sterilization solutions serving the pharma industry … st en rev.03.pdf · sterilization solutions...

“For the Environmentally conscious”

Sterilization solutionsServing the pharma industry worldwide

2

Steelco Headquartes

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

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.

ISO9001:2008Qualitymanagmentsystems

ISO13485:2012 SAIGLOBALISO13485:2003 &CMDCASCERT-0069883

AEO/CCertification

3

“Engineered for quality”

4

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

5

Design warrantyThankstothedesignandqualityofequipment,aswellasthereliabilityofthecomponentsused,Steelcocanofferextendedwarranties.

Standard warranty is 10 years on pressure vessels. Steelco warrants all materials and workmanship to be free of defects for 18monthsfromshipmentdate.Steelco’spharmasterilizerdoorgasketdesigncarriesa4yearswarrantywithoutanylubricationrequired.

Onlythebestavailable“Non-Proprietary”componentssuchasvalves 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.

Extensive customer support servicesSteelcoGroupoffersacomprehensiverangeofservicestoensurethesuccessofprojects at each important step including:

• Processandworkflowdesign• 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.

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

“Service that is second to none”

6

INTEGRATED ARCHITECTURES

PLC

Allen-BradleySiemens

SiemensSiemens

...

AB ABiFix

OP

HMI SCADA


PLC


SiemensSiemens

...

AB ABiFix

OP

HMI SCADA


PLC


SiemensSiemens

...

AB ABiFix

OP

HMI SCADA

International standards:ISA88 Standard addressing batch process control

ISA95 Enterprise-ControlSystemIntegration

IEC61131 Programmablecontrollers

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.

7

“Safe reliable communication”

business logistic systems (erp)

business planning

& logisticsPlantProductionScheduling,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,DetailedProductionScheduling,ReliabilityAssurance...

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.

8

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.

9

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.

10

Compliance and guidelinesSteelcoGroupcomplieswithlatestInternationalrequirementsandguidelines,aswellas local standards as applicable:

European Directives

2006/42/EC Safety of machinery

2004/108/ECandamendments

Electromagnetic compatibility

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 Safety of machinery. Basicconcepts,generalprinciplesfordesign.

EN13857 Safety of machinery. Safety distances to prevent hazard zones being reached by upper and lower limbs.

EN349 Safety of machinery. Minimum gaps to avoid crushing parts of the human body.

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.

United States Standards

OSHA

NFPA

FDA

UL Standard

ASME

Canada Standards

CSA

CRN

Russian Standards

GOST

China Regulation

SELO

CLOSURE PROCESSOR

Completely integrated all in one solution

LT/ST/LS

TSeries

Field of application

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

• Manual• Automatic

• Wheeled tanks• Containers• Sterile bags• SterilebagsthroughHPV

(hydrogenperoxidevapor)isolator

LT/ST/LST SeriesClosure processor

Chamber volume

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

Sterile continuity is the vision

Steelco Group aims at reducing manual contact to theminimumlevel.TheLST/LTseriesisidealforthetreatment of closures for containers normally used in the pharmaceutical industry, where continuous sterility has to be maintained between different phases.

TheLSTSeriesofferswashing, rinsing, siliconizing, sterilizing, drying and cooling all in one solution and iscompatiblewithdifferentloading/unloadingsystems,with the ability to interface with vaporized hydrogen peroxideisolator.

SteelcoGroupproducesa“Closure washer” version -LT series -whichonlyprovideswashing,rinsing,siliconizing, drying and cooling phases.

Thankstoanextendedrangeofcapabilities,SteelcoGroupnowoffersinnovativecustomizedstopperprocessorsolutionsforhighlycost-effectiveprojects.

Useful baskets volume(litres/cu.ft.)

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

•sterlization•drying•cooling

•washing• rinsing•siliconizing

Technicaldata,utilitiesconsumptionsanddrawingsareavailableuponrequest

Closures loading options:

Automatic unloading into:

12

AdvantagesofSteelcotechnology

Physicalseparationoftheloadintodifferentsubbatches(basket)withuniformcapacityoffersthefollowingadvantages:

capable of processing different kinds of stoppers at the same time

elimination of the excessive accumulation of material during treatment phases

minimizing particle generation due to mechanicalstressandeffectiveendotoxinreduction

enhanced surface exposure to processfluids

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

uniform silicone distribution on individual stoppers and the entire batch

optimization of the CIP phase

moreefficientcycle,optimizerunningcosts

Sterilizingqualityprocess

Theprocessconsistsofcombinedphasesandactionsdesignedtoprovidemaximumprocessflexibilityandefficiency.

Thechoiceoftimeandphasesuccessionallowstheusertoobtain the most appropriate cycle to match the characteristics of the material to be processed.

PRES

SURE

(BA

R)

2,5

2

1

0

-1

0

-1

PRESSURE STERILIZATION

STERILIZATION - DRYING - COOLING

non explosive mixtures 10% EO 90% CO2

PRES

SURE

(BA

R)

30%

2

100%

vacuum pulses sterilization drying cooling

WASHING - RINSE - SILICONIZING

CHA

MBE

R W

ATE

R %

WA

SHIN

G

1st R

INSE

2nd R

INSE

3rd R

INSE

SILI

CON

IZIN

G

VACUUM STERILIZATIONexplosive mixtures 90% EO 10% CO2

PRES

SURE

(BA

R)

Pharmaceutical Division

ICOS has a long experience in the treatment of closures for

containers normally used in the pharmaceutical industry.

This new range of ICOS equipment shows a series of innovative

features that satisfy the strict standards of the pharmaceutical

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

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

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

consists of the washing, rinsing, siliconizing,

drying and cooling phases.

CLOSURE PROCESSOR TYPE “LST”: the “LST”

process, in addition to the washing, rinsing,

siliconizing, drying and cooling

phases also includes the sterilizing

phase. The complete process makes it

possible to eliminate needless

intermediate handling of the product

that may cause its contamination.

FIELD OF APPLICATION

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

LOADING SIDE - TYPE LST 20-40-80

LTLST

Series

PROCESS DATA

The process consists of combined phases and actions designed to

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

PHASES ACTIONS

loading of material through prearranged system

washing

drain rotation, water spraying

dripping rotation

1st rinse


dripping rotation

2nd rinse


dripping rotation

3rd rinse


dripping rotation

siliconizing


dripping rotation

sterilization steam at 121 °C

drying sterile air at max. 130 °C

cooling sterile air at 20 °C

product discharge in a clean environment by means of prearranged system

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

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

ICOS RESERVES THE RIGHT TO MAKE PRODUCT CHANGES WITHOUT PRIOR NOTIFICATION

TypeOverall dimensions (mm / inches) Number of

basketsUseful baskets

volume(litres / cu. ft.)

Total baskets volume

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

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

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

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

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

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





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

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

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

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

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

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

CLOSURE PROCESSINGEQUIPMENTCLOSURE PROCESSING EQUIPMENT

ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


TEMPO

PRES

SIO

NE

STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO

TIME

PRES

SURE

(BA

R)


LAVAGGIO - RISCIACQUO - SILICONATURA

ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


LTLST

Series

rev.

01/

12

www.icospharma.com

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

STERILIZATION PROCESS

TEM

PERA

TURE

50

100

150

200

250

CONTROL LIMITALARM LIMIT

LEL

HEATING STERILIZATION COOLING

DRYING PROCESS

TEMPERATURECONCENTRATION

PRES

SURE

(BA

R)

2,5

2

1

0

-1

0

-1




PRES

SURE

(BA

R)

30%

2

100%



CHA

MBE

R W

ATE

R %

WA

SHIN

G

1st R

INSE

2nd R

INSE

3rd R

INSE

SILI

CON

IZIN

G


PRES

SURE

(BA

R)






















LTLST

Series

PROCESS DATA



PHASES ACTIONS


washing


dripping rotation

1st rinse


dripping rotation

2nd rinse


dripping rotation

3rd rinse


dripping rotation

siliconizing


dripping rotation













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

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

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

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

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






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

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

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

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

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


ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


TEMPO

PRES

SIO

NE


TIME

PRES

SURE

(BA

R)



ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


LTLST

Series

rev.

01/

12

www.icospharma.com



TEM

PERA

TURE

50

100

150

200

250


LEL


DRYING PROCESS


Thecontrol system manages the machine and its basic parameters,suchastemperatures,F0,vacuum/pressure,times and level control, and other critical parameters.

Thecontrolsystemmonitors,records,andcontrolstheoperationoftheequipment.

Ethernet ports allow the downloading of data to a local computer or to a future plant data collection system.

PHASES ACTIONS

Loading of material through prearranged system

Washing rotation,fluidbed,detergent

overflow rotation, water diffuser


dripping rotation

3 Rinsing phases rotation,fluidbed

overflow rotation, water diffuser


dripping rotation

Siliconizing rotation,fluidbed,silicone


dripping rotation

Sterilization steamat121°C

Drying sterileairwithHEPAfilters

Cooling sterileairwithHEPAfilters

Product dischargein a sterile environment by means of prearranged system

�

�

�

�

�

�

�

�

“Assured productivity and sterility”

Customized cycle according to client requirements

Cycle phases

13

Sample points available for analysis

Filters available for recycling phase

LT/ST/LST SeriesConstruction featuresThemachinebodyandjacketarecompletelymadeofAISI316Lstainless-steel.Themachinebody is insulated with ceramic material and with an external cladding of stainless steel.

AISI316LstainlesssteelpipingisconnectedwithASMEtri-clampconnections.Theinnerpartof the chamber, the tubings, the baskets and all parts in contact with the product are polished to≤0.5μm/20µ/in.

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

ElectricalPanelincompliance with EU, UL and local standards as needed

Fluid bed washing technology powered by a water recirculation pump

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 recirculation pump loop system.

Lower levels of silicone oil per cycle than other solutions, making the CIP WIP cycle much more effective.

Highly effective drying system by air pulses and a rotating chamber canister.

�

�

�

�

�

�

14

ManualloadingiscarriedoutusingAISI304stainless-steelcontainers of the same capacity as the machine baskets.

Automaticloadingisundertakenusinga:stopperstoragetankwithmixer,suctiontube,measuringtankwithsanitaryvalvesandaspirator.

Loading systems

Chamber featuresEven distribution of load in separate baskets ensures better final results. Washing by a simultaneous combination of basket rotation and fluid-bed action is achieved by a recirculation pump and spray nozzles. It is designed for continuous effective operation withoutexcessiveadjustmentorreplacementduetowear.

Thepossibilitytovisuallychecklineclearancesimplifiestheverificationthatnostoppersareleftinthe unit from previous cycles.

Suspendedparticlesareskimmedoffbysideoverflowdrains.Appropriatesizedreliefvalvesareprovidedasrequiredforeachpressurizedcomponent.

Ten different loading and unloading solutions are offered.

No presence of sharp edges in order to prevent injuries to equipmentoperatorsordamagingof the closures.

The chamber can be completely inspected through a loading door. Thebasketdoorshaveautomaticopening and closure.

�

�

�

“Advanced multitasking process”

15

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-automaticandundertakeninstainlesssteelcontainersprovided with a lid of the same capacity as the machine basket. Theunloadingphaseisprotectedbyasterileairfloworiginatingfromtheinside of the chamber.

Automatic unloading into wheeled containers with Alfa Beta valve Unloading is completely automatic and it is achieved with hermetically sealedwheeledcontainersof100litercapacity;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(eachbagwiththesamecapacityaseachbasketoftheCPE–10littersofstoppers). • Transferringtrolleyforbags.

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

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.

16

STERILIZING AUTOCLAVE

VersatilecGMPSteamSterilizers

AVSeries

TheAVSeriesoffersflexibility configuration and versatility.

Forexample,theelectricalpanelcanbeintegrated or remotely installed.

AV SeriesSaturated steam sterilizers


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

Chamber volume

from 195 litres / 7 cu.ft to 10.000 litres / 353 cu.ft

Obtainthebestresults

In pharmaceutical production, the need to optimize sterilization processes is important to increase safety and productivity.

SteelcoGroupisabletoofferanextremelydiversifiedproductrangecapableofmeetingtherequirementsof the most varied applications and satisfy the strict standards of the pharmaceutical industry.

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

SteelcoGroupoffersawideselectionofsaturatedsteamsterilizerstoexceedindustrystandards,availableinsingleorpass-throughversions,withhinged(AVLSeries)orslidingdoors(AVSSeries).

Builttoaveryhighstandard,eachunitistailoredtothecustomer’sindividualspecifications.

Cartguidesareweldedintochamberfloor.

Round or Rectangular chamber

Technicalarea

shared

Technicalarea

left

Technicalarea

right

Flexiblelayoutoptions

in several different dimensions with configurableoptions

Technicaldata,utilitiesconsumptionanddrawingsavailableuponrequest

Floor or pit mounted solutions

18

Hingeddoor Left or right

SterilizingqualityprocessThesterilizationcyclehasbeenspecificallydesignedtoreducetimeandenergyconsumption,improvingefficiencyandthroughput.

Thepreconditioningphaseatthebeginningofthecycleandthefractionalvacuumphaseattheendhavebeendevelopedtomaximizeperformanceand minimize cycle time and energy use.

Eachsterilizercanbeequippedwithanycombinationofcycleswithcompleteflexibilitytocustomizeeachphaseanditsparameters.CyclesareeasilyrecalledfromtheHMIandareprotectedfromunauthorizedchangesbyamulti-levelpasswordsystem.

Thefollowingcyclesareavailabledependingonmachinespecification:Thecontrol system manages the machine and its basic parameters, suchastemperature,F0andpressure;it enables easy interfacing with the operator and makes the customization of working cycles and maintenance operations possible.

Software used by Steelco is according toGAMPguidelinesanddesignedfor21CFRPart11whererequired.

SCADAsystemavailableforcompleteintegration.

Service programs:

Vacuum leak test

MachineSIP

Bowie&Dicktest

Automaticsterilizationofmachineandvacuumbrakefilter(SIP)

PredispositionforAutomaticintegritytestofvacuumbrakefilter(W.I.T.)

Working programs:

Fractioned vacuum

Rapid cooling by shower and counterpressure

Gravitypurgeandcounter-pressure

Rapid cooling by shower and counterpressure + seal test by vacuum crush

Coolingbywaterinjectioninthejacketandcounter-pressure

Air+steammixtureandcounter-pressure

Tyndalization

Pharmacywithnaturalcooling

Slow heating with drying by slow vacuum

Dryingbyhotair

Pitmounted or Floor loaded

Vertical Sliding downHorizontalSliding

Left or Right

“Sterility Assurance”

19

AV Series Construction featuresIn the standard version, the door seal is achieved by a pneumatically pressurized siliconegasket;ensuringtheintegrityofthedoorinanyphaseofoperation.

Sliding doors are driven by an electromechanical system made in compliance with the requirementsforcleanareasanditisequippedwithbio-sealorairtightseparation.

Doorsealsystemguaranteedfor4yearsoperationalusewithoutlubrication.

AllpipingandportsincontactwiththechamberaremadeofAISI316L,areslopedand self draining. Allcomponentsareofsanitarytypewhereappropriate,includingclampfittings.

Safe applicationsTheunloadingdoorcanbeinterfacedwithaHPV(hydrogenperoxidevapor)generatorand/orisolationtechnologyorwithdedicatedsystemsaccordingtosterilerequirements.

Thesterilizingchamberisentirelycovered by a full jacket system of dimple welded type for fast heat transfer and to optimize chamber temperature distribution.

Single or twin air filters installed in parallel, capable of being sterilized in place.

Air detector followingEN285todetectthepresenceofairornon-condensablegaseswithinpure steam.

Thefrontloadingsideisfittedwithconnection ports for validation testing.

Airtightorbio-sealseparation.

Optimisedforenergysavings&lowwastage.Draincoolingsystemavailabletocooldownalleffluentspriortodischargeintodrains.

IsolationTechnologyHPVgenerator

Low maintenance with long life proven components.

�

�

�

�

�

�

20

TERMINAL STERILIZATION

SteamAirMixtureSterilizer& Superheated Water Sterilizer

AMS/ASWSeries

Versatileloading/unloadingsystemsand automationSteelco can provide a range of automated loading and unloading solutions including integration with robotic systems.

AMS SeriesSteamAirMixturesterilizer

ASW SeriesSuperheated Water sterilizer


Usedtosterilizeliquidsinsealedorheat-sensitivecontainerssuch as: bottles, ampoules, vials, semi-open containers, bags, blister packing, pre-filled syringes, pockets, contact lenses, LPV’s, etc, and also for

the pasteurization of products like blood plasma.

Air-Steam or Superheated Water Process? Selection depends on the products thermal lability, level of dryness to be reached, utilities available on site and running costs.

Chamber volume

from 830 litres / 29 cu.ft to 25.000 litres / 883 cu.ft

Differentoptions for differing needs

Steelco’s range autoclaves using air + steam or superheated water are for the terminal sterilization of injectable solutions.

Bothmethodsofsterilizationavoidanydamageoftheprocessedliquidmaterialandtheircontainers,including heat sensitive materials.

Thankstoaneffectiverecirculationofairorwater,uniform temperature is maintained in the sterilizing chamber, during all process phases.

Requiredpressurebalanceisachievedbyusingsterile compressed air in the chamber.

in several different chamber sizes, configurationsandaccessoriestotailor

eachunittoexactrequirements

Technicaldata,utilitiesconsumptionanddrawingsavailableuponrequestFloor or pit mounted solutions

22

Chamber Seal

AMS Series Thesterilizationprogramusingansteam air mixture is appropriate for different types of loads.

It is also used in microbiological laboratories, particularly in the sterilization of sealed plastic containers.

Theprocessincludestheapplication of counterpressure to avoid permanent deformation of containers.

Anautomaticpressuresealingtypedoorgasketisavailableuponrequest.

Thissystemensuresthesealofthedoorinanyconditionofoperation. SteelcoGroupguaranteesthesedoorsealsforit4years.

ASW Series Thesterilizationprogramusingsuperheated water is used mainly for sterilizing large containers, although it can also be used for other types of loads.

Theproductistreated in counterpressure, in order to avoid deforming or breaking the containers

Rapid, safe and effective terminal sterilization process for high product throughput.

Sterilizingqualityprocess

Sterile compressed air

Pure steam is used in the chamber for heatingliquidsandover-pressure filtered air is injected into chamber to compensate for the rising temperature and pressure inside products.

Internal fans ensure a uniform temperature distribution,between110°Cto135°C,andto avoid cold spots across the chamber.

Rapid heating and cooling are standard phases.Productsarecompletelydryattheend of the cycle.

High capacity pump

Water is continuously circulated through the system and cascades over the load using spray nozzles, high capacity pump and large diameter piping to ensure high water flow rates.

Therecirculatingwaterisheatedand cooled by external heat exchangers.

Meticulous control of heating and sterilization is achieved by superheating the water using modulated steam.

Compressed air at overpressure is injected to compensate for the rising temperature and pressure that builds inside the products when heated.

Thecooling phase brings the product down to ambient temperature by continuously spraying the recirculating water over the load.

Toassistheatpenetrationandwhenfluidsareliabletoseparation,theload can be rotated during the complete cycle.

“Sterility Assurance”

23

AMS/ASW SeriesConstruction features

ThemachinebodyandjacketarecompletelymadeofAISI316Lstainless-steel.Themachinebodyisinsulatedwithceramicmaterialandwithexternalcladdingstainlesssteel.

PipingsincompliancewithASMEBPEmadeofAISI316Lstainlesssteelwithtri-clampfittingsandallmachinecomponentsofsanitarytype.

Theinnerpartofthechamber,thetubings,thebasketsandallpartsincontactwiththeproductarepolishedto≤0.5μm.

Useful combined solution

SteelcoGroupdesignscombined/modularsystemssterilization,where heating and sterilization phases are carried out with saturatedsteam,likeanormalsterilizer,orwithamixtureofsteam and air in the same autoclave, or with hot water.

Uniquesealingoffanshaftforeasy inspection and maintenance

Uniformity of temperature guaranteed by recirculation pump action

Flexible RTDs

Energy savings with recirculation water cooling system

Preprogrammed cycles and self-diagnostics cycles

Front loading side with the connection portsrequiredforthevalidationtests.

Grounding lug for proper static grounding and seismic compliance if required

�

�

�

�

�

�

�

24

CHEMICAL STERILIZATION

EthyleneOxideSterilizer

AGS/AGS-ESeries

26

AGS/AGS-E SeriesEthyleneOxideSterilizer


Used for low temperature sterilization ofheat-sensitiveproductsaccordingtotheEN1422Standardsforthemedical processing industry such as: plastic syringes, perfusion sets, dialysis cartridges, heat-sensitive rubber products and special surgical instruments.

Chamber volume

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

Steelco’s latest range of sterilizing autoclaves using Ethylene Oxideincreasesperformanceandversatility.

Manufactured in our factories in Italy after a long research programandanextensiveseriesoftests,theAGS/AGS-Eseries is the best relationship between engineering, quality, price, operating running costs and most important safety of the system and operators.

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

Productivityandenergysaving

Thenewrangehasbeendesignedforbestinclassenergyrecoveryinorder to optimize consumption.

Thevacuumsystemisprovidedwithawaterringpump,whichissuppliedwithwaterdrawnfromtheseparatorbycreatingaclosedcircuit.Thetemperatureismaintainedatoptimumlevelsbyaheatexchanger.Thepumpoutflowisdirectedtotheseparator,fromwhereitissenttotheneutralizing system.

Followingcustomerrequests,dedicated chambers for separate processes can be supplied:

Conditioning chambersSterilization chambers

Available in a wide range of chamber sizes and volume.

Technical data, utilities consumption and drawings available upon

request

Degassing chambers

PRES

SURE

(BA

R)

2,5

2

1

0

-1

0

-1




PRES

SURE

(BA

R)

30%

2

100%



CHA

MBE

R W

ATE

R %

WA

SHIN

G

1st R

INSE

2nd R

INSE

3rd R

INSE

SILI

CON

IZIN

G


PRES

SURE

(BA

R)






















LTLST

Series

PROCESS DATA



PHASES ACTIONS


washing


dripping rotation

1st rinse


dripping rotation

2nd rinse


dripping rotation

3rd rinse


dripping rotation

siliconizing


dripping rotation













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

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

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

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

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






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

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

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

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

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


ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


TEMPO

PRES

SIO

NE


TIME

PRES

SURE

(BA

R)



ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


LTLST

Series

rev.

01/

12

www.icospharma.com



TEM

PERA

TURE

50

100

150

200

250


LEL


DRYING PROCESS


PRES

SURE

(BA

R)

2,5

2

1

0

-1

0

-1




PRES

SURE

(BA

R)

30%

2

100%



CHA

MBE

R W

ATE

R %

WA

SHIN

G

1st R

INSE

2nd R

INSE

3rd R

INSE

SILI

CON

IZIN

G


PRES

SURE

(BA

R)






















LTLST

Series

PROCESS DATA



PHASES ACTIONS


washing


dripping rotation

1st rinse


dripping rotation

2nd rinse


dripping rotation

3rd rinse


dripping rotation

siliconizing


dripping rotation













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

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

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

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

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






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

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

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

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

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


ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


TEMPO

PRES

SIO

NE


TIME

PRES

SURE

(BA

R)



ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


LTLST

Series

rev.

01/

12

www.icospharma.com



TEM

PERA

TURE

50

100

150

200

250


LEL


DRYING PROCESS


“Optimal cycles”

27

Qualitydetailsineveryphaseoftheprocess

TheETOgasisheatedthroughevaporators,beforebeingintroducedintothechamber. Loadmoistenedthroughtheinflowoflow-pressurecleansteamsuppliedbyasteamgenerator.

Theair,whichissuppliedintothechamberinthedegassingphase,isfilteredthroughabsolutefilterstoguaranteehigherquality.

Process data

Phasesnonexplosivemixtures(AGS)

explosivemixtures(AGS-E)

Heatingofloadwithhotwatercirculating in the heating jacket and alternating vacuum phases followed by theinflowofhotair

� �

Humidificationofload,withalternatingphasesofvacuumandsteaminflowatlow pressure

� �

Sterilization of load by pressurization of thechamberwiththegasmixture

�with preset steam

pressure

Gasdischarge � by vacuum pump

Inflowofinertgas �

Load degassing with alternating vacuumandhot-airinflowphasesforapreset 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.

ProcessunderoptimizedconditionsAGS series Pressuresterilizationprogram

upto10%ofEthyleneOxide,withtheremaining90%madeofinertgas(normallyNitrogen)

AGS-E series Vacuum sterilization program

upto90%ofEthyleneOxide,withtheresidual10%madeofinertgas(normallyNitrogen)

Effective and safe

abatement of Ethylene

Oxide at completion of

sterilization process by

thermal combustion

28

Abatement of Ethylene Oxide at completion of sterilization process: increasingly stringent parameters make it necessary to offer safe accepted abatement systems on every EthyleneOxidesterilizer.

SteelcoGroupfollowstheATEX,UL,OSHA,NFPAandFDAregulationsandcomplieswithISO11135,EN1422.

Design pressure Thechamberisengineeredtakingintoaccountthefollowingparameters:1,5bar+vacuumworkingpressure;2,7bar+vacuumdesignpressure.

Utilities room at the factory

Steelco’s rectangular cross section sterilization chamber is completely surrounded by a high efficiency heating jacket for rapid and even heating of loads.

MachinebodyiscompletelymadeofAISI304stainless-steel, insulated with high density ceramic material, and clad in stainless steel sheet.

Thechamber and the hydraulic system are completely built,andcladstainlesssteel.Processpipingismadetri-clampsandflangeconnections.

Panelsandsterilizationchamberaresatin finished.

Pneumaticcontrolofthevalvesisfitted.

AGS/AGS-E SeriesHighestindustrialstandards

Compliance and solutions

Steelco has developed an automatic horizontal sliding door system with a heated jacket, where the closure of the door is assured by a pneumatically pressurized gasket with a 4 year of warranty.

Dedicatedtoautoclavesthatuseapotentiallyexplosivemixture,Steelcohasspecificallydesigneda safe hermetic closure guaranteed by a pressure-sealing device with automatic tie-rods.

Allsafetydevicesareincompliancewithinternationalstandards with parameters continuously monitored to avoidtheriskofexplosion.

Machine provided with necessary connection ports for validation tests.

Complete protection of the environment

HOT AIR OVEN

Advancedsolutionsfor special applications

SD/EGSeries

hinged doorleft or right

pit mounted andfloorloaded

vertical sliding down horizontal slidingleft or right

30

SD Series HotAirDrying/Sterilization/DepyrogenationOven

Chamber volume

from 330 litres / 11.7 cu.ft to 10.000 litres / 353 cu.ft

SteelcoGroupdesignsandmanufacturesawiderange of Class 100 static depyrogenation sterilizers (ISO14644-1class5)tomeetthemostchallengingpharmaceuticalrequirements.

Thedepyrogenationprocessisaimedatthereductionin the level of pyrogens, with the use of hot air in temperaturewhichrangefrom250°Cupto300°Cforacontrolled period of time.

ThehighperformanceClass100ovensolutionensuresan even distribution of hot air for the entire cycle includinglargeloads,withtheinstalledHEPAfilterspreventing cross contamination.

Alargerangeofchambersandconfigurationsareavailable.

Technicaldata,utilitiesconsumptionanddrawingsavailableuponrequest

Availablewithachoiceofthreetypesofdoors:swing-out,horizontallyslidingandverticallysliding, with the goal to always guarantee the door tightness, regardless of unit dimensions.


Used for the sterilization and depyrogenation of heat resistant materials 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.

Complete layout versatility

PRES

SURE

(BA

R)

2,5

2

1

0

-1

0

-1




PRES

SURE

(BA

R)

30%

2

100%



CHA

MBE

R W

ATE

R %

WA

SHIN

G

1st R

INSE

2nd R

INSE

3rd R

INSE

SILI

CON

IZIN

G


PRES

SURE

(BA

R)






















LTLST

Series

PROCESS DATA



PHASES ACTIONS


washing


dripping rotation

1st rinse


dripping rotation

2nd rinse


dripping rotation

3rd rinse


dripping rotation

siliconizing


dripping rotation













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

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

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

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

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






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

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

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

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

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


ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


TEMPO

PRES

SIO

NE


TIME

PRES

SURE

(BA

R)



ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


LTLST

Series

rev.

01/

12

www.icospharma.com



TEM

PERA

TURE

50

100

150

200

250


LEL


DRYING PROCESS


isolation technologyInspection window in the front loading side

“Drying without compromise”

31

Dryingqualityprocess

Fully compatible with the strict standards of the pharmaceutical industry,theSDSeriesissuppliedwithHEPAfilters(99,99%efficiency)forfiltrationofpressurizedairflow(EU13),airrecyclingandexhaustchamberair(EU12).

TheHEPAfiltersabatethelevelofparticlecontaminationinthe chamber also during critical phases, such as heating and cooling.

Particularcareisusedtoeliminateheat transmission points.

Speciallydesignedfilterretentionsystemto minimise thermal stress.

Thecontrol system manages the machine and its basic parameters, such as temperature, Ft, Fh and pressures.

We guarantee excellent PID control of temperature and chamber pressure throughout all phases.

Adjustabletemperatureramp,sterilizationplateau,cooling temperature, chamber pressure, cooling time are all available.

Water-basedcoolingsystem. Anaircooledsystemcanbe

suppliedonrequest.

Filtration of air recycling

Filtration of chamber exhaustair

Filtration of pressurizedairflowthroughHEPAfiltersof99.99%efficiency(EU13).

Airheatedthroughsteam or electric heating elements.

RTDPT100fortemperature and pressure control.

SetflexibleforRTDsin the chamber.

TheSDseriesfeaturesconnectionportsonthefrontloadingsideforvalidation testing.

Machinesequippedwithspecialproductholdingtraysandhandlingtrolleys,can be also interfaced with the isolation technology.

Perfectcompatibility

�

�

�

��

�

�

32

TheSDSeriesisincompliancewiththefollowinglatestNormsandDirectives:

cGMP;GAMP;FDA;EN1822;ISO14644/1/2;CFR’sincluding21CFRparts,201,211andpart11availableasoption;EUROVENT;

TechnicalReports“ParenteralDrugAssociation”;2014/30/UE,2014/35/UE,2006/42/ECo;plusotherlocalandinternationalstandards as applicable.

SD SeriesConstruction features

Chamber, aeraulic system, doors and other machine structural components are made of AISI 316 stainless steel.

Chamber insulated with high density ceramic insulating material and covered externallybyAISI316stainlesssteelpanel.

Uniform air distribution through differentially perforated walls, particularly suitable for varied loads.

Chamber with rounded internal angles and TIGweldedsmoothseams.

Uniform automatic chamber pressure and temperature control.

Insideofchamberpolishedto≤0.5μm.

Automaticpneumaticdoorlockingmechanism.

Hermeticallysealeddoorswithaspecialprofilesiliconegasketwithdoublesealingstrip.Gasketallowstheformationofvacuum to guarantee perfect door seal during every phase of the cycle.

System designed to minimize cross contamination risk.

Chamber provided with a double bottom for even temperature distribution.�

Normsandstandards

PRES

SURE

(BA

R)

2,5

2

1

0

-1

0

-1




PRES

SURE

(BA

R)

30%

2

100%



CHA

MBE

R W

ATE

R %

WA

SHIN

G

1st R

INSE

2nd R

INSE

3rd R

INSE

SILI

CON

IZIN

G


PRES

SURE

(BA

R)






















LTLST

Series

PROCESS DATA



PHASES ACTIONS


washing


dripping rotation

1st rinse


dripping rotation

2nd rinse


dripping rotation

3rd rinse


dripping rotation

siliconizing


dripping rotation













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

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

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

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

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






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

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

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

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

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


ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


TEMPO

PRES

SIO

NE


TIME

PRES

SURE

(BA

R)



ACQ

UA

IN C

AM

ERA

TEMPO

CHA

MBE

R W

ATER

(%)

TIME


LTLST

Series

rev.

01/

12

www.icospharma.com



TEM

PERA

TURE

50

100

150

200

250


LEL


DRYING PROCESS


Technicaldata,utilitiesconsumptions and drawings

availableuponrequest.

“Drying without compromise”

33

Thehotairdryingovenscanbesuppliedwith a self washing system in the chamber and a device for the removal and insertion of tray support carts.

Uponrequestandforparticulartypesofapplications,theelectrical system and components of the machine can be supplied to be compliant with flameproof type(ATEXDirectives).

EG SeriesHotAirDryingOven

Field of applicationThisrangeofmachinesisusedfordryingbyhotairofmaterials such as granulates, pellets, powders and porous load in pharmaceutical industry processes.

Special applicationFor the treatment of granules with presence of solvents, thedryercanbeequippedtomonitorflammabilityhazardby controlling LEL.

Static tray drying ovens manufactured by Steelco are some of the most technically advanced machines in existence.

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

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

Provisionoftrayhandlingtrolleys,customizedtosuitenduserrequirements.

Chamber volume

from 330 litres / 11.7 cu.ft to 10.000 litres / 353 cu.ft

Main options

34

EG SeriesDryingqualityprocess

Construction features

ThemachinebodyandaeraulicsystemaremadeofAISI316stainlesssteel.

Thechamberhasarectangularcrosssectionandisfittedwitharectangularhatch.

ExternalpanellingismadeofAISI316stainlesssteelwiththechamberhavingapolishedfinish.

Fast-closingswingoutdoorsandgasketsaremade of silicone rubber.

Floor or pit mounted solutions.

ComprehensiveoperatingandmaintenancemanualsandIQ/OQdocumentationis provided as standard.

Steelco helps you to minimize the time needed for validation, with decreased breakdowns, increased production and operative lifetime achieved.

TheEGSerieshasevenhotairdistributionin the chamber. Special perforated walls and temperaturecontrol,ensurethedryingqualityprocess.

Themechanicalconstructionofthemachinebodyisdesignedtoresisttemperaturesofupto300°C.

Theunitisprovidedwithfiltersfortheinletandexhaustairflowsinthechamber.

Steam and electric heated options are available withamaximumtemperatureof120°C.

Documentation/Validation

low impact, high resultswashing and sterilization equipmentfor the environmentally conscious

Steelcoequipmentismanufacturedinmodernfactoriesandprovideasignificantcontributiontoreducingutilitiesconsumptionandwaste.

SteelcoGroupisanactivememberofISPE&ASMEBPECommitteeandwepresentintheISPESustainabilityGuidelines.

www.steelcospa.comwww.icospharma.com

the future today

“For the Environmentally conscious”

Steelco DS PL rangeIndustrial challenging application washers

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

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]

Washing systemsServing the global pharma industry

Allbrand

nam

es,tradem

arks

and

reg

isteredtradem

arks

men

tione

din

thisca

talogbelon

gtothe

irresp

ectiv

eow

ners.

Theproduc

tsand

tec

hnicalspec

ifica

tions

aresub

jected

toch

ange

with

outprio

rno

tice.Pleas

eco

nsultyo

urSteelco

dea

lerforthelatestin

form

ation.

DC-P

D-02

-PH

ST E

N Re

v.03

sterilization solutions serving the pharma industry … st en rev.03.pdf · sterilization solutions...

Documents