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“For the Environmentally conscious”
Washing systemsServing the global pharma industry
Steelco Headquartes
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Solutions for the pharmaceuticals and biotechnology companiesLocated in modern factories near Venice in Italy, Steelco Group is a major global supplier of infection control and contamination prevention for the healthcare, laboratory and pharmaceutical sectors. Steelco’s success is demonstrated by its strong growth, becoming the partner of choice for many of the world’s leading pharmaceutical companies who appreciate the company’s:
Extensive product range
With over 3000 installations worldwide, Steelco offers a wide portfolio including:•Innovativewashingequipment,
customizing loading racks to customer needs.
•Diversified,steamandETOsterilizationrange.
•Innovativefullyautomatedclosureprocessingequipment.
•Dryinganddepyrogenationovens•Automationsystemstomaximize
productivity and safety.
Flexible solutions
•Abilitytomeetthemostchallengingprocessing needs.
•Onlyusingbestprovenreadilyavailablecontrol systems and components.
Experience and knowledge
•Strongtrackrecordofestablishinglongterm global partnerships.
•Integratedin-houseoperationsfromincoming raw materials to installation, validation and technical support.
•Fullycertifiedqualitysystemswithknowledge of pharmaceutical manufacturing standards.
Global footprint
•GlobalHQ in Italywith regional customersupportcentresinAmericaandAsia.
•Networkoffactorytrainedagenciesinover100 countries worldwide.
Center of sterilizers productionCenter of washing systems production
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Quality engineering processSteelco Group’s engineering experience encompasses knowledge and understanding to be able to satisfy the most stringent requests from clients.
Technicalconsulting,design,engineering,projectmanagement,aswellascommissioningand qualification services of our equipment is offered, with customers appreciatingthecosteffectivehighperformancesolutionsofferedtoresolvecomplexwashingandsterilization challenges.
Our respectedengineeringexperience in themedical, laboratory,pharmaceuticalandbiotech fields allows us to develop a proven approach that prioritizes the pharmamanufacturingprocessandsafetybearinginmindlifecyclecostsoftheequipment.
Ourmethodicalapproachistofirstdevelopanin-depthunderstandingoftheprojectandtheproductgoalsinordertoofferthebestequipmentandsolutionfortheapplication.
Customers are always welcome to visit Steelco factories to see design and manufacturing methods and audit our processes.
Quality system certificationIn addition tohavingacertifiedQualitySystemasper ISO9001 (and ISO13485 forMedical Division), our products are subject to rigorous quality control systems andinspection.Thiscoupledwithcontinuouslytrainingourtechnicallyspecializedpersonnelensures you receive best in class product solutions and support.
We constantly strive to improve on our high standards to enable us to deliver optimal solutions for our partners in the pharma industry.
“Engineered for quality”
ISO9001:2008Qualitymanagmentsystems
ISO13485:2012 SAIGLOBALISO13485:2003 &CMDCASCERT-0069883
AEO/CCertification
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DATA INTEGRITY
Standards Directives Regulations
3D project layoutsSteelco Group offers complete ‘turnkey” solutions for washing and sterilization processes in the pharmaceutical sector, with the ability to undertake all stages of a project from concept to delivering solutions that exceed customer expectations.
Steelco’sextensiveexperienceassistscustomerstoincreaseprocessproductivityandqualitywithimprovedergonomicswhilstlimitingcosts.
Steelco Group: Leading the Way with a Risk Based Approach to Data Integrity
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“Service that is second to none”
Extensive customer support servicesSteelcoGroupoffersacomprehensiverangeofservicestoensurethesuccessofprojects at each important step including:
• Process and workflow design• Processequipmentdesignandmanufacture• AutomationandSCADA• Installation and commissioning • Trainingpackages,frombasictoin-depth• Validation and documentation:• cGMPcomplianceconsultancyandassessment• Trainingandassistanceifrequestedbypharmaceuticalcompaniesaswellas
regulatoryinspectorsonGMPrelatedtopics• Sparepartssupplyandfirstlineservicetraining• Fully comprehensive and preventative maintenance contracts• Periodicvalidationandre-qualificationasrequired.
ForallpreviouslyinstalledequipmentSteelcocanofferarangeofcustomizableservicepackages.CustomerserviceexcellenceisSteelcoGroup’scommitmentto our clients and a cornerstone of our success with emergency service support if neededavailable,24hours,7daysaweek.
Design warrantyThankstothedesignandqualityofequipment,aswellasthereliabilityofthecomponentsused,Steelcocanofferextendedwarranties.
PerformanceandguaranteeonSteelcoequipmentisaccordingto the technical characteristics stated in the offer.
Onlythebestavailable“Non-Proprietary” components such as valves are sourced. Components are selected for their reliability and availability to reduce running costs and down time.
Steelco can use customer preferred parts provided that these meetperformanceandreliabilityrequirements.
AcademySubjectmatterexpertiseissharedbyourtrainersat the Steelco academy near Venice, Italy or at locations convenient to customers, with training on a wide range of topics that are focused on:
• Standards and work practices• Equipmentanditsuse• Technicalservicetraining
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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
International standards:ISA88 Standard addressing batch process control
ISA95 Enterprise-ControlSystemIntegration
IEC61131 Programmable controllers
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.
SteelcoGroupcanprovidesoftwaresourcecodes,allowing itscustomerstobecomeowners of the control systemofthemachine(“opensourcearchitecture”).
System platforms available include Siemens and Allen-Bradley which are easilyintegratedwith thosealready installedbypharmaceuticalcompanies.Thesoftware isstructured and commented in English to allow a better understanding of functionality. Multi Language tool for development software is also available.
Software is developed in compliance with current coding rules and programming and accordingtostandardISA88,ISA95,IEC61131-3standard&GAMP5.
Thestructureisdesignedforstraightforwardvalidationbytheenduser.Tools to simplify validationarealsoavailable(validationwizard).
Remote diagnostic capabilities are available for all our controller solutions.
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“Safe reliable communication”
business logistic systems (erp)
business planning
& logisticsPlant Production Scheduling, OperationalManagement,etc
Establishingthebasicplantschedule-production, material use, delivery, and shipping.Determininginventorylevels. Time Frame: Months, weeks, days
manufacturing operations systemsmes, batch, lims, am, etc
manufacturing
operations managementDispatchingProduction,DetailedProduction Scheduling, Reliability Assurance...
Workflow/recipecontroltoproducethedesired end products, maintaining records and optmizing the production process. Time Frame: Days, Shifts, hours, minutes, seconds
control systemsplc, dcs, pac manufacturing control
Basiccontrol,supervisorycontrol, process sensing, process manipulation
Monitoring, supervisory control and automated control of the production process. Time Frame: Minutes, seconds
intelligent devicesflow, vision, pressure, etc
Sensing the production process, manipulating the production process. Time Frame: Minutes, seconds, milliseconds
Theactualproductionprocess. Time Frame: Minutes, seconds, milliseconds
Level 4
Level 3
Level 2
Level 1
Level 0
Integrated architectureSteelco 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,SteelcoGroupoffersremoteserviceaccessbyusingvirtualprivatenetworkstoensuretheconfidentialityandsafety of all transferred data.
SaferemoteaccessusingUMTS/LTE/GPRSnetworkssolutionsarealsoavailable.
All Steelcomachines share the same interface system: despite different functions ofmodels with a logical evolution based graphic interface to ensure easier training and use by operators.
Our machines are level 1 and 2 of the standard ISA 95, with the ability to connect and supply all the next levels.
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Validation documentsUser safety, product quality and data integrity are Steelco Group core values.
Equipment is developed and validated according to the latest GAMP and cGMPstandards.Steelco“know-how”allowstheclient’stobenefitfromoptimalsolutionsfortheirindividualrequirements,inordertoperformeffectivelyandreproducibilitycleaning,sterilization and validation of pharma production components.
A riskbasedapproach to complywith regulatory requirements is fundamental in thedevelopment of our validation documentation. An extensive package is available tominimizeon-sitevalidationtime.
SteelcoGroupdocumentsincludebutarenotlimitedtothefollowing:
• HardwareDesignSpecification• FunctionalDesignSpecification• SoftwareDesignSpecification• P&ID(PipingandInstrumentationDiagram)• Component List• GeneralArrangementDrawing• ElectricalDrawings• QualityandProjectPlan• TraceabilityMatrix
SteelcoGroupisavailabletocustomizedocumentationpackagesaccordingtocustomerstandardrequirementsandtoproducespecificdocumentsuponrequest.
Pre-validationofSteelcoGroupequipmentensuresminimalprojectrisk,lesstimeandcosttoqualifytheunitsonsite.
Acceptance Tests & on site activitiesFactory Acceptance Test and Site Acceptance Tests.
SteelcoGroupisavailableanytimetosupportcustomersduringallacceptanceonsiteincluding process development and mapping.
Allonsiteactivitiesundertakentopre-agreedwrittentopre-agreedprotocolsaccordingtoGDPandHSErequirements.
Steelcokeepsrecordsofthetechnicalfileofeachmachinetoenablefullaccessincaseofthird party inspection to verify compliance with directives and regulations currently in force.
ExpertiseinDesignQualityandHazopisavailabletocustomers.
Installationqualification(IQ),operationalqualification(OQ),andperformancequalification(PQ) are provided in standard version or customized according to the final scope of supply.
Our equipment manufacturing centres are equipped with water production systems that can simulate water quality found at customer sites.
v-model for specification, installation, start up and qualifications
verifies
verifies
verifies
performancequalification
operationalqualification
system build
installationqualification
functional specification
user requirements specification
design specification
“Tested and validated solutions”
Spray coverage test: riboflavin contamination of critic areas before cleaning phase.
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Steelco Group subsidiaries and agents provide technical expertese and support in over 100 countries worldwide
www.steelcospa.comwww.icospharma.com
Think globallyTailoring your future
Compliance and guidelines
The design and the production of our washing and drying systems is based on standards and guidelines recognized both worldwide as well as in the final installation country:
Guidelines:-EuropeancGMPs -USFDACRF -21CFRpart11 -cGLP - UNI-INAIL(similartoOSHAstandards) -ASME-ANNEX15-ICHQ9:QualityriskManagement(Europeanguideline)
-ISPE baseline
Standards-Directive2006/42/EC -Directive2014/30/EU -IEC61010 -ENISO12100 -EN61326-1 -EN13849-1 -ENISO14159 -ASTMA380 -ASTMA967 -ULStandards
-FDA-21CFRpart11-ISO9001
cGMP WASHING SYSTEMS
Unparalleled high performance range
DSPHSeries
Chamber volume
from 230 litres / 8 cu.ft to 2.400 litres / 85 cu.ft
b
c
Steelco PHARMA
range
DS 4000 PH DS 3000 PH
a
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Steelco DS SeriesPharmaGradeWashers
ExceedindustrystandardsPharmaceutical grade machines are available as single door or pass-through double door versions to provide an effective barrier systembetween different zones. Allmachines feature large glass sliding doors to reduce size and assure easily and safety access.
Steelco standard pharma machines range from 0.23to 2,4 m3 volumes capacity for standard washing requirements with customers additionally having theoption of specifying customized chamber dimensions to meet their individual needs.
Using their extensive experience and sophisticatedcomputer modelling Steelco’s engineering department optimizes cart design in order to reduce process time and water consumption whilst maximizing processeffectiveness.
Field of application
Counting some the largest Pharma companies as its customers, Steelco has an in-depth understanding ofthe particular critical cleaning, disinfection and drying requirements of equipment and components used inpharmaceutical production including:
-Glassware -Fillinglinecomponentsandtools -Tubing,TCfittings -Valveandpumpbodies,filterhousings -PunchesandDies -Reactorvesselsanddiverseequipment -Bulkcontainers,tanksandcarboys
in several different dimensions with configurableoptions
Technicaldata,utilitiesconsumptionanddrawingsavailableuponrequest.
Washing/Dryingmachinesavailableassingledoororpass-through double version, with automatic motorized opening in vertical(eitherupordownward)orhorizontalslidingdoors.Alsoavailableinhingeddoorversion.
Complete layout versatility
chamber shape horizontal sliding door
vertical sliding door
Interfacing with isolator
Safety and ergonomy is our priority.Possibility of interfacing unloading door with various models isolators.
Highest cleaning performance
Protection of processed items
Low power and consumption
Drying efficiency system
Repeatable and validatable process
Globally available components and technical support
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DS 2500 PH DS 2000 PH DS 1500 PH DS 1000 PH DS 800 PH
“Safety and efficiency”
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hinged doorright or left technical area
serv
ice
Steelco DS PH rangeTechnicalfeatures
Steelco can provide customised solutions with specialdryingprogramsorHPV(hydrogenperoxidevapor)decontaminationaccordingtocustomer needs.
ThewashingchamberandthehydraulicsystemaredesignedandconstructedwithextremecareandfinishedtoRa<0.5µm/19,7µinsmoothness,ofcrevice-freeconstruction,withorbitalweldingforpiping in order to eliminate water retention and stagnation points where bioburden could form.
AISI316LstainlesssteelisusedinternallythroughoutwithEPDM,PTFEorotherFDAapprovedgaskets(21CFRpart177).
Allmodelsfeatureangledsurfacesandroundedcornerstoensure complete drainage.
Pull out electrical panel configured to different global electrical standards
Special applications
Water treatment supply
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Detergent valvesDetergentinletvalveswithzerodead legs.
Smooth and completely drainable surfaces.
Drying and filteringTheheatingelementsenablevariable drying temperature control.TheHEPAfilterisplaced in line at the end of the drying path before entering the chamber and rack.
Washing pumpStainlesssteelhighqualitywashing pump with drain valve.
Drain valvesDoubledrainsystemwithsingleor double total closure with no residual water left.
Washing chamber and sumpAlltheconnectionstothewashing chamber respect the L/D<3formulatoensurethecleaning integrity of all surfaces.
Combination of clamps and welded constructionExtensivedocumentationisprovided on the orbital welding
Exhaust valveWith partial closure to reduce energy loss. With hermetic closure in case of washing toxicsubstances.
TOCanalysisprovidescleaning validation and detects organic contaminants in process water.
Total Organic CarbonChemical dosing system Alcove for sampling system
“Engineering quality”
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Steelco’sengineersexperienceandsophisticated3DCADprogramsensuresthateverypoint, corner and cavity of an item to be processed is deeply and accurately washed.
Thisavoidsthepossibilityofcross-contaminationandeliminatesallsoilandcontaminant residues from the previous use.
Thesameinjectionportingisusedtoalsoconveyhotsterilefilteredairinsideeachcavity for drying.
Pharma carts and trolleys Standard and customized solutions
Optimized load configuration
Process effectiveness
Reduction of cycle time
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“Flexibility and process safety”
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Customized rack configurations
Steelco has developed a global reputation for being able to respond to the most challengingcustomerrequests.
Steelco designs, develops, manufactures and tests all its own wash cart racks in-house,ensuringthatthequalityofthiscriticalprocessiscarefullymonitored.
Injection wash carts for any applications
Height adjustable transport trolley: flexibility and safety
Construction features
Steelco ML PH SeriesPharmaGradePartsandGlasswareWashers
Chamber volume
from 465 litres / 16 cu.ft to 3800 litres / 134 cu.ft
This machine offers pre-washing, washing, rinsing, drying andcooling phases with optimal performance in a compact size and footprint solution.
Hingedtypechamberdoorswithsingleordoubledooranddoublelocking device made in accordance with requirements for cleanenvironments.
UseofFDAapprovedcomponents(valves,filters,piping,tri-clampfittings,pumps,etc.).DryingbyHEPAfilteredhotairatmax.130°C.
Machines are designed for pharmaceutical products such as glassware, pipettes, machine parts, tanks, glass bottles, pill stamps, carboys, tubes, needles, etc.
Low running and life cycle costs.
Useof316Lstainlesssteelwithroughnesslessthan0.5μm(20microinches)onallcomponentsinprocesscontact(machinebody,machinedoors,spraynozzlesbars,processpiping,instruments,valves,racks,internalcarts,baskets,etc.).
Orbitalweldingonallpipingwithtri-clampfittings.
Respecting3-Ddeadlegswiththeapplicationof Zero-Static(0-Deadlegs)components.
AllinternalcornersofthechamberhaveradiusesaspercGMPrequirement.
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in several different dimensions with configurableoptions
Customized and engineered loadingequipment.
Field of application
CABINET WASHING SYSTEMS
For the perfect cleaning of large items
LC80PHSeries
Steelco LC PH SeriesCabinet washing system
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Chamber volume
from 4.250 litres / 150 cu.ft to 10.500 litres / 371 cu.ft
in several different dimensions withconfigurableoptions
With a full range of washing carts dedicated to:
-Glassware -Fillinglinecomponentsandtools -Tubing,TCfittings -Valveandpumpbodies,filterhousings -PunchesandDies -Reactorvesselsanddiverseequipment -Bulkcontainers,tanksandcarboys
The Steelco LC PH range is a versatile system to wash containers, large components, ultracentrifuges, bulk chemicals: developed for all applications where it is necessary to treat large volume of items or large diameter components.
Themachinebase,manufacturedwitheasyremovablecontinuousmodules,allowstheoperatortowalkwithsafetyonit.Thelateralrotatingwashingtubesachieveperfectwashing results.
Highperformanceefficiencywithsteamheaterversionsavailable.
Highest cleaning performance
Easy cart connections
Double drying unit with capacity of 1000 m3/hour
Lateral rotating washing pipes with nozzles to assure a adequate cleaning of all parts of loaded items.
Repeatable and validatable
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Advantagesfeatures
From concept to execution
“Large object washed to pharmaceutical standard”
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Steelco LC PH SeriesWashers technical features
Filters
AirfilteringsystemwithHEPA,ULPAfiltersavailableoption;DOPtestconnections and filter status check with pressure system.
Fully accessible operating areaThemachineisdevelopedtakingintoconsideration access of technicians to the maintenance and service area.
Easy access to all components, conforming to safety regulations.
Upper level can be walked on and is designed for easy maintenance access
Heaters
Theheaterismadetoaspecialdesign to ensures self cleaning and avoid water stagnation points.
Easy maintenance
Thewashingchamberandwatercircuitsaredesignedandconstructedwithextremecare,finishingwithaminimumsmoothnessofRa<0.5µm/19.7µ/in,withcrevice-freeconstructionof chamber, piping and racks in order to eliminate water retention and stagnation points where biofilm or corrosion could form.
WashingchambermanufacturedinAISI316LstainlesssteelandexternalbodyinAISI304stainlesssteel.AISI316LstainlesssteelisusedthroughoutthemachinewithEPDM,PTFEorotherFDAapprovedgaskets(21CFRpart177).
Allmodelsfeaturesslopedbaseandroundedcornerstoensurecompletedrainage.Extensivedocumentationisprovidedfortheorbitalwelding.
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Globally available componentsGloballyavailablecomponents,e.g.Gemu,Bürkert,Ittprocessvalves,are standard. Melted or forged, weldedonpipeorfixedbyclamps(otherfittingsonrequest).
Control system for chemical dosing with protection of components
Cleaning and inspection
Strong and easily removable grid: enables easy access for cleaning and inspection as well as a rigid stable surface to walk on.
Self cleaning chamber
Self cleaning chamber with nozzles positioned at critical points and sloped surfaces to ensure that no residual water is left.
Cleaning nozzles
Washing nozzles easy to disassemble for periodic maintenance.
Free draining surface
Extremelyaccurateprojectdesignfortheelimination of water stagnation points, surface slopes and complete washing of the whole chamber interior.
Detail thoroughness
Eachsmallcavityisreached.Thecompletewashing of inlet connections for chemical products is assured with special dedicated nozzles.
“Large object washed to pharmaceutical standard”
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Construction features
Steelco’sexperiencedengineersusingsophisticateddesignsoftwareensure thateach point, corner and cavity of the item to be processed is deeply and accurately washed.
Thiseliminatesthepossibilityofcross-contaminationandthedepositionofresiduesfrom previous cycles.
Thesameinjectionportscanbeusedalsotodirecthotsterilefilteredairinsideeachcavity for drying.
Pharma carts and trolleys Standard and customized solutions
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Customized trolley solutions
Easy cart connection
Examplesofcustomizedaccessoriesforcartconnection.
Machinescanbeequippedwithspecialcartconnectionsfor water injection. Manual or automatic versions are available.
“Flexibility and efficacy process safety”
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Specific solutions for the most challenging requests
Flexible cart configurationChangingthededicatedinsert/supportthesamewash cart can be used for different loads.
Steelco LB SeriesBinWasherSolution
The Steelco 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 containerbeingcleanedand/orthespraynozzlearm360°insidetheobjectensuringexceptionalcleaning of all surfaces of the container.
Highest cleaning performance
Continuous moving top spray arms
360° continuous bin rotating during operation
Drying unit with 1000 m3/hour capacity
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Chamber volume
from 5.000 litres / 177 cu.ft to 10.000 litres / 353 cu.ft
in several different dimensions withconfigurableoptions
Field of applicationBins,drums,tanks,IBV,IBC
MixedloadsThechambercanbeconfiguredformixedloads.
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Steelco DS PL SeriesIndustrial challenging application washers
Steelco DS PLrange
DS 500 PL
SteamAirMixtureSterilizer
Superheated Water Sterilizer EthyleneOxideSterilizerClosure Processor
HotAirOven
DS 800 PL DS 1000 PL DS 2000 PL ... DS 4000 PL
Steelco Sterilizers Seriesfor life science and pharmaceutical production
“For the Environmentally conscious”
Steelco DS PL rangeIndustrial challenging application washers
Saturated Steam Sterilizer
Steelcodesignsdedicatedequipmentforindustrialdemand,includingpetrochemicals,cosmeticandnutraceuticalfields. Effectiveness,safetyandhighproductivityequipmentrange.
Steelcooffersanextensiverangeofsteamsterilizingautoclaves for any size facility.
“For the Environmentally conscious”
Steelco DS PL rangeIndustrial challenging application washers
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Washers, disinfectors and automated systems for animal cages, feeding bottles and fish tanks
Steam sterilizers VS L series for pharma and research laboratories
Laboratory glassware washing systems
Steelco DS PL range Industrial challenging application washers
Sterilization solutionsServing the pharma industry worldwide
Worldwide agencies available for sales support.
STEELCO S.p.A.
Via Balegante, 27 31039 Riese Pio X (TV) - ItalyPh. +39 0423 7561 - Fax +39 0423 [email protected]
ICOS PHARMA S.p.A.
Via E. Ellero, 15 33080 Cusano di Zoppola (PN) - ItalyPh. +39 0434 5772911 - Fax +39 0434 [email protected]
Headquarters andCenter of washing systems production Center of sterilizers production
Branches
STEELCO SPAIN Madrid, Spain [email protected]
STEELCO FRANCE Paris, France [email protected]
STEELCO BENELUX Vianen, The Netherlands [email protected]
STEELCO DENMARK Kgs. Lyngby, Denmark [email protected]
STEELCO GERMANY (DACH Area) Gütersloh, Germany [email protected]
STEELCO HUNGARY Budapest, Hungary [email protected]
STEELCO INDIA Gurugram, India [email protected]
STEELCO ASIA Puchong, Malaysia [email protected]
STEELCO USA West Palm Beach, USA [email protected]
STEELCO MEXICO CDMX, Mexico [email protected]
