data sheetdata sheet millipore express shf … developed to enhance buffer filtration millipore...

Data SheetData Sheet

High-flux hydrophilic PES sterilizing-grade •

membrane

Faster flow, up to 2.5 times faster than most other •

sterilizing grade membranes

Increased output without increasing filtration area•

Lower cost from improved process economics•

Optimized for buffer filtration which requires •

sterility assurance and high flow rates

Broad chemical compatibility across a wide pH •

range—NaOH compatible

Millipore Express® SHF Hydrophilic FiltersSterilizing-Grade PES membrane for fast,efficient, economical buffer filtration

MilliporeExpressSHF(SterileHigh-Flux)devicesarethe

choiceforoptimalbufferfiltration.Asterilizinggrade,0.2μm

hydrophilicpolyethersulfone(PES)membrane,Millipore

ExpressSHFfiltersprovidesterilityassurance,broad

chemicalcompatibility,andexceptionallyhighflowratesfor

buffersatthehighandlowrangeofpH,1–14.

ThehighflowrateoftheMilliporeExpressSHFmembrane

cutsyourfiltrationtimeinhalf,dramaticallyimproving

filtrationeconomicsandextendingproductioncapacity.The

membraneiscausticcompatibleandoffershigh-flux

performancewithafullrangeofbufferchemistries.Itslow

extractablesandnon-fiberreleasingpropertiescontributeto

cleanprocesses.WithMilliporeExpressSHFfilters,you

increaseproductivity,shortencycle-timeandreducecosts.

Superior Performance, Speed and ValueForbiotechandpharmaceuticalcustomersseekingfast,

efficientandeconomicalsterilebufferfiltration,noPES

membranedeliversmorethanMilliporeExpressSHF.

• Fastfiltrationwithsterilityassurance

• Broadchemicalcompatibility—evenathighpH

• Lowfiltrationcosts—reducedup-frontfilterand

overallfiltrationcosts.

Membrane Types

•MilliporeExpressSHF

PESmembranes

Filter Formats

OptiScale®small-scale

disposablecapsulefilters

Opticap®XLandXLTdisposable

capsulefilters–autoclavable,

sterileandgammacompatible

Cartridgefilters

2

Developed to Enhance Buffer FiltrationMilliporeExpressSHFfiltersuseafastflowingprocess

membranespecificallydevelopedforthefiltrationof

buffers,pHadjustersandotheraqueousintermediate

pharmaceuticalandbiotechprocesssolutions.Designedto

offerhigh-fluxperformanceandimprovedeconomics,

MilliporeExpressSHFmembraneiscompatiblewithawide

rangeofbufferchemistries,includingacidsandsodium

hydroxide.

More than Twice as FastMilliporeExpressSHFfiltershaveflowratesthatareupto

twototwo-and-a-halftimesfasterthanothersterilizing

grademembranesforlowerfiltrationcostsandincreased

productioncapacity.Yougetfastflowingfilterswithbroad

chemicalcompatibility,especiallyatthehighpHofcaustic

andbuffersolutions.

Reduced Surface Area and Lower CostsBecauseMilliporeExpressSHFfiltersfeatureflowrates

fasterthanmostothermembranes,youcanmaintain

batchvolumewhilereducingfiltrationsurfacearea.This

high-fluxbenefithasbeenshowntodelivergreaterthan

50percentsavingsinfiltrationcosts,improvingyour

processeconomics.

Reduced Process Time and Extended CapacityMilliporeExpressSHFfiltersareidealformaximizingthe

capacityofconstrainedbufferfiltrationsystems.Withits

superiorflux,youcanreduceprocessingtimebyhalf,

doublingyouroutputwithoutsignificantcapitalexpense.

Reliable PerformanceMilliporeExpressSHFmembranedeliversallthebenefitsyou’d

expectfromaqualityMilliporemembrane.Reliablesterilizing

performance.Multiplesteam-in-placeorautoclavesterilization

cycles.Broadchemicalcompatibility.Easyintegritytesting.

Andfastflowtohelpyoufillyourbufferfiltrationtank

quickly—nowwiththeaddedbenefitsofimprovingefficiency

andeconomics.

Regulatory ComplianceMilliporeExpressSHFfiltersaredesigned,developedand

manufacturedinaccordancewithaQualityManagement

Systemapprovedbyanaccreditedregisteringbodyofan

ISO®9000QualitySystemsStandard.Eachdeviceisshipped

withaCertificateofQuality.Allcartridgefiltersare100%

integritytestedduringmanufactureandsupportedbya

ValidationGuideforcompliancewithregulatoryrequirements.

Fortraceabilityandeasyidentification,eachfilterisidentified

withproductnameandothercharacteristics.

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0.0

Millipore Express SHF CartridgeCompetitive Cartridge A

Competitive Cartridge B

25

20

15

10

5

0Flow

Rat

e (m

L/m

in– c

m2)

at 1

0 p

si D

iffe

rent

ial

Water(n=10)

150 mMPhosphate-bufferedsaline

25%Propyleneglycol*

0.1 MAceticacid

1.0 MSodiumhydroxide

0.15 NHydrochloricacid

*Includes 0.2 M Arginine-HCl, 0.5 M Sodium Phosphate

Millipore Express SHF MembraneCompetitor A

Competitor B1

Competitor B2

SuPERioR FLux

RelativeWaterPermeabilityof10-inchCartridges

MilliporeExpressSHFMembraneFluxRelativetoCompetitors(n=2)

3

SecondaryClarification

SterileVent

Fermentation

Primary Clarification

Protein AColumn

MembraneAbsorber

Final SterileFiltration

Filling

BufferFiltration

Buffer Filtration

Low pH NeutralizingBuffer Filtration

BufferFiltration

Buffer Filtration Buffer Filtration

DiafiltrationBuffer Filtration

ColumnProtection

ColumnProtection

Buffer Filtration

BufferFiltration

Concentration(optional) Column

ProtectionVirus

Inactivation

Concentrationand Purification(optional)

PurificationColumn

Polishing Column(optional)

Concentrationand PurificationViral

Clearance


Millipore Express SHF Filters for All Your Buffer Filtration Needs

Typical Monoclonal Antibody Production Process

FinalSterile

Filtration

Clarification

Chromatography

ChromatographyUltrafiltration

ViralClearance

Prefilter

Buffer Filtration

Buffer Filtration

Buffer FiltrationSolvent Detergents


Plasma

Cryoprecipitation

Typical IgG Production Process

4

optiScale Process Development Screening ToolOptiScaledisposablecapsulefilters

provideaconvenientsmall-volume

optionforprocessscreeningand

scaling.These“dropin”filtersare

idealforevaluating

biopharmaceuticals.OptiScalecapsule

filtersofferspeed-to-market

strategiesforefficientlydeveloping

compoundsandbiotherapeutics.

TheOptiScalecapsuleisideally

suitedforprocessdevelopmentand

screening.OptiScalecapsulesare

fasterandeasiertoset-upthan

conventional47mmdiscs,and

completelydisposable.

Cartridge FiltersMilliporeExpressSHF5-10-,20-,and

30-inchcartridgefiltersprovidevery

highflowrates.Cartridgesarerobust,

strong,resilientanddesignedto

withstandmultiplesteam-in-place

cycles.Eachcartridgeisintegrity

testedduringmanufacturing.

Code0andcode7O-ringadaptors

areavailabletosuityourapplication

andhousingneeds.

From process development to full-scale production, Millipore has the right solution for all of your process needs.

OptiScaleFilters CartridgeFilters

5

opticap xL and xLT Disposable Capsule Filters

The Right SizeOpticapXLT10,20and30capsules

areavailabletofitallofyour

applicationneedsandtoalloweasy

scale-upofyoursmallvolumefiltration

stepstolarger,full-scalefiltration

processes.

The Right ConnectionsDesignedtooptimizeyourfiltration

process,OpticapXLandXLTdisposable

capsulefiltersareavailablewitha

choiceofinletandoutletconnections,

includingsanitaryflanges,fractional

sanitaryflangesaswellashosebarbs.

Proven integrityEachcapsuleisintegritytestedduring

themanufacturingprocesstoensure

reliableperformanceinyourprocess.

Convenient and Easy to useOpticapXLandXLTcapsulefilters

eliminatethetimeandexpense

associated

with

assembling,

cleaning,and

validating

stainless

steel

housings.

Adjustable,easy-to-turn,upstream

ventsanddrainvalveswithO-ring

sealsandhosebarbconnectionsallow

foreasyprocesscontrol.Other

ease-of-usefeaturesincludeflow

directionarrowsandribbedhousing

foreasygrippingevenwithgloved

hands.

Robust ConstructionOpticapXLandXLT’scapsuledesign

allowsunparalleledhydraulicstress

resistanceinadisposablefilter.

opticap xL 3, 5 and 10 Capsule FiltersOpticapXLdisposablecapsulefilters

haveauniquedesigntominimize

hold-upvolumeandreduce

productionlosses.

opticap xLT 10, 20 and 30 Capsule FiltersOpticapXLTdisposableT-line

capsulefiltersareavailablewithor

withoutapressuregaugeportfor

easeinmonitoringprocessconditions.

TheT-linedesignaccommodates

seriesorparallelfiltrationtomatch

yourapplicationneeds,anda

specially-designedstandenablesquick

andeasyintegrationintoyourexisting

process.

OpticapXLFilters OpticapXLTFilters

OpticapXLTCapsuleStand

6

SPECiFiCATioNS Cartridge Filters and optiScale Disposable Capsules

OptiScale Capsules Cartridge Filters Per 10-inch Filter 5-inch

Nominal Dimensions Diameter: 69mm(2.75in.) 6.9cm(2.7in.) 6.9cm(2.7in.) Length: 82mm(3.24in.)withflangeinlet/hosebarboutlet 12.5cm(5in.) 25.4cm(10in.) 74mm(2.91in.)withflangeinlet/flangeoutlet 94mm(3.70in.)withhosebarbinlet/hosebarboutlet Weight 67g(2.3oz) —

Filtration Area 17.7cm2 0.29m2(3.1ft2) 0.54m2(5.8ft2)

Materials of Construction Filtermembrane: Hydrophilicpolyethersulfone Hydrophilicpolyethersulfone Filmedge: — Polypropylene Supports: Polypropylene Polypropylene Cageandendcaps: Polycarbonate Polypropylene Core: Polycarbonate Polysulfone Structuralcomponents: Polycarbonate — Ventcap: Polyvinylidenefluoride(PVDF) — O-rings: Fluorocarbonrubber Silicone,EPDMorfluorocarbonrubber

Housing Vent AdjustableventwithmaleluerandfemaleLuer-Lok® — connectionsoninletsideofthedevice

Maximum inlet Pressure 5516mbar(80psi)at25°C —

Maximum Differential Pressure Forward: — 6895mbar(100psi)at25°C 1700mbar(25psi)at80°C 340mbar(5psi)at135°C Reverse: — 2068mbar(30psi)at25°C 69mbar(1psi)at135°C

Bubble Point at 23 °C ≥4000mbar(58psi)airwithwater

Air Diffusion at 23 °C — Throughawaterwetmembraneat 2758mbar(40psi): ≤16.4cc/min.≤30cc/min.

Bacterial Retention — Quantitativeretentionof107CFU/cm2 Brevundimonas diminutaATCC® 19146perASTM®methodology

Bacterial Endotoxin — Aqueousextractioncontains<0.25EU/mLas determinedusingtheLimulusAmebocyteLysate (LAL)test.

ToC/Conductivity — AutoclavedcartridgesmeettheWFI requirementsofUSP<643>forTotalOrganic CarbonandUSP<645>forWater ConductivityafteraWFIwaterflushof: 5.5 L at 25 °C 10 L at 25 °Coxidizable Substances EffluentmeetstheUSPOxidizableSubstanceTest EffluentmeetstheUSPOxidizable requirementsforsterilepurifiedwateraftera SubstanceTestrequirementsforsterile waterflushof≤100mL. purifiedwaterafterawaterflushof: 1000mL.

Sterilization Maybeautoclavedfor3cyclesof60minat126°C. Autoclave:Maybeautoclaved25x,60min cyclesat126°C In-lineSteam: 25x(forward),30mincyclesat135°C,or 22x(forward)and3x(reverse),30mincycles at135°C

uSP Toxicity — Non-toxicperMEMelutionISO®10993-5.

Particle Shedding — PassesUSPtestforparticulatesin injectables.

Non-fiber Releasing MilliporeExpressSHFmembranemeetscriteriafora“nonfiberreleasing”filterasdefinedin21CFR210.3(b)(6).

Component Material Toxicity ComponentmaterialsweretestedandmeetthecriteriaoftheUSP<88>ReactivityTestforClass VIplastics.MilliporeExpressSHFfiltersmeettherequirementsoftheUSP<88>SafetyTest,utilizing a0.9%sodiumchlorideextraction.

indirect Food Additive AllcomponentmaterialsmeettheFDAIndirectFoodAdditiverequirementscitedin21CFR177–182.

Good Manufacturing Practice TheseproductsaremanufacturedinafacilitywhichadherestoFDAGoodManufacturingPractices.

7

SPECiFiCATioNS opticap xL and xLT Disposable Capsules (Autoclavable)

opticap xL 3 opticap xL 5 opticap xL 10 opticap xLT 10 opticap xLT 20 opticap xLT 30

Nominal Dimensions

Maximumlength: 17.3cm(6.8in.) 21.6cm(8.5in.) 33.5cm(13.2in.) 37.6cm(14.8in.) 62.5cm(24.6in.) 87.1cm(34.3in.)

Bodydiameter: 10.7cm(4.2in.) 10.7cm(4.2in.) 10.7cm(4.2in.) — — —

Fitting to Fitting

Sanitaryflangeto

sanitaryflange: — 15.2cm(6.0in.) 15.2cm(6.0in.) 15.2cm(6.0in.)

Sanitaryflangeto

hosebarb: — 17.5cm(6.9in.) 17.5cm(6.9in.) 17.5cm(6.9in.)

Hosebarbtohosebarb: — 19.8cm(7.8in.) 19.8cm(7.8in.) 19.8cm(7.8in.)

Filtration Area 0.16m2(1.7ft2) 0.29m2(3.1ft2) 0.54m2(5.8ft2) 0.54m2(5.8ft2) 1.08m2(11.6ft2) 1.62m2(17.4ft2)

Materials of Construction

Filtermembrane: Hydrophilicpolyethersulfone

Filmedge: Polypropylene

Supports: Polypropylene

Structuralcomponents1: Polypropylene

Core: Polysulfone

VentO-rings Silicone

Vent/Drain ¼in.hosebarbwithdoubleO-ringsealMaximum Differential

Pressure

Forward: 5516mbar(80psi)at25°C

6895mbar(100psi)intermittentat25°C

1034mbar(15psi)at80°C

Reverse: 2068mbar(30psi)intermittentat25°C

Bubble Pointat 23 °C ≥4000mbar(58psi)airwithwater

Air Diffusion at 23 °C Throughawaterwetmembraneat2758mbar(40psi):

≤9.1cc/min.≤16.4cc/min.≤30cc/min.≤30cc/min.≤60cc/min. ≤90cc/min.

Bacterial Retention Quantitativeretentionof107CFU/cm2Brevundimonas diminutaATCC®19146perASTM®methodology

Bacterial Endotoxin Aqueousextractioncontains<0.25EU/mLasdeterminedbytheLimulusAmebocyteLysate(LAL)Test(per10-inch

filter).

ToC/Conductivity AutoclavedfiltermeetstheWFIrequirementsofUSP<643>forTotalOrganicCarbonandUSP<645>for

WaterConductivityafteraWFIwaterflushof10Lat25°C(per10-inchfilter)

oxidizable Substances MeetstheUSPOxidizableSubstancesTestrequirementsforsterilepurifiedwaterafterawaterflushof:

≤1000mL ≤1000mL ≤1000mL ≤1000mL ≤2000mL ≤3000mL

Sterilization Maybeautoclavedfor3cyclesof60minutesat126°C.(Cannotbesteamsterilizedin-line).

Non-Fiber Releasing Componentmaterialsmeetcriteriafora“nonfiberreleasing”filterasdefinedin21CFR210.3(b)(6).

Component Material ComponentmaterialsweretestedandmeetthecriteriaoftheUSP<88>ReactivityTestforClassVIplastics.

Toxicity MilliporeExpressSHFfiltersmeettherequirementsoftheUSP<88>SafetyTest,utilizinga0.9%sodiumchloride

extraction.

uSP Toxicity Non-toxicperMEMElutionISO10993-5

Good Manufacturing TheseproductsaremanufacturedinafacilitywhichadherestoFDAGoodManufacturingPractices. Practices


1Cage,endcapsandcapsulehousing

8

TYPiCAL CLEAN WATER FLoW RATES

Cartridge Filters with Millipore Express SHF Hydrophilic Membrane

opticap xL and xLT Disposable Capsules (Autoclavable)

0 10

0

gpm

psid

20

18

16

14

12

10

8

6

4

2

0

1.4

1.2

1.0

0.8

0.6

0.4

0.2

080

5 10 15 20

20 30 40 50 60 70

5-inch Cartridge10-inch Cartridge20-inch Cartridge30-inch Cartridge

Flow Rate (L/min)

Pres

sure

Dro

p (b

ar)

0 20 40 60 80

0 5 10 15 20

gpm

psid

50

45

40

35

30

25

20

15

10

5

0

3.5

3.0

2.5

2.0

1.5

1.0

0.5

0.0

TTHHTBTH

Flow Rate (L/min)

Pres

sure

Dro

p (b

ar)

0 20 40 60 80

0 5 10 15 20

gpm

psid

40

35

30

25

20

15

10

5

0

3.0

2.5

2.0

1.5

1.0

0.5

0.0

TTHHTBTH

Flow Rate (L/min)

Pres

sure

Dro

p (b

ar)

Opticap XL 5 Capsule Filters with 0.2 μm Millipore Express SHF Membrane


Opticap XLT 10 Capsule Filters with 0.2 μm Millipore Express SHF Membrane




Opticap XL Capsule Legends Refer to Connection TypeTT=38mm(1½in.)SanitaryFlangeInletandOutletHH=14mm(9/16in.)HoseBarbInletandOutlet

TH=38mm(1½in.)SanitaryFlangeInletand 14mm(9/16in.)HoseBarbOutlet

TB=38mm(1½in.)SanitaryFlangeInletand 25mm(1in.)HoseBarbOutlet

Opticap XLT Capsule Legends Refer to Connection TypeTT=38mm(1½in.)SanitaryFlangeInletandOutletTH=38mm(1½in.)SanitaryFlangeInletand 16mm(5/8in.)HoseBarbOutletHH=16mm(5/8in.)HoseBarbInletandOutletBB=25mm(1in.)HoseBarbInletandOutlet

TB=38mm(1½in.)SanitaryFlangeInlet 25mm(1in.)HoseBarbOutlet

9

Opticap XL 150 Opticap XL 300 Opticap XL 600

Nominal Dimensions Maximumlength: 9.7cm(3.8in.) 11.9cm(4.7in.) 16.5cm(6.5in.) Bodydiameter: 5.6cm(2.2in.) 5.6cm(2.2in.) 5.6cm(2.2in.)

Fitting to Fitting Sanitaryflangeto Sanitaryflange: — — — Sanitaryflangeto hosebarb: — — — Hosebarbtohosebarb: — — —

Filtration Area 0.022m2(0.240ft2) 0.048m2(0.514ft2) 0.097m2(1.046ft2)

Materials of Construction Filter membrane: Hydrophilic polyethersulfone Film edge: — Supports: Polyethylene Structural components1: Gamma stable polypropylene Core: Polysulfone Vent O-rings2: SiliconeVent/Drain ¼in.hosebarbwithdoubleO-ringseal

Maximum inlet Pressure 6895mbar(100psi)intermittentat23°C 5515mbar(80psi)at23°C 2758mbar(40psi)at60°C 1035mbar(15psi)at80°C

Maximum Differential Pressure Forward: 6895mbar(100psi)intermittentat25°C 5515mbar(80psi)at25°C 1035mbar(15psi)at80°C Reverse: 2068mbar(30psi)intermittentat25°C

Bubble Pointat 23 °C ≥4000mbar(58psi)airwithwater Air Diffusion at 23 °C Throughawaterwetmembraneat2758mbar(40psi): ≤1.4cc/min.≤2.8cc/min.≤5.8cc/min.


Bacterial Endotoxin Aqueousextractioncontains<0.25EU/mLasdeterminedbytheLimulusAmebocyteLysate(LAL)Test

ToC/Conductivity at 25 °C GammaSterilizedfiltermeetstheWFIrequirementsofUSP<643>forTotalOrganicCarbonandUSP<645> forWaterConductivityafteraWFIwaterflushof: 2L 2.5L 3L

oxidizable Substances MeetstheUSPOxidizableSubstancesTestrequirementsforsterilepurifiedwaterafterawaterflushof: ≤1000mL ≤1000mL ≤1000mL

Sterilization Gammacompatible: Gammacompatibleto45kGy.Maybeautoclavedfor3cyclesof60minutesat123°C.(Cannotbesteam sterilizedin-line).Sterilecapsules: Maybeautoclavedfor3cyclesof60minutesat123°C.(Cannotbesteamsterilizedin-line.)

Sterility Sterilecapsules: MeetscurrentUSPandAAMIguidelinesforsterilityutilizingavalidatedsterilizationcycle.

uSP Toxicity Non-toxicperMEMelutionISO10993-5.

Particle Shedding Passes USP test for particulates in injectables.Non-Fiber Releasing MilliporeExpressSHFmembranemeetsthecriteriafora“non-fiberreleasing”filterasdefinedin21CFR 210.3(b)(6).

Component Material ComponentmaterialsweretestedandmeetthecriteriaoftheUSP<88>ReactivityTestforClassVIplastics.Toxicity MilliporeExpressSHFfiltersmeettherequirementsoftheUSP<88>SafetyTest,utilizinga0.9%sodium chlorideextraction.


Good Manufacturing TheseproductsaremanufacturedinafacilitywhichadherestoFDAGoodManufacturingPractices. Practices

1Cage,endcapsandcapsulehousing2EPDMandfluorocarbonO-ringsavailablebycustomorder

SPECiFiCATioNS opticap xL 150, 300 and 600 Disposable Capsules (Sterile and Gamma Compatible)

Filtersweretestedpostgammaradiationat25-65kGy

10


opticap xL and xLT Disposable Capsules (Sterile and Gamma Compatible*)

Opticap XL 150, 300 & 600 Capsule Connection Type FF=19mm(3/4in.)sanitaryflangeinletandoutlet

FH=19mm(3/4in.)hosebarbinletandand14mm(9/16in.)

hosebarboutlet

HH=14mm(9/16in.)hosebarbinletandoutlet

*Filtersweretestedpostgammaradiationat45-65kGyandautoclaveat123°Cfor60minutes.

Opticap XL 150 with 0.2 μm Millipore Express SHF Membrane



11

SPECiFiCATioNS opticap xL and xLT Disposable Capsules (Sterile and Gamma Compatible) opticap xL 3 opticap xL 5 opticap xL 10 opticap xLT 10 opticap xLT 20 opticap xLT 30Nominal Dimensions Maximumlength: 17.3cm(6.8in.) 21.6cm(8.5in.) 33.5cm(13.2in.) 37.6cm(14.8in.) 62.5cm(24.6in.) 87.1cm(34.3in.)

Bodydiameter: 10.7cm(4.2in.) 10.7cm(4.2in.) 10.7cm(4.2in.) — — —

Fitting to Fitting Sanitaryflangeto

sanitaryflange: — 15.2cm(6.0in.) 15.2cm(6.0in.) 15.2cm(6.0in.)

Sanitaryflangeto

hosebarb: — 17.5cm(6.9in.) 17.5cm(6.9in.) 17.5cm(6.9in.)

Hosebarbtohosebarb: — 19.8cm(7.8in.) 19.8cm(7.8in.) 19.8cm(7.8in.)

Filtration Area 0.17m2(1.8ft2) 0.31m2(3.3ft2) 0.57m2(6.1ft2) 0.57m2(6.1ft2) 1.14m2(12.3ft2) 1.71m2(18.4ft2)

Materials of Construction

Filtermembrane: Hydrophilicpolyethersulfone

Filmedge: Polyethylene

Supports: Polyester

Structuralcomponents1: Gammastablepolypropylene

Core: Polysulfone

VentO-rings Silicone

Vent/Drain ¼in.hosebarbwithdoubleO-ringseal

Maximum Differential Pressure

Forward: 5.5bar(80psi)at25°C

6.9bar(100psi)intermittentat25°C

1.0bar(15psi)at80°C

Reverse: 2.1bar(30psi)intermittentat25°C

Bubble Pointat 23 °C ≥4000mbar(58psi)airwithwater

Air Diffusion at 23 °C Throughawaterwetmembraneat2758mbar(40psi):

≤9.5cc/min.≤17.4cc/min.≤32.7cc/min.≤32.7cc/min.≤65.5cc/min.≤98.2cc/min.


Bacterial Endotoxin Aqueousextractioncontains<0.25EU/mLasdeterminedbytheLimulusAmebocyteLysate(LAL)Test.

ToC/Conductivity AutoclavedfiltermeetstheWFIrequirementsofUSP<643>forTotalOrganicCarbonandUSP<645>for

WaterConductivityafteraWFIwaterflushof11Lat25°C(per10-inchfilter).

oxidizable Substances MeetstheUSPOxidizableSubstancesTestrequirementsforsterilepurifiedwaterafterawaterflushof: >1000mL >1000mL ≤1500mL ≤1500mL ≤3000mL ≤4500mL

Sterilization

Gammacompatible: Gammacompatibleto45kGy.Maybeautoclavedfor3cyclesof60minutesat123°C.(Cannotbesteamsterilized

in-line.)

Sterilecapsules: Maybeautoclavedfor3cyclesof60minutesat123°C.(Cannotbesteamsterilizedin-line.)

Sterility Sterilecapsules: MeetscurrentUSPandAAMIguidelinesforsterilityutilizingavalidatedsterilizationcycle.

Non-Fiber Releasing Componentmaterialsmeetcriteriafora“nonfiberreleasing”filterasdefinedin21CFR210.3(b)(6).

Component Material ComponentmaterialsweretestedandmeetthecriteriaoftheUSP<88>ReactivityTestforClassVIplastics.

Toxicity MilliporeExpressSHFfiltersmeettherequirementsoftheUSP<88>SafetyTest,utilizinga0.9%sodiumchloride

extraction.

uSP Toxicity Non-toxicperMEMElutionISO10993-5

Good Manufacturing TheseproductsaremanufacturedinafacilitywhichadherestoFDAGoodManufacturingPractices.

Practices


1Cage,endcapsandcapsulehousingFiltersweretestedpostgammaradiationat25-45kGy

12


opticap xL and xLT Disposable Capsules (Sterile and Gamma Compatible)




Opticap XL 3 Capsule Filters with 0.2 μm Millipore Express SHF Mem-brane

Opticap XL 5 Capsule Filters with 0.2 μm Millipore Express SHF Mem-brane


TestingwiththeMilliporeExpressSHFfiltersacrossarangeofcommonlyusedbuffersandcleaningsolutions

(pH=1-14)showedanaveragepermeabilityof450litersperhourperpsiper10-inchcartridge.

Filter Sizing

13

K

OpticapXL Filter

Membrane Type

GEP=MilliporeExpressSHF

Connection Type FF = 19mm(3/4in.)sanitaryflangeinletandoutlet

FH = 19mm(3/4in.)hosebarbinletand 14mm(9/16in.)hosebarboutletHH= 14mm(9/16in.)hosebarbinletandoutlet

opticap xL 150/300/600 Filters

Capsule Size015=OpticapXL150

003=OpticapXL300

006=OpticapXL600

Quantity per pkg.

1=1/pack

XL150

gamma

compatible

only

3=3/pack

Sterilization

G=GammaCompatible

S=Sterile

G E P

14

oRDERiNG iNFoRMATioN

C

CartridgeFilter

Membrane Type


Thermoplastic

T

Cartridge Filters

Cartridge Code0=(2-222)O-ring

7=(2-226)O-ringw/lockingtabspear

Cartridge Length5=5-inch(Code7only)

1=10-inch

2=20-inch

3=30-inch

Quantity per pkg.

1=1/pack

3=3/pack

O-ring Material

P=Silicone

E=EPDM

F=Fluorocarbonrubber

G E P

S

OptiScaleCapsuleFilter

Membrane Type


Connection TypeHH= 6mm(¼in.)hosebarbinletandoutlet

FF = 19mm(¾in.)sanitaryflangeinletandoutlet

FH = 19mm(¾in.)sanitaryflangeinletand 6mm(¼in.)hosebarboutlet

A 4 7

optiScale Filters

May beautoclaved

Membrane Disc Size (mm)

3

Quantity per pkg.

3=3/pack

G E P

K

OpticapXL Filter

Membrane Type


Connection Type TT = 38mm(1½in.)sanitaryflangeinletandoutlet

HH= 14mm(9/16in.)hosebarbinletandoutlet

TH = 38mm(1½in.)sanitaryflangeinletand 14mm(9/16in.)hosebarboutlet

TB = 38mm(1½in.)sanitaryflangeinletand 25mm(1in.)hosebarboutlet

opticap xL Filters

Capsule Size03=OpticapXL3

05=OpticapXL5

10=OpticapXL10

Quantity per pkg.

1=1/pack

3=3/pack (XL3only)

Sterilization

A=Autoclavable

G=GammaCompatible

S=Sterile

G E P

15

OpticapXLT filter

Membrane Type


T-line Capsulewithout Gauge Port

opticap xLT Filters

SterilizationA=Autoclavable

G=GammaCompatible

S=Sterile

Capsule Size1=OpticapXLT10

2=OpticapXLT20

3=OpticapXLT30

Quantity per pkg.

1=1/pack

Connection TypeTT = 38mm(1½in.)sanitaryflangeinletand outlet

TH = 38mm(1½in.)sanitaryflangeinletand 16mm(5/8in.)hosebarboutlet

HH= 16mm(5/8in.)hosebarbinletandoutlet

BB = 25mm(1in.)hosebarbinletandoutlet

TB = 38mm(1½in.)sanitaryflangeinletand 25mm(1in.)hosebarboutlet

E PGk t 1

oRDERiNG iNFoRMATioN

16

www.ictsl.net

To PLACE AN oRDER oR RECEiVE TECHNiCAL ASSiSTANCEForadditionalinformationcallyournearestMilliporeoffice:

IntheU.S.andCanada,calltoll-free1-800-MILLIPORE (1-800-645-5476)

IntheU.S.,CanadaandPuertoRico,faxordersto1-800-MILLIFX (1-800-645-5439)

OutsideofNorthAmericacontactyourlocaloffice.

Tofindtheofficenearestyou:www.ictsl.net/localizacion

Internet:www.ictsl.net

TechnicalService:[email protected]

Millipore, Millipore Express, Opticap, OptiScale, and Mobius are registered trademarks of Millipore Corporation.the M mark and Advancing Life Science together are trademarks of Millipore Corporation.ISO is a registered trademark of the International Organization for Standardization.AStM is a registered trademark of the American Society of testing and Materials.AtCC is a registered trademark of American type Culture Collection.Luer-Lok is a registered trademark of Becton, Dickinson and Company.Lit. No. DS1426EN00 Rev. E Printed in U.S.A. 05/08 BP GEN-08-00301© 2008 Millipore Corporation, Billerica, MA 01821 U.S.A. All rights reserved.

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MilliporeExpressSHFhydrophilicfiltersarepartoftheMobius

integrated,disposablebioprocesssolution.Nomatterwhatyour

applicationsteporscale,Mobiuscanhelpyouachievegreater

processefficiencyandproductivitywiththerightcombinationof

single-useproducts,applicationsolutions,andexpertvalidation

support.FromdisposableprocesscontainerstoMilliporepatented

capsulefiltersandconnectors,tovalidated,gamma-compatible

turnkeyassemblies,Mobiussolutionsprovidefasterturnaround

timeandreliableperformance,rightoutofthebox.

data sheetdata sheet millipore express shf … developed to enhance buffer filtration millipore...

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