sterilization & washing systems - icos...

Washing and Sterilization Equipment

high performance solutions to resolve complex sterilization and

washing challenges

Sterilization & washing systemsServing the pharma industry worldwide

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Extensive product rangeWith over 3000 installations worldwide, ICOS Pharma offers a wide portfolio including:• Innovativewashingequipment(MLandLBseries),customizingloadingracks

to customer needs.• Diversified,steamandETOsterilizationrange.• Innovativefullyautomatedclosureprocessingequipment.• Dryinganddepyrogenationovens.• Automationsystemstomaximizeproductivityandsafety.

Flexible solutions • Abilitytomeetthemostchallengingprocessingneeds.• Onlyusingbestprovenreadilyavailablecontrolsystemsandcomponents.

Experience and knowledge• Strongtrackrecordofestablishinglongtermglobalpartnerships.• Integratedin-houseoperationsfromincomingrawmaterialstoinstallation,

validation and technical support.• Fullycertifiedqualitysystemswithknowledgeofpharmaceutical

manufacturing standards

Global footprint• GlobalHQinItalywithregionalcustomersupportcentres inNorthAmericaandAsia.

• Networkoffactorytrainedagenciesinover100countriesworldwide.

Infection control solutionsfor the global Pharmaceutical industryLocatedinmodernfactoriesnearVeniceinItaly,ICOSPharma,memberofSteelcoGroup,isamajorglobalsupplierofinfectioncontrolequipmentandsolutionsforthelaboratory,pharmaceuticalandbiotechsectors.

ICOSPharma’ssuccessisdemonstratedbyitsstronggrowth,becomingthepartnerofchoiceformanyoftheworld’sleadingpharmaceuticalcompanieswhoappreciatethecompany’s:


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Quality engineering processICOS Pharma’s engineering experience encompasses knowledge and understanding to be able to satisfy the most stringent requests from clients.

Technicalconsulting,design,engineering,projectmanagement,aswellascommissioningandqualificationservicesofourequipmentisoffered,withcustomersappreciatingthecosteffectivehighperformancesolutions offered to resolve complex washing and sterilization challenges.

Ourrespectedengineeringexperienceinthelaboratory,pharmaceuticalandbiotechfieldsallowsustodevelopaprovenapproachthatprioritizesthepharmamanufacturingprocessandsafetybearinginmindlifecyclecostsoftheequipment.

Ourmethodicalapproachistofirstdevelopanin-depthunderstandingoftheprojectandtheproductgoalsinordertoofferthebestequipmentandsolutionfortheapplication.

CustomersarealwayswelcometovisitICOSPharmafactoriestoseedesignandmanufacturingmethodsandaudit our processes.

Quality system certificationInadditiontohavingacertifiedQualitySystemasperISO9001:2008(andISO13485forMedicalDivision),ourproductsaresubjecttorigorousqualitycontrolsystemsandinspection.

Thiscoupledwithcontinuouslytrainingourtechnicallyspecializedpersonnelensuresyoureceivebestinclassproduct solutions and support.

We constantly strive to improve on our high standards to enable us todeliveroptimalsolutionsforourpartnersinthepharmaindustry.

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Extensive customer support servicesICOS Pharma offers a comprehensive range of services to ensure the success of projectsateachimportantstepincluding:

• Processandworkflowdesign• Processequipmentdesignandmanufacture• AutomationandSCADA• Installation and commissioning • Trainingpackages,frombasictoin-depth• Validationanddocumentation:• cGMPcomplianceconsultancyandassessment• Trainingandassistanceifrequestedbypharmaceuticalcompaniesaswell

asregulatoryinspectorsonGMPrelatedtopics• Sparepartssupplyandfirstlineservicetraining• Fullycomprehensiveandpreventativemaintenancecontracts• Periodicvalidationandre-qualificationasrequired.

For all previously installed equipment ICOS Pharma can offer a range ofcustomizableservicepackagesandrevampingactivitiesifrequired.Customerservice excellence is ICOS Pharma’s commitment to our clients and a cornerstone ofoursuccesswithemergencyservicesupportifneededavailable,24hours,7daysaweek.

3D project layoutsICOSPharmaofferscomplete‘turnkey”solutionsforwashingandsterilizationprocessesinthepharmaceuticalsector,withtheabilitytoundertakeallstagesofaprojectfromconcepttodeliveringsolutions that exceed customer expectations.

ICOS Pharma’s extensive experience assists customers to increase processproductivityandqualitywithimprovedergonomicswhilstlimiting costs.

Design warrantyThankstothedesignandqualityofequipment,aswellasthereliabilityofthe components used, ICOS Pharma can offer extended warranties. Standard warrantyis10yearsonpressurevessels.ICOSPharmawarrantsallmaterialsandworkmanshiptobefreeofdefectsfor18monthsfromshipmentdate.ICOSPharma’spharmasterilizerdoorgasketdesigncarriesa4yearswarrantywithoutanylubricationrequired.

Onlythebestavailable“Non-Proprietary”componentssuchasvalvesaresourced.Componentsareselectedfortheirreliabilityandavailabilitytoreducerunning costs and down time.

ICOS Pharma can use customer preferred parts provided that these meet performanceandreliabilityrequirements.


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INTEGRATED ARCHITECTURES

PLC

Allen-BradleySiemens

SiemensSiemens

...

AB ABiFix

OP

HMI SCADA


PLC


SiemensSiemens

...

AB ABiFix

OP

HMI SCADA


PLC


SiemensSiemens

...

AB ABiFix

OP

HMI SCADA

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International standards:

ISA 88 Standard addressing batch process control

ISA 95 Enterprise-Control System Integration

IEC 61131 Programmable controllers

Integrated architectureICOS Pharma can install new equipment into an existing automation system through the adoption of a simple (HMI) or more sophisticated (SCADA) man-machine interface.

Completecustomizationofaccesslevelsisavailable(localordomainusers).

Incompliancewiththeindividualinternalpoliciesofeachcustomer,ICOSPharmaoffersremoteserviceaccessbyusingvirtualprivatenetworkstoensuretheconfidentialityandsafetyofalltransferreddata.

SaferemoteaccessusingUMTS/LTE/GPRSnetworkssolutionsarealsoavailable.

All ICOSPharmamachinesshare thesame interfacesystem:despitedifferent functionsof modeswitha logicalevolutionbasedgraphictointerfaceensureeasiertrainingandusebyoperators.

Control systemUser friendly control systems developed according to the latest GAMP and design for 21 CFR Part 11 available, sourced from the best available suppliers avoiding customized electronics.

ICOSPharmacanprovidesoftwaresourcecodes,allowingitscustomerstobecomeownersofthecontrolsystemofthemachine(“opensourcearchitecture”).

System platforms available include Siemens and Allen-Bradley which are easily integrated with those alreadyinstalledby pharmaceutical companies.The software is structured and commented in English to allowa betterunderstandingoffunctionality.MultiLanguagetoolfordevelopmentsoftwareisalsoavailable.

SoftwareisdevelopedincompliancewithcurrentcodingrulesandprogrammingandaccordingtostandardISA88,ISA95,IEC61131-3standard&GAMP5.

Thestructureisdesignedforstraightforwardvalidationbytheenduser.Toolstosimplifyvalidationarealsoavailable(validationwizard).

Telemodemcapabilitiesareavailableforallourcontrollersolutionsaswellasremotediagnosticcapabilities.

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Validation documentsUser safety, product quality and data integrity are core values.

EquipmentisdevelopedandvalidatedaccordingtothelatestGAMPandcGMPstandards.ICOSPharma“know-how”allowstheclient’stobenefitfromoptimalsolutionsfortheirindividualrequirements,inordertoperformeffectivelyandreproducibilitycleaning,sterilizationandvalidationofpharmaproductioncomponents.

A risk based approach to comply with regulatory requirements is fundamental in the development of our validation documentation. An extensive package is available to minimize on-site validation time.

ICOSPharmadocumentsincludebutarenotlimitedtothefollowing:

• HardwareDesignSpecification• FunctionalDesignSpecification• SoftwareDesignSpecification• P&ID(PipingandInstrumentationDiagram)• ComponentList• GeneralArrangementDrawing• ElectricalDrawings• QualityandProjectPlan• TraceabilityMatrix

ICOS Pharma is available to customize documentation packages accordingto customer standard requirements and to produce specific documents uponrequest.

Pre-validation of ICOS Pharma equipment ensures minimal project risk, lesstimeandcosttoqualifytheunitsonsite.


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V-Model for specification, installation, start up and qualifications

Verifies

Verifies

Verifies

perforMancequalification

operationalqualification

systeM Build

installationqualification

functional specification

user requireMents specification

design specification

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Acceptance Tests & on site activitiesFactory Acceptance Test and Site Acceptance Tests.

ICOSPharmaisavailableanytimetosupportcustomersduringallacceptanceonsiteincludingprocessdevelopmentandmapping.Allonsiteactivitiesundertakentopre-agreedwrittenprotocolsaccordingtoGDPandHSErequirements.

ICOSkeepsrecordsofthetechnicalfileofeachmachinetoenablefullaccess incaseofthirdparty inspectiontoverifycompliancewithdirectivesandregulationscurrentlyinforce.

ExpertiseinDesignQualityandHazopisavailabletocustomers.

Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) are provided instandardversionorcustomizedaccordingtothefinalscopeofsupply.

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SafetySafetyfeaturesandinterlocksaremandatoryrequirementsforasafeoperatingsystemandtomaintainrequiredquality.ICOSPharma’sergonomicallydesignedequipmentincludesappropriatealarmsandotherpersonnelprotectivedevices.

Compliance and guidelinesICOSPharmacomplieswithlatestInternationalrequirementsandguidelines,aswellaslocalstandardsasapplicable:

European Directives

2006/42/EC Safetyofmachinery

2004/108/ECandamendments Electromagneticcompatibility

2006/95/ECandamendments Low-voltagedevices

97/23/CE PressureEquipmentDirective-PED

ATEX94/9/CE Electricalequipmentforexplosiveatmospheres

European standards

EN12100-1 Safetyofmachinery.Basicconcepts,generalprinciplesfordesign. Part1:Basicterminology,methodology.

EN12100-2 Safetyofmachinery.Basicconcepts,generalprinciplesfordesign.

EN13857 Safetyofmachinery.Safetydistancestopreventhazardzonesbeingreachedbyupperandlowerlimbs.

EN349 Safetyofmachinery.Minimumgapstoavoidcrushingpartsofthehumanbody.

EN61000-6-2 EN61000-6-4

Electromagneticcompatibility(EMC).Genericstandard.Part6-2:Immunityforindustrialenvironment.Part6-4:EmissionStandardforindustrialenvironments(IEC61000-6-4,modified);GermanversionEN61000-6-4.

EN55011 Industrial,scientificandmedical(ISM)radio-frequencyequipment.

EN61000-4-2(IEC1000.4.2) EN61000-4-4(IEC1000.4.4)

Electromagneticcompatibility(EMC).Part4:Testingandmeasurementtechniques.Section2:Electrostaticdischargeimmunitytest.Section4:Electricalfasttransient/burstimmunitytest

AD2000 CalculationcodeharmonizedwithDirective97/23/EC

EN60204-1(IEC204.1) Safetyofmachinery.Electricalequipmentofmachines.Part1:Generalrequirement

ENISO11135 Specifiesrequirementsforthedevelopment,validationandroutinecontrolofanethyleneoxidesterilizationprocess

EN1422 SterilizersForMedicalPurposes.EthyleneOxideSterilizers.RequirementsAndTestMethods.

North American StandardsOSHA

NFPA

FDA

UL

whenapplicable:

ASME

Canadian Standards

CSA

CRN

Russian Standards

GOST

China Regulation

SELO

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Closure Processing Systems

Completely integrated all in one solution

LST/LTSeries

1010

Closures loading options:

• manual• automatic

Automatic unloading into:

• wheeledtanks• containers• sterilebags• sterilebagsthroughHPV

(hydrogenperoxidevapor)isolator

LST/LT SeriesClosure processing equipment

Chambervolume

from 40 litres / 1.4 cu.ft to 480 litres / 17 cu.ft

Usefulbasketsvolume(litres/cu.ft.)

40/1.480/2.8120/4.2180/6.4 240/8.5480/17

Field of applicationDesignedforthecompletetreatment of closure devices for pharmaceutical products such as: rubber stoppers, plastic stoppers, droppers, pistons, aluminium caps and other similar components.

• sterlization• drying• cooling

•washing• rinsing• siliconizing

Technicaldata,utilitiesconsumptions anddrawingsareavailableuponrequest

“Assured productivity and sterility”

Patent pending

Sterile continuity is the visionICOS Pharma aims at reducing manual contact to the minimum level.TheLST/LTseriesisidealforthetreatmentofclosuresforcontainersnormallyusedinthepharmaceuticalindustry,wherecontinuous sterility has to be maintainedbetweendifferentphases.

TheLSTSeriesofferswashing, rinsing, siliconizing, sterilizing, drying and cooling all in one solution and is compatiblewithdifferentloading/unloadingsystems,withtheabilitytointerfacewithvaporizedhydrogenperoxideisolator.

ICOSPharmaproducesa“Closure washer”version-LT series -whichonlyprovideswashing,rinsing,siliconizing,dryingandcooling phases.

Thankstoanextendedrangeofcapabilities,ICOSPharmanowoffers innovative customized stopper processor solutions for highlycost-effectiveprojects.


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Sterilizing quality processTheprocessconsistsofcombinedphasesandactionsdesignedtoprovidemaximumprocessflexibilityandefficiency.

Thechoiceoftimeandphasesuccessionallowstheusertoobtainthemostappropriatecycletomatchthecharacteristicsofthematerialtobeprocessed.

PRES

SURE

(BA

R)

2,5

2

1

0

-1

0

-1

PRESSURE STERILIZATION

STERILIZATION - DRYING - COOLING

non explosive mixtures 10% EO 90% CO2

PRES

SURE

(BA

R)

30%

2

100%

vacuum pulses sterilization drying cooling

WASHING - RINSE - SILICONIZING

CHA

MBE

R W

ATE

R %

WA

SHIN

G

1st R

INSE

2nd R

INSE

3rd R

INSE

SILI

CON

IZIN

G

VACUUM STERILIZATIONexplosive mixtures 90% EO 10% CO2

PRES

SURE

(BA

R)

Pharmaceutical Division

ICOS has a long experience in the treatment of closures for

containers normally used in the pharmaceutical industry.

This new range of ICOS equipment shows a series of innovative

features that satisfy the strict standards of the pharmaceutical

industry (FDA, cGMP, GAMP 5, etc.).

This range of machines is made up of two main categories:

CLOSURE WASHER TYPE “LT”: the “LT” operating process

consists of the washing, rinsing, siliconizing,

drying and cooling phases.

CLOSURE PROCESSOR TYPE “LST”: the “LST”

process, in addition to the washing, rinsing,

siliconizing, drying and cooling

phases also includes the sterilizing

phase. The complete process makes it

possible to eliminate needless

intermediate handling of the product

that may cause its contamination.

FIELD OF APPLICATION

These machines are designed forthe complete treatment of closure devicesfor pharmaceutical products such as: rubber stoppers,plastic stoppers, droppers, pistons, aluminium caps andother similar components.

LOADING SIDE - TYPE LST 20-40-80

LTLST

Series

PROCESS DATA

The process consists of combined phases and actions designed to

succession make it possible to obtain the most appropriate cycle for the characteristics of the material to be processed.

PHASES ACTIONS

loading of material through prearranged system

washing

drain rotation, water spraying

dripping rotation

1st rinse


dripping rotation

2nd rinse


dripping rotation

3rd rinse


dripping rotation

siliconizing


dripping rotation

sterilization steam at 121 °C

drying sterile air at max. 130 °C

cooling sterile air at 20 °C

product discharge in a clean environment by means of prearranged system

LT SERIES - WASHING, SILICONIZING AND DRYING MACHINES FOR PHARMACEUTICAL CLOSURES

LST SERIES - WASHING, SILICONIZING, STERILIZING AND DRYING MACHINES FORPHARMACEUTICAL CLOSURES

ICOS RESERVES THE RIGHT TO MAKE PRODUCT CHANGES WITHOUT PRIOR NOTIFICATION

TypeOverall dimensions (mm / inches) Number of

basketsUseful baskets

volume(litres / cu. ft.)

Total baskets volume

(litres / cu. ft.)Width Height LenghtLT 20 2000 / 78.5 2600 / 102 1020 / 40 2 20 / 0.7 60 / 2.1

LT 40 2200 / 86.5 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LT 80 2600 / 102 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LT 120 2600 / 102 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LT 180 2800 / 110 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LT 240 3000 / 118 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4





(litres / cu. ft.)Width Height LenghtLST 20 2400 / 94.5 2600 / 102 1020 / 40 2 20 / 0.7 60 / 2.1

LST 40 2600 / 102 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LST 80 2800 / 110 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LST 120 3000 / 118 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LST 180 3200 / 126 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LST 240 3400 / 134 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4

CLOSURE PROCESSINGEQUIPMENTCLOSURE PROCESSING EQUIPMENT

ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


TEMPO

PRES

SIO

NE

STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO

TIME

PRES

SURE

(BA

R)


LAVAGGIO - RISCIACQUO - SILICONATURA

ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


LTLST

Series

rev.

01/

12

www.icospharma.com

ICOS Pharma S.p.A. - Pharmaceutical DivisionVia E. Ellero, 15 - Zona Industriale - 33080 Cusano di Zoppola (PN) - ItalyPhone +39 0434 5772911 - Fax +39 0434 5772900 - e-mail: [email protected]

STERILIZATION PROCESS

TEM

PERA

TURE

50

100

150

200

250

CONTROL LIMITALARM LIMIT

LEL

HEATING STERILIZATION COOLING

DRYING PROCESS

TEMPERATURECONCENTRATION

PRES

SURE

(BA

R)

2,5

2

1

0

-1

0

-1




PRES

SURE

(BA

R)

30%

2

100%



CHA

MBE

R W

ATE

R %

WA

SHIN

G

1st R

INSE

2nd R

INSE

3rd R

INSE

SILI

CON

IZIN

G


PRES

SURE

(BA

R)






















LTLST

Series

PROCESS DATA



PHASES ACTIONS


washing


dripping rotation

1st rinse


dripping rotation

2nd rinse


dripping rotation

3rd rinse


dripping rotation

siliconizing


dripping rotation













LT 40 2200 / 86.5 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LT 80 2600 / 102 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LT 120 2600 / 102 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LT 180 2800 / 110 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LT 240 3000 / 118 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4






LST 40 2600 / 102 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LST 80 2800 / 110 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LST 120 3000 / 118 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LST 180 3200 / 126 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LST 240 3400 / 134 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4


ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


TEMPO

PRES

SIO

NE


TIME

PRES

SURE

(BA

R)



ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


LTLST

Series

rev.

01/

12

www.icospharma.com



TEM

PERA

TURE

50

100

150

200

250


LEL


DRYING PROCESS


Thecontrol systemmanagesthemachineanditsbasicparameters,suchastemperatures,F0,vacuum/pressure,timesandlevelcontrol,and other critical parameters.

Thecontrolsystemmonitors,records,andcontrolstheoperationoftheequipment.

Ethernetportsallowthedownloadingofdatatoalocalcomputerortoafutureplantdatacollectionsystem.

Loading of material throughprearrangedsystem

Washing rotation,fluidbed,detergent

overflow rotation, water diffuser

drain rotation,waterspraying

dripping rotation

3 Rinsing phases rotation,fluidbedoverflow rotation, water diffuserdrain rotation,watersprayingdripping rotationSiliconizing rotation,fluidbed,siliconedrain rotation,watersprayingdripping rotation

Sterilization steamat121°C

Drying sterileairwithHEPAfilters

Cooling sterileairwithHEPAfilters

Product discharge inasterileenvironmentbymeansofprearrangedsystem

Phases Actions

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“Assured productivity and sterility”

Advantages of ICOS Pharma technologyPhysicalseparationoftheloadintodifferentsubbatches(basket)withuniformcapacityoffersthefollowingadvantages:

capableofprocessingdifferent kinds of stoppers at the same time

elimination of the excessive accumulation of material during treatment phases

minimizing particle generation due to mechanical stress and effective endotoxin reduction

enhancedsurfaceexposuretoprocessfluids

optimization of the washing process, with effective endotoxin and particle reduction

uniform silicone distribution on individual stoppersandtheentirebatch

optimization of the CIP phase

moreefficientcycle

Customized cycle according to client requirements.

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“Advanced multitasking process”

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Samplepointsavailableforanalysis FIltersavailablefor recyclingphase

Constructions featuresThemachinebodyandjacketarecompletelymadeofAISI316Lstainless-steel.Themachinebodyisinsulatedwithceramic material and with an external cladding of stainless steel.

AISI316LstainlesssteelpipingisconnectedwithASMEtri-clampconnections.Theinnerpartofthechamber,thetubings,thebasketsandallpartsincontactwiththeproductarepolishedto≤0.5μm/20µ/in.

Allweldsarecontinuous,groundandprovidedwithasurfacefinishequaltotheleveloffinishoftheadjacentsurfacesjoinedbytheweldaccordingtoASMEBPErequirements.Gaskets,elastomers,sleeves,andotherinteriorsealingcomponentsareFDAapproved.

ElectricalPanelincompliancewithEU,ULand local standards as needed

Thestopperprocessorusesfluidbedwashingtechnology,poweredbyawaterrecirculationpump.Thissetsthemachineapartfromothermanufacturersbyproviding:

• Agentler and more effective washing action.

• No use of compressed air during the washing cycle.

• Therecirculationpumpalsoactsasanemulsifier of the silicone oil injected and precisely dosed into the recirculationpumploopsystem,allowingfortheuseofmuchlowerlevelsofsiliconeoilpercyclethanothersolutions,makingtheCIPWIPcyclemuchmoreeffective.

Equipmentisengineeredandmanufacturedtooptimize running costs, saving utility costs.

Highlyeffective drying systembyairpulsesandarotatingchambercanister.� �

LST/LT Series


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Chamber featuresEvendistributionofloadinseparatebasketsensuresbetterfinalresults.Washing by a simultaneous combination of basket rotation and fluid-bed actionisachievedbyarecirculationpumpandspraynozzles.It is designedforcontinuouseffectiveoperationwithoutexcessiveadjustmentorreplacementduetowear.

Thepossibilityto visually check line clearance simplifiestheverificationthatnostoppersareleftintheunitfrompreviouscycles.

Suspendedparticlesareskimmedoffbysideoverflowdrains.Appropriatesizedreliefvalvesareprovidedasrequiredforeachpressurizedcomponent.

Ten different loading and unloading solutions are offered.

No presence of sharp edges in order to prevent injuries to equipment operators or damaging of the closures.

Thechambercanbecompletely inspected through a loading door. Thebasketdoorshaveautomaticopening and closure.

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“Advanced multitasking process”

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Loading systemsAutomaticloadingisundertakenusinga:stopperstoragetankwithmixer,suctiontube,measuringtankwithsanitaryvalvesandaspirator.

ManualloadingiscarriedoutusingAISI304stainless-steelcontainersofthesamecapacityasthemachinebaskets.

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Unloading systemsPossibilitytointerfacetheunloadingdoorwithwheeled tanks, containers, sterile transfer bags and HPV (hydrogen peroxide vapor) isolator.

Unloadingdoorequippedwithasystemforinterfacingwithcleanarea(bio-sealframewith“FDAapprovedfacilities”).

Chamberdoorsmadeinaccordancewithrequirementsforsterileenvironments.

Semiautomatic unloading into containers (“standard” application) Unloadingissemi-automaticandundertakeninstainlesssteelcontainersprovidedwithalidofthesamecapacityasthemachinebasket. Theunloadingphaseisprotectedbyasterileairfloworiginatingfromtheinsideofthechamber.

Automatic unloading into wheeled containers with Alfa Beta valve Unloadingiscompletelyautomaticanditisachievedwithhermeticallysealedwheeledcontainersof100litercapacity;thecontainersarebuiltofAISI316Lstainlesssteelandareinternallysterilizable.

Semiautomatic unloading into Sterile bags UnloadingissemiautomaticanditisdischargedthroughsterilizedPVCbags.Thebagsaretreatedatthestainless-steelstationprovidedwithaheat-sealingsystemforsealingthePVCbags.Theunloadingphaseisprotectedbyasterileairlaminarflow.

Automatic unloading into clean pre-sterilized bags through HPV Isolator

UnloadingiscompletelyautomaticanditiscarriedoutthroughHPVIsolatorandtransferringintoalpha-betasterilizedbags.

Thecompletesystemincludes:• HPVisolatorwithalpha-betaport. • HPVgenerator. • ConveyorsystemfromCPEportandalpha-betaport. • Setofalpha-betabags(eachbagwiththesamecapacityaseachbasket oftheCPE–10littersofstoppers). • Transferringtrolleyforbags.

Patent pending

UnloadingiscompletelyautomaticandiscarriedoutthroughtheBiosafe® BiosteamSPorttransferringtheclosureintogamma-irradiatedBiosafe®Bags.

Thecompletesystemincludes:• Biosafe®BiosteamPortductedtotheclosureprocessingequipment.• Biosafe®110MonoleverPortductedtotheisolatorofthefillingmachine.• DisposableBiosafe®Bags.• TransferringtrolleyforBiosafe®Bagsfilledwithclosure.

Biosafe and Biosteam are registered trademarks of Sartorius Stedim Aseptics S.A.

Automatic unloading into Sartorius Stedim Biotech clean & pre-sterilized Biosafe® Bags through the Biosafe® Biosteam S Port

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LST/LT Series

AVSeries

Saturated Steam Sterilization

Versatile cGMP Steam Sterilizers

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TheAVSeriesoffersflexibility configuration and versatility.Theelectricalpanelcanbeintegratedorremotelyinstalled.

Field of applicationUsed for sterilizing steam safe materials such as: vials, bottles, glass items, fabric materials, sealed or vented containers, rubber parts, machine part and filters, etc.

Chambervolumefrom 195 litres / 7 cu.ft

to 10.000 litres / 353 cu.ft

roundorrectangularchambertechnical area

shared

technical area

left

technical area

right

Flexible layout options

in several different dimensions with configurableoptions

“SterilityAssurance”

Technicaldata,utilitiesconsumptionanddrawingsavailableuponrequest

Floororpitmountedsolutions

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AV SeriesSaturated steam sterilizersObtain the best resultsIn pharmaceutical production, the need to optimize sterilization processes is important to increase safety and productivity.

ICOSPharmaisabletoofferanextremelydiversifiedproductrangecapableofmeetingtherequirementsofthemostvariedapplicationsandsatisfythestrictstandardsofthepharmaceuticalindustry.

Duetoourinvestmentsintheresearchofinnovativesolutions,ICOS Pharma sterilizers are high performing, reliable and easy to use with excellent results.

ICOS Pharma offers a wide selection of saturated steam sterilizers toexceedindustrystandards,availableinsingleorpass-throughversions,withhinged(AVLSeries)orslidingdoors(AVSSeries).

Builttoaveryhighstandard,eachunitistailoredtothecustomer’sindividualspecifications.

Cartguidesareweldedintochamberfloor.


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hinged door left or right

Sterilizing quality process Thesterilizationcyclehasbeenspecificallydesignedtoreducetimeandenergyconsumption,improvingefficiencyandthroughput.

Thepreconditioningphaseatthebeginningofthecycleandthefractionalvacuumphaseattheendhavebeendevelopedtomaximizeperformanceandminimizecycletimeandenergyuse.

Eachsterilizercanbeequippedwithanycombinationofcycleswithcompleteflexibilitytocustomizeeachphaseanditsparameters.CyclesareeasilyrecalledfromtheHMIandareprotectedfromunauthorizedchangesbyamulti-levelpasswordsystem.

Thefollowingcyclesareavailabledependingonmachinespecification:

Thecontrol system manages the machineanditsbasicparameters,suchastemperature,F0andpressure;itenableseasyinterfacingwiththeoperatorandmakesthecustomizationofworkingcyclesandmaintenanceoperationspossible.

SoftwareusedbyICOSPharmaisaccordingtoGAMPguidelinesanddesignedfor21CFRPart11whererequired.

SCADAsystemavailableforcompleteintegration.

Service programs:

Vacuumleaktest

MachineSIP

Bowie&Dicktest

Automaticsterilizationofmachineandvacuumbrakefilter(SIP)

PredispositionforAutomaticintegritytestofvacuumbrakefilter(W.I.T.)

pit mounted orfloorloaded

vertical sliding down horizontal sliding left or right

“SterilityAssurance”

Working programs:

Fractionedvacuum

Rapidcoolingbyshowerandcounterpressure

Gravitypurgeandcounter-pressure

Rapidcoolingbyshowerandcounterpressure+sealtestbyvacuumcrush

Coolingbywaterinjectioninthejacketandcounter-pressure

Air+steammixtureandcounter-pressure

Tyndalization

Pharmacywithnaturalcooling

Slowheatingwithdryingbyslowvacuum

Dryingbyhotair

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Construction featuresInthestandardversion,thedoorsealisachievedbyapneumaticallypressurizedsiliconegasket;ensuringtheintegrityofthedoorinanyphaseofoperation.

Slidingdoorsaredrivenbyanelectromechanicalsystemmadeincompliancewiththerequirementsforcleanareasanditisequippedwithbio-sealorairtightseparation.

Doorsealsystemguaranteedfor4yearsoperationalusewithoutlubrication.

Safe applicationsTheunloadingdoorcanbeinterfacedwithaHPV(hydrogenperoxidevapor)generatorand/orisolationtechnologyorwithdedicatedsystemsaccordingtosterilerequirements.

Thesterilizingchamberisentirelycovered by a full jacket system in AISI 316 L of dimple welded type for fast heat transfer and to optimizechambertemperaturedistribution.

Single or twin air filters installed in parallel, capableofbeingsterilizedinplace.

AirdetectorfollowingEN285to detect the presence of air or non-condensable gases within pure steam.

AllpipingandportsincontactwiththechamberaremadeofAISI316L,areslopedandselfdraining.Allcomponentsareofsanitarytypewhereappropriate,includingclampfittings.

Thefrontloadingsideisfittedwith connection ports for validation testing.

Airtight or bio-seal separation.

Optimised for energy savings & low wastage. Draincoolingsystemavailabletocooldownalleffluents prior to discharge into drains.

isolationtechnologyHPVgenerator

Low maintenance with long life proven components.

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18

AMS/ASWSeries

Terminal Sterilization

Steam and air mixture & Superheated water shower sterilizers

2020

Versatile loading/unloading systems and automation

ICOS Pharma can provide a range of automated loading and unloading solutions includingintegrationwithroboticsystems.

Field of applicationUsedtosterilizeliquidsinsealedorheat-sensitivecontainerssuchas:bottles, ampoules, vials, semi-open containers, bags, blister packing, pre-filled syringes, pockets, contact lenses, LPV’s, etc, and also for the pasteurizationofproductslikeblood plasma.

Air-Steam or Superheated Water Process? Selectiondependsontheproductsthermallability,levelofdrynesstobereached,utilitiesavailableonsiteandrunningcosts.

Chambervolumefrom 830 litres / 29 cu.ft

to 25.000 litres / 883 cu.ft

Different options for differing needsICOS Pharma’s range autoclaves using air + steam or superheated water are for the terminal sterilization of injectablesolutions.

Bothmethodsofsterilizationavoidanydamageoftheprocessedliquidmaterialandtheircontainers,includingheatsensitive materials.

Thankstoaneffectiverecirculationofairorwater,uniformtemperatureismaintainedinthesterilizingchamber,duringall process phases.

Requiredpressurebalanceisachievedbyusingsterilecompressedairinthechamber.

inseveraldifferentchambersizes,configurationsandaccessoriestotailoreachunittoexactrequirements


Floororpitmountedsolutions

AMS/ASW SeriesSteam & air mixture Superheated water shower

“Sterility Assurance”


2121

Chamber Seal

High capacity pump

AMS SeriesThesterilizationprogramusinganair+steam mixture is appropriatefordifferenttypesofloads:bottles,ampoulesandvialsmadeinglassandplastic,multi-singlebags,pre-filledsysringes,contactlens,bloodbags.

Itisalsousedinmicrobiologicallaboratories,particularlyinthesterilization of sealed plastic containers.

Theprocessincludestheapplicationofcounterpressuretoavoidpermanent deformation of containers.

Anautomaticpressuresealingtypedoorgasketisavailableuponrequest.

Thissystemensuresthesealofthedoorinanyconditionofoperation.ICOSPharmaguaranteesthesedoorsealsforit4years.

ASW SeriesThesterilizationprogramusingsuperheated waterisusedmainlyforsterilizinglargecontainers,bottles,ampoulesandvialsmadeinglassandplastic,multi-singlebags,althoughitcanalsobeusedforothertypesofloads.

Theproductistreatedincounterpressure,inordertoavoiddeformingorbreakingthecontainers

TheASWSeriesoffersarapid,safeandeffectiveterminalsterilizationprocessforhigh product throughput.

Puresteamisusedinthechamberforheatingliquidsandover-pressurefilteredairisinjectedintochambertocompensatefortherisingtemperatureandpressure inside products.

Internalfansensureauniformtemperaturedistribution,between110°Cto135°C,andtoavoidcoldspotsacrossthechamber.

Rapidheatingandcoolingarestandardphases.Productsarecompletelydryattheendofthecycle.

TemperaturedistributionaccordingtoInternationalPharmacopeia.

Sterile compressed airWateriscontinuouslycirculatedthroughthesystemandcascadesovertheloadusingspraynozzles,highcapacitypumpandlargediameterpipingtoensurehighwaterflowrates.Therecirculatingwaterisheatedandcooledbyexternalheatexchangers.

Meticulouscontrolofheatingandsterilizationisachievedbysuperheatingthewater using modulated steam.

Compressedairatoverpressureisinjectedto compensate for the rising temperature

andpressurethatbuildsinsidetheproductswhenheated.Thecoolingphasebringstheproductdowntoambienttemperaturebycontinuouslysprayingtherecirculatingwaterover the load.

Toassistheatpenetrationandwhenfluidsareliabletoseparation,theloadcanberotatedduringthecompletecycle.

TemperaturedistributionaccordingtoInternational Pharmacopeia

“Sterility Assurance”

22

Construction featuresThemachinebodyandjacketarecompletelymadeofAISI316Lstainless-steel.Themachinebodyisinsulatedwithceramicmaterialandwithexternalcladdingstainlesssteel.PipingsincompliancewithASMEBPEmadeofAISI316Lstainlesssteelwithtri-clampfittingsandallmachinecomponentsofsanitarytype.

Theinnerpartofthechamber,thetubings,thebasketsandallpartsincontactwiththeproductarepolishedto≤0.5μm.

Thefrontloadingsidethemachineisprovidedwiththeconnectionportsrequiredforthevalidationtests.

Uniquesealingoffanshaftforeasyinspection and maintenance

Uniformityoftemperatureguaranteedbyrecirculationpumpaction

FlexibleRTDs

Energysavingswithrecirculationwatercoolingsystem

Useful combined solutionICOSPharmadesignscombined/modularsystemssterilization,whereheatingandsterilizationphasesarecarriedoutwithsaturatedsteam,likeanormalsterilizer,orwithamixtureofsteamandair in the same autoclave.

Recircutlationsystem

Equipmentisprovidedwithagroundinglug for proper static grounding and seismiccomplianceifrequired

ThecontrolsystemPLCiscapableofstoringandexecutingpreprogrammedcyclesandperformingallself-diagnosticscycles.

22

AGS/AGS-ESeries

Chemical Sterilization

Ethylene oxide media

24

“Optimal cycles”

24

Field of applicationUsed for low temperature sterilization ofheat-sensitiveproductsaccordingtotheEN1422Standardsforthemedicalprocessingindustrysuchas:plastic syringes, perfusion sets, dialysis cartridges, heat-sensitive rubber products and special surgical instruments.

Chambervolume

from 1000 litres / 35 cu.ft to 63.000 litres / 2.225 cu.ft

ICOSPharma’slatestrangeofsterilizingautoclavesusingEthyleneOxideincreasesperformanceandversatility.

ManufacturedinourfactoriesinItalyafteralongresearchprogramandanextensiveseriesoftests,theAGS/AGS-Eseriesisthe best relationship between engineering, quality, price, operating running costs and most important safety of the system and operators.

ICOSPharma’srangeofETOsterilizersusethermal combustion for a complete breakdown of the sterilizing gas.

Productivity and energy savingThenewrangehasbeendesignedforbestinclassenergyrecoveryinorderto optimize consumption.

Thevacuumsystemisprovidedwithawaterringpump,whichissuppliedwithwaterdrawnfromtheseparatorbycreatingaclosedcircuit.Thetemperatureismaintainedatoptimumlevelsbyaheatexchanger.Thepumpoutflowisdirectedtotheseparator,fromwhereitissenttotheneutralizingsystem.

Followingcustomerrequests,dedicatedchambersforseparateprocessescanbesupplied:

Conditioning chambers Sterilization chambersDegassing chambers

Availableinawiderangeofchambersizesandvolume.

Technicaldata,utilitiesconsumption anddrawingsavailableuponrequest

AGS/AGS-E SeriesEthylene oxide sterilization autoclave


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LT 40 2200 / 86.5 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LT 80 2600 / 102 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LT 120 2600 / 102 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LT 180 2800 / 110 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LT 240 3000 / 118 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4






LST 40 2600 / 102 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LST 80 2800 / 110 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LST 120 3000 / 118 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LST 180 3200 / 126 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LST 240 3400 / 134 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4


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LT 40 2200 / 86.5 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LT 80 2600 / 102 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LT 120 2600 / 102 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LT 180 2800 / 110 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LT 240 3000 / 118 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4






LST 40 2600 / 102 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LST 80 2800 / 110 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LST 120 3000 / 118 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LST 180 3200 / 126 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LST 240 3400 / 134 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4


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“Optimal cycles”

25

Quality details in every phase of the process TheETOgasisheatedthroughevaporators,beforebeingintroducedintothechamber.Loadmoistenedthroughtheinflow oflow-pressurecleansteamsuppliedbyasteamgenerator.

Theair,whichissuppliedintothechamberinthedegassingphase,isfilteredthroughabsolutefilterstoguaranteehigherquality.

Process dataPhases non explosive

mixturesexplosive mixtures

Heatingofloadwithhotwatercirculatingintheheatingjacketandalternatingvacuumphasesfollowedbytheinflowofhotair � �

Humidificationofload,withalternatingphasesofvacuumandsteaminflowatlowpressure � �

Sterilizationofloadbypressurizationofthechamberwiththegasmixture �

with preset steam pressure

Gasdischarge �byvacuum

pump

Inflowofinertgas �

Loaddegassingwithalternatingvacuumandhot-airinflowphasesfor a preset time � �

Sterilization temperature up to a max. of 60°C with temperature distribution of ± 1° C. The right sterilization temperature must be matched to the type of the material to be processed.

Process under optimized conditions

AGS series Pressure sterilization program

upto10%ofEthyleneOxide,withtheremaining90%madeofinertgas(normallyNitrogen)

AGS-E series Vacuumsterilizationprogram

upto90%ofEthyleneOxide,withtheresidual10%madeofinertgas(normallyNitrogen)

Effective and safe abatement of Ethylene Oxide at completion of sterilization process by thermal

combustion

26

Manufactured with the highest industrial standardsICOSPharma’srectangularcrosssectionsterilizationchamberiscompletelysurroundedbyahighefficiencyheatingjacketforrapidandevenheatingofloads.MachinebodyiscompletelymadeofAISI304stainless-steel,insulatedwithhighdensityceramicmaterial,andcladinstainlesssteelsheet.Thechamberandthehydraulicsystemarecompletelybuilt,andcladstainlesssteel.Panelsandsterilizationchamberaresatinfinished.

Processpipingismadetri-clampsandflangeconnections.Pneumaticcontrolofthevalvesisfitted.

26

Complete protection of the environmentAbatement of Ethylene Oxide at completion of sterilization process: increasinglystringentparametersmakeitnecessarytooffersafeacceptedabatementsystemsoneveryEthyleneOxidesterilizer.

ICOSPharmafollowstheATEX,US,OSHA,NFPAandFDAregulationsandcomplieswithISO11135,EN1422.

Design pressureThechamberisdimensionedtakingintoaccountthefollowingparameters:1,5bar+vacuumworkingpressure;2,7bar+vacuumdesign pressure.

Compliance and solutions ICOS Pharma has developed an automatic horizontal sliding door systemwithaheatedjacket,wheretheclosureofthedoorisassuredbyapneumaticallypressurizedgasketwitha4yearofwarranty.

Dedicatedtoautoclavesthatuseapotentiallyexplosivemixture,ICOSPharmahasspecificallydesignedasafehermeticclosureguaranteedbyapressure-sealingdevicewithautomatictie-rods.

Allsafetydevicesareincompliancewithinternationalstandardswithparameterscontinuouslymonitoredtoavoidtheriskofexplosion.

Machineprovidedwithnecessaryconnectionportsforvalidationtests.

Advanced solutions for special applications

Dry Heat Sterilizers

SD/EGSeries

28

“Drying without compromise”

hinged doorleft or right

pit mounted andfloorloaded

vertical sliding down horizontal slidingleft or right

28

Chambervolume

from 330 litres / 12 cu.ft to10.000 litres / 353 cu.ft

ICOSPharmadesignsandmanufacturesawiderangeofClass100staticdepyrogenationsterilizers(ISO14644-1class5)tomeetthemostchallengingpharmaceuticalrequirements.

Thedepyrogenationprocessisaimedatthereductioninthelevelofpyrogens,withtheuseofhotairintemperaturewhichrangefrom250°Cupto300°C.

ThehighperformanceClass100ovensolutionensuresanevendistributionofhotairfortheentirecycleincludinglargeloads,withtheinstalledHEPAfilterspreventingcrosscontamination.

Alargerangeofchambersandconfigurationsareavailable.


Complete layout versatilityAvailablewithachoiceofthreetypesofdoors:swing-out,horizontallyslidingandverticallysliding,withthegoaltoalwaysguarantee the door tightness, regardless of unit dimensions.

SD Series Class 100 static air depyrogenation sterilizers

Field of applicationUsed for the sterilization and depyrogenationofheatresistantmaterials such as: bottles, vials, glass containers, metal trays and production equipments such as stainless steel vessel etc.

Laboratory glassware and instruments, materials sensitive to humidity,thermostable basic pharmaceutical products and chemical compounds,nonaqueousliquidmaterialssuchusoils, glycerines, etc.


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LT 40 2200 / 86.5 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LT 80 2600 / 102 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LT 120 2600 / 102 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LT 180 2800 / 110 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LT 240 3000 / 118 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4






LST 40 2600 / 102 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LST 80 2800 / 110 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LST 120 3000 / 118 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LST 180 3200 / 126 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LST 240 3400 / 134 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4


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isolationtechnology


Inspection window in the front loading side

29

Drying quality processFullycompatiblewiththestrictstandardsofthepharmaceuticalindustry,theSDSeriesissuppliedwithHEPAfilters(99,99%efficiency)forfiltrationofpressurizedairflow(EU13),airrecyclingandexhaustchamberair(EU12).

TheHEPAfiltersabatethelevelofparticlecontaminationinthechamberalsoduring critical phases, such as heating and cooling.

Particular care is used to eliminate heat transmission points.

Speciallydesignedfilterretentionsystemtominimisethermalstress.

Thecontrol systemmanagesthemachineanditsbasicparameters,suchastemperature,Ft,Fhandpressures. WeguaranteeexcellentPIDcontroloftemperatureandchamberpressurethroughout all phases.

Adjustabletemperatureramp,sterilizationplateau,coolingtemperature,chamberpressure,coolingtimeareallavailable.

Water-basedcoolingsystem. Anaircooledsystemcanbe

suppliedonrequest.

Filtrationofairrecycling

Filtrationofchamberexhaustair FiltrationofpressurizedairflowthroughHEPAfiltersof99.99%efficiency(EU13).

Airheatedthroughsteamorelectric heating elements.

RTDPT100fortemperatureand pressure control.

SetflexibleforRTDsinthechamber.

Perfect compatibiltyTheSDseriesfeaturesconnectionportsonthefrontloadingsideforvalidationtesting.Machinesequippedwithspecialproductholdingtraysandhandlingtrolleys,canbealsointerfacedwiththeisolationtechnology.

30


30

TheSDSeriesisincompliancewiththefollowinglatestNormsandDirectives:

cGMP-GAMP-FDA-EN1822-ISO14644/1/2-CFR’sincluding21CFRparts,201,211andpart

11availableasoption-EUROVENT-TechnicalReports“ParenteralDrugAssociation”-2004/108/CE,2006/95/CE-plusotherlocalandinternationalstandardsasapplicable.

Construction featuresChamber,areaulicsystem,doorsandothermachinestructuralcomponentsaremadeofAISI316stainlesssteel. ChamberinsulatedwithhighdensityceramicinsulatingmaterialandcoveredexternallybyAISI316stainlesssteelpanel.

Uniformautomaticchamberpressureandtemperature control.

ChamberwithroundedinternalanglesandTIGweldedsmoothseams.

Insideofchamberpolishedto≤0.5μm.

Uniformairdistributionthroughdifferentiallyperforatedwalls,particularlysuitableforvariedloads.

Automaticpneumaticdoorlockingmechanism.

Hermeticallysealeddoorswithaspecialprofilesiliconegasketwithdoublesealingstrip.Gasketallows the formation of vacuum to guarantee perfectdoorsealduringeveryphaseofthecycle.

Systemdesignedtominimizecrosscontaminationrisk.

Chamberprovidedwithadoublebottomforeventemperaturedistribution.

Norms and standards


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LT 40 2200 / 86.5 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LT 80 2600 / 102 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LT 120 2600 / 102 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LT 180 2800 / 110 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LT 240 3000 / 118 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4






LST 40 2600 / 102 2600 / 102 1160 / 45.5 4 40 / 1.4 120 / 4.2

LST 80 2800 / 110 2600 / 102 1330 / 52 8 80 / 2.8 240 / 8.4

LST 120 3000 / 118 2600 / 102 1550 / 61 12 120 / 4.2 360 / 12.7

LST 180 3200 / 126 2800 / 110 1700 / 67 18 180 / 6.3 540 / 19

LST 240 3400 / 134 3000 / 118 1930 / 76 20 240 / 8.4 720 / 25.4


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Technicaldata,utilitiesconsumptionsanddrawingsavailableuponrequest.


31

Thehotairdryingovenscanbesuppliedwith a self washing systeminthechamberandadevicefortheremoval and insertion of tray support carts.

Uponrequestandforparticulartypesofapplications,theelectricalsystemandcomponentsofthemachinecanbesuppliedtobecompliant with flameproof type(ATEXregulation).

EG SeriesTray drying ovensfor granulates

Field of applicationThisrangeofmachinesisusedfordryingbyhotairofmaterialssuchasgranulates, pellets, powders and porous loadinpharmaceuticalindustryprocesses.

Special applicationForthetreatmentofgranuleswithpresenceofsolvents,thedryercanbeequippedtomonitorflammabilityhazardbycontrollingLEL.

StatictraydryingovensmanufacturedbyICOSPharmaaresomeofthemosttechnicallyadvancedmachinesinexistence.

Thankstoalong experience in hot air drying, these machines are designed for optimizing process parameters for effective, uniform and gentledrying.

Awiderangemachines,fullycompatiblewiththestrictstandardsofthepharmaceuticalindustry(FDA,cGMP,GAMP5,etc.)areoffered.

Provisionoftrayhandlingtrolleys,customizedtosuitenduserrequirements.

Chambervolume

from 330 litres / 11.5 cu.ft to 10.000 litres / 308.5 cu.ft

Main options

3232

Fast-closingswingoutdoorsandgasketsaremadeofsiliconerubber.

Floororpitmountedsolutions.

Documentation/ValidationComprehensiveoperatingandmaintenancemanualsandIQ/OQdocumentationisprovidedasstandard.ICOSPharmahelpsyoutominimizethetimeneededforvalidation,withdecreasedbreakdowns,increasedproductionandoperativelifetimeachieved.

Drying quality process TheEGSerieshasevenhotairdistributioninthechamber.Specialperforatedwallsandtemperaturecontrol,ensurethedryingqualityprocess.Themechanicalconstructionofthemachinebodyisdesignedtoresisttemperaturesofupto300°C. ExternalpanellingismadeofAISI316stainlesssteelwiththechamberhavingapolishedfinish.

Theunitisprovidedwithfiltersfortheinletandexhaustairflowsinthechamber. Steamandelectricheatedoptionsareavailablewithamaximumtemperatureof120°C.

ThemachinebodyandaeraulicsystemaremadeofAISI316stainlesssteel.

Thechamberhasarectangularcrosssectionandisfittedwitharectangularhatch.

Bin and cabinet washers Parts and glassware washers

LB Series & ML Series

LBandM

LSeries

34

��

�Highest cleaning performance

Continuous moving top spray arms

360° continuous bin rotating during operation

Drying unit with 1000 m3/hour capacity

34

LB SeriesBin washer system

LB Series is a system specifically designed for the cleaning and drying of containers and drums in pharmaceutical validated processes.

Custom made for individual customer needs, these units feature the possibility to rotate both the container beingcleaned and/or the spray nozzle arm 360° inside the objectensuring exceptional cleaning of all surfaces of the container.

Chambervolumefrom 5.000 litres / 177 cu.ft to 10.000 litres / 353 cu.ft


Bins,drums,tanks,IBV,IBC

Field of application

Construction features


35

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ML Seriesparts and glassware washers

Construction features

Chambervolume

from 465 litres / 16 cu.ft to 3800 litres / 134 cu.ft

Compact footprint & hinged door washerThismachineofferspre-washing,washing,rinsing,dryingandcoolingphaseswithoptimalperformanceinacompact size and footprint solution.

Hingedtypechamberdoorswithsingleordoubledooranddoublelockingdevicemadeinaccordancewithrequirementsforcleanenvironments.

UseofFDAapprovedcomponents(valves,filters,piping,tri-clampfittings,pumps,etc.).Useof316Lstainlesssteelwithroughnesslessthan0.5μm(20microinches)onallcomponentsinprocesscontact(machinebody,machinedoors,spraynozzlesbars,processpiping,instruments,valves,racks,internalcarts,baskets,etc.).

DryingbyHEPAfilteredhotairatmax.130°C.

Lowrunningandlifecyclecosts.

Machinesaredesignedforpharmaceuticalproductssuch as glassware, pipettes, machine parts, tanks, glass bottles, pill stamps, carboys, tubes, needles, etc.

Orbital welding on all piping with tri-clamp fittings.

Respecting 3-D dead legs with the application of Zero-Static (0-Dead legs) components.

3 degree slope on process piping.

All internal corners of the chamber have radiuses as per cGMP requirement.

No. 3 Water supply of “pharma” type with last rinsing water sprayed directly onto spray nozzles/load.


Customizedandengineeredloadingequipment:racks/cartsandbaskets.

Adjustableheighttransporttrolleys.Possibilityofinterfacing unloading door with isolator.

Field of application


memberof

Products offered for sale may differ from those described or illustrated in this brochure due to laterproduction changes or/and optional configurations. The products and technical specifications aresubjectedtochangewithoutpriornotice.PleaseconsultyourICOSdealerforthelatestinformation. DC

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ICOS Pharma S.p.A.ViaE.Ellero,1533080CusanodiZoppola(PN)ITALY

PHONE +3904345772911FAX +3904345772900 [email protected]

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