clean program lighting systems for clean rooms
TRANSCRIPT
CLEAN PROGRAMLighting Systems for Clean Rooms
LUXIONA POLAND – LIDER OŚWIETLENIA POMIESZCZEŃ CZYSTYCH
LUXIONA POLAND IS THE LEADER WHICH OFFERS LIGHTING SOLUTIONSFOR CLEAN PREMISES SUCH AS CLEAN ROOM IN:
• Medical facilities.• Pharmaceutical industry.• Chemical industry.• Food industry.• Precision and electronic industry
33www.luxiona.plwww.luxiona.pl2
PRODUCTION PLANT IN JACENTOW• The process of preparation and disinfection of the luminaries in line with ISO.• Production realisation according to modern solutions and technologies.• Broad machinery park.• Productionflexibility.• Short realisation terms.• Wide variety of products.• Dedicated rooms for medical products manufacturing..
CERTYFICATE ISO 14001:2015
Range: Designing and manufacturing the luminaries
CERTYFICATE ISO 13485:2012
Range: Designing and manufacturing the luminaries for medical purpose
CERTYFICATE ISO 9001:2015
Range: Designing and manufacturing the luminaries
www.luxiona.pl www.luxiona.pl 5www.luxiona.pl4
PREMISE FOR PRODUCTION OF CLEAN LUMINARIESIN PRODUCTION PLANT IN JACENTOW:
Thepremiseofcontrolledenvironmentalparametersespeciallypollutionsuchas:dust,dustlike,bacteria,chemicalvapoursetc.
Depending on required atmosphere cleanliness of the CLEAN ROOMS are divided into classes in which amount and size ofthepollutionpercubicmetreofatmosphereisdefined(alternativelycubicfoot).
Clean room premises can have dimensions of a production hall or even a production plant and a surface of few thousands squ-aremetres. Thesekindsofpremisesarecommonlyusedduringaproductionprocessofprecisesemiconductors,biotechnology andotherfieldsinwhicheventinypollutionarecriticalparameteroftechnology.
Theairispumpedinsidethecleanroomthroughaspecialsystemoffilterswhicheliminatesubsequentfractionsofpollution.TheairinsidetheroomiscontinuouslyfilteredbysetofHEPAfiltersinordertoremovethepollutioncreatedinside.Theemployeesenteringandexitingtheroomhavetodoitthroughtheairlock.Theemployeesinsidethecleanroomshouldwearallthetimeprotectivesuits,masksandshoes.Inlessexpensivesolutionsthereisnoairlock-theentranceisdirectlyfromantechamberwhereaprotectivesuit is worn.
Thedevicesinsideacleanroomhavetobespeciallydesignedsoasnottogenerateadditionalpollution.Itappliesalsotoluminarieswhich are produced in our production plant in specially prepared conditions.
NORM PN-EN 14644-1 - cleanliness class of rooms. Thebasicdocumentdefiningthelevelofpollutioninaroomconcerningitssize,isnormPN-EN14644-1:2005Cleanrooms and connected with them controlled rooms.
The norm includes the classification of air quality in clean rooms and connected with them controlled environment in terms of particles concentration in the air and the methods of testing air quality as well as procedures defining the concentration of particles in the air.
ThenormhasbeenacceptedbytheEuropeanCommitteeforStandarization(CEN)andbyPolishCommitteeforStandarization.
77www.luxiona.pl6
CLEAN ROOM
COLOUR RENDERING INDEX CRI
CRI (Colour Rendering Index)–colourrenderingindex,characterisesthecolourperceptionofilluminatedobjects.
CRIaccountsfornumericvalueoftherangefrom0to100.
CRI is an average component of emission spectrum from R1 to R15.
The scale of CRI–thehigherindexthebetter,morenaturalcolourrenderingis.
Example: CRI=100–perfectlightrenderingcolours(sunlight).CRI = 93 – light accurately renders the colour. CRI = 1 – the monochrome light.
–Dependingontheplacewheretheluminaryisappliedthereispossibilitytoequiptheluminary inanti-reflectiveC56whichminimalizesthereflectionofthelaserlightbeam. –Laminatedmattpanewithanti-reflectivecoating-SLMR.–Hardenedmattpanewithanti-reflectivecoating-SLMR.–Micro-prismaticdiffuserwithlaminatedanti-reflectivepane-MicroPRMSLR.–Micro-prismaticdiffuserwithhardenedanti-reflectivepane-MicroPRMSHR.
–Diffusersresistanttogenerallyavailabledisinfectants,ammoniumsalt,hydrogenperoxide, chlorine and UV radiation.– Laminated matt pane-SLM.–Hardenedmattpane-SHM.–Micro-prismaticdiffuserwithlaminatedpane-Micro-PRMSL.–Micro-prismaticdiffuserwithhardenedpane-Micro-PRMSH.
–Antibacterialcoatingpreventingfrommicro-organismsdevelopment.
–Theluminaryisequippedwithlightsourceofthecolourrenderingindexequalorhigherthan90.
R1: 82
R2: 88
R3: 93
R4: 83
R5: 83
R6: 84
R7: 85
R8: 67
R9: 17
R10: 73
R11: 82
R12: 74
R13: 82
R14: 96
R15: 76
10 20 30 40 50 60 70 80 90 100
R1: 95
R2: 96
R3: 94
R4: 95
R5: 95
R6: 94
R7: 96
R8: 92
R9: 81
R10: 89
R11: 95
R12: 83
R13: 95
R14: 96
R15: 94
10 20 30 40 50 60 70 80 90 100
CRIindexofLUXIONAmodules=95 CRIindexofcompetitorsmodules=83,7
CCT 3316K
CRI 95
Lux 10972,2
λp 627nm
Fc 1019,7
PFlicker 1,0%
CCT 4129K
CRI 83,7
Lux 15639,0
λp 447nm
Fc 1453,4
PFlicker 0,2%
CRI=95LUXIONA’smodulesandsimultaneouspreservationofhighcomponents: R9–responsibleforrendering”deepred”colour(colourofblood)R13 –responsibleforrendering„lightorange”(colouroftissues)
R9: 17
R13: 82
10 20 30 40 50 60 70 80 90 100
R9: 81
R13: 95
10 20 30 40 50 60 70 80 90 100
99www.luxiona.pl8
SPECIAL PROPERTIES OF CLEAN LUMINARIES SYSTEM
E
Legal characteristic of CLEAN luminary CRI90/MEDICAL PRODUCT:
• ProductsubmittedandregisteredintheOfficeforRegistrationofMedicinalProducts,MedicalDevicesandBiocidalProducts.• ProductincompatiblewithbasicrequirementsdefinedindirectivesofEuropeanUnion:Directive of the Council 93/42/EEC (MDD) and the Directive of European Parliament and the Council.• FulfilstherequirementsdefinedinthebillofMay20th2010aboutMedicalProducts.• Product tested and compatiblewith European normPN-EN 60601-1, PN-EN 60601-1-2 (Medical electric devices-overall safetyrequirementsandbasictechnicalrequirements).
For medical products is in force:• Individualproductionprocessinwhichtheproducerisobligedtoensuretheconformityoftheproductsduringthedesignprocess andproductionwithmainrequirementsdefinedintheRegulationoftheHealthMinistry.Mainrequirementsconcernamongother thingsthesafetyoftheproductsandhazardsrelatedtoproductusage,whichshouldbeeliminatedandrestrictedtotheminimum.• Restrictiveproceduresofqualitycontrol.InPolandthesupervisionandcontrolovermedicalproductsisexercisedbytheOffice for Registration of Medicinal Products, Medical Devices and Biocidal Products. The supervision depends on gathering and analy singinformationconcerningsafetyoftheproductsandcontrolofallentitieswhichhavedirectorindirectinfluenceonthemedical product. The control of all entities includes all stages-from the design and manufacturing of medical product till the moment when the medical products is placed on the market or used.• Speciallydedicatedtechnologicalline.
Application:• Operatingrooms.• Intensivemedicalcarerooms/OIOM.• Roomsdedicatedforlaparoscopicandendoscopictreatments.• Recoveryrooms.• Dermatologicalclinics.• Bloodsamplingpoints.
Technical specification:• PowerofLEDsourcefrom29Wto144W.• Powerofluminaryfrom32Wto158W.• LuminousfluxofLEDsourcesfrom3600lmto18000lm.• ColourrenderingindexCRI≥90.• Colourtemperature4000K.• SDCM=3.• LifetimeofLEDsources–60000h(L80/B10). • PossibilitytoequiptheluminarywithLEDmoduleofgreencolourlight (application:operatingroomsforlaparoscopictreatments).• Availableadditionalconstructionversions:INOX,NOFRAME.• Antibacterialcoating.• Anti-reflectivecoating.• IP65.• IK08orIK10(INOX).
Available constructional models:• Agat–recessedluminarydedicatedforsuspendedceilingsofmodulestructure.• Rubin–surfacemountedluminary.• Topaz–luminariesfortechnicalceilings(luminariesopenedfromthetop).
Available diffusers:• Laminated,matt,anti-reflectivepane-SLMR.• Hardened,matt,anti-reflectivepane-SHMR.• Micro-prismaticdiffuserwithlaminatedanti-reflectivepane-MicroPRMSLR.• Micro-prismaticdiffuserwithhardenedanti-reflectivepane-MicroPRMSHR.
Available accessories:Handleforpaneopening(NOFRAME).
1111www.luxiona.pl10
CLEAN LUMINARIES ISO CRI90/MEDICAL PRODUCT
E
Characteristics of CLEAN CLASS luminaries:
• FulfilrequirementsofnormPN-ENISO14644-1concerningI,II,IIIclassesofroomcleanliness.Thenormdefinesairquality classificationintermsofparticlesconcentrationintheairincleanrooms.• Holdsthecertificate(COC)confirmedbyaccredited laboratory.Itmeansthat luminariesCLEANCLASScanbeusedinclean rooms in accordance with norm PN-EN ISO 14644-1, and production process is repetitive and controlled in accordance with theHealthMinistryRegulationof1stOctober2008inthegoodmanufacturingpractice.• Aresubjectoffullvalidationofproductionprocess.Validationoftheprocessaimstoobtaintheconfirmationthatit isuseful for planned usage. The validation procedure takes into account particular aspects of good practices connected with assessed process.• ProductiontakesplaceinCleanRoompremisewhereenvironmentalparametersarecontrolled,especiallypollutionsuchas:dust, bacteria,chemicalvapouretc.• In line with European norm PN-EN 60598-1 – Luminaries – Overall requirements and research. • In line with GMP (good manufacturing practice). It is a set of standards applied in industrial production, specially inpharmaceuticalindustry,foodindustryandotherfieldsofbusinessactivity.
Classes of cleanliness for rooms according to ISO norm:• Iclassofroomcleanliness–(roomsofpossiblyhighestaseptic,minimallevelofbacteria)acceptablebacteriaconcentration JTK70ofbacteria/1m3ofair.• IIclassofroomcleanliness–(roomsoflowbacterialevel)acceptablebacteriaconcentrationJTK300ofbacteria/1m3ofair.• IIIclassofroomcleanliness–(roomsofstandardlevelofbacteria)acceptablebacteriaconcentrationJTK700 ofbacteria/1m3ofair.
Technical specifications:• PowerofLEDsourcesfrom17Wto150W.• PowerofLEDsourcesfrom17Wto150W.• LuminousfluxofLEDsourcesfrom2600lmto18000lm.• ColourrenderingindexCRI≥80orCRI≥90.• Colourtemperature3000Kor4000K.• SDCM=3orSDCM=5.• LifetimeofLEDsources–60000h(L80/B10)or50000h(L70/B50).• PossibilitytoequiptheluminarywithLEDmoduleofyellowlightcolour(application:pharmaceuticalindustry).• Availableadditionalconstructionalversions:INOX,NOFRAME,CORNER.• Antibacterialcoating.• Possibilitytoequiptheluminarywithanti-reflectivecoating.• IP65.• IK08orIK10(INOX,CORNER).
Available constructional versions:• Agat–recessedluminarydedicatedforsuspendedceilingsofmodulestructure.• Rubin–surfacemountedluminary.• Topaz–luminariesfortechnicalceilings(luminariesopenedfromthetop).
Available diffusers:• Laminatedmattpane–SLM.• Hardenedmattpane–SHM.• Micro-prismaticdiffuserwithlaminatedpane–Micro-PRMSL.• Micro-prismaticdiffuserwithhardenedpane–Micro-PRMSH.
Diffusersresistanttogenerallyavailabledisinfectants,ammoniumsalt,hydrogenperoxide,chlorineandUVradiation.
Available accessories:Handleforpaneopening(luminaryNOFRAME).
1313www.luxiona.pl12
CLEAN CLASS LUMINARIES/FULL VALIDATION OF PRODUCTION PROCESS
E
zdjęcieBHU
Technical specifications:• PowerofLEDsourcefrom40Wto75W.• Powerofluminaryfrom43Wto78W.• LuminousfluxofLEDsourcesfrom1300/4400lmto2200/8800lm. • ColourrenderingindexCRI≥80.• Colourtemperaturefrom3000Kto4000K.• SDCM=3.• LifetimeofLEDsources–60000h(L70/B50).• IP40.• IK04.
Available diffusers:• OpalizedPMMA(polymethylmethacrylate)–PLX.
Wall mounting
BHU panel ensures:• Generallightingoftheroombyreflectedlight.• Spotlightingforreadingandexamining.• Nightlighting.• Powersockets230V.• TeleinformaticsocketsRJ45.• Equipotentialisationsocket.• Push-buttonlightingswitch.• Medicalgasoutletpoints.• In-roompagingsystem.
1515www.luxiona.pl14
BEDSIDE LIGHTING PANEL BHU LINEMED W1/MEDICAL PRODUCT
E
zdjęciezeszpitala
Technical specifications:• PowerofLEDsourcesfrom10Wto150W.• Powerofluminaryfrom13Wto180W.• LuminousfluxofLEDsourcesfrom1400lmto18000lm.• ColourrenderingindexCRI≥80orCRI≥90.• Colourtemperature3000Kor4000K.• SDCM=3orSDCM=5.• LifetimeofLEDsources–60000h(L70/B50)or50000h(L70/B50).• Availableadditionalconstructionalversions:INOX,NOFRAME,CORNER,CLIP-IN.• IP65orIP54.• IK08,IK04orIK10(INOX,CORNER,PRISON).
Available mounting models:• Agat–luminariesdedicatedtobemountedinsuspendedceilingsofmodularandplasterboardstructure.• Rubin–surfacemountedluminaries.• Topaz–luminariesfortechnicalceilings(luminariesopenedfromthetop).• BHU–over-bedpanels.• Prison–surfacemountedceilings. • Rubineo–luminariestobemountedinrecessedplasterboardceilings.• Limpio–recessedluminariestobemountedinsuspendedplasterboardceilingsofmodularstructure.
Available diffusers:• Laminatedmattpane–SLM.• Hardenedmattpane–SHM.• OpalizedPMMA–PLX.• Opalizedpolycarbonate–PC.• Microprism–Micro-PRM/Micro-Line.• Microprismaticdiffuserwithlaminatedpane–Micro-PRMSL/Micro-LineSL.• Microprismaticdiffuserwithhardenedpane–Micro-PRMSH/Micro-LineSH.
Available accessories:Handleforpaneopening(NOFRAMEluminaries).
17www.luxiona.pl16
LUMINARIES CLEAN STANDARD
RECESSEDLUMINARY/AGAT CLEAN LED SURFACEMOUNTEDLUMINARY/RUBIN CLEAN LED
additional steel frame around the pane
additional steel frame around the pane
version: STANDARD version: STANDARD
version: NO FRAME
*Luminaryavailableinvariousmodelsintermsofdiffusermodelorthevalueoftheluminousflux.
*Luminaryavailableinvariousmodelsintermsofthevalueoftheluminousflux.
Technicalspecificationsoftheluminariesavailableonwww.luxiona.pl
*Luminaryavailableinvariousmodelsintermsofdiffusermodelorthevalueoftheluminousflux.
*Luminaryavailableinvariousmodelsintermsofdiffusermodelorthevalueoftheluminousflux.
version: NO FRAME
opening the luminary with the clip
opening the luminary with the clip
opening the luminary with the suction cup
opening the luminary with the suction cup
no steel frame around the pane
no steel frame around the pane
SURFACEMOUNTEDLUMINARY/RUBIN CLEAN LED INOXRECESSEDLUMINARY/TOPAZ ODG CLEAN LED(luminarymadeofstainlesssteel)
BEDSIDEPANEL/BHU LINEMED PREMIUM
www.luxiona.pl www.luxiona.pl18 19
M.I.L.S – Medical Intelligent Lighting System:
M.I.L.S isa luminairebasedonLEDlightingtechnologythatprovideshigherqualitythantraditionaloperatingroomlamps and minimizing infrared radiation and ultraviolet light sources. Provides a high-quality lighting with an intensity ofupto160,000luxwithhighcolourrenderingthatallowsabetterperceptionandevaluationofcolour(CRI>95),andmorecomfortableforsurgeonsbecauseitallowstheuseofcolourtemperaturesCCT>4500Kwhichminimizeeyefatigue of the surgeon during the working process.
Theusualwayofworkinoperatingroomsrequiresanoverheadlightontheoperatingtableandoneortwoadditionallampsthatprovideobliquelighttoavoidshadowsonthefieldofview.Traditionalsystemsintroducedovertheareaofsurgerybulkyitemsthatwouldnormallyinterferewiththemobilityofstaffoftheoperatingroomandwhosehandlingduringsurgeryprocessiscumbersome.Incontrast,M.I.L.Sallowsclearingallthespaceontheoperatingtableandsimplifiestheorientationsystemoflightontheoperatingtable,bothbeforestartingoperationandduringtheentireworkprocess.
Theluminaireblendsintotheceilingoftheoperatingroombyasimpleinstallation.Beinglightsourcesrecessedceilingposenointernalheatsourceintheoperatingroombecausemostoftheheatgeneratedbythelightisejectedinthefalseceiling.
M.I.L.Sallowsaperfectlylitareaofoperations,betterinsulated,morefunctionalandcomfortableforthedevelopmentof theactivity. Improvesefficiencyof thehealth centre in functionality,maintenanceand riskof infections,energyconsumption and resource optimization.
2121www.luxiona.plwww.luxiona.pl20
M.I.L.S.
www.luxiona.pl www.luxiona.pl 23www.luxiona.pl22
OFFICE OF THE MANAGEMENT BOARD /TRADE OFFICE:
LUXIONAPolandS.A.MacierzysznearWarsawul.Sochaczewska110,[email protected]
www.luxiona.pl/en www.luxiona.com
EXPORT DEPARTMENT:
UK, IR+44(0)[email protected]
BE, FR, LU, [email protected]
DE,AT,CH,[email protected]
SE, NO, DK, IS, [email protected]
RU, UA, LV, BY, MD, GE, AM, AZ, KZ, UZ, TM, TJ, [email protected]
LT, EE, [email protected]
HR,HU,RO,[email protected]
CZ,SK,BA,ME,MK,XK,AL,[email protected]
DESIGN DEPARTMENT:
LUXIONAPolandispartoftheSpanishLUXIONAGroup,whichformorethan80yearshasbeensuccessfullyoperatingontheinternationalmarketofthelightingindustry.ThemissionofLUXIONAPolandistocreatecomplementarylightingsolutions, in accordance with the most recent technologies as well as legal and social requirements. For that reason, an active team constantly works on innovative technical solutions, keeping in mind the need for saving energy and protecting theenvironment.Theteamdoesnotceasetoenhancethequalityofourproductsandtheefficiencyofourservices,permanently analyzing the needs of our Customers.
TheLUXIONAGroup,includingLUXIONAPolandwhichcontinuestoimplementtheGroupstrategy,specializesinthecompo-sitionandcreationofindoorandoutdoorlightingsystems,basingonthevastexperts’experienceandthebroadscopeofproductbrands.AnintegralpartintheofferofLUXIONAPolandarecomprehensivelightingsolutions,whichcoverboththeproductionanddesignservices,inthewidestsenseoftheword,deliveredbyhighclassdesignersandreadytomeet the requirements of, among others: architectural spaces, areas in the so-called clean rooms, commercial surfaces etc. TheLUXIONAPolandteamspecializesinimplementingprojectswhichrequireanindividualapproachandtheapplicationof modern technologies.