Butt weld ends havesufficient turnback for orbitalweld installation.

Top EntryDesigned for in-linemaintenance essentialfor welded systems.

Forged BodiesAll aseptic valve bodies areprofiled for low turbulenceflow. Forged in316L/1.4435 stainlesssteel to maximum ferritecontent level 0.5%. Cavityfree design eliminatesentrapment areas andenhances diaphragm life.

Position IndicationHighly visible from a distance with positiveindication of valve position.

Sealed Bonnet ‘O’ Ring sealed bonnet as standard to preventingress from externalenvironment.

Performance Bonnet AssemblyPolyethersulphone (PES) suitable forwash-down with detergents, sodiumhydroxide, hypochlorite, alcohols, diluteacids and autoclaving at up to 160°C.

Modular OptionsAlternative modular optionsavailable including padlockingfacility, proximity sensors andlimit open stop versions.

ShroudedShrouded bonnetconstruction coversbody fasteners for cleanexterior profile.

FDA ConformingBoth PES bonnet shell andinternal components are fullyFDA conforming.

HandwheelHigh integrity handwheelwith ergonomic designensures comfortable,precise control.

ContouredContoured design to optimise externalwashdown andcleanability.

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Saunders AFP Type Diaphragm ValvesStandard 2-Way Bodies

4 Crane Process Flow Technologies

Saunders invented the diaphragm valveconcept and then pioneered the developmentof the first true high purity diaphragm valve withthe introduction of the AFP forged 316L/1.4435body range. The entrapment free design andself-draining characteristics of the diaphragmvalve body make it the ideal choice for bothaseptic processes and systems that must becleaned in place. Top entry design allowsmaintenance while the valve is installed andthus permits the valve to be welded in placereducing the required number of mechanicaljoints and enhancing system security.

AFP Forged Stainless Steel Bodies(DN15–DN80)

Saunders standard AFP body is forged fromwrought 316L/1.4435 stainless steel bar. Theforging process results in a homogeneous surfacethat is free of defects such as porosity, inclusionsor shrinkage cavities. This defect free surface isan ideal substrate for the high levels ofmechanical and electropolished surfacesdemanded by the biopharm industry to maintainsterility and optimise cleaning processes.Saunders forged bodies are manufactured toachieve low ferrite levels of less than 0.5%maximum. This reduces the potential formigration of oxides through a high purity watersystem. These bodies are fully FDA compliant,meet all existing ASME BPE (American Society ofMechanical Engineers Bioprocessing Equipment)standards and cGMP (current GoodManufacturing Practice) principles and are idealfor all high purity biopharm applications.

Drainability

The diaphragm valve has outstanding self drainingcharacteristics when compared with other valvetypes and this feature has contributed in makingthe valve a standard for hygienic/asepticapplication requirements. Factors which affectdrainability are:-

◆ Valve size and end specification

◆ Internal surface finish

◆ Drain orientation (as shown)

◆ Surface tension and viscosity of media

◆ Pipe run angle – generally recommended at 2 to 3 degrees

Valves with body orientation indicators areavailable on request (the marks must be located ina plane cutting the vertical centreline of the pipe).

Guideline drain orientation angles for individualsize and tube specifications are readily availablefrom Saunders on request. Please note thatdrainability in a process system is ultimately theresponsibility of the system designer and/or end

user as a result of the variance factorsdenoted above.

Saunders Valve Body Highlights◆ Cavity free and self draining

◆ Isolating diaphragm, top entry design, and positive closure.

◆ Low maintenance costs.

◆ Readily incorporated into valve cluster and access valve/fitting fabrications.

◆ Materials of construction compatible to entire system.

◆ Bubble tight closure against both pressure and vacuum.

◆ Bi-directional flowpath

◆ Diaphragm valves are recognised by the biopharm industry as the only truly aseptic valve.

Standard 2-Way Valves

Pure performance forged valves 8 – 15 mm

Forged stainless steel valves 15 – 80 mm

Solid block stainless steel valves 100 – 150 mm

Cast stainless steel valves 8 – 100 mm

α

Saunders AFP Type Diaphragm ValvesStandard 2-Way Bodies

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Saunders

Machined from BlockStandard AFP ValveBodies (DN100–DN150)

Larger size designationsare now machinedintegrally from solidwrought stainless steel barstock. Thisconstruction brings thesame high level ofsurface integrity andmetallurgical security as available with the AFP forgings.

Pure Performance (Bio-Seal) Forged Bodies (DN8–DN15)

Saunders Pure Performance fractional valvebodies offer a compact, space saving, high integrity solution for critical applications. Manufactured from a 316L/1.4435stainless steel forging, the valve is used widely as a sample or drain port in biopharm system design. All major tube designations (O.D., butt weld, Tri-Clamp, DIN/ISO) are machined integrally from the forging and coversizes, DN8, DN10 and DN15. This flexibility is achieved by utilisation of thesame DN8 body design for all options and machining inlet/outlet ports tothe desired end specification. This allows the valve to utilise the same size(DN8) diaphragm, bonnet and actuator across all specificationrequirements regardless of end connection size.

AFP Investment Cast StainlessSteel Bodies (DN8–DN100)

Saunders’ investment cast rangeuses high quality materials andselective casting processes toprovide an economical solution for the food, beverage, dairy, andbioprocess industries. Available in all major international tubedesignations including, O.D. tubing, Tri-Clamp, DIN and ISO. Stringentquality control is employed tominimise any risk of porosity andensure a finished product of thehighest integrity.

Saunders Type AFP Diaphragm ValvesBody Material Specification (Forgings)


Saunders standard body material for all forged bodies is stainless steel 316L/1.4435. This provides conformity with most majorinternational specification requirements andensures compatibility with Biopharm pipework.

Full material traceability to EN10204 (DIN 500493.1b) is available for all body combinations tocompliment the availability of data on physicalproperties for all elastomer and polymerdiaphragms within the range. Consequently allwetted areas in contact with the process are fullytraceable and adhere to cGMP guidelines.

Material 1.4435/316L EN 10222-5

Forged SS %

Carbon max. 0.03

Silicon max. 1.00

Manganese max. 2.00

Phosphorus max. 0.045

Sulphur max. 0.03

Chromium 17.0/19.0

Nickel 12.5/15.0

Molybdenum 2.5/3.0

Nitrogen 0.11

In certain application areas in biopharmaceuticalinstallations there may be arequirement for specialalloys/materials – forinstance, the presence ofhigh chloride concentrationsmay necessitate the use of aspecial material to avoid theeffects of ‘pitting corrosion’.Under these demandingapplication conditionsSaunders are able to offerany of the following material options:

◆ Hastelloy™

◆ Titanium

◆ AL6XN

◆ 904L

Body options in special alloy material may bemanufactured from forgingsor wrought barstockdepending on the material,size, volume and bodyconfiguration.

Saunders AFP 2-Way BodiesEnd Connections and Specifications

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Saunders

S

16swg 18swg 5S 10S 40S Series1 Series2 Series3

BS O.D. Tubing Schedule ISO1127 DIN 11850 SMS 3008

Ø D

Dimensions (mm)DN BS O.D. Tubing Schedule ISO 1127 DIN 11850 SMS3008

16swg18swg 5S 10S 40S Series 1 Series 1 Series 2 Series 3

D S S D S S S D S D S D S D S D S

8 6.35 1.63 1.22 13.72 – 1.65 2.24 13.5 1.6 – – – – – – – –10 9.53 1.63 1.22 17.15 – 1.65 2.31 17.2 1.6 12 1.0 13 1.5 14 2 – –15 12.70 1.63 1.22 21.34 1.65 2.11 2.77 21.3 1.6 18 1.0 19 1.5 20 2 – –20 19.05 1.63 1.22 26.67 1.65 2.11 2.87 26.9 1.6 22 1.0 23 1.5 24 2 – –25 25.40 1.63 1.22 33.40 1.65 2.77 3.38 33.7 2.0 28 1.0 29 1.5 30 2 25 1.232 31.75 1.63 1.22 42.16 1.65 2.77 3.56 42.4 2.0 34 1.0 35 1.5 36 2 33.7 1.240 38.10 1.63 1.22 48.26 1.65 2.77 3.68 48.3 2.0 40 1.0 41 1.5 42 2 38.0 1.250 50.80 1.63 1.22 60.33 1.65 2.77 3.91 60.3 2.6 52 1.0 53 1.5 54 2 51.0 1.265 63.50 1.63 1.22 73.03 2.11 3.05 5.16 76.1 2.6 70 2.0 – – – – 63.5 1.680 76.20 1.63 1.22 88.90 2.11 3.05 5.49 88.9 2.6 85 2.0 – – – – 76.1 1.6

100 101.60 # # 114.30 2.11 3.05 6.02 114.3 2.6 104 2.0 – – – 101.6 2.0

# 14swg standard on DN100/4” (S = 2.11)OD. Tubing conforms to ASTM A269/A270

Saunders provide weld and mechanical endconnections to meet the vast majority ofinternational piping standards. Standard bodiesfeature integral buttweld or hygienic clampends for maximum integrity without therequirement of fabrication welds. Saundersbuttweld bodies have tangent lengths longenough to permit weld installation with standardorbital welding equipment. This eliminates theneed for costly tube end extensions andreduces the number of system welds,associated documentation and manufacturingdelays. Saunders bodies can be welded intopipework without dis-assembly* and are alsoavailable with hash marks to indicate optimumdrain angle for easy field installation.

* Please note that the bonnet flange area should be kept at or below 175°C

Butt Weld Specifications

Saunders range of AFP aseptic bodies isavailable with a wide variety of standard butt weldconnections. The dimensions of the outsidediameter and wall thickness differ according tothe tube specification as illustrated in the exampleshown below for valve size DN25.

Screwed EndsBS1864, SMS, DIN 11851,ISO 2853 and BS4825 Pt4

Butt Weld ConnectionsBS – OD tubing, ISO 1127,DIN11850 and SMS3008

Clamp End ConnectionsTri-clamp, Tri-clover ®, ISO 2852and DIN 32676

Saunders Type AFP Diaphragm ValvesStandard 2-Way Bodies – Surface Finish


Ra

y

X

Im = measuring length

I0 I0I0I0 I0

Cleaning Time (minutes)

Number of organisms/cm2

10

100

1,000

10,000

100,000

0

2.4 µm Ra

0.65 µm Ra

0.42 µm Ra

10 20 300

MAXIMUM Ra (µm)Internal Surface External Surface

Vacublast 1.6 As forged/cast

Satin 0.5 0.5

Mirror 0.25* 0.25*

* Mirror finish is available only for forged bodies

Saunders valve bodies are available in acomplete range of mechanically polished andelectropolished surface finish options to matchsystem design requirements. All bodies arepermanently marked with heat number codingand are available with full material traceabilitycertification against request. Major objectives inspecifying the appropriate surface finish are:

◆ To minimise product adhesion to the interior surface of the valve and pipework

◆ To achieve a surface which is readily cleanableby SIP/CIP (Steam in Place/Clean in Place) in theminimum of time.

◆ To result in a defect free and consistent surfaceto minimise any risk of process contamination

There is little published information on therelationship between surface finish and residual soil levels. Although research work* has shownthat it takes approximately twice as long toclean a surface of 1.0 µm Ra as it does to oneof 0.5 Ra µm Ra (see above graph).

Saunders utilise a surtronic measurementdevice as part of our standard quality controlprocedures and can, if requested, supplyofficial certification for a particular order.Designated points (internally and externally) aremeasured to provide consistent methodology.

The Ra value (roughness average) has becomethe accepted methodology for quantifying thesurface finish of a stainless steel surface, andremoves the confusion and misintepretationassociated with grit designations.

It can be identified as the average value of all the absolute distances of the roughness profile R from the centre line within the measuring length lm. (The prescribed sample length).

Surface Finish can then be described by usingthe roughness average (Ra) value.

Conversion – micro metres to micro inches

1 micro metre = 39.3701 micro inches1 micro inch = 0.0254 micro metres

Ra = 1

lm

x = lm

y dx

x = 0

Effect of Surface Finish on Cleaning Time

Arithmetic mean roughness value:

*Timperley and Lawson

Saunders standard surface finish designations are detailed in the table below. Importantly allvalues are quantified as maximum Ra figures toavoid the misinterpretation associated withaverage readings.

Standard 2-Way BodiesElectropolishing

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Saunders

3

2

1

Diagram showing stages of removing metal byelectropolishing to providethe highest surface quality

Diagram showing metalsurface profile produced by machining

200

100

100

200 5

5

µin. µm

MEANSURFACE

TYPICAL SIZEBACTERIUM

PROFILEHEIGHT

4

3

2

1

0

1

2

3

4

Surface finish research* (above) has shown that asuccession of valleys and peaks of approximately4µm in height would successfully hidecontaminating bacteria (normally quantified ot0.28µm in diameter). By comparison a highlypolished surface finish (0.25µm) would facilitateeffective cleaning and sterilisation cycles.

The most effective method of eliminating burrs,folds, inclusions and other surface abnormalitiesis through electropolishing. This electrolyticprocess, the opposite of the plating process, isdesigned to remove metal without smearing orfolding. 'Peaks' are dissolved more quickly than'valleys' as a result of the greater concentrationof current over the protruberances. This actionproduces a smoothing and rounding of thesurface profile.

Mechanical polishing or machining may leavenumerous microscopic surface imperfections whichcause areas of differing electrical potential due tosurface stresses. An electropolished surface isessentially balanced. Local corrosive cells cannot beset up, because galvanic differences caused bypolishing stresses in the stainless surfaces havebeen eliminated.

Electropolishing can result in up to 50% improvementin surface finish of machined or mechanically polishedsurfaces. The inherent benefits of electropolishingsubsequent to mechanical polishing can besummarised as follows:

◆ Superior surfaces for cleaning and sterilisation

◆ Superior passivated surfaces for corrosionresistance by virtue of enhanced chrome oxidesurface layer

◆ Superior high lustre aesthetic appearance

◆ Superior elimination of smeared or torn surfacescaused by abrasive finishing

◆ Superior removal of inclusions and entrappedcontaminants such as lubricants and grit particles

*Timperley and Lawson

Ø D

C (STANDARD LENGTH)

B –

CLO

SED

A –

OPE

N

Standard 2-Way BodiesValve Dimensions


Pure Performance Bonnet Assembly

Ø D

C (STANDARD LENGTH)

A –

OPE

NB

– C

LOSE

D

DN A B C D

8 67 62 78 34

Stainless Steel Bonnet Assembly

C (STANDARD LENGTH)

A –

OPE

NB

– C

LOSE

D

Ø D

DN A B C D

15 88 81 108 6220 91 85 117 6225 114 104 127 8040 164 147 159 12050 185 161 190 12065 239 207 217 17080 260 225 254 230100 323 281 329 280150 445 375 406 368

C (STANDARD LENGTH)

B –

CLO

SED

A –

OPE

N

Ø D

White Epoxy Bonnet Assembly

C (STANDARD LENGTH)

B –

CLO

SED

A –

OPE

N

Ø D

DN A B C D

15 88 81 108 6220 91 85 117 6225 114 104 127 8040 164 147 159 12050 185 161 190 12065 239 206 217 17080 260 225 254 230

DN15–DN50 DN65–DN80

DN8

DN65–DN150DN15–DN50

Standard 2-Way BodiesValve Dimensions

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Saunders

Ø D

C (STANDARD LENGTH)

B –

CLO

SED

A –

OPE

N

DN A B C D

15 110 103 108 6220 116 106 117 6225 146 132 127 8040 203 181 159 14050 212 183 190 14065 216 189 217 14080 288 245 254 250

Stainless Steel Sealed Bonnet Assembly

Ø D

A –

OPE

NB

–C

LOSE

D

C (STANDARD LENGTH) C (STANDARD LENGTH)

Ø D

B –

CLO

SED

A –

OPE

N

DN A B C D

15 101 94 108 6220 105 98 117 6225 122 112 127 8040 161 146 159 10050 188 164 190 11265 227 196 217 17080 252 215 254 220

PES – Performance Bonnet Assembly



C (STANDARD LENGTH)

A –

OPE

NB

– C

LOSE

D

Ø D

Saunders Customised Fabrication OptionsTandem Valves


Saunders Tandem Valve

◆ Full range of horizontal and vertical,drainable options

◆ Can be configured toyour exact pipe layoutwith minimum deadlegs

◆ Product transfer,purging, steamsterilisation,condensate drains, CIP systems

Welded Valve Fabrications

The first and still most common customised valve concept is the tandem valve or valve and fitting combination. A main valve is ported and a section of tube is welded to the port to create an access point into the valve. This tube can in turn be welded to a second valve forming a two-valve cluster, or the tube can be turned into a weld end, hygienic clamp or other type of fitting. The fabrication weld is polished to match the required surface finish specification. The resulting assembly is designed to optimise drainablity and meetstandard process considerations includingcGMPs for dead legs.

Applications include diverse requirements such asflow diversion, sampling, steam injection orcondensate drain and block and bleed applications.

The following rules help define the possibleorientation of tandem valves:

◆ The main valve and access valve may beinstalled to drain in either the horizontal orvertical position. When installed in a horizontalrun the valve must be rotated into the self-drainposition to drain.

◆ Allowance must be made to permit access tobonnet or actuator fasteners and for diaphragmmaintenance.

◆ The access valve can be any size including thesame size as the main valve.

◆ The amount of dead leg between main andaccess valves will vary depending on respectivevalve sizes and orientation. Virtually allcombinations fall within cGMP requirements.

◆ ‘Handwheel opposite’ designs generally haveshorter tangents than configurations with thehandwheel of the main and access valves in thesame quadrant.

◆ All Saunders welded valve fabrications are 100%hydro-tested before and after all welding andpolishing processes to ensure mechanicalintegrity. Full material certification of all tube andfittings utilised is standard.

◆ Saunders bonnets, actuators and diaphragms fitfabricated valve assemblies without adaptors ordistance pieces.

Saunders has created electronic tools to assistour customers in the selection and orientation ofthese fabrications. Saunders Tandem ValveSelection Programme enables engineers anddesign detailers to select the optimum orientationto suit system requirements and produce a fullycoded 3D graphic for immediate translation tovalve manufacture.

Saunders Customised Fabrication Body OptionsTandem Valve Orientation Options

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Saunders

Horizontal main at drain angle/vertical tandem

Horizontal main at drain angle/vertical tandem

Horizontal main/vertical tandem

H 04 54 H 04 36 H 04 00 H 04 18

H 32 36

H 18 36 H 18 18 H 18 54 H 18 00

H 14 32H 14 04H 22 40H 22 68

H 32 18 H 32 54 H 32 00

Horizontal main and tandem at drain angle

Vertical main/tandem at drain angle

V 18 50V 18 22V 18 14V 18 58

Saunders Customised Fabrication OptionsZDL Zero Deadleg Valve ‘L’ Pattern


DN A B C D E F G H I

15 111 104 108 62 44 9 115 110 7020 117 107 117 62 50 14 160 152 10325 147 133 127 80 56 16 168 160 10340 204 181 159 140 58 16 231 217 15350 212 183 190 140 64 26 249 229 15365 216 189 217 140 92 35 – – –80 288 245 254 250 100 42 – – –

Dimensions based on BS OD 16swg. Please refer to Saunders for all other specifications.

Ø I

G –

OPE

NH

– C

LOSE

D

F

E

C (STANDARD LENGTH)

F

E

A –

OPE

NB

– C

LOSE

D

C (STANDARD LENGTH)

Ø D

The Saunders ZDL ‘L’ pattern diaphragm valve is typically installed in a vertical line. The function of a 90 degree fitting and a take-off valve are combined with the valvebody. The bore of the third port is situated inline with the point of seal where the diaphragmmeets the weir. This ensures low pointdrainability and elimination of deadlegs.

The ZDL valve is available with tri-clamp or butt-weld end connections in sizes DN8–DN100.

Common applications include WFI (Water forInjection) point of use, CIP manifolds and verticalinlet/outlet piping to process equipment requiringlow point drainage.

Saunders Customised Fabrication OptionsValve Manifolds/Clusters

Specialised valve and actuator cluster

Customised 5-way diverterfabricated manifold

Configuration of optimum process fabricationpresents system designers with an ongoingchallenge. Minimum space envelope, reducedhold up areas, reduced cost and facilitatingease of installation are all key considerations.

All Saunders process fabrications utilise eitherforgings or machined barstock components toensure process integrity.

15

Saunders

Saunders provides all of its customers with anexpert, yet straightforward customisation servicedesigned to create the optimum valveconfiguration for their process. Our engineers canreview either sketch detail or P+ ID’s (Piping andInstrumentation Drawings) and put forward aninnovative solution. Saunders will rapidly respondwith a fully detailed CAD (Computer AidedDesign) drawing for you to verify and approve.This process ensures that the product we makematches client requirements in every respect.

The benefits of such fabrications include:

◆ Manufacture by Saunders under stringent ISO 9001 quality control

◆ Tailor-made solutions to customerrequirements

◆ Fully tested assembled units manufacturedunder controlled conditions

◆ Full traceability of all components

Manual valve cluster

Standard Machined Block BodiesZDT Zero Deadleg ‘T’ Pattern


Essential in the elimination of dead legs anddesigned to ease installation and validation,Saunders Zero Deadleg T pattern range (ZDT)makes an important contribution in enhancing the integrity of critical systems. Machined integrally from a forging, the ZDT normally features three common ports with the samebore dimensions and incorporates a valve bodyand tee fitting into a single solution. ZDT valvesform the ideal solution for feeding laterals offrecirculating loops, sample points or use pointapplications. The bodies can be supplied withweld or hygienic clamp end connections orincluded in a U-bend configuration for point-of-use service.

Major benefits of the range include:-

◆ Virtual elimination of deadleg to enhance process integrity

◆ Highly compact, space saving design providingideal solution where space is a concern

◆ Excellent drainage characteristics to facilitate quick and effective sterilisation

◆ Patented design to aid validation for FDA and cGMP compliance

◆ Machined integrally from Stainless Steel316L/1.4435 forging (no welds)

◆ Available in size range DN15–DN50 with full range of FDA conformingdiaphragm/bonnet/actuation options

Saunders ZDT*Zero deadleg ‘T’ Pattern Valvesprovide excellent drainability andelimination of deadleg forprocess sampling.

* (Worldwide Patents Apply)

Standard Machined Block BodiesZDT Zero Deadleg ‘T’ Pattern

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Saunders

DN A B C D E F G H I J K L M

15 111 104 62 30 54 13.1 5 108 54 28 115 110 7020* 111 104 62 30 54 11.9 6 108 54 28 115 110 7025 147 133 80 28.5 63.5 15.6 6.2 127 63.5 25 167 161 10340 204 181 159 34 79.5 24.4 29.1 159 79.5 29 231 217 15350 212 183 190 41 95 36 11 190 95 31 250 230 153

* Note: DN20 comes from DN15 or DN25 forging depending on end specification.Dimensions based on BS OD 16swg. Please refer to Saunders for all other specifications.

Dimensions and Centre Lines

F CRS

G CRS

A –

OPE

NB

– C

LOSE

D

D

E

Ø C

J

I

H

F CRS

Ø M

K –

OPE

NL

– C

LOSE

D

E

D

G CRS

Standard Machined Block BodiesCCB Close-Coupled Branch Valves


Saunders Close-Coupled Branch Valve◆ Compact flexible design providing excellent

drainage characteristics and absence of deadleg

◆ Machined block construction provides securityof installation, rapid sterilisation and easierregulatory compliance

◆ Ideal solution when main process line is largerthan valve/branch size (i.e. main line DN50valve/branch DN25) utilises DN25diaphragm/bonnet/ actuator

◆ Sampling/injection points on high purity water systems

Saunders Close Coupled Branch Valve (CCBV)directly compliments the patented ZDT design byfacilitating larger main line size options andproviding the ideal solution when the mainprocess line is at least one size larger than thevalve/branch size. The unique tee construction isengineered from a machined billet to enhancestructural integrity and ease installation and validation.

The CCB valve provides a straight throughunobstructed main line flow path and will eliminatethe deadleg normally associated with welding aconventional two-way valve to a T-piece. By virtueof the weir size, the CCB offers a compact, flexibleand economic design solution.

TECHNICAL DATA

Standard Machined Block BodiesClose-Coupled Branch Valves

19

Saunders

Sizes (DN) 16swg/tri-clamp only

ED

Ø J

H –

OPE

NI –

CLO

SED

F

F

B –

CLO

SED

A –

OPE

N

ED

Ø C

G

BRANCH MAIN A B C D E F G H I J

15 20 107 101 62 54 11.2 12.7 127 111 106 7015 25 107 101 62 54 14.5 16.7 127 111 106 7015 40 107 101 62 54 20.7 22.7 127 111 106 7015 50 107 101 62 54 27.2 27.9 139.7 111 106 7015 65 107 101 62 54 33.6 31.2 139.7 111 106 7015 80 107 101 62 54 40.5 34.7 139.7 111 106 7015 100 107 101 62 54 53.2 42.8 152.4 111 106 7020 25 114 104 62 58.5 14.9 13.5 139.7 156 148 10320 40 114 104 62 58.5 20.5 19.4 139.7 156 148 10320 50 114 104 62 58.5 26.9 24.7 152.4 156 148 10320 65 114 104 62 58.5 33.2 27.9 152.4 156 148 10320 80 114 104 62 58.5 39.6 31.4 152.4 156 148 10320 100 114 104 62 58.5 52.3 40.1 165.1 156 148 10325 40 144 130 80 63.5 21.4 19.3 149.2 164 156 10325 50 144 130 80 63.5 27.8 24.7 161.9 164 156 10325 65 144 130 80 63.5 34.1 29.3 161.9 164 156 10325 80 144 130 80 63.5 40.5 32.3 161.9 164 156 10325 100 144 130 80 63.5 53.2 40.3 174.6 164 156 10340 50 198 176 140 79.5 28.7 18.0 184.2 225 211 15340 65 198 176 140 79.5 35.1 23.0 184.2 225 211 15340 80 198 176 140 79.5 41.4 30.0 184.2 225 211 15340 100 198 176 140 79.5 53.8 39.2 196.9 225 211 15350 65 206 178 140 95.0 36.1 22.2 203.2 244 224 15350 80 206 178 140 95.0 42.4 26.9 203.2 244 224 15350 100 206 178 140 95.0 54.8 38.3 215.9 244 224 153


Standard Machined Block BodiesPoint-of-Use Options (Close-Coupled Branch Valve ‘U’ Bend)


Optional integral sample portscan be included to permit realtime sampling of WFI withoutbreaking a sterile use pointconnection. Valve for point ofuse service can be fitted with awide variety of end connectionsand orientations to meet specificsystem requirements. Alternateuse point designs can bemanufactured to accommodatespecial centre lines, reducedenvelope requirements or otherdesign considerations.

Saunders Point-of-Use Valve

Horizontal or vertical drainport. Significantly reduces thehold-up volume and necessarysite welds associated withconventional ‘U’ bends andbranch tee assemblies.Sampling or injection points on high integrity systems.

Use Point Options

One of the most sensitive applications in a WFI loop is the use point valve. These valvesrepresent the barrier between the safety of therecirculating loop and the potential hazards ofthe environment and function as the take offpoint for consumption of WFI. Valves for thisapplication need the highest level of design security, integrity and cleanliness. Saunders point-of-use valves are engineered to minimise dead areas and fully drain all associated tubing.

Sample quality directly fromwater loop with integral

back sample option.

TECHNICAL DATA

Standard Machined Block BodiesPoint-of-Use (Close-Coupled Branch Valve ‘U’ Bend)

21

Saunders

Ø K

I– O

PE

NJ

– C

LOS

ED

D E G

F

Ø C

F

A–

OP

EN

B–

CLO

SE

D

GED

H

BRANCH MAIN A B C D E F G H I J K

15 20 107 101 62 54 11.2 12.7 76.2 126.7 111 106 7015 25 107 101 62 54 14.5 16.7 76.2 126.7 111 106 7015 40 107 101 62 54 20.7 22.7 114.3 164.8 111 106 7015 50 107 101 62 54 27.2 27.9 145.0 195.5 111 106 7015 65 107 101 62 54 33.6 31.2 145.0 195.5 111 106 7015 80 107 101 62 54 40.5 34.7 165.1 215.6 111 106 7015 100 107 101 62 54 53.2 42.8 215.9 266.4 111 106 7020 25 114 104 62 58.5 14.9 13.5 76.2 140.7 156 148 10320 40 114 104 62 58.5 20.5 19.4 114.3 178.8 156 148 10320 50 114 104 62 58.5 26.9 19.4 114.3 178.8 156 148 10320 65 114 104 62 58.5 33.2 27.9 145.0 209.5 156 148 10320 80 114 104 62 58.5 39.6 31.4 165.1 229.6 156 148 10320 100 114 104 62 58.5 52.3 40.1 215.9 280.4 156 148 10325 40 144 130 80 63.5 21.4 19.3 114.3 188.3 164 156 10325 50 144 130 80 63.5 27.8 24.7 145.0 219.0 164 156 10325 65 144 130 80 63.5 34.1 29.3 145.0 219.0 164 156 10325 80 144 130 80 63.5 40.5 32.3 165.1 239.1 164 156 10325 100 144 130 80 63.5 53.2 40.3 215.9 289.9 164 156 10340 50 198 176 140 79.5 28.7 18.0 145.0 247.0 225 211 15340 65 198 176 140 79.5 35.1 23.0 145.0 247.0 225 211 15340 80 198 176 140 79.5 41.4 30.0 165.1 267.1 225 211 15340 100 198 176 140 79.5 53.8 39.2 215.9 317.9 225 211 15350 65 206 178 140 95.0 36.1 22.2 145.0 273.0 244 224 15350 80 206 178 140 95.0 42.4 26.9 165.1 293.1 244 224 15350 100 206 178 140 95.0 54.8 38.3 215.9 343.9 244 224 153

Sizes (DN) 16swg/tri-clamp only


Standard Machined Block BodiesTank Bottom Valves


The Saunders tank bottom valve incorporatesthe performance and features of a diaphragmvalve into a one piece fully forged tank outletdesign. These valves are free from fabricationwelds and dead legs, enhancing structuralintegrity and reducing the potential for processcontamination. The absence of dead legs alsoimproves drainability, and facilitates effectivemixing. Sample valves, purge valves and portsare easily incorporated into the tank bottomdesign to achieve the desired performance.

Tank bottom valveWeld installation at low point ofvessel base enabling optimumdrainage, cleaning andsterilisation.

Conventional purge fabrication

Internal purge optionsavailable either on vessel sideor outlet side depending onsystem requirements

TECHNICAL DATA

Standard Machined Block BodiesTank Bottom Valves

23

Saunders

35°

G

F Ø D

E

A – OPEN

B – CLOSED

Ø C

35°

Ø J

H – O

PEN

I – CLOSED

G

F

E

Ø D

DN A B C D E F G H I J

15 110 103 62 65 49.6 54.0 45.4 115 110 7020 110 103 62 65 49.6 54.0 45.4 115 110 7025 147 133 80 107 60.2 63.5 59.5 168 160 10340 204 181 140 140 82.0 79.5 72.1 231 217 15350 213 184 140 166 96.5 95.0 82.2 249 229 15365 288 245 250 237 134.5 127.0 107.0 – – –80 288 245 250 237 134.5 127.0 107.0 – – –

Sizes

* Note: DN20 comes from DN15 or DN25 forging depending on end specification.Dimensions based on BS OD 16swg. Please refer to Saunders for all other specifications.

Standard Machined Block BodiesMulti-port Diverter Valves


Diverter Valves

Modern machining technology is employed in the design and manufacture of Saunders rangeof Bio-Block diverter valves. This productbrings two or more weirs or control pointstogether in a single configuration that ismanufactured from a single block of stainlesssteel. This results in a completed designwithout internal fabrication welds for maximumstrength with reduced holdup volumes andwithout stagnant areas. On one side of theweirs there is a common chamber and on theother side of the weir the flow is divided andsplit into multiple control points. Diverter valvedesigns are ideal solutions whenever a processline needs to be divided into two or moreprocess streams or when multiple lines arecombined into one.

Two weir diverter valves drain in horizontal and vertical orientation. Diverter valves with three or more weirs only drain vertically. Divertervalves can be supplied with either autoweld orhygienic clamp ends arranged to meet systemdesign requirements.

Standard Machined Block BodiesDiverter Multi-port Configurations

25

Saunders

Saunders multiport divertervalves have significantadvantages overconventional multiple valveassemblies.

◆ Machined Blockconstruction, free fromfabrication welds toenhance structural integrity

◆ Minimal deadleg design toreduce risk of processcontamination

◆ Inlet machined integrallyeliminates a potentialsource of contamination(many other designsemploy bolted inlet)

◆ Excellent drainagecharacteristics for quickand effective sterilisation

◆ Reduced spacerequirement providesgreater flexibility in systemdesign and simplifiedinstallation

◆ Complete aseptic solutionincluding FDA compliantdiaphragms, manualbonnets and actuators

◆ Fully certified range, withcomprehensive validationsupport documentation on request

The Saunders diverter softwareselection programme supports themulti-port diverter range. Like thetandem valve programme, thiselectronic tool enables our customersto select the ideal multi-port valvesolution including end selection andvalve arrangement and then print theselection in a 3D format.

Bio-Block Customised Design OptionsComputer Aided Engineering Capability (CAE)


Bio-Block Standard and Compound Valves

There exists in almost every process system a unique piping challenge that does not lenditself to conventional solutions. Saundersdesign team recognise this and have developeda philosophy of working with customers tocreate unique machined valve designs that wecall Bio-Blocks. The type of requirements thatengineers face that command these ‘outside of the box’ solutions may be driven by process,space constraints, regulatory issues or otherspecific requirements.

The key elements in producing Bio-Block valvesolutions have been the development of advancedCAE (Computer Aided Engineering) design andmanufacturing tools that enable our engineers toconvert concept into reality. This approach tomanufacturing makes possible custom machinedvalve products without incurring long lead times indesign or production. Saunders work closely withcustomers to co-ordinate solutions to uniqueapplication challenges.

All standard and custom Bio-Block valve bodies accept Saunders standard diaphragms, bonnetsand actuators without modification or adaptors.The compact design of the EC actuator rangeenables Saunders to produce the most compactsolutions in the industry.

Engineering team with client

Typical CAD threedimensional image

Five axis machining centre

Saunders custom Bio-Block valves replacewelded valve clusters, manifolds and valve/fittingcombinations. Machined Bio-Blocks have theadvantages of reduced wetted area and dead-legs; no internal fabrication welds and reduceddocumentation for installation and validation. Faster and easier installation of processmanifolds can be achieved using advanced“machined from solid” valves.

Tool path verification

Bio-Block Customised Design OptionsConceptual Approach

27

Saunders

There are some key considerations when configuring custom “machined from solid” valves.

◆ Valve centrelines

◆ Drain point of body bore and any associated tubing

◆ Drain point of weirs

◆ Centre to face dimensions

◆ Allowance for bonnet or actuator assembly and diaphragm maintenance

◆ Internal flow patterns and drain paths

◆ Minimise deadleg area

◆ Meet cGMP requirements

Double tandem valvemachined from solid barstock.Main weir inclined at optimumdrain angle.

Bio-Block Compound Valve Solutions

Many of today's most challenging applicationscannot be addressed by one valve configuration.Instead, a combination of two or more valveconcepts must be machined from a single blockof stainless to meet system requirements.

The resulting valve types are a hybrid orcompound solution that entails the use of morethan one valve concept. For example combining a tank bottom valve with an access valve, a multi-port valve with access valves to perform assteam and condensate port or a point-of-usevalve together with a sample valve. Saundershighly trained and experienced engineering staffand modern CAD design tools combined with ourmanufacturing expertise result in custom valveconfigurations that combine utility and performance.

Bio-Block Customised Design Options


Bio-Block Machined Tandem Valves

This design is a machined from solid version ofthe welded valve-to-valve or tandem valveassembly. Machined from a single block ofwrought stainless steel it provides severalbenefits.

◆ Absence of internal fabrication welds enhancesproduct integrity

◆ Hold up volumes can be reduced

◆ Dead legs minimised

◆ Reduced number of material certificates required

These advantages are especially realised in thesmaller sizes where valve geometry makes itdifficult to achieve cGMP requirements forminimum dead legs.

Bio-Block Integral Steam, Purge and Condensate Porting

Rather than control steam supply andcondensate drain by means of ‘stand off’ weldedaccess valves that may entail large designenvelopes or dead legs, Saunders Bio-Blockvalves can be machined with integral weirsand/or ports.

Bio-Block tank manifold arrangement.Combining conventional tank bottom andZDT technology into a high integrity machinedblock configuration for bio-pharm vesselapplications. Cleanability, facilitated bypurging into offset weirs (sterile barrier).

Bio-Block Customised Design OptionsConceptual Approach

29

Saunders

Bio-Block Controlled Inlet Option

Generally associated with multi-port designs, this option involves machining a weir at the inlet to the common chamber of a Bio-Block valve.This design permits control of flow entering intothe multi-port valve. The controlled inlet optioncan be included in any number of compound Bio-Block solutions to comply with specificsystem requirements.

Bio-Block Serial Weir Option

This concept puts two weirs in line but 180˚ apartand sharing a common chamber. This allows thecommon chamber to be sterilised and form abarrier between two process flow streams. Ourcustomers have incorporated this concept inrequirements as diverse as Point-of-Use, TankOutlet and in ‘Mix-Proof’ applications.

Bio-Block Customised Design Options


Design and Installation Advantages

Bio-Block machined valve solutions are theideal compliment to modular componentdesign and construction. One Bio-Blockvalve can replace a welded piping manifoldcomprised of several valves and fittingsresulting in both reduced design envelope,installation times and thus overall costsavings. All this accomplished whilerequiring fewer welds and lessdocumentation.

Steam-cross arrangementmachined from solid barstock

Bio-Block Chromatography Valves

This Bio-Block option incorporates a centralcontrol weir to permit the division of flowinto distinct process streams or to allowflow to pass through the valve as requiredduring resin regeneration or cleaning cycles.

Typical chromatographyBio-Block arrangement

Typical steam-crossfabrication arrangement

Bio-Block Customised Design OptionsAdvanced Aseptic Valve Design Tools

31

Saunders

It is important that all aspects of the application be properly communicated between customerand designer ensuring that the resulting designmeets expected performance criteria. Saundershas adopted tools to better communicate andunderstand the configuration of unique and often complex concepts such as compound Bio-Block designs.

Foremost of these is the use of 3D software utility. This computer program produces a 3D model of aproposed valve complete with a viewer in an e-mailable format that can be shared easilybetween Saunders design and applicationsengineering and our customers. The 3Drepresentation of the valve design is derived fromthe same programme file that is used in the designand in the manufacturing of the final product.

Using this software utility our customers canselect from five isometric 3D views or freely rotatethe valve to confirm flow paths or drainability.

Additional features include both zoom and the facility to ‘wire frame’ the view and access the internal configuration.

CFD analysis of sterile barrier

manifold

CFD analysis of standard AFP forging

CFD analysis ofBio-Block five-way

diverter

Computational Fluid Dynamics (CFD)

Saunders employs the use of Computational Fluid Dynamics softwareto ensure that flow characteristics including Cv (Kv), pressure dropand flow paths meet client requirements. Actual flow paths can beviewed to eliminate low flow areas or potential cavitation.

Trained and experienced Saunders sales and engineering staff areready to work with you to develop unique Bio-Block valve solutions.Saunders is committed to excellence in the application, design andmanufacture of custom machined valve solutions as reflected in its innovative and evolving range of Bio-Block valves.

Manual Biopharm Bonnet AssembliesPolymer and Stainless Steel


Stainless Steel Bonnet Assembly

Constructed from materials whichfulfil all FDA requirements, thisbonnet offers the best possiblelevels of security, durability andcorrosion resistance.

◆ Represents a high integrity solutionfor situations where coated orplastic bonnets would beunacceptable

◆ Features smooth contours and an electropolished surface toeliminate bug traps

◆ Fully autoclavable up to 140°C toensure maximum levels of sterility

◆ Supplied with PES (polyethersulphone) handwheel to offer hightemperature performance andexcellent chemical resistance

◆ Available in size rangeDN15–DN150

◆ Suitable for Steam-in-Place (SIP)

Biopharm Bonnet AssembliesThe best all-round choice for your application

The unique needs of the Biopharm Industryhave been considered in every aspect ofdesign. Saunders manual bonnet rangeincorporates:

◆ Hi-tech polymer materials that are lightweight and corrosion resistant

◆ Truly autoclavable models

◆ Modular options to suit all application needs

◆ Stainless steel and polymer options that are contoured for ease of cleaning

Stainless Steel Sealed Bonnet Assembly

Meeting all FDA requirements, this is the optimum solution in bonnetassemblies for the Biopharm market.

◆ Thrust pad and 'O' rings apart,completely constructed fromstainless steel ensuring long lifeand providing the ultimate insecurity, reliability and corrosionresistance

◆ Fully sealed, with a primary sealthat provides absolute containmentfor critical applications

◆ Electropolished to meet bothaesthetic and aseptic requirements

◆ Operational at temperatures up to 160°C


◆ Available in size range DN15–DN80

White Epoxy Coated Bonnet

This consistently popular bonnet is the economic solution forapplications which do not requirehigh temperature steam autoclaving.

◆ Suitable for washing externally with semi-corrosive fluids

◆ Engineered in sizes DN15–DN100with a white epoxy coating

◆ Features an easily cleaned surface,which is free from pits or crevices


Pure Performance Bonnet

Available only in size DN8 (4 bolt), this bonnet is produced in PPS(Poly-phenylenesulphide). Features include:

◆ Built in overclosure stop for greater process control

◆ ‘O’ Ring seal preventing ingress of foreign material and providingcontainment of process media

◆ 4-Bolt design providing optimumsealing capability

◆ Fully autoclavable up to 140°C

Manual BonnetsBlack PES Performance Bonnet

33

Saunders

Padlock Option

The padlocking facility can besupplied to order or is available in kitform for retro-fitting to the bonnetsub-assembly or whole valve.

Black PES (Polyethersulphone)

Designed for the most demanding Biopharmapplications and featuring PES, a highperformance thermoplastic material withexcellent chemical resistance, to ensure longlife and high reliability.

Fully autoclavable, the PES bonnet is availableacross the size range DN15–DN80.

Lock-Screw

Lock Washers

Handwheel

Limit-Adjust Bush

Spindle

Bonnet

Limit-Adjust BushSpindle

DN15 - DN25

Plan View2:1

Cover Cap

Limit open stop option

Limit open stop bonnet tofacilitate effective running ofsystem under normal capacity

Limit closing stop option

A fully adjustable limit closingstop is fitted as standard to all‘Performance’ bonnets. The limitclosure stop is located under thehandwheel and is adjusted byfirst removing the handwheelfixing screw and the handwheelassembly.

The PES Performance Bonnet offers several key features:

◆ High integrity, ergonomichandwheel. Design ensurescomfortable operation and precise control

◆ Fully autoclavable to 140°C

◆ ‘O’ Ring seal prevents both theescape of product and thepotential ingress of contaminates

◆ Shrouded bonnet constructionprovides maximum containmentand diaphragm support for critical applications

◆ Modular options available includingpadlocking facility, proximitysensors, ‘V’ notch vent plugs andlimit open stop version

◆ Fully FDA conforming materials of construction

◆ Limit closing stop to provideprocess/flow control option

Locknut

Handwheel

Limit adjust spindle

Set screw

Spindle

Bonnet

Limit stop nut

Cover Cap

Security Lock-Screw

LockingHandwheel

LockingCollar

Indicator

Locking Pin

PadlockCover Cap

Lock Washer

Lock Washer

Saunders Pneumatic Valve ActuationCompact Actuators that Provide Reliable Remote Control


Saunders EC and SSC Pneumatic Actuatorsfacilitate remote operation of the valve, eitheras a simple alternative to manual bonnetassemblies or as an integral part of the controlsystem. Both are compact piston styleactuators with excellent chemical andtemperature resistance.

The versatile and robust design derived from theuse of high technology materials of construction,results in an actuator suitable for a wide range ofprocess industry applications.

EC

The EC is manufactured by injectionmoulding in PES (polyethersulphone),which has a temperature range of -10°to +100°C ambient (autoclave maximum150°C). Actuators can be supplied asspring close, spring open or double actingwith various spring pack options for avariety of pressure requirements.

All three operation modes, double acting,spring to close and spring to open featurethe same physical dimensions for a givenvalve size. This provides uniform compact envelope dimensions and outstandingeconomic benefits particularly for spring return failsafe actuation.

Field conversion of manual valves to poweractuation is readily achieved ‘in-line’ withoutspecial tools or modification.

SSC

With the same flexibility as the ECActuator, the SSC has been manufacturedwith a 316L stainless steel investment casthousing. Suitable for both aseptic andindustrial applications the SSC providesexcellent resistance to both chemical andsteam duties.

SSC Actuator Size range: DN8 – DN50

EC Actuator mounted on a ZDT valveSize range: DN8 – DN50

35

Saunders

ECX Actuator with Module SwitchboxSize range: DN65 – DN150

Available in spring close, springopen and double acting modes ofoperation to suit process needs. Awide range of options includingswitches, positioners, limit stop andvisual open/close indication are alsoavailable.

ECX

Saunders ECX type actuators aredesigned to offer an extension to theEC size range whilst still maintainingthe compact envelope size. Thehousing is manufactured in coatedsilicon aluminium for optimumchemical resistance and long life.With the extensive range of springpacks we can offer an actuator tosuit a wide range of pressure andflow variations.

ECX Actuator with visual indicator Size range: DN65 – DN150

Pneumatic Actuators for Larger ValvesEV and ES


The EV/ES actuator range directly replacesmanual bonnet assemblies and may be orderedas part of a whole valve or separately to converta manual valve to automatic operation.Installation may be carried out with the valvebody in the pipeline.

Saunders EV/ES actuators are designed with closecoupled bonnet assemblies and have completeflexibility of performance. Several different actuatormodels may be provided for each valve size to suitdifferent application requirements. The rangeallows valve closure against the maximum valveworking pressures and can be successfully usedfor modulating control duties in addition to morenormal isolation functions.

Failsafe closing actuators are fully adjustable, i.e. spring compression can be externallyadjusted to provide optimum diaphragm forcesand hence provide extremely long diaphragm life in service.

Many accessory options are available whichinclude solenoid valves, remote indication devices(switches or sensors) to suit environmentalconditions such as hazardous services. Limitstops and positioners and many other devicesmay be offered to allow usage within particularcontrol systems. EV/ES actuators are providedwith a tough epoxy coating which gives maximumdurability, even in exposed locations.

ES ActuatorSize range: DN15 – DN200

EV ActuatorSize range: DN15 – DN200

Saunders diaphragm valves offerexcellent control capabilities within abroad range of pressure, flow or levelcontrol applications.

Rangeability (ratio of maximum flow vs.minimum control flow) of Saunders weirtype valves is 35:1 extending beyondthe range of most process and servicecontrol systems.

The positive shut-off characteristics of the valve can, in many instances,eliminate the need for independentblock valves, a major component in thepiping system cost.

The inherent flow characteristicsillustrated shows linearity up to 60% oftravel (80% of flow).

The chart illustrates installedcharacteristics affected by the dynamicfriction loss for the remainder of thepiping system. Equal % characteristicscan be obtained through the use ofcharacterised positioners.

Pressure recovery factor = 0.7.

Pneumatic Valve ActuationValve Throttling and Flow Control

37

Saunders

100

90

80

70

60

50

40

30

20

10

00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Instrument Signal psi

% M

axim

um

Flo

w (C

on

stan

t ∆

P)

100

90

80

70

60

50

40

30

20

10

00 10 20 30 40 50 60 70 80 90 100

Percent of Rated Travel

Perc

ent o

f Rat

ed F

low

QUICK OPENING

LINEAR

EQUAL PERCENTAGE

100

90

80

70

60

50

40

30

20

10

00 10 20 30 40 50 60 70 80 90 100

SHUT OPEN

Percent Valve Travel

% M

axim

um

Flo

w (C

on

stan

t ∆P

)

% flow/% travel, weirtype diaphragm valve

Hysteresis for weirtype diaphragm valve

fitted with actuatorplus valve positioner

Diaphragm valvecharacteristic curves


EC Spring Opening

EC Spring Closing

EC Double Acting

1234

5

6

7

8

12

13

14

15

16

17

18

12

91011

34

5

6

7

12

13

14

15

16

17

18

123

4

8

9

10

11

12

13

14

567

8

91011

Item Component MaterialMATERIALS OF CONSTRUCTION EC/SC

1 Indicator seal Fluoroelastomer2 Cap washer PES (DN8-DN25) IXEF (DN40-DN50)3 Cap PES (DN8-DN25) IXEF (DN40-DN50)4 Loading plate Mild steel5 Outer spring Steel6 Inner spring Steel7 Bonnet cap ‘O’ ring Nitrile8 Indicator IXEF9 Outer piston seal Fluoroelastomer

10 Piston PES (DN8-DN25) IXEF (DN40-DN50)11 Inner piston seal Nitrile12 Bonnet washer PES13 Spindle seal Fluoroelastomer14 Spindle PES15 Bonnet insert PES (DN40-DN50)16 Bonnet PES17 Line diaphragm Rubber, Rubber/PTFE18 Compressor Mazak (DN8),

Mild Steel (DN15-25), Silicon Aluminium (DN15-DN50)

Item Component MaterialMATERIALS OF CONSTRUCTION EC/SO

1 Indicator IXEF2 Indicator seal Fluoroelastomer3 Cap washer PES (DN8-DN25) IXEF (DN40-DN50)4 Cap PES (DN8-DN25) IXEF (DN40-DN50)5 Outer spring Steel6 Inner spring Steel7 Bonnet cap ‘O’ ring Nitrile8 Spring support plate PES9 Outer piston seal Fluoroelastomer

10 Piston PES (DN8-DN25) IXEF (DN40-DN50)11 Inner piston seal Fluoroelastomer12 Bonnet washer PES13 Spindle seal Nitrile14 Spindle PES15 Bonnet insert PES (DN40-DN50)16 Bonnet PES17 Line diaphragm Rubber, Rubber/PTFE18 Compressor Mazak (DN8),


Item Component MaterialMATERIALS OF CONSTRUCTION EC/DA

1 Indicator seal Fluoroelastomer2 Cap washer PES (DN8-DN25) IXEF (DN40-DN50)3 Cap PES (DN8-DN25) IXEF (DN40-DN50)4 Indicator IXEF5 Outer piston seal Fluoroelastomer6 Piston PES (DN8-DN25) IXEF (DN40-DN50)7 Inner piston seal Fluoroelastomer8 Bonnet washer PES9 Spindle seal Nitrile

10 Spindle PES11 Bonnet PES12 Bonnet insert PES (DN40-DN50)13 Line diaphragm Rubber, Rubber/PTFE14 Compressor Mazak (DN8),


TECHNICAL DATA

EC Pneumatic Actuators DN8 -- DN50Materials of Construction

TECHNICAL DATA

SSC (Stainless Steel) Compact Pneumatic Actuators DN8 -- DN50Materials of Construction

39

Saunders

SSC Spring Closing

12

3

4

5

6

7

11

12

13

14

15

8910

161718

Item Component MaterialMATERIALS OF CONSTRUCTION SSC/SC

1 Indicator seal Viton2 Cap Stainless Steel3 Outer spring Steel4 Inner spring Steel5 Indicator IXEF6 Bonnet cap ‘O’ ring Nitrile7 Bonnet Stainless Steel8 Outer piston seal Fluoroelastomer9 Piston inner ‘O’ ring Nitrile

10 Piston PES (DN8-DN25) IXEF (DN40-DN50)11 Spindle PES12 Spindle ‘O’ ring Fluoroelastomer13 Thrust pad Nylatron (DN8-DN20)14 Line diaphragm Rubber, Rubber/PTFE15 Compressor Stainless Steel16 Body/bonnet nut Stainless Steel17 Body/bonnet washer Stainless Steel18 Body/bonnet bolt/stud Stainless Steel

Item Component MaterialMATERIALS OF CONSTRUCTION SSC/SO

1 Indicator seal Viton2 Cap Stainless Steel3 Outer spring Steel4 Inner spring Steel5 Indicator IXEF6 Bonnet cap ‘O’ ring Nitrile7 Bonnet Stainless Steel8 Outer piston seal Fluoroelastomer9 Piston inner ‘O’ ring Nitrile

10 Piston PES (DN8-DN25) IXEF (DN40-DN50)11 Spindle PES12 Spindle ‘O’ ring Fluoroelastomer13 Thrust pad Nylatron (DN8-DN20)14 Line diaphragm Rubber, Rubber/PTFE15 Compressor Stainless Steel16 Body/bonnet nut Stainless Steel17 Body/bonnet washer Stainless Steel18 Body/bonnet bolt/stud Stainless Steel

Item Component MaterialMATERIALS OF CONSTRUCTION SSC/DA

1 Indicator seal Viton2 Cap Stainless Steel3 Indicator IXEF4 Bonnet cap ‘O’ ring Nitrile5 Bonnet Stainless Steel6 Outer piston seal Fluoroelastomer7 Piston inner ‘O’ ring Nitrile8 Piston PES (DN8-DN25) IXEF (DN40-DN50)9 Spindle PES

10 Spindle ‘O’ ring Fluoroelastomer11 Thrust pad Nylatron (DN8-DN20)12 Line diaphragm Rubber, Rubber/PTFE13 Compressor Stainless Steel14 Body/bonnet nut Stainless Steel15 Body/bonnet washer Stainless Steel16 Body/bonnet bolt/stud Stainless Steel

SSC Spring Opening

SSC Double Acting

12

3

4

5

6

7

11

12

13

14

15

12

3

4

5

9

10

11

12

13

678

8910

161718

141516


ECX Spring Opening

ECX Double Acting

123

4

10

11

1213

1415

16

1920

21

17,18

10

11

1213

1415

1617

2021

22

12

3

45

18,19

6789

222324

232425

1

2

3

Item Component MaterialMATERIALS OF CONSTRUCTION ECX/SC

1 Plug Polyethylene2 Cover Silicon aluminium3 Upper spring plate SG iron4 Outer spring Steel5 Middle spring Steel6 Inner spring Steel7 Spring retaining bolt Mild steel8 Diaphragm plate Forged steel9 Operating diaphragm Rubber

10 Clamp washer Mild steel11 Lower cylinder Silicon aluminium12 Cylinder/bonnet bolt Steel13 Bonnet ‘O’ ring Nitrile14 Bonnet/cylinder joint Klingersil15 Bonnet Cast iron16 Spindle Stainless Steel17 Compressor pin Steel18 Compressor Cast iron19 Line diaphragm Rubber, Rubber/PTFE20 Screw cover PE21 Cylinder cover screw Steel22 Cylinder cover nut Steel23 Cylinder cover washer Steel24 Body/bonnet nut Stainless steel25 Body/bonnet stud Stainless steel26 Body/bonnet washer Stainless steel

Item Component MaterialMATERIALS OF CONSTRUCTION ECX/SO

1 Cover plug Mild steel2 Cover plug ‘O’ ring Rubber3 Spindle screw Steel4 Clamp washer Mild steel5 Upper cylinder Silicon aluminium6 Screw cover PE7 Cylinder screw Steel8 Cylinder nut Steel9 Cylinder washer Steel

10 Operating diaphragm Rubber11 Spacer ring Silicon aluminium12 Lower cylinder Silicon aluminium13 Diaphragm plate SG iron14 Spring Steel15 Cylinder/bonnet bolt Steel16 Bonner ‘O’ ring Nitrile17 Bonnet Cast iron18 Spindle Stainless steel19 Spindle limit pin Steel20 Compressor pin Steel21 Compressor Cast iron22 Line diaphragm Rubber, Rubber/PTFE23 Body/bonnet nut Stainless steel24 Body/bonnet stud Stainless steel25 Body/bonnet washer Stainless steel

Item Component MaterialMATERIALS OF CONSTRUCTION INDICATOR

1 Indicator cover Polycarbonate2 Indicator Polycarbonate3 Indicator ‘O’ ring Rubber

Item Component MaterialMATERIALS OF CONSTRUCTION ECX/DA

1 Cover plug Mild steel2 Cover plug ‘O’ ring Rubber3 Upper cylinder Silicon aluminium4 Spindle screw Steel5 Upper diaphragm plate Mild steel6 Screw cover PE7 Cylinder screw Steel8 Cylinder nut Steel9 Cylinder washer Steel

10 Operating diaphragm Rubber11 Lower diaphragm plate Mild steel12 Lower cylinder Silicon aluminium13 Bonnet ‘O’ ring Rubber14 Cylinder/bonnet bolt Steel15 Cylinder/bonnet joint Klingersil16 Bonnet Cast iron17 Spindle Stainless steel18 Spindle limit pin Steel (150mm)19 Compressor pin Steel20 Compressor Cast iron21 Line diaphragm Rubber, Rubber/PTFE22 Body/bonnet nut Stainless steel23 Body/bonnet stud Stainless steel24 Body/bonnet washer Stainless steel

Note: Visual indicator is anoptional extra on the ECX.

ECX Spring Closing

1

2

3

4

5

6

7

8

9

10

11

13

14

15

16

17

1819

242526

1220212223

TECHNICAL DATA

ECX Pneumatic Actuators DN65 -- DN150Materials of Construction

TECHNICAL DATA

ES/EV Pneumatic Actuation DN15 -- DN200Materials of Construction

41

Saunders

1 Operating Diaphragm Rubber2 Spindle Stainless Steel3 Compressor Cast Iron4 Line Diaphragm Rubber, Rubber/PTFE5 Cylinder Plug Malleable Iron6 Bonnet ‘O’ ring Rubber

Item Component MaterialMATERIALS OF CONSTRUCTION ES DA

1 Operating Diaphragm Rubber2 Spindle Stainless Steel3 Compressor Cast Iron4 Line Diaphragm Rubber, Rubber/PTFE5 Cylinder Plug Malleable Iron6 Bonnet ‘O’ ring Rubber7 Indicator Solid Nylon 66

(natural dyed yellow)8 Indicator cover Polyamide 6-3-T

Item Component MaterialMATERIALS OF CONSTRUCTION EV DA

1 Operating Diaphragm Rubber2 Spindle Stainless Steel3 Compressor Cast Iron4 Line Diaphragm Rubber, Rubber/PTFE5 Bonnet ‘O’ ring Rubber 6 Spring Adjusting Spindle Steel7 Cylinder Plug Malleable Iron8 Indicator Rod Steel9 Weatherproof Seal PVC

Item Component MaterialMATERIALS OF CONSTRUCTION EV SC

1 Operating Diaphragm Rubber2 Spindle Stainless Steel3 Compressor Cast Iron4 Line Diaphragm Rubber, Rubber/PTFE5 Weatherproof Seal PVC6 Spring Adjusting Spindle Steel7 Cylinder Plug Malleable Iron8 Indicator Rod Steel

Item Component MaterialMATERIALS OF CONSTRUCTION EV SO

Item Component MaterialMATERIALS OF CONSTRUCTION ES SC

1 Operating Diaphragm Rubber2 Spindle Stainless Steel3 Compressor Cast Iron4 Line Diaphragm Rubber, Rubber/PTFE5 – –6 Cylinder Plug Malleable Iron7 Bonnet ‘O’ ring Rubber8 Indicator Rod Steel9 Weatherproof Seal PVC

10 Handwheel Cast Iron

Item Component MaterialMATERIALS OF CONSTRUCTION ES SO

ES double acting

EV double acting

ES spring closing

EV spring closing

ES spring opening

EV spring opening

1 Operating Diaphragm Rubber2 Spindle Stainless Steel3 Compressor Cast Iron4 Line Diaphragm Rubber, Rubber/PTFE5 Spring Adjusting Spindle Steel6 Bonnet ‘O’ ring Rubber7 Cylinder Plug Malleable Iron8 Indicator Rod Steel9 Weatherproof Seal PVC

10 Handwheel Cast Iron

10

10

TECHNICAL DATA

EC/SSC/ECX Actuator Dimensions


15 115 110 10820 160 152 11725 168 161 12740 231 217 15950 249 229 190

Size DN A B C

Size DN A B C DHeads L1, L2 & L365 411 55 217 26680 426 55 254 266100 468 55 329 266

SSC actuator

ECX spring closing actuator

ECX double acting and spring opening actuator

EC actuator

Note: Dimension ‘B’ is for Indicator

A –

OP

EN

B –

CLO

SE

D

C

A –

OP

EN

B –

CLO

SE

D

C

A

B

C

C

ECX/SO

ECX/SC

Size DN A B C D65 258 55 217 26680 300 55 254 266100 317 55 329 266

ECX/DA

Size DN A B C D65 268 55 217 26680 284 55 254 266100 327 55 329 266

ECX/SC

Size DN A B C DHeads S1, SL2 & S365 372 55 217 26680 386 55 254 266100 428 55 329 266

A

B

TECHNICAL DATA

ES/EV Actuator Dimensions

43

Saunders

Model ∅ H (TYPE AFP VALVE) – SIZE IN MM

Fail Safe Spring

CLOSING

Fail Safe Spring

OPENING

DOUBLE ACTING

15 20 25 32 40 50 65 80 100 125 150 200

368 376 386 – 415384 397 408 – 427– – 464 486 491 504 516– – 487 505 513 524 534– – – – – 617 637 653– – – – – 667 683 692– – – – – – – 779 820 836– – – – – – – 826 863 879– – – – – – – – 1051 – 1131

214 221 278 – 299 331255 262 371 – 407 435– – – 374 384 444 480 483– – – 450 456 555 570 582– – – – – – – 514 555– – – – – – – 619 660– – – – – – – – 671 690 753– – – – – – – – 831 846 912– – – – – – – – – – 974 1040

184 196 200 – 224 233129 136 142 – 165 196– – – 287 303 312 327 340 377– – – 215 221 232 245 257 290– – – – – – – 360 397 412– – – – – – – 298 337 350– – – – – – – – 437 452 519– – – – – – – – 355 370 436– – – – – – – – – – 462 530

EV 61 168ES 61 168EV 62 260ES 62 260EV 63 318ES 63 318EV 64 425ES 64 425ES 65 549



Dimension table shows in mm diameter/width of actuators and the maximum heightof the actuator from the centre of the valve flange or pipeline, the dimensions shownare to aid planning.

∅ = Actuator Diameter/Width H = Actuator Height

ESO 68-72

ESDA 54-58

ESC 61-65

EVC 61-64 EVO 68-71 EVDA 54-57

Ø

H

A wide range of locally mounted banjo solenoidvalves can be fitted to the Saunders actuatorrange with a manual override option and varioushazardous area classifications.The solenoid range isdesigned tocover allrequirements.

Actuation Accessories


MODEL SIZE RANGE STYLE MATERIAL SOLENOID SWITCH BOX POSITIONER AIR FILTER HANDWHEEL

EC DN8-50 A, AFP PES ✓ ✓ ✓ ✘ ✘

SSC DN8-50 A, AFP 316 C12 ✓ ✓ ✓ ✘ ✓

ECX DN65-150 A, AFP SiAl Coated ✓ ✓ ✘ ✓ ✘

EV DN15-150 A, AFP, KB SiAl Coated ✓ ✓ ✓ ✓ ✘

ES DN15-200 A, AFP, KB SiAl Coated ✓ ✓ ✓ ✓ ✓

✓ = Available and ✘ = Not available

For control applicationon the EC and SSC theVIAPOS mini offers bothpneumatic, electro-pneumatic and digitalinputs with sensorfeedback option andlinear mounting designproviding a compactcontrol solution.

This highly modularswitchbox option isavailable for EC/SSC &ECX actuator ranges.The switchbox offers awide range of V3mechanical andproximity sensors withspace for up to 4switch, integral solenoid valve & ASI* interface.

*ASI Interface can be retrofitted.

Suitable for both the EC and SSC. This lowcost switchbox offersremote, open andclosed indication of thevalve position. Availablewith two V4 mechanicalor proximity switchesand intrinsically safeoptions.

Overview

Solenoid Valves

Mini Positioner

A

Module Switchbox

Mini Switchbox

Saunders

45

Manufactured frompolyester coatedaluminium. Thisswitchbox is used forthe ES and EV linearactuators. It has thecapability for up to 4 switches and canincorporate internalsolenoid valve and ASI system.

The EC/SSC limit openstop can be supplied toorder and offers a fullyadjustable travel stop.With the removal of theplastic indicator the limitstop is easily accessible. �

1

2

S DANGER

OUTLET

SUPPLY

NPT 1/4"1/8"

FILTERPLUGWARNINGDO NOT REMOVETHE PLUG WHEN THEUNIT IS PRESSURIZED

NPT 1/8"

Providing precise controlof the flow through thevalve. This long lifecorrosion resistant rangesuits a wide variety ofapplications withreliability and accuracy.Available as pneumatic,electro pneumatic,intrinsically safe andexplosion proof,together with a variety offeedback options.

SSC Manual Over-Ride

007 Switchbox

ES Positioner

EC & SSC Limit Open Stop

For extra security theSSC can be suppliedwith an emergencymanual over-ridemanufactured fromstainless steel. Pleasecontact Crane forfurther information.

Shown mounted to ES Actuator

Shown mounted to ES Actuator

ALLDIAPHRAGMS

CONFORM TO FDA

REGULATIONS

Saunders Type AFP Diaphragm ValvesDiaphragms for Aseptic Applications


The Diaphragm – Key to Successful Valve Performance

Saunders continues to lead the diaphragm valve industry in the development andmanufacture of elastomer components basedon our in-house core competence in rubber and plastic technologies.

The diaphragm is the key performancecomponent within a diaphragm valve. The diaphragm forms both the differential andatmospheric seal and isolates the topworksfrom the process media. As the innovator andleader in diaphragm valves, we continuouslydevelop our diaphragm technology and remainthe only manufacturer to have front to backownership of all aspects of polymer researchand development, diaphragm design and production.

The main categories ofaseptic diaphragms are:

Synthetic elastomer – black internallyreinforced grades

◆ Grade 300 – Butyl

◆ Grade 325 – EPDM,peroxide cured

◆ Grade 425 – EPM,peroxide cured

◆ Grade E5 – EPDM,peroxide cured, post cured

◆ Grade E3 – EPM,peroxide cured,post cured.

Synthetic elastomer – white internallyreinforced grades

◆ Grade 500 – Silicone

◆ Grade E4 – EPDM,peroxide cured

PTFE

◆ PTFE virgin grade white, grade 214 witheither 300, 325 or 425backing support

◆ PTFE modified gradewhite, grade 214S with 325 or 425 backing

Saunders offers a full range of diaphragmselections engineered to meet the exactingdemands of the pharmaceutical industry. PTFE,modified PTFE and elastomer types are availableto suit individual system requirements.

All Saunders aseptic diaphragms are formulated in-house and manufactured from FDA conformingmaterials to meet the requirements of CFR (Codeof Federal Regulations) Chapter 1 Title 21 and aretested and certified to USP Classes V and VI.Certificates of Conformity to FDA and USP areavailable upon request.

To assist in the validation process and to providethe highest level of reliability, security andregulatory compliance, Saunders provides fullbatch traceability for all grades of asepticdiaphragms.

Key elements in diaphragm design and selectioninclude media compatibility, levels of extractables,flex and closure performance, resistance tocompression set, longevity and regulatoryconformance. Saunders elastomer technology andapplication engineering specialists are available toconsult on specifics of material selection.

The Saunders range of FDA conformingdiaphragms has been designed to meet thehighest standards of performance and reliabilitybased on current elastomer and plasticstechnology. Equally important is the associateddocumentation support to assist regulatorycompliance and aid plant and system validation.Only Saunders matches the quality andperformance of its diaphragms with the higheststandard of documentation and validation supportavailable in the industry.

Saunders DiaphragmsDiaphragm Design/Performance

47

Saunders

300 Resin cured butyl rubber Black DN8–DN200 -30 to 130 62–68° 12.9 ✓ ✓ ✓(isobutylene/isoprene)

425 Ethylene Propylene, co-polymer Black DN8–DN100 -40 to 140 61–67° 12 ✓ ✓ ✓peroxide cured

325 Ethylene propylene (EPDM) Black DN8–DN200 -40 to 140 60–65° 12.5 ✓ ✓ ✓diene-modified, peroxide cured

E5 Ethylene propylene (EPDM) Black DN8–DN100 -40 to 140 60–65° 12.5 ✓ ✓ ✓diene-modified, peroxide cured,post cured

E3 Ethylene Propylene, co-polymer Black DN8–DN100 -40 to 140 61–67° 12 ✓ ✓ ✓peroxide cured, post cured

E4 Ethylene propylene (EPDM) White DN8–DN100 -40 to 110 60–66° 11 ✓ – –diene-modified, peroxide cured

214/300 PTFE/Butyl backed White facing, black backing DN8–DN200 -20 to 150 – 32 ✓ ✓ ✓

214/425 PTFE/EPM backed White facing, black backing DN8–DN200 -20 to 160 – – ✓ ✓ ✓

214S/425 PTFE/EPM backed for steam White facing, black backing DN8–DN200 -20 to 160 – – ✓ ✓ ✓

214/325 PTFE/EPDM backed White facing, black backing DN8–DN200 -20 to 160 – 32 ✓ ✓ ✓

500 Silicone DBPH cured White DN8–DN200 -40 to 150 67–73° 7.1 ✓ ✓ –

214S/300 PTFE/Butyl backed for steam White facing, black backing DN8–DN200 -20 to 150 – 30 ✓ ✓ ✓

214S/325 PTFE/EPDM backed for steam White facing, black backing DN8–DN200 -20 to 160 – 30 ✓ ✓ ✓

Grade Material Colour Size Range Continuous Hardness Tensile ApprovalsLower–Upper Temperature IRHD Strength FDA 3A USP

Range °C Mpa Class IV Class V & VI

PTFE Diaphragms

PTFE diaphragms are twopiece construction backedwith a rubber diaphragm to increase their pressurerating and durability. PTFEfaced diaphragms are fittedwith a bayonet fitting toensure reliable installationand maximum life rating.

PTFE diaphragm bayonet fixing

Rubber Diaphragms

The polymer material isbonded with a highstrength wovenreinforcement to ensuremaximum strength anddurability.

Rubber diaphragm screw fixing

Diaphragm Construction

Saunders Type AFP Diaphragm ValvesDiaphragm Traceability and Validation


Full traceability and product validation

The Saunders valve range is acknowledged rightacross industry as being a leader in qualityassurance techniques and design criteria forbiopharm processes. This has led the Saundersproduct to be taken still one step further, andthrough its range of fully traceable diaphragmsprovides its valve users with uniquely valuablesupport in the validation process.

◆ A unique moulded reference number givesprecise batch traceability

◆ Access is available to all relevant physical data

◆ Diaphragms that meet the most stringentvalidation requirements

◆ A certificate of the physical properties of eachbatch is issued to ensure consistency andsupport validation on request

◆ A profile of the complete physical data of eachbatch is available to help trouble shooting

◆ Complete documentation package is availablefor all valve components in contact with theprocess fluids (EN 10204 3.1b certification).

Validation support

Diaphragms conform tosection 177,1550(Perfluorocarbon resins) or177.2600 (Rubber Articles) inChapter 1 Title 21 of the FDARegulations (revised 1st April2001) USP Class V and VI.

Traceable to EN10204 3.1b(was DIN 50049 3.1b)

VALIDATION PACK INCLUDES:

Certificate of Traceability

Certificate of conformity FDA

USP Certificate

Validation support – from raw materials to your system

◆ All ingredients – base polymer, filler, accelerators, etc – are manufactured from FDA conforming materials

◆ All diaphragms are fully batch traceable and carry a unique moulded batch identification number

◆ All diaphragms can be issued with a certificate of FDA conformity to assist in FDAvalidation and internal quality controls

◆ Physical property data is also available upon request

Saunders diaphragms offer enhancedperformance with more confidence

◆ The integrity of the product and the quality of your process is assured. All extractables arefully identified and guaranteed to meet FDAlimits. Access to all physical data is availableupon written request.

Expert and independent verification

◆ Saunders has worked with the Rubber and Plastics Research Association (RAPRA) toprovide complete and detailed identification of extractables and leachables – leading the wayand reaffirming our commitment to ourcustomers and the industry.

Saunders Type AFP Diaphragm ValvesDiaphragm Traceability and Validation

49

Saunders

Moulded and coined to provideoptimum flex life

Reinforcing materialto ensure maximumstrength in eitherpositive or vacuumpressure duties.

Stud anchorage is fullyencapsulated to ensuremaximum strength andlife rating of thediaphragm.

Less deformationfor longerdiaphragm life.

Proven manufacturing process

Blend No. BOTTOM

TOP

DN8

425

Year

Gradeindentification

Top

Bottom

Size

1237/011234/01

1234/01 1236/01 1237/011235/01

Blend make-up of raw material, usually 30kg each, weighed out

RUBBER BLENDIndividual make-ups are mixed together to form a blend of up to 180kg and identified by a numeric system 01 and upwards

Full physical testing to

confirm within specification

Blend is callendered into liners, continuous rubber sheet in rolls of 100m lengths

Liner is cut to length for construction of diaphragm

TRACEABLE DIAPHRAGM

•

•

••

USP Approval

Saunders aseptic range now incorporates a fullrange of Elastomer and PTFE FDA conformingdiaphragms that fulfil the rigorous requirementsof USP* Class V and VI accreditation whichindicates that products are fit for medical use(implant or injectable).

The stringent systemic and implant toxicity testingregimes associated with USP Class VI means thatcustomers can be fully confident in the quality of theirprocessing. For added confidence, however, and togive further assurance that the polymer element ofthe valve as well as the valve body itself meet thehighest standards of integrity, toxicity testing wasundertaken by an independent authority.

USP Class VI approval applies to Saunders’Elastomer and PTFE diaphragms already in serviceas well as those that may be installed in the future,and adds one more benefit to the establishedadvantages of using Saunders products from CraneProcess Flow Technologies. Weare proud to declare that we arealmost unique in having polymerscientists engaged in research,development and manufacture ofour diaphragm range. This enablesus to manufacture all elements ofthe diaphragm in-house and givesus total control of every aspect ofmaterial content, design andproduction. It also assures customersthat they are using products ofunrivalled reliability that extend servicelife and minimise downtime.

Grade 425 EPM Diaphragms

Designed specifically for the mostdemanding biopharmaceutical applications,the 425 EPM elastomer diaphragm providesoptimum process security. Manufactured fromEPM (a copolymer of ethylene-propylenemonomers), this compound uses the latestvulcanisation technology coupled with the inherentstability of the copolymer to eliminate ‘weak points’associated with traditional solutions. Used widely inbiopharm on aqueous media, CIP fluids, dilute acidsand steam duties.

* United States Pharmacopeia

Purity for Demanding Biopharm ProcessesSaunders EPDM diaphragms

Ethylene propylene diene monomer (Grade 325) hasgood mechanical properties and is resistant to ageing,ozone, oxygen and ultra-violet radiation. The diaphragmis cured with an organic peroxide rather than the morecommonly used sulphur to optimise product purity.

Used in biotech and pharmaceutical industries onaqueous media with good resistance to steam and CIP fluids, chlorinated caustic and dilute acids.

Approved to USP Class V and VI. Fully traceable to EN 10204 3.1b

The range also includes the E5 EPDM elastomerdiaphragm which gives complete confidence that

process product is free fromleachables and extractables.Manufactured from EPDM(Ethylene Propylene DieneMonomer), the diaphragm issubjected to a post curingprocess to enhance polymer

cross-linking and reduce thelevel of extractables. Theresult is improved productpurity with minimal or zero

contamination. Lasting longerthan conventionally producedelastomer diaphragms, the E5 EPDM also provides betterreliability and therefore less

disruption to your processes.

The E5 EPDM has more qualityapprovals than any other grade

of diaphragm available today. It actually exceeds current FDA

inspection criteria, which means itcan replace existing EPDM type diaphragms withoutany need for FDA revalidation.

The E5 EPDM has been specifically designed inconjunction with leading pharmaceutical manufacturers to:

◆ Overcome the problem of sulphur leachables which can be introduced through conventionalvulcanisation process

◆ Improve product purity

◆ Provide a longer life alternative to traditionaldiaphragms

◆ Fully support and simplify the validation process.

Saunders Type AFP Diaphragm ValvesDiaphragms – USP Approval, EPDM and EPM Grades


DiaphragmsPTFE Grades

51

Saunders

Less Deformation for Longer Diaphragm Life

The PTFE 214S diaphragm has been designedspecifically to improve performance in applicationswhere steam is present. It displays improvedelastic modulus at high temperature, resulting inless movement due to the effects of cold and hotflow. Indeed, the increased resistance to creepand cold flow of the 214S grade at elevatedtemperatures make the 214S diaphragm theoptimum choice for environments, which call forintermittent steam.

The Saunders range of FDA, USP Class V and VIdiaphragms, which includes the PTFE 214S, hasbeen designed to meet the highest standards ofreliability and quality today. Equally importantly,however, they are supplied with supportingmaterial that will help you meet your regulatoryrequirements in full. Only Saunders asepticdiaphragms match the quality of its products withthis high standard of documentation to provide allround support in smoothing the demands of FDAvalidation of plant and process.

Improved life rating

Users of diaphragm valves withinthe biopharm industry canachieve major processingadvantages using the PTFE 214Sdiaphragm. An innovativeformulation means that it can stayin service up to four times longerthan conventional PTFEdiaphragms without deformation.The net result is less time spentroutinely replacing diaphragmsand, consequently, fewerinterruptions in process run time.

30

25

20

15

10

5

0

15(2175)

10(1450)

5(725)

0

Standard 214 PTFE214S PTFE

PRESSURE N/mm2

% D

EFO

RM

ATI

ON

By virtue of its material properties, standard PTFE tends to creep or flow intothe body of the valve following steam sterilisation. This occurs when avacuum is created in the system as the steam condenses. The resultingdeformation, over time, reduces the valve’s flow capacity, necessitatingregular changes of the diaphragm.

Type 214 PTFE (polytetrafluoroethylene) diaphragms

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