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 perf o rm a n c ecomponent within a diaphragm valve. The diaphragm forms both the diff e rential andatmospheric seal and isolates the topworksf rom the process media. As the innovator andleader in diaphragm valves, we continuouslydevelop our diaphragm technology and re m a i nthe only manufacturer to have front to backownership of all aspects of polymer re s e a rc hand development, diaphragm design and pro d u c t i o n .

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 perf o rmance, resistance toc o m p ression set, longevity and re g u l a t o ryc o n f o rmance. 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/Perf o rm a n c e

S a u n d e r s

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 pre s s u rerating and durability. PTFEfaced diaphragms are fittedwith a bayonet fitting toe n s u re reliable installationand maximum life rating.

PTFE diaphragm bayonet fixing

Rubber Diaphragms

The polymer material isbonded with a highs t rength wovenre i n f o rcement to ensuremaximum strength andd u r a b i l i t y.

Rubber diaphragm screw fixing

Diaphragm Construction

Saunders Type AFP Diaphragm ValvesDiaphragm Traceability and Va l i d a t i o n

Full traceability and product validation

The Saunders valve range is acknowledged righta c ross industry as being a leader in qualityassurance techniques and design criteria forb i o p h a rm processes. This has led the Saundersp roduct to be taken still one step furt h e r, andt h rough its range of fully traceable diaphragmsp rovides its valve users with uniquely valuables u p p o rt in the validation pro c e s s .

◆ 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:

C e rtificate of Tr a c e a b i l i t y

C e rtificate of conformity FDA

USP Cert i f i c a t e

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 Va l i d a t i o n

S a u n d e r s

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

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USP Approval

Saunders aseptic range now incorporates a fullrange of Elastomer and PTFE FDA conform i n gdiaphragms that fulfil the rigorous re q u i re m e n t sof 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 Processes

Saunders EPDM diaphragms

Ethylene propylene diene monomer (Grade 325) hasgood mechanical pro p e rties 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 C I P fluids, chlorinated caustic and dilute acids.

A p p roved 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

p rocess product is free fro mleachables and extractables.M a n u f a c t u red from EPDM(Ethylene Propylene DieneMonomer), the diaphragm issubjected to a post curingp rocess to enhance polymer

c ross-linking and reduce thelevel of extractables. Theresult is improved pro d u c tpurity with minimal or zero

contamination. Lasting longerthan conventionally pro d u c e delastomer diaphragms, the E5 EPDM also provides betterreliability and there f o re less

d i s ruption to your pro c e s s e s .

The E5 EPDM has more qualitya p p rovals 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 re v a l i d a t i o n .

The E5 EPDM has been specifically designed inconjunction with leading pharmaceutical m a n u f a c t u rers 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 A p p roval, EPDM and EPM Grades

D i a p h r a g m sPTFE Grades

S a u n d e r s

Less Deformation for Longer Diaphragm Life

The PTFE 214S diaphragm has been designedspecifically to improve performance in applicationsw h e re steam is present. It displays impro v e delastic modulus at high temperature, resulting inless movement due to the effects of cold and hotf l o w. Indeed, the increased resistance to cre e pand cold flow of the 214S grade at elevatedt e m p e r a t u res make the 214S diaphragm theoptimum choice for environments, which call fori n t e rmittent 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 import a n t l y,h o w e v e r, they are supplied with support i n gmaterial that will help you meet your re g u l a t o ryre q u i rements 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 pro c e s s .

Improved life rating

Users of diaphragm valves withinthe biopharm industry canachieve major pro c e s s i n gadvantages using the PTFE 214Sdiaphragm. An innovativef o rmulation means that it can stayin service up to four times longerthan conventional PTFEdiaphragms without deform a t i o n .The net result is less time spentroutinely replacing diaphragmsand, consequently, feweri n t e rruptions in process run time.

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

◆ Fully fluorinated carbon backbone

◆ Widest temperature range of any polymer

◆ Inert to corrosive chemicals, only attackedby molten alkali metals, fluorides ofchlorine or oxygen and free fluorine

◆ Low co-efficient of friction – good anti-stick properties

PTFE – % Deformation under pressure at 150°C after 100 hour loading

D i a p h r a g m sDiaphragm Design/Perf o rm a n c e

Te m p e r a t u re and pre s s u re are the major limitations of valve operating capability although there can be many other aspects of a process specification that could affect both valve and diaphragm life.It is there f o re essential with any valve selection to provide the fullest process and operating detailssuch as operating cycles, speed of temperature fluctuations, sterilising fluids, steam sterilisationt e m p e r a t u res or any other parameter that may be present.

The Saunders aseptic diaphragm range has the following temperature and pre s s u re characteristics: –

Type AFP – Maximum rated Working Pressure (bar)

-20° 214S/325 & 214/325 160°

-20° 214/425 & 214S/425 160°

-20° 214/300 & 214S/300 150°

-40º E3 140°

-40° E4 110°

-30° 300 130°

-40° 325 140°

-40° (500) GRADE 150°

Diaphragm Temperature Type AFP (°C)

Valve Body Temperature/Pressure Relationship

-60°C -40°C -20°C 0°C 20°C 40°C 60°C 80°C 100°C 120°C 140°C 160°C 180°C

16

14

12

10

8

6

4

2

MAXIMUM FOR VALVES DN8 -- DN50

TEMPERATURE

MAXIMUM FOR VALVES DN65 -- DN80AND PTFE (214) DIAPHRAGM

◆ Moulded and coinedto provide optimumflex performance.

◆ Reinforcing materialto ensure maximumstrength in eitherpositive or vacuumpressure duties.

◆ Optimum studanchorage, to providemaximum bondstrength andincreased life rating ofthe diaphragm.

-40º E5 140°

-40º 425 140°

DIAPHRAGM SIZE DN 8 10 15 20 25 40 50 65 80

PTFE – (214) 10 10 10 10 10 10 10 10 10All rubber types 16 16 16 16 16 16 16 10 10

QA

Quality Statements and Approvals

S a u n d e r s

Certified Quality from Crane Process Flow Technologies

The Complete Approach to Quality

Quality Management system re g i s t e red to ISO 9001 standard in which our R & D andmanufacturing process are optimised to maintainour product quality and serv i c e .

T U V-Merkblatt HPO Qualification for our pro d u c tmanufacturing and cert i f i c a t i o n .

C e rtified compliance to the European Pre s s u reEquipment Directive 97/23/EC authorisingSaunders to CE mark relevant valve pro d u c t s .

I n t e rnational product approval from authoritiessuch as Bureau Veritas, American Bureau ofS h i p p i n g .

Polymer/Rubber materials certified as meeting there q u i rements of FDA, 3A, WRAS and USP.

Validation Documentation

Saunders can supply the following validationdocumentation on re q u e s t :

◆ 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 biopharmdiaphragm grades

◆ Certificate of conformity to order specification

◆ ISO 9001 certification

◆ Certification of testing to BS 6755-1

QUALITY ASSURANCEAPPROVALS

BS EN ISO 9001

TÜV AD-MERKBLATTHPO

COMPLIANCE WITH FDA

TNO CERTIFICATION3A

cGMPUSP

FDA

USP

ISO 9001

Aseptic Product andQuality Approvals