Washing and Sterilization Equipment
high performance solutions to resolve complex sterilization and
washing challenges
Sterilization & washing systemsServing the pharma industry worldwide
22
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:
Washing and Sterilization Equipment
33
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.
44
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.
Washing and Sterilization Equipment
5
INTEGRATED ARCHITECTURES
PLC
Allen-BradleySiemens
SiemensSiemens
...
AB ABiFix
OP
HMI SCADA
INTEGRATED ARCHITECTURES
PLC
Allen-BradleySiemens
SiemensSiemens
...
AB ABiFix
OP
HMI SCADA
INTEGRATED ARCHITECTURES
PLC
Allen-BradleySiemens
SiemensSiemens
...
AB ABiFix
OP
HMI SCADA
5
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.
66
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.
Washing and Sterilization Equipment
7
V-Model for specification, installation, start up and qualifications
Verifies
Verifies
Verifies
perforMancequalification
operationalqualification
systeM Build
installationqualification
functional specification
user requireMents specification
design specification
7
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.
88
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
9
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.
Washing and Sterilization Equipment
11
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
drain rotation, water spraying
dripping rotation
2nd rinse
drain rotation, water spraying
dripping rotation
3rd rinse
drain rotation, water spraying
dripping rotation
siliconizing
drain rotation, water spraying
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
TypeOverall dimensions (mm / inches) Number of
basketsUseful baskets
volume(litres / cu. ft.)
Total baskets volume
(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
WASHING - RINSE - SILICONIZING
TEMPO
PRES
SIO
NE
STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO
TIME
PRES
SURE
(BA
R)
STERILIZATION - DRYING - COOLING
LAVAGGIO - RISCIACQUO - SILICONATURA
ACQ
UA
IN C
AM
ERA
TEMPO
CHA
MBE
R W
ATER
(%)
TIME
WASHING - RINSE - SILICONIZING
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
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
drain rotation, water spraying
dripping rotation
2nd rinse
drain rotation, water spraying
dripping rotation
3rd rinse
drain rotation, water spraying
dripping rotation
siliconizing
drain rotation, water spraying
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
TypeOverall dimensions (mm / inches) Number of
basketsUseful baskets
volume(litres / cu. ft.)
Total baskets volume
(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
WASHING - RINSE - SILICONIZING
TEMPO
PRES
SIO
NE
STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO
TIME
PRES
SURE
(BA
R)
STERILIZATION - DRYING - COOLING
LAVAGGIO - RISCIACQUO - SILICONATURA
ACQ
UA
IN C
AM
ERA
TEMPO
CHA
MBE
R W
ATER
(%)
TIME
WASHING - RINSE - SILICONIZING
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
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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11
“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.
12
“Advanced multitasking process”
12
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
Washing and Sterilization Equipment
13
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”
13
Loading systemsAutomaticloadingisundertakenusinga:stopperstoragetankwithmixer,suctiontube,measuringtankwithsanitaryvalvesandaspirator.
ManualloadingiscarriedoutusingAISI304stainless-steelcontainersofthesamecapacityasthemachinebaskets.
14
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
14
LST/LT Series
AVSeries
Saturated Steam Sterilization
Versatile cGMP Steam Sterilizers
16
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
16
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.
Washing and Sterilization Equipment
17
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
17
18
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
Technicaldata,utilitiesconsumptionanddrawingsavailableuponrequest
Floororpitmountedsolutions
AMS/ASW SeriesSteam & air mixture Superheated water shower
“Sterility Assurance”
Washing and Sterilization Equipment
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
Washing and Sterilization Equipment
25
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
drain rotation, water spraying
dripping rotation
2nd rinse
drain rotation, water spraying
dripping rotation
3rd rinse
drain rotation, water spraying
dripping rotation
siliconizing
drain rotation, water spraying
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
TypeOverall dimensions (mm / inches) Number of
basketsUseful baskets
volume(litres / cu. ft.)
Total baskets volume
(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
WASHING - RINSE - SILICONIZING
TEMPO
PRES
SIO
NE
STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO
TIME
PRES
SURE
(BA
R)
STERILIZATION - DRYING - COOLING
LAVAGGIO - RISCIACQUO - SILICONATURA
ACQ
UA
IN C
AM
ERA
TEMPO
CHA
MBE
R W
ATER
(%)
TIME
WASHING - RINSE - SILICONIZING
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
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
drain rotation, water spraying
dripping rotation
2nd rinse
drain rotation, water spraying
dripping rotation
3rd rinse
drain rotation, water spraying
dripping rotation
siliconizing
drain rotation, water spraying
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
TypeOverall dimensions (mm / inches) Number of
basketsUseful baskets
volume(litres / cu. ft.)
Total baskets volume
(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
WASHING - RINSE - SILICONIZING
TEMPO
PRES
SIO
NE
STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO
TIME
PRES
SURE
(BA
R)
STERILIZATION - DRYING - COOLING
LAVAGGIO - RISCIACQUO - SILICONATURA
ACQ
UA
IN C
AM
ERA
TEMPO
CHA
MBE
R W
ATER
(%)
TIME
WASHING - RINSE - SILICONIZING
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
“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.
Technicaldata,utilitiesconsumptionanddrawingsavailableuponrequest
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.
Washing and Sterilization Equipment
29
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
drain rotation, water spraying
dripping rotation
2nd rinse
drain rotation, water spraying
dripping rotation
3rd rinse
drain rotation, water spraying
dripping rotation
siliconizing
drain rotation, water spraying
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
TypeOverall dimensions (mm / inches) Number of
basketsUseful baskets
volume(litres / cu. ft.)
Total baskets volume
(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
WASHING - RINSE - SILICONIZING
TEMPO
PRES
SIO
NE
STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO
TIME
PRES
SURE
(BA
R)
STERILIZATION - DRYING - COOLING
LAVAGGIO - RISCIACQUO - SILICONATURA
ACQ
UA
IN C
AM
ERA
TEMPO
CHA
MBE
R W
ATER
(%)
TIME
WASHING - RINSE - SILICONIZING
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
isolationtechnology
“Drying without compromise”
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
“Drying without compromise”
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
Washing and Sterilization Equipment
31
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
drain rotation, water spraying
dripping rotation
2nd rinse
drain rotation, water spraying
dripping rotation
3rd rinse
drain rotation, water spraying
dripping rotation
siliconizing
drain rotation, water spraying
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
TypeOverall dimensions (mm / inches) Number of
basketsUseful baskets
volume(litres / cu. ft.)
Total baskets volume
(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
WASHING - RINSE - SILICONIZING
TEMPO
PRES
SIO
NE
STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO
TIME
PRES
SURE
(BA
R)
STERILIZATION - DRYING - COOLING
LAVAGGIO - RISCIACQUO - SILICONATURA
ACQ
UA
IN C
AM
ERA
TEMPO
CHA
MBE
R W
ATER
(%)
TIME
WASHING - RINSE - SILICONIZING
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
Technicaldata,utilitiesconsumptionsanddrawingsavailableuponrequest.
“Drying without compromise”
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
in several different dimensions with configurableoptions
Bins,drums,tanks,IBV,IBC
Field of application
Construction features
Washing and Sterilization Equipment
35
���
�
�
35
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.
in several different dimensions with configurableoptions
Customizedandengineeredloadingequipment:racks/cartsandbaskets.
Adjustableheighttransporttrolleys.Possibilityofinterfacing unloading door with isolator.
Field of application
Washing and Sterilization Equipment
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
-PD-
02-IC
OS P
H ST
EN
Rev.
01
ICOS Pharma S.p.A.ViaE.Ellero,1533080CusanodiZoppola(PN)ITALY
PHONE +3904345772911FAX +3904345772900 [email protected]