Saunders hc4 afp valves product overview

Saunders HC4 Product Overview

Saunders The first name in diaphragm valve technology

HC4 Diaphragm Valves for Aseptic and Sanitary Processes Saunders originated the diaphragm valve concept over 75 years ago, and remains the technology leader with advanced solutions for the life science’s most demanding applications.

The Saunders range of sanitary and hygienic weir type diaphragm valves spans the range from manual and automated two way product to complex fabrications and multiple weir Bio-Block designs.

Saunders forged 2 way bodies are manufactured from select lots of 316L Stainless Steel and meet requirements of ASTM A-182, DIN 1.4435 and ASME BPE requirements for controlled sulfur – 0.005-0.017%.

Machined from solid block bodies are made from 316L Stainless Steel, ASTM A-479. Other available materials include Hastelloy, AL6XN and Titanium.

Saunders HC4 aseptic diaphragm valves have long been accepted as the industry standard for performance and security. All FDA diaphragms are formulated and manufactured entirely in-house.

Elastomer and PTFE grades are fully compliant to all applicable industry standards and government regulations; including ASME BPE, CFR Section 21, FDA, 3A and USP class V and VI. Additionally, all Saunders diaphragms are fully lot traceable to the original batch of elastomer or polymer used in manufacture.

Saunders has a complete offering of polymer and stainless steel manual bonnets engineered to meet the rigorous applications of the bio-process industry.

Compact pneumatic actuators from Saunders provide automated control, including conventional electrical feedback, valve positioners and fieldbus options. All are hygienic designs that are well suited to the aesthetic and performance demands encountered in the sanitary industries.

All diaphragms conform to FDA regulations.

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HC4 Diaphragm Valves for Aseptic and Sanitary Processes Saunders HC4 diaphragm valves take many forms to meet specific application requirements; including sterility, cleanability, reduced wetted area and drainability. However, all Saunders diaphragm valves meet the following product demands: n Unobstructed, cavity free flow path n Self draining n Isolating diaphragm

n Top entry design n Positive closure n Integral piping component Modular Options

Handwheel High integrity handwheel with ergonomic design assures comfortable, precise control.

Available modular options include padlocking device, proximity switches and limit open stop.

Contoured Contoured design optimizes external washdown and cleanability.

Position Indication

Sealed Bonnet

Highly visible from a distance with clear indication of valve position.

“O” Ring sealed bonnet prevents contamination from external environment.

FDA Conforming Performance Bonnet Assembly

Both PES bonnet shell and internal components are fully FDA conforming.

Polyethersulphone (PES) suitable for wash-down with detergents, sodium hydroxide, hypochlorite, alcohols, dilute acids and autoclaving at up to 150°C (302°F).

Shrouded Top Entry

Shrouded bonnet construction covers body fasteners for clean exterior profile.

Designed for in-line maintenance, essential for welded systems.

End Connections Body is machined from a single 316L SS forging with integral ends.

Butt-weld ends have sufficient turnback for orbital weld installation. Now available with weld chemistry to ASME BPE table DT-3 with sulfur between 0.005% and 0.017%.

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Diaphragms

Forged Bodies All sanitary valve bodies are profiled for low turbulence flow. Forged in 316L/1.4435 stainless steel (ASTM A-182) to maximum ferrite content level 0.5%. Cavity-free design eliminates entrapment areas and enhances diaphragm life.

Saunders unique FDA/USP c o n f o r m i n g d i a p h ra g m s a re manufactured in-house from raw polymer. All diaphragms are fully traceable back to the physical characteristics of the rubber blend.

HC4 Bodies Saunders HC4 Bodies are manufactured from select lots of 316L stainless steel forgings with integral autoweld and clamp ends in sizes from sizes 0.25”-3.00”. Autoweld bodies have integral ends that comply to ASTM A-182 with controlled sulfur weld chemistry as per ASTM BPE table DT-3. Autoweld ends have 1.50” tangent length to facilitate orbital welding and compliance to ASME BPE table DT-2.

Valve sizes 4.00” -8.00” are machined from solid 316L stainless steel wrought bar, ASTM A-467. Alternate materials including AL6XN, Hastelloy and Titanium are available machined from solid bar or billet.

Cast 316L bodies are available for less critical applications including those frequently found in the food, beverage and cosmetics industries.

Saunders valve bodies are available in a complete range of mechanically polished and electro-polished surface finish options to match system requirements. All surface finishes are per ASME BPE SFV DT-V-3.2 Other surface finish options available on request.

Valve ends have hashmarks as standard to indicate self drain angle.

All bodies are permanently marked with heat code, material grade, surface finish specification and a unique identification number.

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Customized Valve Options Tandem Valves - The original customized valve concept is the welded tandem valve combination. A main valve is ported and a second, access valve is welded to the main valve to create a tandem cluster. Tandem access valves are designed to optimize drainability and meet process design requirements including cGMP for deadlegs. Please refer to Saunders interactive Tandem Valve Selection program for design options, ordering information and fully dimensioned drawings.

Machined from Solid Block Bodies - Saunders Bio-Block valves offer the foremost expression of aseptic diaphragm valve technology. Bio-Blocks designs are machined from solid bar or billet to create clusters of two or more weirs with shared chambers that result in a single design with reduced wetted area, optimum drainability and the utmost in integrity.

Saunders has divided Block Bodies into categories based on primary design feature: Zerostatic Weir, Serial Weir, Multiple Weir, Tank Weir and Compound Bio-Blocks.

Bio-Blocks permit a wide range of standard and custom designs engineered and manufactured using state of the art 3D design and manufacturing software including direct tool interface to produce exacting designs while minimizing manufacturing lead times.

Saunders comprehensive and unique Bio-Block Design Manual is a valuable resource for the identification and selection of both standard and custom Bio-Block valves and the reduction in process lead times and costs.

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Manual Bonnets Saunders provides the industry’s widest and most advanced selection of manual bonnets – all designed for the rigorous duty typical of the bio-process industries. All feature rising handwheel operation, bright yellow indicator sleeve, polymer or stainless steel shell and handwheel, stainless steel compressor and a smooth hygienic exterior. Options include:

Performance Bonnet: 0.25”-4.00” with PES shell and handwheel, internal adjustable closing stop, stainless steel internals and enclosed or covered fastenings. The bonnet is fully autoclaveable.

Stainless Steel Non-Sealed Bonnet: 0.50”-6.00” with stainless steel shell and internals and PES handwheel. The bonnet is fully autoclaveable.

Para Bonnet: 0.50” – 2.00” with Para shell and handwheel and sanitary internals. This bonnet is not autoclaveable.

Pneumatic Actuation Saunders EC actuators are piston type for long service life and compact size. The EC actuator is available in spring to close, spring to open and double acting modes for valves 0.25”-2.00”. The actuator features a clean exterior design and PES construction which is ideal for wash down areas within clean plants. Stainless steel compressor, air inserts and fasteners are standard. The SSEC ia a similar design but with stainless steel housing. Both the EC and the SSEC can be autoclaved.

Saunders ECX and ES actuators are available for valves 0.50” – 8.00”.

The EC actuator can be fitted from the factory or in field with a vast array of accessories including switchboxes, positioners, adjustable opening and closing stops, solenoid valves and fieldbus monitoring units. Among the choices are the Saunders Opti-SET self setting switch and the Mark IV module.

Please consult the Saunders engineering binder or your local distributor for additional information including sizing tables and actuators for larger sizes.

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Diaphragm Technology Saunders continues to lead the industry in the development and production of elastomer components based on our in-house core competence in rubber and plastic technologies. The diaphragm is the key performance element within the diaphragm valve. As the innovator and leader in diaphragm technology, Saunders continuously develops our elastomer technology and remains the only manufacturer to have front to back ownership of all aspects of polymer research and development, diaphragm design and production.

Saunders offers the following range of HC4 diaphragms: n Type E Grade 425 - EPM – Ethylene propylene co-polymer, peroxide cured n Type E3 Grade E3 – EPM – Ethylene propylene co-polymer, peroxide cured and post cured n Type D Grade 300 – Butyl, resin cured n Type P2 Grade 214/425 – PTFE/EPM – PTFE faced with leaf type EPM backing cushion n Type S5 Grade 214S/425 – PTFE/EPM – Modified PTFE with leaf type EPM backing cushion for steam service

All Saunders diaphragms are FDA conforming, meet 21CFR177, are third party tested and certified to USP Class VI for extractables and cytotoxicity and are fully lot traceable. Full documentation is available to support industry required requirements and as an aid to system and operational validation.

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Diaphragm Valve Ordering Information & Configuration Schedules Diverter Only

Size

Body Type

End Type

Options

Material

Polish

10

1

2

3

4

5

6

Schedule 1: Sizes

Ordering Code

BioSeal Sizes

Ordering Code

Description

0.50” 0.75” 1.00” 1.50” 2.00” 2.50” 3.00” 4.00” 6.00”

0.25” 0.38” 0.50”

7 8 9 B

Forged (Std. Bodies) Cast (Available in SFV3 Finish only) BioSeal Bodies Block Bodies Machined from Bar or Billet

0 A C E F T U V W X

Description

Standard Valve/Valve Access Assy Close Coupled Branch Valve Tube Extensions Valve/Fitting Access Assy ZDT Forged Valve Close Coupled Branch Valve “U-Bend” Tank Bottom/Weld Flange Tank Bottom/Bolt Flange Special

Ordering Code

0 3 4 5 7 8 9 A B C F G H X

9

Standard Triclamp 14ga. 0.083” Wall Tube (Std. for 4.00” Valves) Male Threaded NPT SCH 5 Pipe 20ga. 0.035” Wall Tube 16ga. 0.065” Wall Tube (Std. for 0.50” - 3.00” Valves) 18ga. 0.049” Wall Tube (Std. for 0.25” - 0.38” BioSeal) SCH 10 Pipe SCH 40 Pipe Combination Ends (ie: Std. Buttweld/Hygienic Clamp) Female Threaded NPT 150# ANSI Flange 12ga. 0.102” Wall Tube (Std. for 6.00” Valves) Special

Description

316L-Forged 1.4435* AL6XN Hastelloy Titanium

Schedule 6: Surface Finish Ordering Code 1 2 3 5 6 7 8 X

*Controlled Sulfur Buttweld Bodies (0.25”-3.00”) ASME BPE Compliant W/0.005-0.017% Sulfur Content

7

*

8

Description

Schedule 5: Materials

6 A H T

7A

Schedule 3: End Connections

Standard Sizes

Ordering Code

7

Schedule 2: Body Types

Schedule 4: Options

Orientation Code

Topworks Accessories Diaphragm

Description

SFV7-10Ra SFV5-20Ra SFV3-30Ra SFV2-25Ra SFV6-25Ra SFV1-20Ra SFV4-15Ra Special

Max Max Max Max Max Max Max

Mech/EP Mech/EP Mech Mech Mech/EP Mech Mech/EP

Diaphragm Valve Ordering Information & Configuration Schedules Schedule 7: Topworks

Schedule 8: Diaphragms

Standard Sizes: 0.50” - 6.00”

Standard Sizes: 0.50” - 6.00”

Ordering Code 11 18 18A 36 36A 50 59 60 C41-C44 C51-C54 C61-C64 EC4 ECX4 EC5 ECX5 EC6 ECX6 SSC4 SSC5 SSC6

Description

Iron Manual Bonnet Stainless Steel-2 “O” Ring Seals Stainless Steel-2 “O” Ring Seals (3A) Stainless Steel Non-Corroding Internals Stainless Steel Non-Corroding Internals (3A) Black PES Sealed Manual Bonnet PARA Polymer Bonnet-Rubber Diaphragm (0.50”-2.00”) PARA Polymer Bonnet-PTFE Diaphragm (0.50”-2.00”) Double Acting Actuator Spring to Close Actuator Spring to Open Actuator Double Acting EC Actuator (0.50”-2.00”) Double Acting ECX Actuator (2.50”-6.00”) Spring to Close EC Actuator (0.50”-2.00”) Spring to Close ECX Actuator (2.50”-6.00”) Spring to Open EC Actuator (0.50”-2.00”) Spring to Open ECX Actuator (2.50”-6.00”) Double Acting Stainless Steel EC Actuator (0.50”-2.00”) Spring to Close Stainless Steel EC Actuator (0.50”-2.00”) Spring to Open Stainless Steel EC Actuator (0.50”-2.00”)

Ordering Code D E2 E3 P2 P3 P3S S5 SI

B29T B36T BEC4T BEC5T BEC6T BES4T BES5T BES6T

Description

Ordering Code BS6 BSIT BE8 BE9

Bonnet & Actuator Accessories Ordering Code

Description

Weep Holes Vent Plug Locking Kit Limit Open Stop Limit Close Stop 3A Version Actuator Accessories

Ordering Code /ENM12 /ENP92 /MK4 /MK12 /P9 /S /60

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Description

PTFE/EPM Backed, FDA (214S/425C) Steam Grade, Threaded Silicone, FDA (500) Threaded Black EPM, FDA (425C) Peroxide Cured, Threaded Black EPM, FDA (E3C) Peroxide Cured, Post Cured, Threaded

Schedule 9: Access Assy Orientation Codes Ordering Code

Description

Polyphenylene Sulphone (PPS) Manual Bonnet Threaded A01-A28 Valve/Valve Access Assemblies Stainless Steel Manual Bonnet Threaded F29-F34 Valve/Fitting Access Assemblies Double Acting EC Actuator Threaded Spring to Close EC Actuator Threaded Spring to Open EC Actuator Threaded Double Acting Stainless Steel EC Actuator Threaded Spring to Close Stainless Steel EC Actuator Threaded Schedule 10: Diverter Spring to Open Stainless Steel EC Actuator Threaded

Schedule 7A: Topworks Accessories

/W /V /LK /LOS /LCS /3A

Butyl Rubber (300) Black EPM, FDA (425) Peroxide Cured Black EPM, FDA (425) Peroxide Cured, Post Cured PTFE/EPM Backed, FDA (214/425) PTFE/Viton Backed, FDA (214/226) PTFE/Viton Backed, FDA (214S/226) Steam Grade PTFE/EPM Backed, FDA (214S/425) Steam Grade Silicone, FDA (500) BioSeal Sizes: 0.25”, 0.38”, 0.50”

BioSeal Sizes: 0.25”, 0.38”, 0.50” Ordering Code

Description

Description

Opti-Set Switch Package (Mech Type (2) SPDT) Opti-Set Switch Package (Prox Type (2) NPN/PNP) Mark IV Switch Package Mark 12 SST Switch Package Mark IV Proximity Switch Slotted Version 60# Spring Option

Ordering Code D2 D3 D4 D5

Codes

Description

2 3 4 5

Way Way Way Way

(1 (1 (1 (1

Inlet Inlet Inlet Inlet

-

2 3 4 5

Outlets) Outlets) Outlets) Outlets)

Saunders Selection Tools The Diaphragm Valve is the primary valve used in aseptic applications in the life science industries. The valve has evolved from the standard two way valve to welded tandem fabrications onto custom Bio-Block solutions that incorporate multiple weirs into a single, machined from solid design that replaces several valves and fittings or even a complete valve manifold.

As the potential number of valve solutions has increased, so has amount of time and effort required to select the best option based on system demands. Saunders has recognized this and has risen to the challenge with a set of tools to make valve selection more efficient.

The Saunders Technical Sales Binder is a valuable tool loaded with important data on the application and use of aseptic and sanitary Diaphragm Valves. Complete product leaflets and technical data sheets are included.

The Saunders Tandem Selection Program is a web based tool invaluable in the selection of welded Tandem Valves. The program fully configures assemblies and generates a 2D drawing for submittal purposes.

The Saunders Bio-Block Manual is the industry’s most inclusive and powerful tool for the selection of custom machined from solid multiport valves. It includes key information on the technology, term and symbol glossaries, P&ID schedule and over 100 examples.

Saunders uses .vrml files to improve understanding of complex valve designs. These 3D files can be e-mailed and viewed by engineers and designers to accelerate the selection process.

Please contact your local Saunders office, your Saunders distributor or www.cranesaunders.com for additional information on obtaining these useful tools.

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Diaphragm Valve Specification Body Valve shall be weir type diaphragm valve with forged type 316L stainless steel body (ASTM A-182), with additional requirements of sulfur content of 0.005% to 0.017% per ASME BPE table DT-3 and maximum ferrite content of 0.5%. Valve shall have integral buttweld ends or integral hygienic clamp ends. Valve with buttweld ends shall have sufficient tangent length to accommodate orbital welding without the addition of welded tube end extensions. Interior surface shall conform to specified ASME BPE surface finish code per table SFV-6. Exterior surface finish shall be as forged. Valve shall fully drain when installed in the self-drain angle as indicated by orientation marks on valve ends. Valve shall be permanently marked with heat number, pressure rating, material type and SFV code per ASME BPE DT-V-3.1 and DT-V-3.2. Additionally, unique order reference number will be marked on valve.

Topworks Bonnet shall be O-ring sealed, rising handwheel type with high visibility yellow position indicator. Bonnet shell and handwheel shall be of polyethersulphone (PES) suitable for wash down protocols and autoclaving to 150째 C. OD profile shall be smooth and hygienic with enclosed fasteners when possible. Spindle, compressor and fasteners shall be stainless steel. Bonnet shall incorporate internal adjustable travel stop to prevent diaphragm overclosure. Modular design can incorporate optional features such as limit open stop, proximity sensors, padlocking device, V-notch plug.

Pneumatic actuator shall be compact piston-type with polyethersulphone (PES) housing and stainless steel air connections and fastener inserts. High visibility yellow position indicator shall be standard. Actuator shall be suitable for wash down protocols and autoclaving to 150째C. OD profile shall be smooth and hygienic with enclosed fasteners when possible. All three operational modes (double-acting spring-to-close, spring-to-open) will feature the same physical dimensions for a given valve size and can be easily converted to different modes. Actuator shall be of inherently safe design with no hazardous spring-load during disassembly.

Modular design can incorporate optional features such as switch modules, solenoids, positioners, limit opening stop.

Stainless steel option available with all features as described above.

Diaphragm E2: Diaphragm shall be peroxide cured EPM with threaded stud connection. Diaphragm shall be FDA conforming, comply to 21CFR177, be third party tested and certified to USP Class V and VI, be certified ADCF (animal derived compound free) and phthalate free, and be fully lot traceable. Sealing beads shall be molded into diaphragm face and located at perimeter and across weir of diaphragm.

E3: Diaphragm shall be peroxide cured EPM and post cured at 240째F for 144 hours and shall have threaded stud connection.

Diaphragm shall be FDA conforming, comply to 21CFR177, be third party tested and certified to USP Class V and VI, be certified ADCF (animal derived compound free) and phthalate free, and be fully lot traceable. Sealing beads shall be molded into diaphragm face and located at perimeter and across weir of diaphragm.

P2: Diaphragm shall be two-piece leaf-type with wetted PTFE face and EPM backing cushion and be connected to compressor with quarter-turn bayonet connection. Diaphragm shall be FDA conforming, comply to 21CFR177, be third party tested and certified to USP Class V and VI, be certified ADCF (animal derived compound free) and phthalate free, and be fully lot traceable. Sealing beads shall be molded into diaphragm face and located at perimeter and across weir of diaphragm.

S5: Diaphragm shall be two-piece leaf-type with wetted modified PTFE face and EPM backing cushion and be connected to compressor with quarter-turn bayonet connection. Diaphragm shall be FDA conforming, comply to 21CFR177, be third party tested and certified to USP Class V and VI, be certified ADCF (animal derived compound free) and phthalate free, and be fully lot traceable.

Sealing beads shall be molded into diaphragm face and located at perimeter and across weir of diaphragm.

Additional Information Additional specifications, including specifications for Zerostatic Tee, U-bend, Tandem and machined from solid Bio-Block Valves as well as control options, alternate materials and end specifications are available on request. Please contact your local Saunders HC4 distributor or CPFT sales office for assistance.

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HC4 AFP-Type Standard 2-Way Diaphragm Valves The standard 2-way valve body is the basic building block of diaphragm valve technology.

Its design and characteristics make it the ideal choice for all categories of “clean” processing systems. Optional materials, surface finish specifications (in compliance with ASME BPE) and international tube designations are all available to suit your application/specification criteria.

Standard 2-Way Bodies Saunders invented the diaphragm valve concept and then pioneered the development of the first true high purity diaphragm valve with the introduction of the AFP forged 316L/1.4435 body range.

The entrapment free design and self-draining characteristics of the diaphragm valve body make it the ideal choice for both aseptic processes and systems that must be cleaned in place. Top entry design allows maintenance while the valve is installed and permits the valve to be welded in place reducing the required number of mechanical joints and enhancing system security.

Drainability The diaphragm valve has outstanding self draining characteristics when compared with other valve types and this feature has contributed to making the valve a standard for hygienic/aseptic application requirements.

Factors which affect drainability are: ■ Valve size and end specification ■ Internal surface finish ■ Drain orientation (as shown) ■ Surface tension and viscosity of media ■ Pipe run angle – generally

Saunders Valve Body Highlights ■ Cavity free and self draining.

■ Isolating diaphragm, top entry design,

and positive closure.

recommended at 2 to 3 degrees Valves with body orientation indicators are available on request (the marks must be located in a plane cutting the vertical centreline of the pipe).

■ Controlled sulphur forged bodies

(0.005% – 0.017%) meets ASME BPE DT-3 requirement for low sulphur content.

■ Low maintenance costs.

α

■ 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.

Guideline drain orientation angles for individual size and tube specifications are readily available on request. Please note that drainability in a process system is ultimately the responsibility of the system designer and/or end user as a result of the variance factors denoted above.

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HC4 AFP-Type Standard 2-Way Diaphragm Valves

Saunders HC4 AFP-Type Diaphragm Valves

Standard 2-Way Bodies

Standard 2-Way Valves Pure performance forged valves* Forged stainless steel valves* Solid block stainless steel valves Cast stainless steel valves

8 – 15 mm 15 – 80 mm 100 – 150 mm 8 – 100 mm

* Compliant with ASME BPE Table DT-3 for low sulphur requirement

Forged Stainless Steel Bodies (DN15–DN80) Saunders standard AFP body is forged from wrought 316L/1.4435 stainless steel bar. The forging process results in a homogeneous surface that is free of defects such as porosity, inclusions or shrinkage cavities. This defect free surface is an ideal substrate for the high levels of mechanical and electropolished surfaces demanded by the clean processing industries to maintain sterility and optimise cleaning processes. Saunders forged bodies are manufactured to achieve low ferrite levels of less than 0.5% maximum. This reduces the potential for migration of oxides through a high purity water system. These bodies are fully FDA compliant, meet all existing ASME BPE (American Society of Mechanical Engineers Bioprocessing Equipment) standards and cGMP (current Good Manufacturing Practice) principles and are ideal for all high purity applications.

Pure Performance (Bio-Seal) Forged Bodies (DN8–DN15) Saunders Pure Performance fractional valve bodies offer a compact, space saving, high integrity solution for critical applications. Manufactured from a 316L/1.4435 stainless steel forging, the valve is used widely as a sample or drain port in hygienic system design.

All major tube designations (O.D., butt weld, Tri-Clamp, DIN/ISO) are machined integrally from the forging and cover sizes, DN8, DN10 and DN15. This flexibility is achieved by utilisation of the same DN8 body design for all options and machining inlet/outlet ports to the desired end specification.

This allows the valve to utilise the same size (DN8) diaphragm, bonnet and actuator across all specification requirements regardless of end connection size.

Saunders HC4 AFP-Type Diaphragm Valves

Standard 2-Way Bodies

Chemical Composition – HC4 AFP Forgings ASME BPE Table DT-3

Element

%

%

Carbon

0.03 max.

0.03 max.

Silicon

1.00 max.

1.00 max.

Manganese

2.00 max.

2.00 max.

Phosphorus

0.04 max.

0.04 max.

Sulphur

0.025 max.

Investment Cast Stainless Steel Bodies (DN8–DN100)

Chromium

17.0/18.0

17.0/18.0

Nickel

12.5/13.5

12.5/13.5

The Saunders investment cast range uses high quality materials and selective casting processes to provide an economical solution for the food, beverage, dairy, and bioprocess industries. Available in all major international tube designations including, O.D. tubing, Tri-Clamp, DIN and ISO. Stringent quality control is employed to minimise any risk of porosity and ensure a finished product of the highest integrity.

Molybdenum

2.5/3.0

2.5/3.0

Nitrogen

0.11

0.11

Machined from Block Standard Valve Bodies (DN100–DN150)

Controlled Sulphur Forged Bodies (DN8 – DN80)

Larger size designations are now machined integrally from solid wrought stainless steel barstock.

This construction brings the same high level of surface integrity and metallurgical security as available with the AFP forgings. We can support the increasing demand for special alloys ((Hastelloy, Titanium, AL6, XN etc.) with an economic and flexible solution, even for small volumes, because we machine from solid barstock.

316L/1.4435 forgings are now available with sulphur composition between 0.005% and 0.017%, conforming to ASME BPE Table DT-3. Conventional bodies average 0.03% sulphur.

➔ 0.005/.017

These controlled sulphur bodies eliminate the need to incorporate costly tube-end extensions, so reducing lead time and paperwork requirements. Additional benefits include improved dimensional stability of weld ends and improved electro-polish finish.

➔

1.4435/316L EN 10222-5 ASTM A-182

HC4 AFP-Type Standard 2-Way Diaphragm Valves

Saunders HC4 Diaphragm Valve Features Handwheel

Contoured

High integrity handwheel with ergonomic design ensures comfortable, precise control.

Contoured design to optimise external washdown and cleanability.

•

•

Sealed Bonnet ‘O’ Ring sealed bonnet as standard to prevent ingress from external environment.

Position Indication Highly visible from a distance with positive indication of valve position.

•

• Performance Bonnet Assembly

• FDA Conforming

•

Both PES bonnet shell and internal components are fully FDA conforming.

•

Polyethersulphone (PES) suitable for wash-down with detergents, sodium hydroxide, hypochlorite, alcohols, dilute acids and autoclaving at up to 160°C. Shrouded

•

•

Top Entry Designed for in-line maintenance essential for welded systems.

•

•

End Connections Body is machined from single forging with integral ends.

Butt weld ends have sufficient turnback for orbital weld installation. Now available with weld chemistry to ASME BPE Table DT-3 with sulphur level between 0.005% and 0.017%.

Forged Bodies All HC4 valve bodies are profiled for low turbulence flow. Forged in 316L/1.4435 stainless steel to maximum ferrite content level 0.5%. Cavity free design eliminates entrapment areas and enhances diaphragm life.

Shrouded bonnet construction covers body fasteners for clean exterior profile.

Diaphragms Saunders unique FDA/USP conforming diaphragms are totally manufactured from raw polymer in-house. All diaphragms are fully traceable back to physical characteristics of the rubber blend.

Modular Options Alternative modular options available including padlocking facility, proximity sensors and limit open stop versions.

This Product Leaflet is one of a set detailing the complete range of Saunders brand Diaphragm Valves, Diaphragms and Accessories.

ERIKS bv I P.O. box 280 I 1800 BK Alkmaar I T +31 72 514 18 00 I F +31 72 515 56 45 I E valves@eriks.nl I www.eriks.nl

HC4 Standard Machined Block Valves The Saunders range of HC4 Standard Machined Block valves uniquely provides the user with compact, minimum deadleg construction, full drainability, flexible high-integrity configuration and, ultimately, security of processing.

Zero Deadleg ‘T’ Pattern Essential for the elimination of dead legs and designed to ease installation and validation, Saunders Zero Deadleg T pattern range (ZDT) enhances the integrity of critical systems.

Machined integrally from a forging, the ZDT normally features three common ports with the same bore dimensions and incorporates a valve body and tee fitting into a single solution.

ZDT valves form the ideal solution for feeding laterals off recirculating loops, sample points or use point applications. The bodies can be supplied with weld or hygienic clamp end connections or included 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

providing ideal 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 Steel

316L/1.4435 forging (no welds) ■ Available in size range DN15–DN50 with

full range of FDA conforming diaphragm/bonnet/actuation options

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HC4 Standard Machined Block Valves

Close-Coupled Branch Valves The Saunders Close Coupled Branch Valve (CCBV) compliments the patented ZDT design by facilitating larger main line size options. They provide the ideal solution when the main process line is at least one size larger than the valve/branch size. The unique tee construction is engineered from a machined billet to enhance structural integrity and ease installation and validation.

The CCB valve provides a straight through unobstructed main line flow path and will eliminate the deadleg normally associated with welding a conventional two-way valve to a T-piece. By virtue of the weir size, the CCB offers a compact, flexible and economic design solution.

Major benefits of the range include: ■ Compact flexible design providing excellent drainage

characteristics and absence of deadleg ■ Machined block construction provides security of

installation, rapid sterilisation and easier regulatory compliance ■ Ideal solution when main process line is larger than

valve/branch size (i.e. main line DN50 valve/branch DN25) utilises DN25 diaphragm/bonnet/ actuator ■ Sampling/injection points on high purity water systems

Point-of-Use Options (Close-Coupled Branch Valve ‘U’ Bend) One of the most sensitive applications in a WFI loop is the use point valve. These valves represent the barrier between the safety of the recirculating loop and the potential hazards of the environment and function as the take off point for consumption of WFI. Valves for this application 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.

Saunders Point-of-Use Valve Horizontal or vertical drain port. Significantly reduces the hold-up volume and necessary site welds associated with conventional ‘U’ bends and branch tee assemblies. Sampling or injection points on high integrity systems.

Multi-port Diverter Valves Modern machining technology is employed in the design and manufacture of Saunders range of Bio-Block diverter valves.

This product brings two or more weirs or control points together in a single configuration that is manufactured from a single block of stainless steel. The result is a single valve without internal fabrication welds for maximum strength, with reduced holdup volumes and without stagnant areas. On one side of the weirs there is a common chamber and on the other side of the weir the flow is divided and split into multiple control points. Diverter valve designs are ideal solutions whenever a process line needs to be divided into two or more process streams or when multiple lines are combined into one.

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

E Tools The Saunders diverter software selection programme supports the multi-port diverter range. Like the tandem valve programme, this electronic tool enables our customers to select the ideal multi-port valve solution including end selection and valve arrangement and then print the selection in a 3D format.

Saunders multiport diverter valves have significant advantages over conventional multiple valve assemblies.

■ Machined Block construction, free from fabrication

welds to enhance structural integrity ■ Minimal deadleg design to reduce risk of process

contamination ■ Inlet machined integrally eliminates a potential source of

contamination (many other designs employ bolted inlet) ■ Excellent drainage characteristics for quick and

effective sterilisation ■ Reduced space requirement provides greater flexibility

in system design and simplified installation ■ Complete solution including FDA compliant

diaphragms, manual bonnets and actuators ■ Fully certified range, with comprehensive validation

support documentation on request

HC4 Standard Machined Block Valves

Integral Sampling Ports Saunders Close Coupled Branch Valves (both T and U bend) can be supplied with optional integral sample ports to permit real-time sampling of WFI without breaking a sterile use point connection.

This provides a number of key process advantages: ■ Minimum product envelope

Sample quality directly from water loop with integral back sample option.

■ Minimum deadleg ■ Less system welds

Integral ports can be positioned on main line or branch connections (see section views) according to user requirements. ➔ ➔

Alternate use point designs can be manufactured to accommodate special centre line dimensions, reduced envelope requirements and other design considerations (see image of CCB 90˚ to reduce centre dimensions).

Sample port positioned integrally on branch connection.

CCBV 90˚ option

Tank Bottom Valves

ERIKS bv I P.O. box 280 I 1800 BK Alkmaar I T +31 72 514 18 00 I F +31 72 515 56 45 I E valves@eriks.nl I www.eriks.nl

Internal purge options available either on vessel side or outlet side depending on system requirements

➔

These valves are free from fabrication welds and dead legs, enhancing structural integrity and reducing the potential for process contamination.

The absence of dead legs also improves drainability, and facilitates effective mixing. Sample valves, purge valves and ports are easily incorporated into the tank bottom design to achieve the desired performance.

➔

The Saunders tank bottom valve incorporates the performance and features of a diaphragm valve into a one piece fully forged tank outlet design.

For applications where deadleg needs to be reduced to an absolute minimum, we can provide a “reduced pocket” design which facilitates enhanced vessel agitation.

Ask for further details.

HC4 Customised Fabrication Options For applications where a standard machined block valve is not sufficient, but a full custom solution is not required, there is a wide variety of fabricated options that will provide the optimum valve configuration.

Tandem Valves (Sterile Access Valves) 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 meet standard process considerations including cGMPs for dead legs.

The following rules help define the possible orientation of tandem valves: ■ The main valve and access valve

may be installed to drain in either the horizontal or vertical position.

When installed in a horizontal run the valve must be rotated into the self-drain position to drain.

■ Allowance must be made to permit

access to bonnet or actuator fasteners and for diaphragm maintenance.

■ The access valve can be any size

including the same size as the main valve.

■ The amount of dead leg between main

and access valves will vary depending on respective valve sizes and orientation. Virtually all combinations fall within cGMP requirements.

■ ‘Handwheel opposite’ designs

generally have shorter tangents than configurations with the handwheel of the main and access valves in the same quadrant.

■ All Saunders welded valve fabrications

are 100% hydro-tested before and after all welding and polishing processes to ensure mechanical integrity. Full material certification of all tube and fittings utilised is standard.

■ Saunders bonnets, actuators and

Applications include flow diversion, sampling, steam injection or condensate drain and block and bleed applications.

diaphragms fit fabricated valve assemblies without adaptors or distance pieces.

3

HC4 Customised Fabrication Options

Tandem Valve Orientation Options â– Full range of horizontal and vertical, drainable options â– Can be configured to your exact pipe layout with minimum deadlegs â– Product transfer, purging, steam sterilisation, condensate drains, CIP systems

Horizontal main at drain angle/vertical tandem

H 04 54

H 04 36

H 04 00

H 04 18

H 32 18

H 32 54

H 32 00

H 18 18

H 18 54

H 18 00

W 18 22

W 18 50

H 14 04

H 14 32

Horizontal main at drain angle/vertical tandem

H 32 36

Horizontal main/vertical tandem

H 18 36

Vertical main/tandem at drain angle

V 18 58

V 18 14

Horizontal main and tandem at drain angle

H 22 68

H 22 40

E Tools Electronic tools exist to assist customers in the selection and orientation of these fabrications.

Saunders Tandem Valve Selection Programme enables engineers and design detailers to select the optimum orientation to suit system requirements and produce a fully coded 3D graphic for immediate translation to valve manufacture.

ZDL Zero Deadleg Valve ‘L’ Pattern The Saunders ZDL ‘L’ pattern diaphragm valve is typically installed in a vertical line. The functions of a 90 degree fitting and a take-off valve are combined within the valve body.

The bore of the third port is situated in line with the point of seal where the diaphragm meets the weir. This ensures low point drainability 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 for Injection) point of use, CIP manifolds and vertical inlet/outlet piping to process equipment requiring low point drainage.

HC4 Customised Fabrication Options

Valve Manifolds/Clusters Configuration of optimum process fabrication presents system designers with an ongoing challenge. Minimum space envelope, reduced hold up areas, reduced cost and facilitating ease of installation are all key considerations.

Our expert customisation service is designed to create the optimum valve configuration for customers’ specific processes. Working from your sketch details or Piping and Instrumentation Drawings (P+IDs), our engineers will propose the solution, realised in a fully detailed CAD drawing for you to verify and approve. This straightforward process ensures that the product we make matches customer requirements in every respect.

The benefits of such fabrications include: ■ Manufactured under stringent ISO 9001:2000 ■ Tailor-made solutions to customer requirements ■ Fully tested assembled units manufactured under

➔

quality control Customised 5-way diverter fabricated manifold

controlled conditions ■ Full traceability of all components

All Saunders process fabrications utilise either forgings or machined barstock components to ensure process integrity.

➔

➔ Specialised steam manifold

Specialised 2-way diverter manifold

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HC4 Bio-Block Customised Design Solutions Almost every process system includes a unique piping challenge that does not lend itself to conventional solutions. Saunders custom designed HC4 Bio-Block valves replace welded clusters, manifolds and valve/fitting combinations and offer the most compact, minimum deadleg design for optimum process integrity.

Computer Aided Design Capability (CAE) Bio-Block Standard & Compound Valves

Converting vision into reality

Our design teams work closely with customers to create unique machined valve designs that we call Bio-Blocks. These ‘outside of the box’ solutions may be driven by process, space constraints, regulatory issues or other specific requirements.

➔

The key element in producing Bio-Block valve solutions has been the development of advanced CAE (Computer Aided Engineering) design and manufacturing tools that enable our engineers to convert concept into reality. This approach to manufacturing provides custom machined valve products with the shortest possible lead times in design and production. We work closely with customers to co-ordinate solutions to unique application challenges.

Engineering team with client

All custom Bio-Block valve bodies accept Saunders standard diaphragms, bonnets and actuators without modification or adaptors. The compact design of the EC actuator range enables us to produce the most space-efficient solutions in the industry.

➔

Machined Bio-Blocks have the advantages of reduced wetted area and dead-legs, no internal fabrication welds and reduced documentation for installation and validation. Faster and easier installation of process manifolds can be achieved using advanced “machined from solid” valves.

Tool path verification

Five axis machining centre

4

HC4 Bio-Block Customised Design Solutions

Advanced Valve Design Tools It is important that all aspects of the application be properly communicated between customer and designer to ensure that the resulting design meets expected performance criteria. Saunders has adopted advanced electronic tools to configure unique and often complex concepts such as compound Bio-Block designs.

Foremost of these is the use of 3D modelling software. This program produces a 3D model of a proposed valve complete with a viewer in an e-mailable format that can be shared easily between the Saunders design and applications engineering teams and our customers.

The 3D representation of the valve design is derived from the same program file that is used to design and manufacture the final product.

Conceptual Approach Bio-Block Compound Valve Solutions Many of today’s most challenging applications cannot be addressed by one valve configuration. Instead, a combination of two or more valve concepts must be machined from a single block of stainless steel to meet system requirements.

The resulting valve types are a hybrid or compound solution that entails the use of more than one valve concept.

For example combining a tank bottom valve with an access valve, a multi-port valve with access valves to perform as steam and condensate port or a point-of-use valve together with a sample valve. Highly trained and experienced engineering staff and modern CAD design tools combined with our manufacturing expertise result in custom valve configurations that combine utility and performance.

Converting vision into reality

Using this software our customers can select from five isometric 3D views, or freely rotate the valve to confirm flow paths or drainability.

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

Customer pipework schematic

➔

Computational Fluid Dynamics (CFD)

CAD rendering

➔

We routinely use Computational Fluid Dynamics software to ensure that flow characteristics including Cv (Kv), pressure drop and flow paths meet client requirements.

Actual flow paths can be viewed to eliminate low flow areas or potential cavitation.

Double tandem valve machined from solid barstock. Main weir inclined at optimum drain angle.

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

➔

➔

■ Valve centrelines CFD analysis of Bio-Block five-way diverter

CFD analysis of standard AFP forging

■ Drain point of body bore and any associated tubing ■ Drain point of weirs

Trained and experienced sales and engineering staff are ready to work with you to develop unique Bio-Block valve solutions. The Saunders brand delivers excellence in the application, design and manufacture of custom machined valve solutions as reflected in its innovative and evolving range of Bio-Block valves.

■ 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

Conceptual Approach Bio-Block Machined Tandem Valves (Serial Weir) This design is a solid version of the welded valve-to-valve or tandem valve assembly. Machined from a single block of wrought stainless steel it provides several benefits.

■ Absence of internal fabrication welds enhances

product integrity ■ Hold up volumes can be reduced ■ Dead legs minimised ■ Reduced number of material certificates required

Bio-Block Serial Weir Option This concept puts two weirs in line, but 180˚ apart and sharing a common chamber. This allows the common chamber to be sterilised and form a barrier between two process flow streams. Our customers have incorporated this concept in requirements as diverse as Point-of-Use, Tank Outlet and in ‘Mix-Proof’ applications.

These advantages are especially realised in the smaller sizes where valve geometry makes it difficult to achieve cGMP requirements for minimum dead legs.

Bio-Block Integral Steam, Purge and Condensate Porting (Tank Weir) Rather than control steam supply and condensate drain by means of ‘stand off’ welded access valves that may entail large design envelopes or dead legs, Saunders Bio-Block valves can be machined with integral weirs and/or ports.

Bio-Block Controlled Inlet Option (Multiple Weir)

➔

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 into the multi-port valve.

The controlled inlet option can be included in any number of compound Bio-Block solutions to comply with specific system requirements.

Bio-Block tank manifold arrangement.

Combining conventional tank bottom and ZDT technology into a high integrity machined block configuration for bio-pharm vessel applications. Cleanability, is facilitated by purging into offset weirs (sterile barrier).

HC4 Bio-Block Customised Design Solutions

Conceptual Approach Bio-Block Chromatography Valves (Multiple Weir)

Bio-Block machined valve solutions are the ideal compliment to modular component design and construction.

■ One Bio-Block valve can replace a welded piping

manifold comprising several valves and fittings ■ Reduced design envelope and installation times

giving overall cost savings ■ Fewer welds and less documentation required

➔

This Bio-Block option incorporates a central control weir to permit the division of flow into distinct process streams or to allow flow to pass through the valve as required during resin regeneration or cleaning cycles.

Design and Installation Advantages

Typical steam-cross fabrication arrangement

➔

➔

Typical chromatography BioBlock arrangement

Our unique Bio-Block design and specification manual is available on request. This provides a mechanism for rapid, efficient and accurate communication of Bio-Block designs.

It allows the customer to specify and select a fully-coded 3D design to meet P+ID system requirements without an on-going exchange of 2D drawings, rough sketches and data which may be confusing. Containing over 100 product designs in coded 3D representation, the manual includes a detailed explanation of design principles and valving terminology, P+ID coding structure and categorised 3D design options. Bio-Block specification/selection data sheets are also available.

➔

Bio-Block Specification and Selection

Bio-Block Steam-cross arrangement machined from solid barstock

This Product Leaflet is one of a set detailing the complete range of Saunders brand Diaphragm Valves, Diaphragms and Accessories.

For further information, or to request additional data, please contact us. Due to constant product improvements, details shown in this publication are subject to change.

Saunders® is a registered trademark of Crane Process Flow Technologies Ltd. Crane® is a registered trademark of Crane Corporation.

Crane Process Flow Technologies Ltd. Grange Road, Cwmbran, Gwent, UK. NP44 3XX Tel: +44 1633 486666 Fax: +44 1633 486724/486544 E-mail: technical.sales@craneflow.com Web: www.saundersvalves.com

5

HC4 Diaphragms

The critical component of any diaphragm valve is the diaphragm itself, due to its function as a dynamic seal and its continuous contact with highly valuable process media. Through continuous in-house development of our core expertise in this area, the Saunders brand provides customers with class-leading, traceable solutions to meet the most stringent process needs.

The Diaphragm – Key to Successful Valve Performance The diaphragm is the key performance component within a diaphragm valve. The diaphragm forms both the differential and atmospheric seal and isolates the topworks from the process media.

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

We remain the only manufacturer to have front to back ownership of all aspects of polymer research and development, diaphragm design and production.

We offer a full range of diaphragm selections engineered to meet the exacting demands of the pharmaceutical industry. PTFE, TFM and elastomer types are available to suit individual system requirements.

The main categories of aseptic diaphragms are: Synthetic elastomer – black internally reinforced grades ■ Grade 300 – Butyl ■ Grade 425 – EPM, peroxide cured ■ Grade E3 – EPM, peroxide cured,

post cured Synthetic elastomer – white internally reinforced grades ■ Grade 500 – Silicone ■ Grade E4 – EPDM peroxide cured

PTFE All Saunders brand aseptic diaphragms are formulated in-house and manufactured from FDA conforming materials to meet the requirements of CFR (Code of Federal Regulations) Chapter 1 Title 21 and are tested and certified to USP Classes V and VI. Certificates of Conformity to FDA and USP are available upon request.

All diaphragms within the range are certified ADCF (Animal Derivative Component Free).

All Diaphragms conform to FDA Regulations

■ PTFE virgin grade

white, grade 214 with either 300, 325 or 425 backing support ■ TFM white, grade 214S with 325

or 425 backing

HC4 Diaphragms

➔

➔

Diaphragm Construction

Rubber diaphragm screw fixing

PTFE diaphragm bayonet fixing

Rubber Diaphragms

PTFE Diaphragms

The polymer material is bonded with a high strength woven reinforcement to ensure maximum strength and durability.

PTFE diaphragms are two piece construction backed with a rubber diaphragm to increase their pressure rating and durability. PTFE faced diaphragms are fitted with a bayonet fitting to ensure reliable installation and maximum life rating.

Size Range Continuous Hardness Lower–Upper Temperature IRHD Range °C

Material

Colour

300

Resin cured butyl rubber (isobutylene/isoprene)

Black

DN8–DN200

-30 to 130

62–68°

12.9

✓

✓

✓

425

Ethylene Propylene, co-polymer Black peroxide cured

DN8–DN100

-40 to 140

61–67°

12

✓

✓

✓

325

SUPERCEDED BY NEW ENHANCED EPM

E5

SUPERCEDED BY NEW ENHANCED E3

Tensile Strength FDA Mpa

Approvals 3A USP Class IV Class V & VI

Grade

E3

Ethylene Propylene, co-polymer Black peroxide cured, post cured

DN8–DN100

-40 to 140

61–67°

12

✓

✓

✓

E4

Ethylene propylene (EPDM) diene-modified, peroxide cured

White

DN8–DN100

-40 to 110

60–66°

11

✓

–

–

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

–

–

✓

✓

✓

White facing, black backing DN8–DN200

-20 to 160

–

–

✓

✓

✓

214S/425* PTFE/EPM backed for steam

SUPERCEDED BY NEW ENHANCED 214/425

214/325 500

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 * DN8-50 conforms to new Hi-Steam design

SUPERCEDED BY NEW ENHANCED 214S/425

Diaphragms Type 425 Grade EPM diaphragms Delivers highest levels of performance and security for the most demanding biopharmaceutical applications.

Ethylene propylene based elastomer is the most commonly used diaphragm material in the Pharmaceutical industry.

Saunders EPM diaphragms offer enhanced performance for the demanding application criteria found in the Biopharmaceutical environment.

Full Traceability To assist in the validation process and to provide the highest level of reliability, security and regulatory compliance, we provide full batch traceability for all grades of aseptic diaphragms.

Key elements in diaphragm design and selection include: ■ Media compatibility ■ Levels of extractables ■ Flex and closure performance ■ Resistance to compression set ■ Longevity ■ Regulatory conformance

Our elastomer technology and application engineering specialists are available to consult on specifics of material selection.

■ Manufactured from inherently stable EPM

(A copolymer of Ethylene and Propylene monomers) ■ Uses the latest vulcanisation technology ■ Enhanced temperature performance and chemical

resistance due to the elimination of any double bond active sites as displayed with EPDM molecular structure ■ Improved steam life cycle and flex life ■ Longer lasting diaphragm provides better reliability

with less disruption to pharmaceutical processes ■ Fully complies with all international standards for

toxicity and purity as defined by regulatory bodies such as FDA, USP and ISO is confirmed by independent laboratory studies ■ Full traceability documentation available to confirm

specific batch number and critical data. This aids validation, assists in trouble shooting and is a guarantee of product quality ■ Certified as ADCF (Animal Derivative Component Free)

to ensure maximum product purity and integrity

The Saunders range of FDA conforming diaphragms has been designed to meet the highest standards of performance and reliability based on current elastomer and plastics technology. Equally important is the associated documentation support to assist regulatory compliance and aid plant and system validation.

Only the Saunders brand matches diaphragm quality and performance with the highest standard of documentation and validation support.

HC4 Diaphragms

Diaphragms Hi-Steam TFM Diaphragms (DN8-50) Delivers the best performance and security for steam duties in biopharmaceutical applications.

Saunders Hi-Steam TFM diaphragms offer the biopharmaceutical industry a major improvement in service life and reliability. Applying core competence in polymer technology and diaphragm design, the Saunders Hi-Steam diaphragm benefits from recent advances to uniquely address the problem posed by intermittent steam sterilisation when combined with small surface area of diaphragm.

The range offers:

Type 214S TFM diaphragms (DN65-250) Improved life rating Users of diaphragm valves within the biopharm industry can achieve major processing advantages using the TFM 214S diaphragm. An innovative formulation means that it can stay in service up to four times longer than conventional PTFE diaphragms without deformation. The net result is less time spent routinely replacing diaphragms and, consequently, fewer interruptions in process run time.

■ Fully fluorinated carbon backbone ■ Widest temperature range of any polymer ■ Inert to corrosive chemicals, only attacked by molten alkali

metals, fluorides of chlorine or oxygen and free fluorine ■ Low co-efficient of friction – good anti-stick properties

Less Deformation for Longer Diaphragm Life The TFM 214S diaphragm has been designed specifically to improve performance in applications where steam is present.

It displays improved elastic modulus at high temperature, resulting in less movement due to the effects of cold and hot flow. Indeed, the increased resistance to creep and cold flow of the 214S grade at elevated temperatures make the 214S diaphragm the optimum choice for environments, which call for intermittent steam.

The Saunders range of FDA, USP Class V and VI diaphragms, which includes the PTFE 214S, has been designed to meet the highest standards of reliability and quality today. Equally importantly, however, they are supplied with supporting material that will help you meet your regulatory requirements in full. Only Saunders aseptic diaphragms match the quality of its products with this high standard of documentation to provide all round support in smoothing the demands of FDA validation of plant and process.

■ Significant reduction in cold flow deformation typically

associated with conventional PTFE components present in biopharmaceutical systems.

■ Significant performance improvement under aggressive

steam sterilisation and pure water based media.

■ Manufactured from TFM (modified Polytetrafluorethylene

[PTFE]) backed with EPM (a copolymer of Ethylene and Propylene monomers) from raw polymer ingredients employing Crane Process Flow Technologies Ltd’s unique moulding competence.

■ Significant improvement in valve flow capacity to

maintain processing efficiency.

■ Energizer ribs moulded into the EPM backing material

assist diaphragm closure under demanding operating conditions by directing closure loads on the weir area minimising deformation and compression set and lowering the amount of force required to effect closure.

■ All formulation, blending and processing is performed

in-house allowing full production control and lot traceability.

■ Fully complies with all international standards for

toxicity and purity as defined by regulatory bodies such as FDA, USP and ISO and confirmed by independent laboratory testing.

■ Certified as ADCF (Animal

Derivative Component Free) to ensure maximum product purity and integrity.

ERIKS bv I P.O. box 280 I 1800 BK Alkmaar I T +31 72 514 18 00 I F +31 72 515 56 45 I E valves@eriks.nl I www.eriks.nl

Saunders® EX Endurance Diaphragm Ideal for Extended High Temperatures

www.cranechempharma.com

Key features of the Saunders® EX Endurance Diaphragm include:

Outstanding high temperature performance and resistance to long term exposure at elevated temperatures

Ideal for steam distribution and supply, sterile barrier, and block-and-bleed applications

Improved seal-to-atmosphere performance and reduced requirements for re-torqueing of fasteners after thermo cycling

Saunders® EX Endurance Diaphragm features twopiece leaf-type construction. The diaphragm consists of a wetted modified PTFE face with a non-wetted fabric reinforced Silicone backing cushion.

The Silicone backing offers exceptional resistance to high temperatures compared to EPDM. EPDM rubbers suffer damage with prolonged exposure to temperature such as encountered during heat sterilization. This damage results in loss of resiliency and resistance to compression set and reduces the ability of the EPDM backing to properly energize the wetted PTFE diaphragm face.

The EX Silicone backing can handle these same elevated temperatures with no deterioration of physical properties.

The Saunders® Endurance Diaphragm is also ideal for applications that require service at unusually high temperatures. The EX Diaphragm has been tested on continuous steam at 175°C (347°F).

Saunders® EX Endurance Diaphragm

EX Design Features

Temperature

Modified PTFE Wetted Face • Optimum ratio of crystalline and amorphous microstructure • Reduced creep and flow at elevated temperatures means less deformation • Ideal for high steam applications

Maximum constant 175°C (347°F) Maximum intermittent 175°C (347°F) Minimum temperature - 20°C (-4°F)

Silicone Backing Cushion • Dicumyl peroxide cured • Outstanding thermal properties • Best-in-class resistance to compression set • Fabric reinforced to optimize flex performance

Size DN8-100 (¼"- 4")

Marking and Identification Marking system includes date of production, cure date, diaphragm grade, size, and Saunders® ID to provide full traceability.

The EX Endurance Diaphragm features Saunders® bayonet type compressor attachment for optimum performance and ease of assembly DN15-100 (½"-4") and screw fix DN8 (¼").

Conformance

Applications The ideal solution for applications that have extended exposure to high temperatures such as during steam sanitization. This includes: • Steam block • Sterile barrier • Steam distribution and supply • Process lines subjected to long duration steam cleaning

• • • • •

FDA-compliant to 21CFR part 177 USP Class VI <87>, <88> (third party tested) ASME BPE part SG Certified ADCF (Animal Derived Component Free) Fully lot traceable to EN 10204 3.1

Use only genuine Saunders® spare parts to ensure optimum performance, reliability, and regulatory conformance.

Valve Body Temperature/Pressure Relationships 32

Temperature (°F)

68 104

140 176

212

248 284 320 356 261

16

232

14

203

12

174

10

145

8

116

6

87

4

58

2

29

0 -60

Maximum for valves: DN8 - DN50 (¼" - 2") EX Endurance Maximum for valves: DN65 - DN100 (2½" - 4")EX Endurance

0 -40

-20

0

20

40

60

80

100

120 140 160 180

Temperature (°C)

Please visit our Web-Based Drawing Library at: www.saundersdrawings.com for current database of drawings in PDF, 2D DWG, and 3D STP formats.

ERIKS bv I P.O. box 280 I 1800 BK Alkmaar I T +31 72 514 18 00 I F +31 72 515 56 45 I E valves@eriks.nl I www.eriks.nl

E-D-003-0

-4

CP-SAUNDERS-EX DIAPHRAGM-FE-EN-L15-0712-AF

-40

Line Pressure (PSI)

Line Pressure (bar)

-76 18

HC4 Top Works Manual Bonnets, Actuators & Accessories

The Saunders HC4 range of manual and actuated Top Works provides industry-leading features with ergonomic, compact design. Ease of operation and high temperature resistant materials (polymer and stainless steel) compliment a wide choice of modular options.

HC4 Manual Bonnets

Black PES Performance Bonnet

Black PES (Polyethersulphone) Perfomance Bonnet Designed for the most demanding applications and featuring PES, a high performance thermoplastic material with excellent chemical resistance, to ensure long life and high reliability.

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

The PES Performance Bonnet offers several key features: ■ High integrity, ergonomic handwheel.

Design ensures comfortable operation and precise control ■ Fully autoclavable to 140°C ■ ‘O’ Ring seal prevents both the escape of

product and the potential ingress of contaminates ■ Shrouded bonnet construction provides

maximum containment and diaphragm support for critical applications ■ Modular options available including

padlocking facility, proximity sensors, ‘V’ notch vent plugs and limit open stop version ■ Fully FDA conforming materials

of construction ■ Limit closing stop to provide process/flow

control option

Padlock Option The padlocking facility can be supplied to order or is available in kit form for retro-fitting to the bonnet sub-assembly or whole valve.

Limit open stop option Limit open stop bonnet to facilitate effective running of system under normal capacity.

Limit closing stop option A fully adjustable limit closing stop is fitted as standard to all ‘Performance’ bonnets. The limit closure stop is located under the handwheel and is adjusted by first removing the handwheel fixing screw and the handwheel assembly.

6

HC4 Top Works

Manual Bonnets, Actuators & Accessories

HC4 Manual Bonnet Assemblies

Polymer and Stainless Steel

The best all-round choice for your application

Stainless Steel Sealed Bonnet Assembly

The unique needs of the Clean Processing Industries have been considered in every aspect of design.

Our manual bonnet range incorporates:

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

■ 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

■ Thrust pad and 'O' rings apart,

completely constructed from stainless steel ensuring long life and providing the ultimate in security, reliability and corrosion resistance ■ Fully sealed, with a primary seal that provides

absolute containment for critical applications ■ Electropolished to meet both aesthetic and

Stainless Steel Bonnet Assembly

aseptic requirements ■ Operational at temperatures up to 160°C ■ Suitable for Steam-in-Place (SIP)

Constructed from materials which fulfil all FDA requirements, this bonnet offers the best possible levels of security, durability and corrosion resistance.

■ Available in size range DN15–DN80

White Epoxy Coated Bonnet

■ Represents a high

integrity solution for situations where coated or plastic bonnets would be unacceptable ■ Features smooth contours and an electropolished

surface to eliminate bug traps

This consistently popular bonnet is the economic solution for applications which do not require high temperature steam autoclaving.

■ Fully autoclavable up to 140°C to ensure ■ Suitable for washing

maximum levels of sterility ■ Supplied with PES (polyethersulphone)

handwheel to offer high temperature performance and excellent chemical resistance ■ Available in size range DN15–DN150 ■ Suitable for Steam-in-Place (SIP)

externally with semicorrosive fluids ■ Engineered in sizes DN15–DN100 with a white

epoxy coating ■ Features an easily cleaned surface, which is free

from pits or crevices ■ Suitable for Steam-in-Place (SIP)

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 providing containment of

process media ■ 4-Bolt design providing optimum sealing capability ■ Fully autoclavable up to 140°C

Compact Actuators that provide reliable remote control Saunders EC and SSC Pneumatic Actuators facilitate remote operation of the valve, either as a simple alternative to manual bonnet assemblies or as an integral part of the control system. Both are compact piston style actuators with excellent chemical and temperature resistance.

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

EC, SSC & ECX

SSC Actuator With the same flexibility as the EC Actuator, the SSC has been manufactured with a 316L stainless steel investment cast housing.

Suitable for a wide range of demanding applications the SSC provides excellent resistance to both chemical and steam duties.

➔

HC4 Pneumatic Valve Actuation

SSC Actuator Size range: DN8 – DN50

ECX Actuator EC Actuator

Field conversion of manual valves to power actuation can be readily achieved ‘in-line’ without special tools or modification.

ECX Actuator with visual indicator Size range: DN65 – DN150

EV & ES Modular

The EV and ES actuator range directly replaces manual bonnet assemblies and may be ordered as part of a whole valve or separately to convert a manual valve to automatic operation.

Installation may be carried out with the valve body in the pipeline.

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

Saunders EV and ES actuators are designed with close coupled bonnet assemblies and have complete flexibility of performance.

Several different actuator models may be provided for each valve size to suit different application requirements. The range allows valve closure against the maximum valve working pressures and can be successfully used for modulating control duties in addition to more normal isolation functions.

➔

Pneumatic Actuators for Larger Valves

EV Actuator Size range: DN15 – DN150

Many accessory options are available which include solenoid valves, remote indication devices (switches or sensors) to suit environmental conditions such as hazardous services. Limit stops and positioners and many other devices may be offered to allow usage within particular control systems. EV and ES actuators are provided with a tough epoxy coating which gives maximum durability, even in exposed locations.

➔

All three operation modes, double acting, spring to close and spring to open feature the same physical dimensions for a given valve size. This provides uniform compact envelope dimensions and outstanding economic benefits particularly for spring return failsafe actuation.

➔

EC Actuator mounted on a ZDT valve Size range: DN8 – DN50

Available in spring close, spring open and double acting modes of operation to suit process needs. A wide range of options including switches, positioners, limit stop and visual open/close indication are also available.

➔

➔

The EC is manufactured by injection moulding in PES (polyethersulphone), which has a temperature range of -10° to +100°C ambient (autoclave maximum 150°C). Actuators can be supplied as spring close, spring open or double acting with various spring pack options for a variety of pressure requirements.

Saunders ECX type actuators are designed to offer an extension to the EC size range whilst still maintaining the compact envelope size. The housing is manufactured in coated silicon aluminium for optimum chemical resistance and long life. With an extensive range of spring packs available we can offer an actuator to suit a wide range of pressure and flow variations.

ECX Actuator with Module Switchbox Size range: DN65 – DN150

ES Modular Size range: DN15 – DN200

HC4 Top Works

Manual Bonnets, Actuators & Accessories

HANDWHEEL

AIR FILTER

DN8-50

A, AFP

PES

✓ ✓ ✓

✗

✗

SSC DN8-50

A, AFP

316 C12

✓ ✓ ✓

✗

✓

SiAl Coated

✓ ✓

Overview MODEL SIZE RANGE

EC

STYLE

ECX DN65-150 A, AFP

MATERIAL

SOLENOID

POSITIONER

SWITCH BOX

Actuation Accessories

✓

✗

EV

DN15-150 A, AFP, KB SiAl Coated

✓ ✓ ✓ ✓

✗

✗

ES

DN15-200 A, AFP, KB SiAl Coated

✓ ✓ ✓ ✓ ✓

Opti-SET Suitable for EC and SSC actuators. It is a unique valve position monitoring unit designed for use with Saunders EC actuated diaphragm valve sizes DN8 to DN50. It provides quick and easy installation and commissioning, compactness and reliability. The Opti-SET unit automatically sets by stroking the actuator, significantly reducing installation cost and validation time.

✓ = Available ✗ = Not available Mini Positioner A

For control application on the EC and SSC the VIAPOS mini offers both pneumatic, electro-pneumatic and digital inputs with sensor feedback option and linear mounting design providing a compact control solution.

Providing precise control of the flow through the valve. This long life corrosion resistant range suits a wide variety of applications with reliability and accuracy. Available as pneumatic, electro pneumatic, intrinsically safe and explosion proof, together with a variety of feedback options.

Module Switchbox This highly modular switchbox option is available for EC/SSC & ECX actuator ranges. The switchbox offers a wide range of V3 mechanical and proximity sensors with space for up to 4 switch, integral solenoid valve & ASI* interface.

1

S

2

➔

ES Positioner

A wide range of locally mounted banjo solenoid valves can be fitted to the Saunders actuator range with a manual override option and various hazardous area classifications. The solenoid range is designed to cover all requirements.

Shown mounted to ES Actuator

➔

Solenoid Valves

Shown mounted to ES Actuator

EC & SSC Limit Open Stop The EC/SSC limit open stop can be supplied to order and offers a fully adjustable travel stop. With the removal of the plastic indicator the limit stop is easily accessible.

*ASI Interface can be retrofitted.

SSC Manual Over-Ride

007 Switchbox

For extra security the SSC can be supplied with an emergency manual over-ride manufactured from stainless steel. Contact us for further information.

Manufactured from polyester coated aluminium. This switchbox is used for the ES and EV linear actuators. It has the capability for up to 4 switches and can incorporate internal solenoid valve and ASI system.

ERIKS bv I P.O. box 280 I 1800 BK Alkmaar I T +31 72 514 18 00 I F +31 72 515 56 45 I E valves@eriks.nl I www.eriks.nl

7

HC4 Quality Standards, Traceability & Validation Through continuous focus on quality, the Saunders brand offers the clean processing industries complete peace of mind. All international standards and conformances are rigidly adhered to throughout the HC4 product portfolio to assist the user in achieving secure, repeatable and reliable processing when using Saunders brand valves.

Quality Statements and Approvals The Complete Approach to Quality

Validation Documentation

■ Quality Management system registered to

ISO 9001:2000 standard in which our R & D and manufacturing process are optimised to maintain our product quality and service.

Saunders can supply the following validation documentation on request: ■ Certification of chemical composition

to EN 10204 for body material ■ Traceability certification for

diaphragm grade ■ Full validation manual (polymers) ■ Surface trace certification ■ USP Class V and VI diaphragm

certification ■ FDA conformance certification for

all biopharm diaphragm grades ■ Certificate of conformity to order

specification ■ TUV AD2000 Merkblatt HPO and A4

Qualifications for our product manufacturing and certification.

■ ISO 9001:2000 certification ■ Certification of testing to BS 6755-1

■ CE marked products for compliance to

European Directive ATEX 94/9/EC for Group II, Categories 2 and 3 applications.

■ Certified compliance to the European Pressure

Equipment Directive 97/23/EC authorising Saunders to CE mark relevant valve products.

■ International product approval from

authorities such as Bureau Veritas, American Bureau of Shipping.

■ Polymer/Rubber materials certified as meeting

the requirements of FDA, 3A, WRAS and USP.

QA FDA USP ISO 9001:2000

Aseptic Product and Quality Approvals

HC4 Quality Standards, Traceability & Validation

HC4 Diaphragm Traceability & Validation 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 FDA validation and internal quality controls ■ All diaphragm grades certified ADCF (Animal

Derivative Component Free) ■ Physical property data is also available upon request

Saunders diaphragms offer enhanced performance with more confidence The integrity of the product and the quality of your process is assured. All extractables are fully identified and guaranteed to meet FDA limits. Access to all physical data is available upon written request.

Expert and independent verification

Validation support ■ Diaphragms conform to section 177,1550

(Perfluorocarbon resins) or 177.2600 (Rubber Articles) in Chapter 1 Title 21 of the FDA Regulations (revised 1st April 2001) USP Class V and VI. ■ Traceable to EN10204 3.1b (was DIN 50049 3.1b)

Saunders has worked with the Rubber and Plastics Research Association (RAPRA) to provide complete and detailed identification of extractables and leachables – leading the way and reaffirming our commitment to our customers and the industry.

Full traceability and product validation The Saunders valve range is acknowledged right across industry as being a leader in quality assurance techniques and design criteria for clean processes. The Saunders product, through its range of fully traceable diaphragms provides its users with valuable support in the validation process.

■ A unique moulded reference number gives precise

batch traceability ■ Access is available to all relevant physical data ■ Diaphragms that meet the most stringent validation

requirements ■ A certificate of the physical properties of each batch

is issued to ensure consistency and support validation on request ■ A profile of the complete physical data of each batch

is available to help trouble shooting ■ Complete documentation package is available for all

valve components in contact with the process fluids (EN 10204 3.1b certification).

Validation Pack includes: ■ Certificate of Traceability ■ Certificate of conformity FDA ■ USP Certificate

HC4 Diaphragm Traceability & Validation

Moulded and coined to provide optimum flex life

Less deformation for longer diaphragm life.

•

•

Proven manufacturing process •

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

•

Stud anchorage is fully encapsulated to ensure maximum strength and life rating of the diaphragm.

RUBBER BLEND Individual 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

Reinforcing material to ensure maximum strength in either positive or vacuum pressure duties.

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

1234/01

Blend No.

1235/01

1236/01

1237/01

Year

BOTTOM Size

Liner is cut to length for construction of diaphragm

DN8 1234/01

1237/01

425 TOP

Grade indentification TRACEABLE DIAPHRAGM

Top

Bottom

HC4 Quality Standards, Traceability & Validation

Diaphragms â&#x20AC;&#x201C; USP Approval, PTFE, EPDM and EPM Grades USP Approval Saunders aseptic range incorporates a full range of Elastomer and PTFE FDA conforming diaphragms that fulfil the rigorous requirements of USP Class V and VI accreditation which indicates that products are fit for medical use (implant or injectable).

ERIKS bv I P.O. box 280 I 1800 BK Alkmaar I T +31 72 514 18 00 I F +31 72 515 56 45 I E valves@eriks.nl I www.eriks.nl

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T +31 72 514 15 14 E info@eriks.nl www.eriks.nl

www.eriks.nl

ERIKS bv I P.O. box 280 I 1800 BK Alkmaar I T +31 72 514 18 00 I F +31 72 515 56 45 I E valves@eriks.nl I www.eriks.nl